Side effect information for Olanzapine

Side effects

Options: Hide MedDRA Preferred Terms , display only 20 labels

MedDRA Preferred Term	Side effect	Data for drug	Placebo	Labels
				1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21	22	23	24	25	26	27	28	29	30	31	32	33	34	35	36	37	38	39	40	41	42	43	44	45	46	47	48	49	50	51	52	53
Somnolence	Somnolence	very common, 3% - 39.1%	3% - 16.2%	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Headache	Headache	13% - 18%	6% - 17%														x	x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Increased appetite	Increased appetite	common — 1% - 29%	0% - 9%	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Nervousness	Nervousness	16%	14%														x	x	x																															x	x	x	x	x	x	x
Tension	Nervousness	16%	14%														x	x	x																															x	x	x	x	x	x	x
Hallucination	Hallucination	very common, 0% - 3%	2%	x	x	x	x	x	x	x	x	x	x	x	x		x	x	x	x																														x	x	x	x	x	x	x
Lethargy	Lethargy	very common		x	x	x	x	x	x	x	x	x	x	x	x			x	x		x										x	x								x	x	x	x	x	x	x	x	x	x
Blood prolactin increased	PRL increased	very common, 47.4%		x	x	x	x	x	x									x	x
	Increased prolactin level				x	x	x	x	x
	Serum prolactin increased																x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Hypersomnia	Hypersomnia	very common		x	x	x	x	x	x	x	x	x	x	x	x			x	x		x										x	x								x	x	x	x	x	x	x	x	x	x
Blood bilirubin decreased	Bilirubin total decreased	very common, 22.1%		x	x	x	x	x	x	x	x	x	x	x	x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Blood bilirubin decreased	Bilirubin total low	very common, 22.1%		x	x	x	x	x	x	x	x	x	x	x	x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Hostility	Hostility	15%	14%														x	x	x																															x	x	x	x	x	x	x
Weight increased	Weight increased	common — 1% - 43.5%	1% - 9%	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Injury	Accidental injury	12%	8%													x	x	x	x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Injury	Intentional injury	infrequent, 1%	0%														x	x	x																															x	x	x	x	x	x	x
Parkinsonism	Parkinsonism	0% - 20%	0% - 15%	x	x	x	x	x	x	x	x	x	x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Parkinsonism	Parkinson's disease			x	x	x	x	x	x	x	x	x	x	x	x		x	x	x
Insomnia	Insomnia	postmarketing, 12% - 20%	11% - 19%	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Asthenia	Asthenia	common, 2% - 27%	1% - 23%	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Asthenia	Fatigue	common, 1.5% - 14%	2% - 6%	x	x	x	x	x	x	x	x	x	x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x							x
Pain	Pain	0% - 10%	0% - 9%														x	x	x	x																														x	x	x	x	x	x	x
Anxiety	Anxiety	postmarketing, 9%	8%	x	x	x	x	x	x	x	x	x	x	x	x		x	x	x																															x	x	x	x	x	x	x
Anxiety	Phobia	infrequent																																																x	x	x	x	x	x	x
Constipation	Constipation	common, 4% - 14.5%	0% - 9%	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Dizziness	Dizziness	common, 1% - 18%	2% - 11%	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Dizziness	Syncope	infrequent						x	x																					x								x	x							x	x		x		x	x	x	x	x	x
Personality disorder	Personality disorder	8%	4% - 8%													x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Alanine aminotransferase increased	Alanine aminotransferase increased	8%	3%													x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Dyspepsia	Dyspepsia	3% - 11%	1% - 5%													x	x	x	x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Rhinitis	Rhinitis	7% - 10%	6%													x	x	x	x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Fatigue	Fatigue	common, 1.5% - 14%	2% - 6%	x	x	x	x	x	x	x	x	x	x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x							x
Gamma-glutamyltransferase increased	Gamma-glutamyltransferase increased	very common, 2% - 10.1%	1%			x	x	x	x	x	x	x	x	x	x		x	x	x
Abdominal pain	Abdominal pain	infrequent, 3% - 6%	2% - 7%														x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Gastrointestinal pain	Abdominal pain	infrequent, 3% - 6%	2% - 7%														x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Dry mouth	Dry mouth	common, 2% - 22%	0% - 7%	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Cough	Cough increased	5% - 6%	3%													x	x	x	x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Cough	Cough	3% - 9%	5%																	x
Gait disturbance	Gait disturbance	infrequent — 6%	1%	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Back pain	Back pain	3% - 5%	2% - 4%													x	x	x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Conjunctivitis	Conjunctivitis	frequent															x	x	x																															x	x	x	x	x	x	x
Delusion	Delusion	frequent																																																x	x	x	x	x	x	x
Dyspnoea	Dyspnoea	frequent														x				x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Ecchymosis	Ecchymosis	5%	3%													x	x	x	x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Eosinophilia	Eosinophilia	common		x	x	x	x	x	x	x	x	x	x	x	x
Body temperature increased	Body temperature increased	rare — 0% - 6%	0% - 3%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Flatulence	Flatulence	frequent, 1% - 2%	0%																	x																														x	x	x	x	x	x	x
Orthostatic hypotension	Orthostatic hypotension	common — 1% - 5%	0% - 5%	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Influenza	Influenza	frequent																																																x	x	x	x	x	x	x
Pain in extremity	Pain in extremity	5% - 6%	0% - 3%													x					x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Paraesthesia	Paraesthesia	frequent														x	x	x	x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Pneumonia	Pneumonia	common		x	x	x	x	x	x	x	x	x	x	x	x		x	x	x
Salivary hypersecretion	Salivary hypersecretion	frequent														x	x	x	x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Thirst	Thirst	frequent														x						x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Toothache	Toothache	frequent, 3% - 4%	0%																	x																														x	x	x	x	x	x	x
Vaginal inflammation	Vaginal inflammation	frequent														x	x	x				x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Vaginal infection	Vaginal inflammation	frequent														x	x	x				x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Mood swings	Mood swings	infrequent, frequent															x	x	x																															x	x	x	x	x	x	x
Affect lability	Mood swings	infrequent, frequent															x	x	x																															x	x	x	x	x	x	x
Mania	Manic psychosis	frequent																																																x	x	x	x	x	x	x
Injection site pain	Injection site pain	frequent, 2% - 3%	0%																	x										x								x	x							x	x		x		x	x	x	x	x	x
Schizophreniform disorder	Schizophrenic reaction	frequent															x	x	x																															x	x	x	x	x	x	x
Joint stiffness	Joint stiffness	frequent																																																x	x	x	x	x	x	x
Akathisia	Akathisia	infrequent, 0% - 27%	0% - 23%	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Nasopharyngitis	Nasopharyngitis	1% - 6%	2%																	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Pharyngitis	Pharyngitis	1.6% - 10.1%	1.5% - 3%													x	x	x	x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Speech disorder	Speech disorder	4%	1%	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Tremor	Tremor	postmarketing, 0% - 7%	0% - 3%	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Vaginal discharge	Vaginal discharge	0% - 4%	0%																	x
Amblyopia	Amblyopia	3% - 5%	2% - 4%													x	x	x	x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Arthralgia	Arthralgia	uncommon — 2% - 5%	0% - 3%			x	x	x	x		x	x	x	x	x	x		x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Musculoskeletal discomfort	Arthralgia	uncommon — 2% - 5%	0% - 3%			x	x	x	x		x	x	x	x	x	x		x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Musculoskeletal discomfort	Myalgia																x	x	x																															x	x	x	x	x	x	x
Chest pain	Chest pain	3% - 4%	1% - 2%													x	x	x	x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Diarrhoea	Diarrhoea	infrequent, 2% - 7%	0% - 4%														x	x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Hypertonia	Hypertonia	3% - 4%	2% - 3%													x	x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Respiratory tract infection	Respiratory tract infection	3%	2%														x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Sinusitis	Sinusitis	3%	0%																			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Tachycardia	Tachycardia	3% - 4%	1%					x	x							x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Upper respiratory tract infection	Upper respiratory tract infection	1% - 4%	2%																	x																				x	x	x	x	x	x	x	x	x	x
Agitation	Agitation	1% - 23%	2% - 17%														x	x	x	x		x	x	x	x	x	x	x	x	x	x	x			x	x	x	x	x		x	x	x	x	x	x	x
Agitation	Hyperkinesia																x	x	x		x																			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Hepatic enzyme increased	Hepatic enzyme increased	1% - 4%	1%																	x
Laryngeal pain	Pharyngolaryngeal pain	2% - 3%	2%																	x
Amnesia	Amnesia	uncommon — 2%	0%			x	x	x	x						x	x	x	x	x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Phonological disorder	Phonological disorder	infrequent, 2%	1%													x						x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Blepharitis	Blepharitis	infrequent, 2%	1%														x	x	x																															x	x	x	x	x	x	x
Fungal skin infection	Fungal skin infection	2%	0%														x	x	x
Oedema	Oedema	2%	0%							x	x	x	x	x	x	x	x	x	x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Eye disorder	Eye disorder	2%	1%														x	x	x
Hypertension	Hypertension	0% - 3%	0% - 1%													x	x	x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Hypotension	Hypotension	common — 2%	0% - 1%					x	x							x	x	x	x											x								x	x							x	x		x	x	x	x	x	x	x	x
Arthropathy	Arthropathy	infrequent, 2%	1%														x	x	x																															x	x	x	x	x	x	x
Osteoarthritis	Arthropathy	infrequent, 2%	1%														x	x	x																															x	x	x	x	x	x	x
Osteoarthritis	Dysarthria	infrequent, 0% - 2%	0%												x					x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Menstrual disorder	Menstrual disorder	2%	0%														x	x	x																																				x	x
Nasal congestion	Nasal congestion	1% - 7%	3%																	x
Muscle spasms	Muscle spasms	1% - 3%	0%																x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
	Cramps of lower extremities	infrequent																																																x	x	x	x	x	x	x
	Generalised spasm																x	x	x		x																			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Urinary incontinence	Urinary incontinence	very rare — 2%	1%	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Urinary tract infection	Urinary tract infection	2%	1%													x						x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Oedema peripheral	Oedema peripheral	common, 1% - 3%	0% - 1%	x	x	x	x	x	x							x	x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
	Edema of lower extremities	infrequent																																																x	x	x	x	x	x	x
	Upper limb oedema	infrequent																																																x	x	x	x	x	x	x
Musculoskeletal stiffness	Neck stiffness	infrequent, 2%	1%														x	x	x		x																			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Musculoskeletal stiffness	Musculoskeletal stiffness	1% - 4%	0% - 1%																	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Nuchal rigidity	Neck stiffness	infrequent, 2%	1%														x	x	x		x																			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Rash pustular	Vesiculobullous rash	infrequent, 2%	1%														x		x																															x	x	x	x	x	x	x
Rash pustular	Rash pustular	rare																																																x	x	x	x	x	x	x
Dermatitis bullous	Vesiculobullous rash	infrequent, 2%	1%														x		x																															x	x	x	x	x	x	x
Aspartate aminotransferase increased	Aspartate aminotransferase increased	very common, 2% - 27.6%	0%	x	x	x	x	x	x								x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Muscle twitching	Muscle twitching	infrequent — 2%	1%														x	x	x		x																			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Euphoric mood	Euphoric mood	frequent, 2%	0%													x	x	x	x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Acne	Acne	0% - 2%	0%													x				x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Drug dependence	Drug dependence	2%	0%														x	x	x
	Dependence psychological																																																		x
	Drug seeking behavior																																																		x
Abnormal dreams	Abnormal dreams	frequent, 0% - 4.3%	0%														x	x	x	x																														x	x	x	x	x	x	x
Neurosis	Neurosis	1%	0%														x	x	x
Corneal lesion	Corneal lesion	rare, 1%	0%														x	x	x																															x	x	x	x	x	x	x
Abdominal distension	Abdominal distension	uncommon				x	x	x	x		x	x	x	x	x
Abdominal distension	Enlargement abdomen	infrequent																																																x	x	x	x	x	x	x
Acidosis	Acidosis	infrequent																																																x	x	x	x	x	x	x
Alopecia	Alopecia	very rare — infrequent		x	x	x	x	x	x	x	x	x	x	x	x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Amenorrhoea	Amenorrhoea	infrequent			x	x	x	x	x	x	x	x	x	x	x					x													x	x	x	x	x	x	x									x	x	x	x	x	x	x	x	x
Anaemia	Anaemia	infrequent																																																x	x	x	x	x	x	x
Apnoea	Apnoea	infrequent																																																x	x	x	x	x	x	x
Arthritis	Arthritis	infrequent																																																x	x	x	x	x	x	x
Arthritis	Rheumatoid arthritis	rare																																																x	x	x	x	x	x	x
Asthma	Asthma	infrequent																																																x	x	x	x	x	x	x
Ataxia	Ataxia	infrequent																		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Atrial fibrillation	Atrial fibrillation	infrequent																																																x	x	x	x	x	x	x
Atrioventricular block	Atrioventricular block	infrequent																																																	x	x	x	x	x	x
Atrioventricular block	Block heart	infrequent																																																	x	x	x	x	x	x
Candida infection	Candida infection	infrequent																																																x	x	x	x	x	x	x
Candida infection	Oral candidiasis	infrequent																																																x	x	x	x	x	x	x
Oral candidiasis	Oral candidiasis	infrequent																																																x	x	x	x	x	x	x
Neck pain	Neck pain	infrequent																																																x	x	x	x	x	x	x
Confusional state	Confusional state	infrequent														x	x	x	x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Feeling abnormal	Confusional state	infrequent														x	x	x	x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Feeling abnormal	Malaise	infrequent																																																x	x	x	x	x	x	x
Cyanosis	Cyanosis	infrequent																																																x	x	x	x	x	x	x
Cystitis	Cystitis	infrequent																																																x	x	x	x	x	x	x
Bladder pain	Cystitis	infrequent																																																x	x	x	x	x	x	x
Cystitis noninfective	Cystitis	infrequent																																																x	x	x	x	x	x	x
Deafness	Deafness	infrequent																																																x	x	x	x	x	x	x
Libido decreased	Libido decreased	infrequent			x	x	x	x	x	x	x	x	x	x	x					x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Disturbance in sexual arousal	Libido decreased	infrequent			x	x	x	x	x	x	x	x	x	x	x					x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Disturbance in sexual arousal	Libido increased	infrequent															x	x	x																															x	x	x	x	x	x	x
Dysphagia	Dysphagia	infrequent																		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Dehydration	Dehydration	infrequent																																																x	x	x	x	x	x	x
Delirium	Delirium	infrequent																																																x	x	x	x	x	x	x
Dental caries	Dental caries	infrequent															x	x	x																															x	x	x	x	x	x	x
Depersonalisation	Depersonalisation	infrequent																																																x	x	x	x	x	x	x
Dermatitis contact	Dermatitis contact	infrequent																																																x	x	x	x	x	x	x
Diabetes mellitus	Diabetes mellitus	very rare — infrequent		x	x	x	x	x	x	x	x	x	x	x	x		x	x	x																															x	x	x	x	x	x	x
Diplopia	Diplopia	infrequent																																																x	x	x	x	x	x	x
Dysarthria	Dysarthria	infrequent, 0% - 2%	0%												x					x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Dysgeusia	Dysgeusia	infrequent																																																x	x	x	x	x	x	x
Dysuria	Dysuria	infrequent																																																x	x	x	x	x	x	x
Dysuria	Urination impaired	infrequent																		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Ear pain	Ear pain	infrequent, 1% - 4%	2%																	x																														x	x	x	x	x	x	x
Eczema	Eczema	infrequent																																																x	x	x	x	x	x	x
Endophthalmitis	Endophthalmitis	infrequent																																																x	x	x	x	x	x	x
Panophthalmitis	Endophthalmitis	infrequent																																																x	x	x	x	x	x	x
Epistaxis	Epistaxis	infrequent — 3%	0%			x	x	x	x		x	x	x	x	x					x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Oesophagitis	Oesophagitis	infrequent																																																x	x	x	x	x	x	x
Eye haemorrhage	Eye haemorrhage	infrequent																																																x	x	x	x	x	x	x
VIIth nerve paralysis	Facial paralysis	infrequent																																																x	x	x	x	x	x	x
Faecal incontinence	Faecal incontinence	infrequent																																																x	x	x	x	x	x	x
Faecalith	Faecalith	infrequent																																																x	x	x	x	x	x	x
Faecaloma	Faecalith	infrequent																																																x	x	x	x	x	x	x
Gastritis	Gastritis	infrequent																																																x	x	x	x	x	x	x
Gastroenteritis	Gastroenteritis	infrequent																																																x	x	x	x	x	x	x
Gingivitis	Gingivitis	infrequent																																																x	x	x	x	x	x	x
Glycosuria	Glycosuria	infrequent, common		x	x	x	x	x	x	x	x	x	x	x	x				x																															x	x	x	x	x	x	x
Gynaecomastia	Gynaecomastia	infrequent		x	x	x	x	x	x	x		x	x	x																																				x	x	x	x	x	x	x
Cardiac arrest	Cardiac arrest	infrequent			x	x	x	x	x																																									x	x	x	x	x	x	x
Cardiac failure congestive	Cardiac failure congestive	infrequent																																																x	x	x	x	x	x	x
Haematuria	Haematuria	infrequent																																																x	x	x	x	x	x	x
Haemoptysis	Haemoptysis	infrequent																																																x	x	x	x	x	x	x
Haemorrhage	Haemorrhage	infrequent																																																x	x	x	x	x	x	x
Haemoglobin	Haemorrhage	infrequent																																																x	x	x	x	x	x	x
Hyperbilirubinaemia	Hyperbilirubinaemia	infrequent																		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Hypercholesterolaemia	Hypercholesterolaemia	postmarketing — common		x	x	x	x	x	x	x	x	x	x	x	x		x	x	x																															x	x	x	x	x	x	x
Hyperlipidaemia	Hyperlipidaemia	infrequent															x	x	x																															x	x	x	x	x	x	x
Hyperventilation	Hyperventilation	infrequent																																																x	x	x	x	x	x	x
Hypoaesthesia	Hypoaesthesia	infrequent																																																x	x	x	x	x	x	x
Hypoglycaemia	Hypoglycaemia	infrequent																																																x	x	x	x	x	x	x
Hypokalaemia	Hypokalaemia	infrequent																																																x	x	x	x	x	x	x
Hyponatraemia	Hyponatraemia	infrequent																																																x	x	x	x	x	x	x
Hypoproteinaemia	Hypoproteinaemia	rare, infrequent																		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Libido increased	Libido increased	infrequent															x	x	x																															x	x	x	x	x	x	x
Laryngitis	Laryngitis	infrequent																																																x	x	x	x	x	x	x
Leukocytosis	Leukocytosis	infrequent																																																x	x	x	x	x	x	x
Leukopenia	Leukopenia	postmarketing — 1%	0%	x	x	x	x	x	x	x	x	x	x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Breast pain	Breast pain	infrequent																		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Melaena	Melaena	infrequent																																																x	x	x	x	x	x	x
Menorrhagia	Menorrhagia	infrequent																		x													x	x	x	x	x	x	x									x	x	x	x	x	x	x	x	x
Metrorrhagia	Metrorrhagia	infrequent																		x													x	x	x	x	x	x	x									x	x	x	x	x	x	x	x	x
Hypotonia	Hypotonia	infrequent																																																x	x	x	x	x	x	x
Muscle relaxant therapy	Hypotonia	infrequent																																																x	x	x	x	x	x	x
Nausea	Nausea	postmarketing — 0% - 9%	2% - 9%	x	x	x	x	x	x	x	x	x	x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Pallor	Pallor	infrequent																																																x	x	x	x	x	x	x
Palpitations	Palpitations	infrequent																																																x	x	x	x	x	x	x
Pelvic pain	Pelvic pain	infrequent																																																x	x	x	x	x	x	x
Tooth abscess	Abscess periodontal	infrequent																																																x	x	x	x	x	x	x
Polyuria	Polyuria	infrequent																		x													x	x	x	x	x	x	x									x	x	x	x	x	x	x	x	x
Urine output increased	Polyuria	infrequent																		x													x	x	x	x	x	x	x									x	x	x	x	x	x	x	x	x
Premenstrual syndrome	Premenstrual syndrome	infrequent																																																x	x	x	x	x	x	x
Pyuria	Pyuria	infrequent																																																x	x	x	x	x	x	x
Seborrhoeic dermatitis	Seborrhoeic dermatitis	infrequent																																																x	x	x	x	x	x	x
Skin ulcer	Skin ulcer	infrequent																																																x	x	x	x	x	x	x
Stomatitis	Stomatitis	infrequent																																																x	x	x	x	x	x	x
Stomatitis	Mouth ulceration	infrequent																																																x	x	x	x	x	x	x
Cerebrovascular accident	Cerebrovascular accident	infrequent																		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Dysphemia	Stuttering	infrequent																																																x	x	x	x	x	x	x
Withdrawal syndrome	Withdrawal syndrome	infrequent																																																x	x	x	x	x	x	x
Completed suicide	Suicide	infrequent																				x	x	x	x	x	x	x	x	x	x	x								x	x	x	x	x	x	x	x
Suicide attempt	Suicide attempt	infrequent																		x	x												x	x	x	x	x	x	x									x	x	x	x	x	x	x	x	x
Hyperhidrosis	Sweating	postmarketing — frequent		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Hyperhidrosis	Sweating increased	postmarketing															x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Shock	Syncope	infrequent						x	x																					x								x	x							x	x		x		x	x	x	x	x	x
Syncope	Syncope	infrequent						x	x																					x								x	x							x	x		x		x	x	x	x	x	x
Loss of consciousness	Syncope	infrequent						x	x																					x								x	x							x	x		x		x	x	x	x	x	x
Thrombocytopenia	Thrombocytopenia	very rare — infrequent		x	x	x	x	x	x	x		x	x	x	x					x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Tinnitus	Tinnitus	infrequent																																																x	x	x	x	x	x	x
Pollakiuria	Pollakiuria	infrequent																		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Pollakiuria	Micturition urgency	infrequent																		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Vertigo	Vertigo	infrequent																																																x	x	x	x	x	x	x
Vomiting	Vomiting	postmarketing — 1% - 6%	2% - 3%	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Urinary retention	Urinary retention	very rare, infrequent			x	x	x	x	x	x	x	x	x	x	x					x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Micturition urgency	Micturition urgency	infrequent																		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Akinesia	Akinesia	infrequent															x	x	x		x																			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Stupor	Stupor	infrequent																		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Depressed level of consciousness	Stupor	infrequent																		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Hypokinesia	Hypokinesia	infrequent															x	x	x		x																			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Cataract	Cataract	infrequent																																																x	x	x	x	x	x	x
Mouth ulceration	Mouth ulceration	infrequent																																																x	x	x	x	x	x	x
Migraine	Migraine	infrequent																																																x	x	x	x	x	x	x
Cogwheel rigidity	Cogwheel rigidity	infrequent															x	x	x		x																			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Blood creatine phosphokinase increased	Creatine phosphokinase increased	very rare — 1%	0%		x	x	x	x	x								x	x	x											x								x	x							x	x		x		x	x	x	x	x	x
Tongue disorder	Tongue oedema	infrequent																		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Tongue oedema	Tongue oedema	infrequent																		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Ventricular extrasystoles	Ventricular extrasystoles	infrequent																																																x	x	x	x	x	x	x
Galactorrhoea	Lactation female	infrequent																																																x	x	x	x	x	x	x
Galactorrhoea	Galactorrhoea			x	x	x	x	x	x	x	x	x	x	x	x
Eye pain	Eye pain	infrequent																																																x	x	x	x	x	x	x
Blood alkaline phosphatase increased	Phosphatase alkaline increased	very rare — infrequent		x	x	x	x	x	x	x	x	x	x	x	x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Skin discolouration	Skin discolouration	infrequent																																																x	x	x	x	x	x	x
Dry skin	Dry skin	infrequent														x						x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Uterine leiomyoma	Uterine fibroids enlarged	infrequent																																																x	x	x	x	x	x	x
Accommodation disorder	Accommodation disorder	infrequent																		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Photosensitivity reaction	Photosensitivity reaction	infrequent, uncommon		x	x	x	x	x	x	x	x	x	x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Malaise	Malaise	infrequent																																																x	x	x	x	x	x	x
Discomfort	Malaise	infrequent																																																x	x	x	x	x	x	x
Ill-defined disorder	Malaise	infrequent																																																x	x	x	x	x	x	x
Antisocial personality disorder	Antisocial behaviour	infrequent																																																x	x	x	x	x	x	x
Antisocial behaviour	Antisocial behaviour	infrequent																																																x	x	x	x	x	x	x
Asocial behaviour	Antisocial behaviour	infrequent																																																x	x	x	x	x	x	x
Erectile dysfunction	Erectile dysfunction	infrequent			x	x	x	x	x	x	x	x	x	x	x					x													x	x	x	x	x	x	x									x	x	x	x	x	x	x	x	x
Rectal haemorrhage	Rectal haemorrhage	infrequent																																																x	x	x	x	x	x	x
Dry eye	Dry eye	infrequent																		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Phobia	Phobia	infrequent																																																x	x	x	x	x	x	x
Rash maculo-papular	Rash maculo-papular	infrequent															x	x	x																															x	x	x	x	x	x	x
Bradycardia	Bradycardia	infrequent, uncommon		x	x	x	x	x	x	x	x	x	x	x	x		x	x	x											x								x	x							x	x		x	x	x	x	x	x	x	x
Lymphadenopathy	Lymphadenopathy	infrequent																																																x	x	x	x	x	x	x
Dementia	Dementia	infrequent																																																x	x	x	x	x	x	x
Coordination abnormal	Coordination abnormal	infrequent														x						x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Face oedema	Face oedema	infrequent																		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Tardive dyskinesia	Tardive dyskinesia	infrequent		x	x	x	x	x	x	x	x	x	x	x	x		x	x	x		x																			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Blood uric acid increased	Hyperuricaemia	infrequent																																																x	x	x	x	x	x	x
Blood uric acid increased	Uric acid high					x	x	x	x		x	x	x	x	x
Hyperuricaemia	Hyperuricaemia	infrequent																																																x	x	x	x	x	x	x
Muscular weakness	Myasthenia	infrequent																																																x	x	x	x	x	x	x
Ejaculation disorder	Abnormal ejaculation	infrequent																																																x	x	x	x	x	x	x
Vaginal haemorrhage	Vaginal haemorrhage	infrequent																																																x	x	x	x	x	x	x
Chills	Chills	rare, infrequent																		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Albuminuria	Albuminuria	rare																																																x	x	x	x	x	x	x
Angioedema	Angioedema	postmarketing		x	x	x	x	x	x								x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Arteritis	Arteritis	rare																																																x	x	x	x	x	x	x
Rheumatoid arthritis	Rheumatoid arthritis	rare																																																x	x	x	x	x	x	x
Atelectasis	Atelectasis	rare																																																x	x	x	x	x	x	x
Pneumothorax	Atelectasis	rare																																																x	x	x	x	x	x	x
Bursitis	Bursitis	rare																																																x	x	x	x	x	x	x
Coma	Coma	rare								x	x	x	x	x	x					x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Sudden death	Sudden death	rare								x	x	x	x	x	x					x	x												x	x	x	x	x	x	x									x	x	x	x	x	x	x	x	x
Sudden death	Sudden death, cause unknown				x	x	x	x	x
Diabetic ketoacidosis	Diabetic ketoacidosis	very rare — rare		x	x	x	x	x	x								x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Enteritis	Enteritis	rare																																																x	x	x	x	x	x	x
Eructation	Eructation	rare																																																x	x	x	x	x	x	x
Dermatitis	Rash	postmarketing — 2%	1%	x	x	x	x	x	x	x	x	x	x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Rash	Rash	postmarketing — 2%	1%	x	x	x	x	x	x	x	x	x	x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Glaucoma	Glaucoma	rare																																																x	x	x	x	x	x	x
Glossitis	Glossitis	rare																																																x	x	x	x	x	x	x
Goitre	Goitre	rare																																																x	x	x	x	x	x	x
Gout	Gout	rare																																																x	x	x	x	x	x	x
Cardiac failure	Cardiac failure	rare																																																x	x	x	x	x	x	x
Hepatitis	Hepatitis	postmarketing — infrequent		x	x	x	x	x	x	x	x	x	x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Hiccups	Hiccups	rare																																																x	x	x	x	x	x	x
Hirsutism	Hirsutism	rare																																																x	x	x	x	x	x	x
Hyperglycaemia	Hyperglycaemia	postmarketing — infrequent		x	x	x	x	x	x								x	x	x																															x	x	x	x	x	x	x
Hyperkalaemia	Hyperkalaemia	rare, infrequent																																																x	x	x	x	x	x	x
Hypernatraemia	Hypernatraemia	rare																																																x	x	x	x	x	x	x
Hypersensitivity	Hypersensitivity	very rare, postmarketing		x	x	x	x	x	x	x	x	x	x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Hypertriglyceridaemia	Hypertriglyceridaemia	postmarketing		x	x	x	x	x	x								x	x	x
Blood triglycerides increased	Hypertriglyceridaemia	postmarketing		x	x	x	x	x	x								x	x	x
Intestinal obstruction	Intestinal obstruction	rare																		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Jaundice	Jaundice	very rare, postmarketing		x	x	x	x	x	x									x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x						x	x
Keratitis	Keratoconjunctivitis	rare																																																x	x	x	x	x	x	x
Ketosis	Ketosis	rare																																																x	x	x	x	x	x	x
Mastitis	Mastitis	rare																																																x	x	x	x	x	x	x
Miosis	Miosis	rare																																																x	x	x	x	x	x	x
Myopathy	Myopathy	rare																																																x	x	x	x	x	x	x
Mydriasis	Mydriasis	rare																		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Neuralgia	Neuralgia	rare																																																x	x	x	x	x	x	x
Neutropenia	Neutropenia	postmarketing — common		x	x	x	x	x	x	x	x	x	x	x	x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x							x
Nystagmus	Nystagmus	rare																																																x	x	x	x	x	x	x
Oliguria	Oliguria	rare																																																x	x	x	x	x	x	x
Osteoporosis	Osteoporosis	rare																		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Pancreatitis	Pancreatitis	very rare, postmarketing		x	x	x	x	x	x	x	x	x	x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Priapism	Priapism	very rare, postmarketing		x	x	x	x	x	x	x	x	x	x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Pruritus	Pruritus	postmarketing, infrequent		x	x	x	x	x	x								x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Pulmonary oedema	Pulmonary oedema	rare																		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Pulmonary embolism	Pulmonary embolism	very rare — rare		x	x	x	x	x	x	x	x	x	x		x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Rhabdomyolysis	Rhabdomyolysis	very rare, postmarketing		x	x	x	x	x	x	x	x	x	x	x	x		x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x		x	x	x	x
Convulsion	Convulsion	postmarketing, rare		x	x	x	x	x	x				x				x	x	x
Aphthous stomatitis	Aphthous stomatitis	rare																																																x	x	x	x	x	x	x
Stridor	Stridor	rare																																																x	x	x	x	x	x	x
Subarachnoid haemorrhage	Subarachnoid haemorrhage	rare																																																x	x	x	x	x	x	x
Urticaria	Urticaria	postmarketing, infrequent		x	x	x	x	x	x								x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Water intoxication	Water intoxication	rare																																																x	x	x	x	x	x	x
Normochromic normocytic anaemia	Normocytic anemia	rare																																																x	x	x	x	x	x	x
Encephalopathy	Encephalopathy	rare																																																x	x	x	x	x	x	x
Deep vein thrombosis	Deep vein thrombosis	very rare, postmarketing		x	x	x	x	x	x	x	x	x	x	x	x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x		x	x	x	x
Tongue discolouration	Tongue discolouration	rare																																																x	x	x	x	x	x	x
Lenticular pigmentation	Lenticular pigmentation	rare																																																x	x	x	x	x	x	x
Hepatic steatosis	Liver fatty deposition	rare																		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Bone pain	Bone pain	rare																																																x	x	x	x	x	x	x
Paraesthesia oral	Circumoral paresthesia	rare																																																x	x	x	x	x	x	x
Oesophageal ulcer	Oesophageal ulcer	rare																																																x	x	x	x	x	x	x
Urinary hesitation	Urinary hesitation	very rare, postmarketing		x	x	x	x	x	x	x	x	x	x	x	x
Leukoderma	Leukoderma	rare																																																x	x	x	x	x	x	x
Hangover	Hangover	rare																		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Hepatobiliary disease	Hepatobiliary disease	postmarketing		x	x	x	x	x	x	x	x	x	x	x	x			x	x
Anaphylactic shock	Anaphylactoid reaction	postmarketing		x	x	x	x	x	x								x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Anaphylactoid reaction	Anaphylactoid reaction	postmarketing		x	x	x	x	x	x								x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Neuropathy peripheral	Neuropathy	rare																																																x	x	x	x	x	x	x
Paralysis	Paralysis	rare																																																x	x	x	x	x	x	x
Thrombocytosis	Thrombocytosis	rare																																																x	x	x	x	x	x	x
Embolism	Thromboembolic event	postmarketing																		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x		x	x	x	x
	Embolism													x
	Thromboembolism									x	x	x	x	x	x
Ileus	Ileus	rare																		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Diabetic hyperglycaemic coma	Diabetic coma	very rare, postmarketing		x	x	x	x	x	x								x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Diabetic coma	Diabetic coma	very rare, postmarketing		x	x	x	x	x	x								x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Breast enlargement	Breast enlargement	rare		x	x	x	x	x	x	x	x	x	x	x	x																																			x	x	x	x	x	x	x
Hypoxia	Hypoventilation	rare																																																x	x	x	x	x	x	x
Respiratory failure	Hypoventilation	rare																																																x	x	x	x	x	x	x
Hypoventilation	Hypoventilation	rare																																																x	x	x	x	x	x	x
Neuroleptic malignant syndrome	Neuroleptic malignant syndrome	very rare, postmarketing		x	x	x	x	x	x		x	x	x	x	x
Blood bilirubin increased	Bilirubin total increased	very rare, postmarketing		x	x	x	x	x	x	x	x	x	x	x	x			x	x
Embolism venous	Venous thromboembolism	very rare, postmarketing		x	x	x	x	x	x								x	x	x
Embolism venous	Thromboembolism									x	x	x	x	x	x
Dementia Alzheimer's type	Dementia Alzheimer's type															x					x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Decreased appetite	Anorexia																x	x	x																															x	x	x	x	x	x	x
Mental disorder	Mental disorder																			x
Breast disorder	Breast disorder									x	x	x	x	x	x					x
Infection	Infection																			x	x										x	x
Connective tissue disorder	Connective tissue disorder									x	x	x	x	x	x					x
Depression	Depression																					x	x	x	x	x	x	x	x		x	x	x	x	x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Dyskinesia	Dyskinesia			x	x	x	x	x	x	x	x	x	x	x	x		x	x	x		x																			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Dyskinesia	Buccoglossal syndrome																x	x	x		x																			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Dysmenorrhoea	Dysmenorrhoea															x	x					x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x			x	x	x	x
Extrapyramidal disorder	Extrapyramidal disorder			x	x	x	x	x	x	x	x	x	x	x	x		x	x	x		x																			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Fasting	Fasting																	x		x
Gastrointestinal disorder	Gastrointestinal disorder									x	x	x	x	x	x					x
Cardiac disorder	Cardiac disorder									x	x	x	x	x	x
Body temperature decreased	Body temperature decreased									x	x	x	x	x	x
Hypothermia	Body temperature decreased									x	x	x	x	x	x
Immune system disorder	Immune system disorder									x	x	x	x	x	x
Mediastinal disorder	Mediastinal disorder										x	x	x	x	x					x
Muscle rigidity	Muscle rigidity																		x
Myoclonus	Myoclonus																x	x	x		x																			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Drug withdrawal syndrome neonatal	Drug withdrawal syndrome neonatal									x	x	x	x	x	x
Nervous system disorder	Nervous system disorder									x	x	x	x	x	x					x
Obesity	Obesity				x	x	x	x	x
Parkinson's disease	Parkinson's disease			x	x	x	x	x	x	x	x	x	x	x	x		x	x	x
Pregnancy	Pregnancy									x	x	x	x	x	x
Sneezing	Sneezing	0% - 2%	0%																	x
Torsade de pointes	Torsade de pointes				x	x	x	x	x
Torticollis	Torticollis																x	x	x		x																			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Unintended pregnancy	Unintended pregnancy																x	x	x
Erythema	Erythema									x	x	x	x	x	x
Urethral disorder	Urinary tract disorder									x	x	x	x	x	x
Urinary tract disorder	Urinary tract disorder									x	x	x	x	x	x
Angiopathy	Angiopathy									x	x	x	x	x	x					x
Ventricular tachycardia	Ventricular tachycardia									x	x	x	x	x	x
Viral infection	Viral infection	0% - 2%	0%																	x
Weight decreased	Weight decreased				x	x	x	x	x																																									x	x	x	x	x	x	x
Choreoathetosis	Choreoathetosis																x	x	x		x																			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Hepatic failure	Hepatic failure																	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Ventricular arrhythmia	Ventricular arrhythmia				x	x	x	x	x
Apathy	Apathy															x	x	x	x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Flat affect	Apathy															x	x	x	x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Oculogyric crisis	Oculogyric crisis																x	x	x		x																			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Oculogyric crisis	Oculogyration									x					x
Lower respiratory tract infection	Lower respiratory tract infection																																							x	x	x	x	x	x	x	x	x	x
Buccoglossal syndrome	Buccoglossal syndrome																x	x	x		x																			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Injection site reaction	Injection site reaction																			x
Injection site mass	Injection site mass																			x
Opisthotonus	Opisthotonus																x	x	x		x																			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Paranoia	Paranoid reaction																x	x	x																															x	x	x	x	x	x	x
Haemoglobin decreased	Haemoglobin decreased																x	x	x
Malnutrition	Malnutrition									x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Skin disorder	Unspecified disorder of skin and subcutaneous tissue									x	x	x	x	x	x					x
Ketoacidosis	Ketoacidosis									x	x	x	x	x	x
Myalgia	Myalgia																x	x	x																															x	x	x	x	x	x	x
Musculoskeletal pain	Buttock pain																			x
Cardiac fibrillation	Cardiac fibrillation									x	x	x	x	x	x
Abdominal pain upper	Abdominal pain upper																				x										x	x								x	x	x	x	x	x	x	x	x	x
Abdominal pain lower	Abdominal pain lower																				x										x	x								x	x	x	x	x	x	x	x	x	x
Psychiatric symptom	Psychiatric symptom															x					x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Thinking abnormal	Thinking abnormal	0% - 3%	1%														x	x	x	x																														x	x	x	x	x	x	x
Mental disability	Thinking abnormal	0% - 3%	1%														x	x	x	x																														x	x	x	x	x	x	x
Hallucination, visual	Hallucination, visual									x	x	x	x	x	x
Drug tolerance	Tolerance development																																																		x
Throat tightness	Throat tightness																			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Blood pressure systolic decreased	Blood pressure systolic decreased																x	x	x
Dependence	Dependence physiological																																																		x
Dependence	Dependence																																																		x
Induration	Induration																			x
Viral upper respiratory tract infection	Viral upper respiratory tract infection																				x										x	x								x	x	x	x	x	x	x	x	x	x
Platelet count decreased	Platelet count decreased																			x
Hyperkinesia	Hyperkinesia																x	x	x		x																			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Masked facies	Masked facies																x	x	x		x																			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Injection site induration	Injection site induration																			x
Haematocrit decreased	Haematocrit decreased																x	x	x
Infestation	Infestation NOS																			x
Sleep disorder	Sleep disorder	0% - 2%	1%																	x																														x	x	x	x	x	x	x
Electrocardiogram change	Electrocardiogram change																x	x	x	x																														x	x	x	x	x	x	x
Electrocardiogram QT prolonged	Electrocardiogram QT corrected interval prolonged	0% - 2%	1%							x	x	x	x	x	x					x
Thrombocytopenic purpura	Thrombocytopenic purpura																x	x	x
Schizophrenia	Acute schizophrenia																				x																			x	x	x	x	x	x		x				x	x	x	x	x	x
Blood glucose increased	Glucose increased				x	x	x	x	x
Blood albumin decreased	Albumin low																x	x	x
Blood creatine increased	Creatine increased									x	x	x	x	x	x
Tooth infection	Tooth infection	0% - 4%	0%																	x
Respiratory tract infection viral	Respiratory tract infection viral																				x										x	x								x	x	x	x	x	x	x	x	x	x
Liver disorder	Hepatic impairment																			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Procedural pain	Procedural pain	0% - 2%	0%																	x
Mixed liver injury	Mixed liver injury									x	x	x	x	x	x					x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Visual impairment	Abnormal vision															x						x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x

Indication	Labels
Agitation					x	x							x			x			x		x	x			x		x				x	x	x	x	x	x			x				x	x	x	x		x	x	x	x	x	x
Bipolar disorder							x	x	x	x	x	x		x	x	x																															x	x	x	x	x	x	x
Bipolar I disorder	x	x	x	x	x	x							x	x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Childhood schizophrenia																		x	x	x	x	x	x	x	x	x	x	x				x	x		x		x	x	x	x	x	x	x			x
Dementia							x	x	x	x	x	x		x	x	x
Depression													x														x								x
Drug abuse																																																x
Extrapyramidal symptoms														x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Hyperlipidaemia																		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x		x	x	x	x	x	x	x		x	x
Increased activity													x														x								x	x							x	x		x		x	x	x	x	x	x
Major depression													x														x								x								x			x
Mania	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x											x								x	x							x	x		x	x	x	x	x	x	x	x
Mania acute					x	x
Manic episode							x	x	x	x	x	x
Mental disorder																					x	x	x	x			x								x		x	x	x	x		x	x			x
Movement disorder	x	x	x	x	x	x	x	x	x	x	x	x
Psychotic disorder	x	x	x	x	x	x	x	x	x	x	x	x		x	x	x																															x	x	x	x	x	x	x
Schizoaffective disorder															x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x							x
Schizophrenia	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Tension													x														x								x	x							x	x		x		x	x	x	x	x	x
Weight increased																		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x		x	x	x	x	x	x	x		x	x

Side effects:	70
Source:	medicines.org.au

Side effects:	83
Source:	medicines.org.au

Side effects:	90
Source:	medicines.org.au

Side effects:	90
Source:	Medsafe

		100%
		75%
		50%
		10%
		frequent (1% to 100%)
		infrequent (0.1% to 1%)
		rare (<0.1%)
		postmarketing
		0%
		no frequency information
		not found on label

Side effects:	55
Source:	FDA Structured Product Label

Side effects:	131
Source:	Health Canada

Side effects:	143
Source:	Health Canada

Side effects:	146
Source:	Health Canada

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