Side effect information for Topiramate

Side effects

Options: Hide MedDRA Preferred Terms , display all 68 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
Neuropathy peripheral	Neuropathy peripheral	2% - 32%	15%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Neuropathy peripheral	Neuropathy	infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Headache	Headache	postmarketing — 1% - 29%																				x
Upper respiratory tract infection	Upper respiratory tract infection	12% - 36.7%	12%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Nervousness	Nervousness	0% - 19.3%	2% - 7.4%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Nervousness	Feeling jittery
Tension	Nervousness	0% - 19.3%	2% - 7.4%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Vaginal inflammation	Vaginal inflammation	13%					x	x
Vaginal infection	Vaginal inflammation	13%					x	x
Asthenia	Fatigue	postmarketing — 1% - 30.7%	4% - 13.4%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Asthenia	Asthenia	very rare — 0% - 8%	1% - 1.8%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Fatigue	Fatigue	postmarketing — 1% - 30.7%	4% - 13.4%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Nystagmus	Nystagmus	6.1% - 15%	6.8% - 9.3%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Abnormal behaviour	Abnormal behaviour	0% - 11.2%	3.9% - 9%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Irritability	Irritability	2% - 14.6%	1% - 8.8%					x														x
Decreased appetite	Anorexia	postmarketing — 2% - 24.5%	1% - 15%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Decreased appetite	Decreased appetite	1.3% - 19.2%	2% - 12.7%																			x
Malnutrition	Malnutrition	postmarketing, 6% - 21%	3% - 4%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Somnolence	Somnolence	postmarketing — 0% - 30.1%	2% - 16%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Purpura	Purpura	4% - 8.2%	4%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Vascular purpura	Purpura	4% - 8.2%	4%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Weight decreased	Weight decreased	postmarketing — 2.5% - 31%	0% - 4.2%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Disturbance in attention	Disturbance in attention	2.6% - 11.9%	1.8% - 2.3%																			x
	Cerebration impaired	postmarketing, 0% - 15%	0% - 2%			x	x	x			x	x	x	x	x	x	x	x	x	x	x		x
	Attention concentration difficulty	postmarketing			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Insomnia	Insomnia	very rare — 0% - 14%	3% - 7%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Depression	Depression	rare, 0% - 13%	3.4% - 6%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
	Depression aggravated	1% - 3%	1%				x	x													x		x
	Anxiety depression
Dizziness	Dizziness	postmarketing, 0% - 34.1%	2% - 15.3%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Dizziness	Syncope	infrequent — 1%		x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Paraesthesia	Paraesthesia	postmarketing — 0% - 51%	0% - 6%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Mental disability	Cerebration impaired	postmarketing, 0% - 15%	0% - 2%			x	x	x			x	x	x	x	x	x	x	x	x	x	x		x
	Mental disability	0.4% - 5%	0.9% - 1.3%																			x
	Thinking abnormal						x															x
Lethargy	Lethargy	1.2% - 13.5%	2.1% - 8.8%																			x
Abdominal pain	Abdominal pain	very rare — 1.1% - 15%	0.8% - 5%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Gastrointestinal pain	Abdominal pain	very rare — 1.1% - 15%	0.8% - 5%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Nausea	Nausea	postmarketing — 0% - 15.1%	5% - 8.4%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Salivary hypersecretion	Salivary hypersecretion	4% - 6.1%	4%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Viral infection	Viral infection	1% - 15%	1% - 3%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Anaemia	Anaemia	frequent, 0.8% - 3%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Arthralgia	Arthralgia	postmarketing — 1% - 7%	2%	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Musculoskeletal discomfort	Arthralgia	postmarketing — 1% - 7%	2%	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Musculoskeletal discomfort	Myalgia	postmarketing, 2% - 2.5%	1% - 1.3%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Conjunctivitis	Conjunctivitis	frequent, 0% - 7%	1%	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Diarrhoea	Diarrhoea	very rare — 2% - 14%	1% - 5.2%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Hallucination	Hallucination	very rare — frequent		x	x		x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Pain	Pain	2.9% - 6.2%	4.2%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Pharyngitis	Pharyngitis	2% - 21%	2% - 4%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Pneumonia	Pneumonia	1% - 5.1%	1%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Psychotic disorder	Psychotic disorder	very rare — frequent		x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Psychotic disorder	Paranoia	infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Sinusitis	Sinusitis	1% - 15%	4% - 6%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Suicide attempt	Suicide attempt	postmarketing — frequent		x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Shock	Syncope	infrequent — 1%		x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Syncope	Syncope	infrequent — 1%		x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Loss of consciousness	Syncope	infrequent — 1%		x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Erectile dysfunction	Erectile dysfunction	frequent, 1% - 2%		x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Agitation	Hyperkinesia	postmarketing, 0% - 21%	4%			x	x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x
Agitation	Agitation	postmarketing — 1% - 4.4%	1% - 2%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Hyperkinesia	Hyperkinesia	postmarketing, 0% - 21%	4%			x	x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x
Vomiting	Vomiting	very rare — 1% - 14%	2%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Bradyphrenia	Bradyphrenia	0% - 19.5%	1.4% - 3.1%																			x
Expressive language disorder	Expressive language disorder	postmarketing, 3.5% - 9.4%	1.4% - 1.6%																			x
Anxiety	Anxiety	0% - 10.4%	1.8% - 6%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Ataxia	Ataxia	postmarketing, 1% - 21.2%	1% - 7%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Confusional state	Confusional state	very rare — 0% - 14%	0.8% - 5%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Feeling abnormal	Confusional state	very rare — 0% - 14%	0.8% - 5%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
	Feeling abnormal	very rare, postmarketing																				x
	Malaise																					x
Constipation	Constipation	0% - 7%	0% - 4.9%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Dysarthria	Dysarthria	1.6% - 6.2%	1%																			x
Osteoarthritis	Dysarthria	1.6% - 6.2%	1%																			x
Osteoarthritis	Arthropathy	infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Dyspepsia	Dyspepsia	0% - 8%	0% - 6.5%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Breast pain	Breast pain	0% - 8.3%	1.7% - 2%			x	x			x	x	x	x	x	x	x	x	x	x	x	x		x
Breast pain	Breast pain female							x	x
Rhinitis	Rhinitis	0% - 21%	0% - 6.9%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Speech disorder	Speech disorder	very rare — 1% - 16.8%	0.5% - 2.3%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Coordination abnormal	Coordination abnormal	3.6% - 11.4%	1.9% - 4.2%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Action tremor	Action tremor	3.1% - 4.8%	2.9%																			x
Abdominal pain upper	Abdominal pain upper	3.7% - 3.9%	2.1%																			x
Balance disorder	Balance disorder	0.4% - 5.8%	0% - 2.4%																			x
Amnesia	Amnesia	very rare — 2.9% - 5.3%	0.5% - 1%				x															x
Dysmenorrhoea	Dysmenorrhoea	0% - 8.3%	6.8%		x	x	x	x	x	x	x	x	x	x	x		x	x	x	x	x		x
Abdominal discomfort	Upset stomach	1% - 3.2%	0.2% - 1.3%																			x
Abdominal discomfort	Abdominal discomfort																					x
Convulsion	Convulsions aggravated	3% - 3.1%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Convulsion	Convulsion	postmarketing — 1% - 2.3%	0%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Bronchitis	Bronchitis	0% - 7%	2%			x	x	x	x	x		x	x	x	x	x	x	x	x	x	x		x
Dysgeusia	Dysgeusia	very rare — 0% - 15.4%	0% - 1%			x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x
Gastroenteritis	Gastroenteritis	0% - 7%	1% - 2%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Skin disorder	Skin disorder	1% - 3.1%	1% - 2%		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	postmarketing																				x
Tremor	Tremor	0% - 10.6%	1.4% - 6%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Mood swings	Mood swings	postmarketing, 0% - 5.1%	0.2% - 2%				x	x		x	x	x	x	x		x	x	x	x	x	x	x	x
Mood swings	Mood alteration NOS							x
Affect lability	Mood swings	postmarketing, 0% - 5.1%	0.2% - 2%				x	x		x	x	x	x	x		x	x	x	x	x	x	x	x
Affect lability	Affect lability	0.2% - 1.1%	0.2%																			x
Influenza like illness	Influenza-like symptoms	0% - 7%	1% - 3.2%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Influenza like illness	Influenza like illness	postmarketing																				x
Gait disturbance	Gait disturbance	0% - 8%	1% - 5%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Aggression	Aggressive reaction	0% - 9.2%	0% - 4%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Aggression	Aggression	very rare — 2.8% - 8.7%	1.8% - 6.9%																			x
Hypoaesthesia	Hypoaesthesia	1% - 8%	0% - 2%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Hypoaesthesia	Hypoaesthesia facial	0.4% - 2%																				x
Disorientation	Disorientation	1.7% - 3.2%	1%																			x
Muscle spasms	Muscle spasms	1.7% - 3.3%	0.8%																			x
Muscle spasms	Cramps of lower extremities	0% - 2%	0%			x	x	x	x	x		x	x	x	x	x	x	x	x	x	x		x
Alopecia	Alopecia	postmarketing — 0% - 6.3%	1%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Amenorrhoea	Amenorrhoea	2%	1%			x			x	x	x	x	x	x	x	x	x	x	x	x	x		x
Aphasia	Aphasia	2%	0%																			x
	Dysphasia	1%	0%																			x
	Word finding difficulty							x
Back pain	Back pain	0% - 6.2%	0% - 4.2%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Chest pain	Chest pain	1% - 4.4%	1% - 3%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Infection	Infection	postmarketing, 0% - 14%	1% - 13%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Cough	Cough	0% - 7%	2%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Cystitis	Cystitis	0% - 3%	0%			x	x	x		x		x	x	x	x	x	x	x	x	x	x		x
Bladder pain	Cystitis	0% - 3%	0%			x	x	x		x		x	x	x	x	x	x	x	x	x	x		x
Cystitis noninfective	Cystitis	0% - 3%	0%			x	x	x		x		x	x	x	x	x	x	x	x	x	x		x
Dermatitis	Dermatitis	0% - 7%	0%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Dermatitis	Rash	very rare — 0.4% - 6.7%	1% - 5.9%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Diplopia	Diplopia	0% - 12.1%	0% - 5%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Oedema	Oedema	postmarketing, 1% - 2%	1%			x			x	x	x	x	x	x	x	x	x	x	x	x	x		x
Epistaxis	Epistaxis	0% - 8%	0.5% - 1%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Congenital eye disorder	Congenital eye disorder	1% - 2%	1%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Eye disorder	Congenital eye disorder	1% - 2%	1%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Eye disorder	Eye disorder	postmarketing																				x
Body temperature increased	Body temperature increased	very rare — 0% - 12%	1%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Haematuria	Haematuria	0% - 2%	1%			x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Hypersensitivity	Hypersensitivity	0% - 7%	1%			x						x	x	x	x	x	x	x	x	x	x		x
Hypertrichosis	Hypertrichosis	1% - 2%	1%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Pain in extremity	Leg pain	1% - 8%	2% - 2.3%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Leukopenia	Leukopenia	postmarketing, 0% - 2.7%	0% - 1%			x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x
Vaginal discharge	Leukorrhea	2%	0%			x	x	x		x	x	x	x	x	x	x	x	x	x	x	x		x
Menorrhagia	Menorrhagia	1% - 2%	0%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Menstrual disorder	Menstrual disorder	0.8% - 4.2%	0% - 2%			x	x	x		x	x	x	x	x	x	x	x	x	x	x	x		x
Otitis media	Otitis media	0% - 8%	1%				x	x													x		x
Prostatic disorder	Prostatic disorder	0% - 2.2%	1% - 0.6%			x	x	x		x	x	x	x	x	x	x	x	x	x	x	x		x
Tachycardia	Tachycardia	2%					x	x
Thirst	Thirst	1% - 2%	1%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Tinnitus	Tinnitus	0.4% - 2%	0% - 1%			x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x
Urinary incontinence	Urinary incontinence	1% - 4.1%	1% - 2%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Urinary tract infection	Urinary tract infection	0% - 5%	1% - 2%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Urethral disorder	Urinary tract disorder	postmarketing, 0% - 4.1%	0%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Urinary tract disorder	Urinary tract disorder	postmarketing, 0% - 4.1%	0%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Visual impairment	Disorder sight	0% - 13%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
	Abnormal vision	0% - 14.2%	0% - 2%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
	Visual disturbance	postmarketing — 1.4% - 2%	0.3%				x															x
	Visual impairment						x
Dry mouth	Dry mouth	0.4% - 5%	0% - 2.5%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Stupor	Stupor	1% - 2%	0%			x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Depressed level of consciousness	Stupor	1% - 2%	0%			x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Depressed level of consciousness	Depressed level of consciousness
Oedema peripheral	Oedema peripheral	2%					x	x
Hyporeflexia	Hyporeflexia	0% - 2%	0%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Myalgia	Myalgia	postmarketing, 2% - 2.5%	1% - 1.3%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Rash erythematous	Rash erythematous	0% - 8%	0% - 1%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Muscle contractions involuntary	Muscle contractions involuntary	0% - 8%	1%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Vision blurred	Vision blurred	postmarketing — 2% - 8.9%	2% - 2.5%				x	x													x	x	x
Depressed mood	Depressed mood	0.4% - 2.9%	0.9%																			x
Psychomotor retardation	Psychomotor retardation	2%	0%
Menopausal symptoms	Hot flush	postmarketing, 0.7% - 2.7%	1% - 1.9%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Hot flush	Hot flush	postmarketing, 0.7% - 2.7%	1% - 1.9%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Acne	Acne	0% - 3%				x	x	x		x		x	x	x	x	x	x	x	x	x	x
Deafness	Hearing impaired	1% - 2%	1%			x				x	x	x	x	x	x	x	x	x	x	x	x	x	x
Deafness	Deafness																					x
Hearing impaired	Hearing impaired	1% - 2%	1%			x				x	x	x	x	x	x	x	x	x	x	x	x	x	x
	Auditory disorder NOS	1% - 2%	1%		x				x
	Deafness unilateral																					x
Anger	Anger	1.7% - 2.1%	0.5%																			x
Depersonalisation	Depersonalisation	1% - 2.2%	0.9% - 1%			x	x	x		x		x	x	x	x	x	x	x	x	x	x		x
Apathy	Apathy	1% - 3.1%	0% - 1%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Flat affect	Apathy	1% - 3.1%	0% - 1%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Flat affect	Flat affect																					x
Paraesthesia oral	Paraesthesia oral	1.2% - 3.3%	0.5%																			x
Learning disability	Learning disability	0% - 3.2%																				x
Coagulopathy	Coagulopathy	1% - 2%	1%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Coagulopathy	Clotting				x
Cardiovascular disorder	Cardiovascular disorder	1% - 2%	0%		x	x			x	x	x	x	x	x	x	x	x	x	x	x	x		x
Haemorrhage	Haemorrhage	1% - 2%	1%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Haemoglobin	Haemorrhage	1% - 2%	1%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Musculoskeletal chest pain	Musculoskeletal chest pain	1.1% - 1.8%	0.3%																			x
Mental retardation	Mental disability	0.4% - 5%	0.9% - 1.3%																			x
Personality disorder	Personality disorder	0% - 11.2%	9%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Muscle twitching	Muscle twitching	0.4% - 1.8%	0.7%																			x
Cognitive disorder	Cognitive disorder	0.4% - 2%																				x
Cognitive disorder	Cognitive impairment																				x		x
Memory impairment	Memory impairment	postmarketing, 1.2% - 10.8%	1% - 1.8%					x														x
Candida infection	Candida infection	0% - 1%	0% - 1%			x				x	x	x	x	x	x	x	x	x	x	x	x		x
Libido decreased	Libido decreased	0% - 3%	1%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Disturbance in sexual arousal	Libido decreased	0% - 3%	1%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
	Libido increased	rare, infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
	Disturbance in sexual arousal																					x
Dysphagia	Dysphagia	1%	0%			x			x	x	x	x	x	x	x	x	x	x	x	x	x		x
Dyspnoea	Dyspnoea	1% - 6%	0.9% - 2%			x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x
Eczema	Eczema	0% - 1%	0%			x			x	x	x	x	x	x	x	x	x	x	x	x	x		x
Grand mal convulsion	Grand mal convulsion	0% - 7%	0%			x					x	x	x	x		x	x	x	x	x	x		x
Rash	Rash	very rare — 0.4% - 6.7%	1% - 5.9%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Faecal incontinence	Faecal incontinence	0% - 1%	0%			x			x	x	x	x	x	x	x	x	x	x	x	x	x		x
Flatulence	Flatulence	1%	0%			x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Gastrooesophageal reflux disease	Gastrooesophageal reflux disease	0.4% - 2%	0% - 0.5%			x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Gingival hyperplasia	Gingival hyperplasia	1%	0%			x				x	x	x	x	x	x	x	x	x	x	x	x		x
Gingivitis	Gingivitis	1%	1%			x			x	x	x	x	x	x	x	x	x	x	x	x	x		x
Glossitis	Glossitis	1%	0%			x			x	x	x	x	x	x	x	x	x	x	x	x	x		x
Haematoma	Haematoma	0% - 2%	0%			x	x	x	x		x	x	x	x	x	x	x	x	x	x	x		x
Hypertension	Hypertension	1% - 3%	0% - 1%			x				x	x	x	x	x	x	x	x	x	x	x	x		x
Hypoglycaemia	Hypoglycaemia	0% - 1%	0%			x			x	x	x	x	x	x	x	x	x	x	x	x	x		x
Myopia	Myopia	very rare — 0% - 1%	0%			x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x
Neurosis	Neurosis	infrequent, 1%	0%			x				x	x	x	x	x	x	x	x	x	x	x	x		x
Nocturia	Nocturia	0% - 1%	0%			x				x	x	x	x	x	x	x	x	x	x	x	x		x
Pallor	Pallor	1%	0%			x				x	x	x	x	x	x	x	x	x	x	x	x		x
Pruritus	Pruritus	0% - 4%	2%			x	x	x		x		x	x	x	x	x	x	x	x	x	x	x	x
Seborrhoeic dermatitis	Seborrhoeic dermatitis	0% - 1%	0%			x			x	x	x	x	x	x	x	x	x	x	x	x	x		x
Thrombocytopenia	Thrombocytopenia	postmarketing, 1%	0%			x	x			x	x	x	x	x		x	x	x	x	x	x	x	x
Toothache	Toothache	1% - 7%					x	x
Pollakiuria	Pollakiuria	0% - 4%	1%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Pollakiuria	Micturition urgency																					x
Vertigo	Vertigo	0% - 3.2%	1%			x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x
Weight increased	Weight increased	postmarketing, 0% - 1%	0%			x		x		x	x	x	x	x	x	x	x	x	x	x	x	x	x
Skin odour abnormal	Body odor	0% - 1%	0%			x			x	x	x	x	x	x	x	x	x	x	x	x	x		x
Skin odour abnormal	Skin odour abnormal																					x
Migraine	Migraine	postmarketing, 0% - 2%						x
Migraine	Migraine aggravated						x														x		x
Gamma-glutamyltransferase increased	Gamma-glutamyltransferase increased	infrequent, 1% - 3%				x				x	x	x	x	x	x	x	x	x	x	x	x		x
Muscular weakness	Muscular weakness	frequent, 1%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Bone pain	Bone pain	0% - 1%	0%			x				x	x	x	x	x	x	x	x	x	x	x	x		x
Prothrombin level increased	Prothrombin level increased	1%	0%			x			x	x	x	x	x	x	x	x	x	x	x	x	x		x
Skin discolouration	Skin discolouration	0% - 1%	0%			x				x	x	x	x	x	x	x	x	x	x	x	x	x	x
Increased appetite	Increased appetite	1%	0%			x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Urine abnormality	Urine abnormality	0% - 1%	0%			x				x	x	x	x	x	x	x	x	x	x	x	x		x
Urine analysis abnormal	Urine abnormality	0% - 1%	0%			x				x	x	x	x	x	x	x	x	x	x	x	x		x
Lacrimal disorder	Lacrimation abnormal NOS	0% - 1%	0%			x			x	x	x	x	x	x	x	x	x	x	x	x	x		x
Rash maculo-papular	Rash maculo-papular	0% - 2%					x	x
Chills	Rigors	1%	0%			x				x	x	x	x	x	x	x	x	x	x	x	x		x
Bradycardia	Bradycardia	1%	0%			x				x	x	x	x	x	x	x	x	x	x	x	x		x
Hyperhidrosis	Sweating increased	1% - 2%	1%			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Psychomotor skills impaired	Psychomotor skills impaired	0% - 2%																				x
Ear pain	Ear pain	0% - 1.3%					x	x														x
Dry eye	Dry eye	0% - 1.3%																				x
Pruritus generalised	Pruritus generalised	0% - 1.3%																				x
Nasopharyngitis	Rhinorrhoea	0% - 1.3%																				x
Nasopharyngitis	Nasopharyngitis	postmarketing																				x
Rhinorrhoea	Rhinorrhoea	0% - 1.3%																				x
Agranulocytosis	Agranulocytosis	infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Albuminuria	Albuminuria	infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Angina pectoris	Angina pectoris	infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Apraxia	Apraxia	infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Atrioventricular block	Atrioventricular block	infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Dehydration	Dehydration	postmarketing — frequent		x	x		x		x	x	x	x	x	x	x	x	x	x	x	x	x		x
Delirium	Delirium	infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Delusion	Delusion	postmarketing, infrequent		x	x		x		x	x	x	x	x	x	x	x	x	x	x	x	x		x
Diabetes mellitus	Diabetes mellitus	rare, infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Diabetes mellitus	Diabetic
Dyskinesia	Dyskinesia	infrequent		x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Eosinophilia	Eosinophilia	infrequent		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	x	x	x	x	x	x	x	x		x
Flushing	Flushing	postmarketing — 0% - 5%		x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Gastritis	Gastritis	infrequent, 0% - 3%		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Gingival bleeding	Gingival bleeding	infrequent, 0% - 1.3%		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Haemorrhoids	Haemorrhoids	infrequent, frequent		x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Hyperaesthesia	Hyperaesthesia	infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Hyperglycaemia	Hyperglycaemia	infrequent		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	x	x	x	x	x		x
Hypocalcaemia	Hypocalcaemia	infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Hypokalaemia	Hypokalaemia	postmarketing, infrequent			x		x	x	x		x				x								x
Hypotension	Hypotension	infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Orthostatic hypotension	Orthostatic hypotension	infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Arthropathy	Arthropathy	infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Lymphopenia	Lymphopenia	infrequent		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	x	x	x	x	x	x	x	x		x
Oliguria	Oliguria	infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Phlebitis	Phlebitis	infrequent		x	x				x	x	x	x	x	x	x	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
Urine output increased	Polyuria	infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Pulmonary embolism	Pulmonary embolism	rare, infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Scotoma	Scotoma	infrequent, 0.4% - 1.3%		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Stomatitis	Stomatitis	infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Urticaria	Urticaria	infrequent, frequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Urticaria	Urticaria localised																					x
Vasodilation procedure	Vasodilation	infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Xerophthalmia	Xerophthalmia	infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Urinary retention	Urinary retention	infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Encephalopathy	Encephalopathy	postmarketing, infrequent		x	x	x			x	x	x	x	x	x	x	x	x	x	x	x	x		x
Photophobia	Photophobia	infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Breast discharge	Breast discharge	infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Deep vein thrombosis	Deep vein thrombosis	infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Electroencephalogram abnormal	Electroencephalogram abnormal	infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Paranoia	Paranoid reaction	infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Paranoia	Paranoia	infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Blood alkaline phosphatase increased	Phosphatase alkaline increased	infrequent			x				x		x				x								x
Blood alkaline phosphatase increased	Alkaline phosphatase serum increased					x
Aspartate aminotransferase increased	Aspartate aminotransferase increased	infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Alanine aminotransferase increased	Alanine aminotransferase increased	infrequent		x	x				x	x	x	x	x	x	x	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
Photosensitivity reaction	Photosensitivity reaction	infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Euphoric mood	Euphoric mood	infrequent, frequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Hair texture abnormal	Hair texture abnormal	infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Ejaculation disorder	Ejaculation disorder	infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Abdominal distension	Enlargement abdomen	infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Abdominal distension	Abdominal distension	0% - 1.3%	0.2%																			x
Lymphadenopathy	Lymphadenopathy	infrequent		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
Renal pain	Renal pain	infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Thrombocytosis	Thrombocytosis	infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Parosmia	Parosmia	infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Dysphonia	Dysphonia	infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Ageusia	Ageusia	infrequent, 1% - 2%	1%	x	x		x		x	x	x	x	x	x	x	x	x	x	x	x	x		x
Neoplasm	Neoplasm	1% - 2%	1%		x		x		x	x	x	x	x	x	x	x	x	x	x	x	x		x
Renal tubular acidosis	Renal tubular acidosis	very rare, postmarketing			x						x				x							x	x
Road traffic accident	Renal tubular acidosis	very rare, postmarketing			x						x				x							x	x
Mental disorder	Mental disorder	postmarketing			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Bipolar disorder	Bipolar disorder	postmarketing						x
Bipolar I disorder	Bipolar disorder	postmarketing						x
Cerebellar syndrome	Cerebellar syndrome	rare		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Nervous system disorder	Cerebellar syndrome	rare		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Nervous system disorder	Nervous system disorder	postmarketing					x	x														x
Connective tissue disorder	Connective tissue disorder	postmarketing																				x
Toxic epidermal necrolysis	Toxic epidermal necrolysis	postmarketing			x	x			x	x		x	x	x	x	x	x	x	x	x	x	x	x
Epilepsy	Epilepsy	postmarketing						x
Erythema multiforme	Erythema multiforme	postmarketing			x	x			x	x		x	x	x	x	x	x	x	x	x	x	x	x
Erythema multiforme	Stevens-Johnson syndrome	postmarketing			x	x			x	x		x	x	x	x	x	x	x	x	x	x	x	x
Angle closure glaucoma	Angle closure glaucoma	very rare, postmarketing						x														x
Hepatitis	Hepatitis	postmarketing			x	x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Hypernatraemia	Hypernatraemia	rare		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Hypohidrosis	Hypohidrosis	postmarketing					x	x								x	x	x	x	x
Hypohidrosis	Sweating decreased	postmarketing, infrequent					x	x			x
Hyponatraemia	Hyponatraemia	rare		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Immune system disorder	Immune system disorder	postmarketing																				x
Libido increased	Libido increased	rare, infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Iritis	Iritis	rare		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Lymphocytosis	Lymphocytosis	rare		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Chloasma	Chloasma	rare		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Musculoskeletal pain	Musculoskeletal pain	postmarketing
Mydriasis	Mydriasis	rare, infrequent		x	x			x	x	x	x	x	x	x	x	x	x	x	x	x	x		x
Neutropenia	Neutropenia	very rare, postmarketing																				x
Eye movement disorder	Eye movement disorder	postmarketing																				x
Pancreatitis	Pancreatitis	postmarketing			x	x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Pancytopenia	Pancytopenia	rare		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Pancytopenia	Bone marrow depression	rare		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Pemphigus	Pemphigus	postmarketing			x	x			x	x		x	x	x	x	x	x	x	x	x	x	x	x
Polycythaemia	Polycythaemia	rare		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Stevens-Johnson syndrome	Stevens-Johnson syndrome	postmarketing			x	x			x	x		x	x	x	x	x	x	x	x	x	x	x	x
Completed suicide	Suicide	postmarketing					x															x
Completed suicide	Completed suicide	postmarketing					x	x
Hepatic failure	Hepatic failure	postmarketing			x	x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Vasospasm	Vasospasm	rare		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Hyperchloraemia	Hyperchloraemia	rare, infrequent			x		x		x		x				x								x
Hypophosphataemia	Hypophosphataemia	rare			x				x		x				x								x
Periorbital oedema	Periorbital oedema	postmarketing																				x
Alcohol intolerance	Alcohol intolerance	rare		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Blood creatinine increased	Creatinine increased	rare		x	x	x			x	x	x	x	x	x	x	x	x	x	x	x	x		x
Generalised oedema	Generalised oedema	postmarketing																				x
Fluid retention	Generalised oedema	postmarketing																				x
Tongue disorder	Tongue oedema	rare, infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Tongue oedema	Tongue oedema	rare, infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Hypocholesterolaemia	Hypocholesterolaemia	rare		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Mania	Manic psychosis	rare, infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Mania	Mania
Eye pain	Eye pain	very rare, postmarketing			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Joint swelling	Joint swelling	postmarketing																				x
Eyelid oedema	Eyelid oedema	postmarketing																				x
Metabolic acidosis	Metabolic acidosis	very rare, postmarketing				x	x	x								x	x	x	x	x		x
Hyperammonaemia	Hyperammonaemia	postmarketing				x										x	x	x	x	x		x
Temperature intolerance	Heat intolerance	postmarketing
Feeling of despair	Feeling of despair	postmarketing																				x
Tongue paralysis	Tongue paralysis	rare		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Ocular hyperaemia	Eye redness	postmarketing						x
Ocular hyperaemia	Ocular hyperaemia							x
Upper motor neurone lesion	Upper motor neurone lesion	rare, infrequent		x	x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Hepatic enzyme increased	Hepatic enzyme increased	postmarketing
Nephrolithiasis	Nephrolithiasis	postmarketing — 0% - 2.6%																				x
Nephrolithiasis	Calculus of kidney	frequent, 0% - 7%	0%			x	x	x			x	x	x	x	x	x	x	x	x	x	x	x	x
Suicidal ideation	Suicidal ideation	very rare, postmarketing					x															x
Abnormal sensation in eye	Abnormal sensation in eye	postmarketing																				x
Drug interaction	Drug interaction	postmarketing
Maculopathy	Maculopathy	postmarketing				x				x		x	x	x		x	x	x	x	x	x	x
Allergic oedema	Allergic oedema	postmarketing																				x
Infestation	Infestation NOS	postmarketing																				x
Limb discomfort	Limb discomfort	postmarketing																				x
Pancreatitis acute	Pancreatitis acute	very rare																				x
Blindness transient	Blindness transient	very rare																				x
Acidosis	Acidosis	postmarketing — 0% - 7%					x	x	x		x												x
Respiratory alkalosis	Respiratory alkalosis							x
Amblyopia	Amblyopia						x															x
Anhidrosis	Anhidrosis																					x
Anosmia	Anosmia
Asthma	Asthma	0% - 2%					x	x													x		x
Blepharospasm	Blepharospasm																					x
Breast disorder	Breast disorder																					x
Calcinosis	Calcinosis																					x
Collagen disorder	Collagen disorder						x	x
Dermatitis atopic	Dermatitis atopic
Drooling	Drooling																					x
Drug abuse	Drug abuse
Dysuria	Dysuria	frequent, 0% - 2%				x	x	x		x	x	x	x	x	x	x	x	x	x	x	x	x	x
Effusion	Effusion							x
Endocrine disorder	Endocrine disorder
Flank pain	Flank pain																					x
Formication	Formication																					x
Gastrointestinal disorder	Gastrointestinal disorder	postmarketing, 0% - 7%					x	x														x
Glaucoma	Glaucoma						x															x
Glossodynia	Glossodynia																					x
Breath odour	Breath odour																					x
Deafness neurosensory	Deafness neurosensory
Cardiac disorder	Cardiac disorder
Hyperplasia	Hyperplasia
Hyperthyroidism	Hyperthyroidism	0% - 8%
Body temperature decreased	Body temperature decreased					x										x	x	x	x	x
Hypothermia	Body temperature decreased					x										x	x	x	x	x
Incontinence	Incontinence																					x
Nephropathy	Nephropathy							x
Laryngitis	Laryngitis	0% - 8%
Mastitis	Mastitis	0% - 2%					x	x
Mediastinal disorder	Mediastinal disorder																					x
Metrorrhagia	Metrorrhagia	0% - 3%					x	x								x	x	x	x	x	x		x
Metrorrhagia	Bleeding breakthrough
Hypertonia	Hypertonia	frequent, 0% - 7%				x	x	x		x	x	x	x	x	x	x	x	x	x	x	x		x
Nail disorder	Nail disorder	0% - 2%					x	x
Nasal congestion	Nasal congestion																					x
Night blindness	Night blindness																					x
Obesity	Obesity						x
Osteomalacia	Osteomalacia							x
Palpitations	Palpitations						x	x														x
Panic reaction	Panic reaction
Panic disorder	Panic disorder																					x
Pemphigoid	Pemphigoid																					x
Premature ejaculation	Premature ejaculation	0% - 3%	0%				x	x													x		x
Presbyopia	Presbyopia																					x
Renal failure	Renal failure							x
Respiratory tract infection	Respiratory tract infection
Rickets	Rickets							x
Status epilepticus	Status epilepticus							x
Mouth ulceration	Ulcerative stomatitis						x	x
Testicular disorder	Testicular disorder						x	x
Tooth disorder	Tooth disorder						x																x
Unintended pregnancy	Unintended pregnancy						x	x
Erythema	Erythema																					x
Erythema	Redness							x
Angiopathy	Angiopathy						x	x
Acidosis hyperchloraemic	Acidosis hyperchloraemic
Polydipsia	Polydipsia																					x
Micturition urgency	Micturition urgency																					x
Sinus bradycardia	Sinus bradycardia																					x
Akinesia	Akinesia
Burning sensation	Burning sensation																					x
Photopsia	Photopsia
Hypokinesia	Hypokinesia																					x
Panic attack	Panic attack																					x
Conjunctival oedema	Conjunctival oedema																					x
Swelling face	Swelling face																					x
Hypogeusia	Hypogeusia																					x
Sensory disturbance	Sensory disturbance						x														x	x	x
Renal colic	Renal colic																					x
Lacrimation increased	Lacrimation increased																					x
Endophthalmitis	Ocular hyperaemia							x
Rash macular	Rash macular
Oral pain	Oral pain
Malaise	Malaise																					x
Discomfort	Malaise																					x
Ill-defined disorder	Malaise																					x
Dyspnoea exertional	Dyspnoea exertional																					x
Abdominal pain lower	Abdominal pain lower
Abdominal tenderness	Abdominal tenderness																					x
Distractibility	Distractibility																					x
Elevated mood	Elevated mood
Thinking abnormal	Thinking abnormal						x															x
Perseveration	Perseveration																					x
Hallucination, auditory	Hallucination, auditory
Hallucination, visual	Hallucination, visual
Clumsiness	Clumsiness																					x
Anorgasmia	Anorgasmia
Dysgraphia	Dysgraphia																					x
Visual acuity reduced	Visual acuity reduced							x														x
Intraocular pressure increased	Intraocular pressure increased							x
Dizziness postural	Dizziness postural																					x
Scintillating scotoma	Scintillating scotoma
Aura	Aura																					x
Pharyngeal oedema	Pharyngeal oedema	0% - 8%
Hypomania	Hypomania
Food interaction	Drug - food interaction
Muscle fatigue	Muscle fatigue
Ketogenic diet	Ketogenic diet							x
Essential tremor	Essential tremor
Familial tremor	Essential tremor
Blindness unilateral	Blindness unilateral
Peripheral coldness	Peripheral coldness																					x
Sensory loss	Sensory loss																					x
Genital candidiasis	Genital candidiasis						x														x		x
Repetitive speech	Repetitive speech																					x
Dysaesthesia	Dysaesthesia																					x
Initial insomnia	Initial insomnia																					x
Middle insomnia	Middle insomnia																					x
Crying	Tearfulness																					x
Tearfulness	Tearfulness																					x
Blood bicarbonate	Bicarbonate level							x
Dependence	Dependence
Dyslexia	Dyslexia																					x
Hypoaesthesia oral	Hypoaesthesia oral																					x
Electrocardiogram abnormal	Electrocardiogram abnormal							x
Feeling drunk	Feeling drunk																					x
Terminal insomnia	Terminal insomnia
Feeling jittery	Feeling jittery
Altered state of consciousness	Depressed level of consciousness
Sexual dysfunction	Sexual dysfunction																					x
Blood potassium decreased	Serum potassium decreased					x
Blood potassium decreased	Potassium low					x
Presyncope	Presyncope																					x
Diabetic neuropathy	Diabetic peripheral neuropathy						x
White blood cell count decreased	White blood cell count decreased																					x
Partial seizures	Partial seizures																					x
Administration site reaction	Administration site reaction																					x
Sleep disorder	Sleep disorder	0% - 2%					x	x														x
Blood bicarbonate decreased	Blood bicarbonate decreased
Lack of spontaneous speech	Lack of spontaneous speech																					x
Unresponsive to stimuli	Unresponsive to stimuli																					x
Embolism	Thromboembolic event						x	x														x
Liver function test abnormal	Raised liver function tests																					x
Circadian rhythm sleep disorder	Circadian rhythm sleep disorder
Hypersomnia	Hypersomnia
Sluggishness	Sluggishness
Crystal urine present	Crystal urine present
Ear discomfort	Ear discomfort																					x
Musculoskeletal stiffness	Musculoskeletal stiffness																					x
Orgasmic sensation decreased	Orgasmic sensation decreased
Dysphemia	Dysphemia																					x
Altered visual depth perception	Altered visual depth perception
Paranasal sinus hypersecretion	Paranasal sinus hypersecretion																					x
Tandem gait test abnormal	Tandem gait test abnormal																					x
Autonomic neuropathy	Unspecified disorder of autonomic nervous system				x				x	x	x	x	x	x	x	x	x	x	x	x	x		x
Poor quality sleep	Poor quality sleep																					x
Epigastric discomfort	Epigastric discomfort																					x
Calculus ureteric	Calculus ureteric
Sudden unexplained death in epilepsy	Sudden unexplained death in epilepsy															x	x	x	x	x
Suicidal behaviour	Suicidal behaviour					x										x	x	x	x	x
Hyposmia	Hyposmia
Deafness unilateral	Deafness unilateral																					x
Vaginal haemorrhage	Vaginal haemorrhage	0% - 3%				x				x		x	x	x	x	x	x	x	x	x	x
Loss of libido	Loss of libido																					x

Side effects:	85
Source:	FDA Structured Product Label

Side effects:	144
Source:	FDA Structured Product Label

Side effects:	160
Source:	FDA Structured Product Label

Side effects:	170
Source:	Health Canada

Side effects:	173
Source:	Health Canada

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Indication
Bipolar disorder			x	x
Cerebration impaired					x
Chronic migraine			x	x
Cluster headache			x	x
Convulsion	x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Drop attacks																		x
Drug interaction				x
Epilepsy	x	x	x	x	x	x		x	x	x	x	x	x	x	x	x	x	x	x
Fatigue					x
Grand mal convulsion	x	x			x	x	x	x	x	x	x	x	x	x	x	x	x		x
Headache			x	x
Lennox-Gastaut syndrome	x			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Liver disorder				x
Migraine			x	x													x	x	x
Nephrolithiasis				x
Nervousness					x
Renal failure chronic				x
Renal impairment				x
Tonic-clonic seizures																		x

		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