Side effect information for 5-ASA

Side effects

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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
Muscle spasms	Cramp muscle	66%	10%					x			x									x
	Muscle spasms	postmarketing																	x
	Cramps of lower extremities														x	x	x						x
Discomfort	Discomfort	66%	10%					x			x
Discomfort	Malaise	postmarketing, 1% - 28%	1% - 8%					x			x				x	x	x			x	x	x	x
Oropharyngeal discomfort	Throat sore	19%	9%					x			x
Oropharyngeal pain	Throat sore	19%	9%					x			x
Eructation	Eructation	postmarketing, 16%	15%												x	x	x			x	x	x	x
Pain	Pain	postmarketing, 11% - 23%	1% - 11%					x			x	x						x	x	x	x	x	x
Pain	Ache																			x
Abdominal distension	Abdominal bloating	12%	2%					x			x
	Enlargement abdomen	postmarketing, 2% - 3%	0%															x		x	x	x	x
	Abdominal distension	postmarketing, 1.3%							x					x	x	x	x		x
Flatulence	Abdominal bloating	12%	2%					x			x
Flatulence	Flatulence	postmarketing — 0.7% - 50%	2% - 30%		x			x	x		x		x	x				x	x	x	x	x	x
Haemorrhoids	Haemorrhoids	postmarketing, 11%	0%					x			x								x		x	x
Pharyngitis	Pharyngitis	postmarketing, 11% - 22%	9% - 15%																		x	x	x
Asthenia	Asthenia	postmarketing, 1% - 20%	4% - 16%					x	x		x				x	x	x	x	x	x	x	x	x
Asthenia	Fatigue	postmarketing, 1% - 28%	8%					x	x		x	x		x					x	x
Back pain	Back pain	postmarketing, 1.2% - 21%	1% - 11%					x	x		x							x	x	x	x	x	x
Back pain	Back distress																			x
Nervousness	Nervousness	postmarketing, 6%	2%															x		x	x	x	x
Tension	Nervousness	postmarketing, 6%	2%															x		x	x	x	x
Arthralgia	Arthralgia	very rare — 1.1% - 17%	1% - 9%					x	x	x	x	x	x		x	x	x	x	x	x	x	x	x
Musculoskeletal discomfort	Arthralgia	very rare — 1.1% - 17%	1% - 9%					x	x	x	x	x	x		x	x	x	x	x	x	x	x	x
	Myalgia	very rare — 3% - 8%	1% - 5%										x		x	x	x		x	x	x	x	x
	Back distress																			x
Constipation	Constipation	postmarketing, 4% - 13%	1% - 13%					x			x			x	x	x	x		x	x	x	x	x
Body temperature increased	Body temperature increased	postmarketing — 0% - 26%	0% - 13%	x	x			x	x	x	x			x	x	x	x	x	x	x	x	x
Body temperature increased	Drug fever	very rare, postmarketing								x		x	x	x				x		x	x	x	x
Headache	Headache	postmarketing — 2% - 53%	0.559% - 49%		x		x	x	x	x	x	x	x	x	x	x	x		x	x	x	x	x
Hypertonia	Hypertonia	postmarketing, 4% - 5%	3%																		x	x	x
Rhinitis	Rhinitis	postmarketing, 5% - 43%	5% - 36%															x		x	x	x	x
Tenderness	Tenderness	5%	3%					x			x
Dysuria	Micturition burning	5%	4%					x			x
Dysuria	Dysuria	postmarketing, 1% - 2%	1%															x		x	x	x	x
Nasopharyngitis	Nasopharyngitis	1.4% - 15%	3%									x								x	x	x
Nasopharyngitis	Rhinorrhoea	postmarketing																	x
Anorectal disorder	Rectal disorder	1% - 7%	2%															x		x			x
Anorectal disorder	Anorectal disorder	postmarketing																	x
Influenza like illness	Influenza like illness	postmarketing, 4%	4%									x							x
Colitis ulcerative	Colitis ulcerative	uncommon, 0.8% - 12%							x											x	x	x	x
Proctocolitis	Colitis ulcerative	uncommon, 0.8% - 12%							x											x	x	x	x
Diarrhoea	Diarrhoea	postmarketing — 0% - 40%	5% - 49%		x		x	x	x	x	x	x	x	x	x	x	x		x	x	x	x	x
Proctalgia	Rectal tenesmus	postmarketing, 6% - 7%	5%											x				x		x	x	x	x
Proctalgia	Proctalgia	postmarketing, 1.8% - 10%	0% - 3%	x	x			x			x			x					x
Rectal tenesmus	Rectal tenesmus	postmarketing, 6% - 7%	5%											x				x		x	x	x	x
Anorectal discomfort	Rectal tenesmus	postmarketing, 6% - 7%	5%											x				x		x	x	x	x
	Anal pruritus	postmarketing												x
	Anal discomfort	postmarketing																	x
	Anorectal discomfort	postmarketing												x
	Discomfort rectal												x
Abdominal pain	Abdominal pain	postmarketing — 1.5% - 66%	10% - 44%		x		x	x		x	x		x	x	x	x	x	x	x	x	x	x	x
Abdominal pain	Abdominal cramps	postmarketing												x					x
Gastrointestinal pain	Abdominal pain	postmarketing — 1.5% - 66%	10% - 44%		x		x	x		x	x		x	x	x	x	x	x	x	x	x	x	x
Gastrointestinal pain	Gastrointestinal pain	postmarketing																	x
Chest pain	Chest pain	postmarketing — 3% - 8%	2% - 6%												x	x	x		x	x	x	x	x
Colitis	Colitis	1.2% - 10%	0% - 8%	x										x
Colitis	Pancolitis	very rare											x
Dizziness	Dizziness	postmarketing — 0.7% - 15%	2.4% - 8%	x	x			x		x	x		x	x	x	x	x		x	x	x	x	x
Dizziness	Syncope																			x
Dysmenorrhoea	Dysmenorrhoea	postmarketing, 1% - 5%	2% - 3%																		x	x	x
Influenza	Influenza	0% - 14%	2% - 20%									x						x	x	x	x	x	x
Nausea	Nausea	postmarketing — 1.3% - 47%	3% - 15%		x		x	x		x	x	x	x	x	x	x	x		x	x	x	x	x
Sinusitis	Sinusitis	postmarketing, 0% - 7%	3% - 6%									x						x		x	x	x	x
Hyperhidrosis	Sweating	postmarketing, 3%	1%												x	x	x			x	x	x	x
Hyperhidrosis	Hyperhidrosis	postmarketing																	x
Chills	Chills	postmarketing, 3%	2%																	x	x	x	x
Oedema peripheral	Oedema peripheral	postmarketing, 3% - 5%	2% - 11%					x			x								x	x	x	x	x
Myalgia	Myalgia	very rare — 3% - 8%	1% - 5%										x		x	x	x		x	x	x	x	x
Nervous system disorder	Nervous system disorder	2% - 3%	0%						x	x			x						x
Lipase increased	Lipase increased	0% - 5%																		x
Liver function test abnormal	Liver function test abnormal	0.565% - 2.3%	1.12%				x
Anxiety	Anxiety	postmarketing, 2% - 3%	2%															x		x	x	x	x
Arthritis	Arthritis	postmarketing, 1% - 2%	0% - 2%																x	x	x	x	x
Arthritis	Rheumatoid arthritis	postmarketing																		x	x	x	x
Bronchitis	Bronchitis	postmarketing, 2% - 3%	2%															x			x	x	x
Conjunctivitis	Conjunctivitis	postmarketing, 2%	0%												x	x	x				x	x	x
Fatigue	Fatigue	postmarketing, 1% - 28%	8%					x	x		x	x		x					x	x
Arthropathy	Arthropathy	postmarketing, 2% - 3%	0%															x		x	x	x	x
Osteoarthritis	Arthropathy	postmarketing, 2% - 3%	0%															x		x	x	x	x
Pruritus	Pruritus	postmarketing — 0.565% - 10%	0% - 7%				x	x	x		x		x	x	x	x	x		x	x	x	x	x
Malaise	Malaise	postmarketing, 1% - 28%	1% - 8%					x			x				x	x	x			x	x	x	x
Feeling abnormal	Malaise	postmarketing, 1% - 28%	1% - 8%					x			x				x	x	x			x	x	x	x
Feeling abnormal	Confusional state	postmarketing																x		x	x	x	x
Ill-defined disorder	Malaise	postmarketing, 1% - 28%	1% - 8%					x			x				x	x	x			x	x	x	x
Cough	Cough increased	0.7% - 12%	1% - 16%																				x
Cough	Cough	very rare — 0% - 5%											x						x	x	x	x
Acne	Acne	1.2% - 3.5%	0% - 1%	x	x									x			x			x
Insomnia	Insomnia	postmarketing, 1% - 5%	0% - 5%					x			x				x	x	x		x		x	x	x
Dyspepsia	Dyspepsia	rare, 0.8% - 9%	1% - 9%												x	x	x			x	x	x	x
Dermatitis	Rash	postmarketing — 1% - 23%	0% - 4%	x	x		x	x	x	x	x		x	x	x	x	x	x	x	x	x	x	x
Rash	Rash	postmarketing — 1% - 23%	0% - 4%	x	x		x	x	x	x	x		x	x	x	x	x	x	x	x	x	x	x
Amblyopia	Amblyopia	1% - 2%	0%																				x
Epistaxis	Epistaxis	1% - 2%	0%																				x
Lacrimal disorder	Lacrimal disorder	1% - 2%	0%																				x
Lacrimal structural disorder	Lacrimal disorder	1% - 2%	0%																				x
Prostatic disorder	Prostatic disorder	1% - 2%	0%																				x
Vomiting	Vomiting	postmarketing — 0.6% - 6%	2% - 7%						x	x			x	x	x	x	x		x	x	x	x	x
Abdominal pain upper	Abdominal pain upper	postmarketing, 1.2% - 5%	3%									x							x	x
Asthma	Asthma	0% - 2%	0%
Asthma	Exacerbation of asthma	postmarketing																x		x	x	x	x
Cystitis	Cystitis	0% - 2%	0%																				x
Bladder pain	Cystitis	0% - 2%	0%																				x
Cystitis noninfective	Cystitis	0% - 2%	0%																				x
Hypertension	Hypertension	1%							x
Vaginal inflammation	Vaginal inflammation	0% - 2%	0%																				x
Vaginal infection	Vaginal inflammation	0% - 2%	0%																				x
Alanine aminotransferase increased	Alanine aminotransferase increased	0.565% - 1.12%	0%						x
Drug ineffective	Drug ineffective	uncommon
Crohn's disease	Crohns disease aggravated	uncommon
Agranulocytosis	Agranulocytosis	very rare, postmarketing				x					x	x	x	x	x	x	x	x	x	x	x	x	x
Alopecia	Alopecia	very rare — 0% - 7%	0%						x					x					x	x		x
Alopecia	Alopecia reversible
Alveolitis allergic	Alveolitis allergic	postmarketing											x	x	x	x	x
Anaphylactic shock	Anaphylactic shock	postmarketing
Anaemia	Anaemia	postmarketing				x					x		x		x	x	x	x		x	x	x	x
Aplastic anaemia	Aplastic anaemia	very rare, postmarketing				x	x				x	x	x	x	x	x	x	x		x	x	x	x
Angina pectoris	Angina pectoris	postmarketing																	x
Angioedema	Angioedema	postmarketing														x	x
Decreased appetite	Anorexia	postmarketing													x	x	x	x		x	x	x	x
Decreased appetite	Decreased appetite
Rheumatoid arthritis	Rheumatoid arthritis	postmarketing																		x	x	x	x
Atrial fibrillation	Atrial fibrillation	postmarketing																	x
Mental disorder	Mental disorder	postmarketing								x				x
Breast feeding	Breast feeding	postmarketing																	x
Neck pain	Neck pain	postmarketing																x	x	x	x	x	x
Cholecystitis	Cholecystitis	postmarketing										x						x		x	x	x	x
Coma	Coma	postmarketing																	x
Infection	Infection	postmarketing, 3.2% - 9%	3%															x	x	x	x	x	x
Confusional state	Confusional state	postmarketing																x		x	x	x	x
Connective tissue disorder	Connective tissue disorder	postmarketing							x	x
Libido decreased	Libido decreased	postmarketing																		x	x	x	x
Disturbance in sexual arousal	Libido decreased	postmarketing																		x	x	x	x
Delirium	Delirium	postmarketing																	x
Depression	Depression	postmarketing																x		x
Dysgeusia	Dysgeusia	postmarketing																x	x	x	x	x	x
Ear disorder	Ear disorder	postmarketing																x			x	x	x
Ear pain	Ear pain	postmarketing							x									x			x	x	x
Eating disorder	Eating disorder	postmarketing																	x
Oedema	Oedema	postmarketing													x	x	x	x		x	x	x	x
Eosinophilia	Eosinophilia	postmarketing, uncommon				x					x		x		x	x	x	x		x	x	x	x
Epididymitis	Epididymitis	postmarketing																x		x	x	x	x
Erythema nodosum	Erythema nodosum	postmarketing										x		x	x	x	x	x		x	x	x	x
Eye disorder	Eye disorder	postmarketing												x
Cardiac flutter	Cardiac flutter	postmarketing																	x
Gastritis	Gastritis	postmarketing										x						x		x	x	x	x
Gastroenteritis	Gastroenteritis	postmarketing, 2% - 5%	1%									x						x		x	x	x	x
Gastrointestinal disorder	Gastrointestinal disorder	postmarketing							x	x			x	x					x
Gastrointestinal disorder	Gastrointestinal symptom NOS																				x	x
Gastrointestinal haemorrhage	Gastrointestinal haemorrhage	postmarketing, 8% - 10%	8%									x		x	x	x	x	x		x	x	x	x
Glossodynia	Glossodynia	postmarketing																	x
Gout	Gout	postmarketing																x		x	x	x	x
Guillain-Barre syndrome	Guillain-Barre syndrome	postmarketing										x		x						x	x	x	x
Cardiac disorder	Cardiac disorder	postmarketing								x			x	x					x
Haematochezia	Haematochezia	postmarketing																	x
Haematuria	Haematuria	postmarketing, 0% - 3%	1%									x			x	x	x	x		x	x	x	x
Hepatitis	Hepatitis	very rare, postmarketing					x	x		x		x	x	x	x	x	x	x			x	x	x
Hepatitis toxic	Hepatitis toxic	postmarketing																	x
Hyperaesthesia	Hyperaesthesia	postmarketing																x		x	x	x	x
Hypocalcaemia	Hypocalcaemia	postmarketing																	x
Hypotension	Hypotension	postmarketing							x										x
Immune system disorder	Immune system disorder	postmarketing											x
Jaundice	Jaundice	postmarketing										x		x	x	x	x	x			x	x
Jaundice cholestatic	Jaundice cholestatic	postmarketing										x		x	x	x	x	x			x	x
Nephropathy	Nephropathy	postmarketing										x		x					x
Renal failure acute	Renal failure acute	postmarketing													x	x	x		x
Renal failure chronic	Renal failure chronic	postmarketing													x	x	x		x
Leukopenia	Leukopenia	very rare, postmarketing					x						x		x	x	x	x		x	x	x	x
Liver disorder	Liver disorder	postmarketing												x
Liver disorder	Hepatic impairment													x
Hepatocellular injury	Liver disorder	postmarketing												x
Hepatocellular injury	Hepatocellular injury	postmarketing													x	x	x	x			x	x
Foetor hepaticus	Liver disorder	postmarketing												x
Malabsorption	Malabsorption	postmarketing																	x
Mediastinal disorder	Mediastinal disorder	postmarketing							x	x				x					x
Menorrhagia	Menorrhagia	postmarketing													x	x	x	x		x	x	x	x
Musculoskeletal pain	Musculoskeletal pain	postmarketing																	x
Myelitis transverse	Myelitis transverse	postmarketing										x		x				x		x	x	x	x
Myocarditis	Myocarditis	postmarketing, rare										x		x	x	x	x	x	x	x	x	x	x
Tubulointerstitial nephritis	Nephritis interstitial	postmarketing								x				x	x	x	x	x	x	x	x	x	x
Tubulointerstitial nephritis	Chronic interstitial nephritis	very rare					x	x					x
Glomerulonephritis minimal lesion	Lipoid nephrosis	postmarketing																x		x	x	x	x
Azoospermia	Oligospermia	very rare, postmarketing				x					x	x	x	x						x
Palpitations	Palpitations	postmarketing													x	x	x		x				x
Pancreatitis	Pancreatitis	postmarketing	0%	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Paraesthesia	Paraesthesia	postmarketing, 0% - 5%	5%												x	x	x	x		x	x	x	x
Peptic ulcer perforation	Peptic ulcer perforation	postmarketing										x						x		x	x	x	x
Pericardial effusion	Pericardial effusion	postmarketing										x		x							x	x
Pericarditis	Pericarditis	postmarketing, rare	0%				x	x				x	x	x	x	x	x	x	x	x	x	x	x
Pericarditis constrictive	Pericarditis constrictive	postmarketing																	x
Neuropathy peripheral	Neuropathy peripheral	very rare, postmarketing										x	x	x				x		x	x	x	x
Neuropathy peripheral	Neuropathy						x
Pleurisy	Pleurisy	postmarketing								x								x		x	x	x	x
Pneumonia aspiration	Pneumonia aspiration	postmarketing																	x
Anal pruritus	Anal pruritus	postmarketing												x
Pruritus genital	Anal pruritus	postmarketing												x
Psoriasis	Psoriasis	postmarketing										x		x				x		x	x	x	x
Pulmonary eosinophilia	Pulmonary eosinophilia	very rare, postmarketing											x	x
Pyoderma	Pyoderma	postmarketing																		x
Dermatitis infected	Pyoderma	postmarketing																		x
Renal failure	Renal failure	very rare, postmarketing								x				x				x		x	x	x	x
Renal failure	Renal impairment	very rare											x	x							x	x
Reye's syndrome	Reye's syndrome	postmarketing																	x
Steatorrhoea	Steatorrhoea	postmarketing																	x
Erythema multiforme	Stevens-Johnson syndrome	postmarketing
Stevens-Johnson syndrome	Stevens-Johnson syndrome	postmarketing
Stomatitis	Stomatitis	postmarketing																		x	x	x	x
Stomatitis	Mouth ulceration	postmarketing													x	x	x	x		x	x	x	x
Sinus tachycardia	Sinus tachycardia	postmarketing																	x
Thrombocytopenia	Thrombocytopenia	very rare, postmarketing				x	x				x		x	x	x	x	x	x		x	x	x	x
Thrombosis	Thrombosis	postmarketing																	x
Tinnitus	Tinnitus	postmarketing										x						x		x	x	x	x
Tremor	Tremor	postmarketing							x									x	x	x	x	x	x
Erythema	Erythema	postmarketing												x					x
Pollakiuria	Pollakiuria	postmarketing													x	x	x	x		x	x	x
Pollakiuria	Micturition urgency	postmarketing																x		x			x
Urticaria	Urticaria	postmarketing — 0% - 2%	1%				x		x				x	x	x	x	x	x	x	x	x	x	x
Vasodilation procedure	Vasodilation	postmarketing													x	x	x	x		x	x	x	x
Vertigo	Vertigo	postmarketing										x						x		x	x	x	x
Weight decreased	Weight decreased	postmarketing																	x
Dry mouth	Dry mouth	postmarketing, 1% - 2%	0%															x		x	x	x	x
Acute febrile neutrophilic dermatosis	Acute febrile neutrophilic dermatosis	postmarketing																	x
Hepatic failure	Hepatic failure	postmarketing										x	x	x	x	x	x	x			x	x
Micturition urgency	Micturition urgency	postmarketing																x		x			x
Burning sensation	Burning sensation	postmarketing																	x
Mood swings	Mood swings	postmarketing								x								x		x	x	x	x
Affect lability	Mood swings	postmarketing								x								x		x	x	x	x
Rash pustular	Rash pustular	postmarketing																	x
Pyoderma gangrenosum	Pyoderma gangrenosum	postmarketing										x		x				x			x	x	x
Mouth ulceration	Mouth ulceration	postmarketing													x	x	x	x		x	x	x	x
Migraine	Migraine	postmarketing																x		x	x	x	x
Blood urea increased	Blood urea increased	postmarketing																	x
Diarrhoea haemorrhagic	Diarrhoea haemorrhagic	postmarketing														x	x	x		x	x	x	x
Tongue discolouration	Tongue discolouration	postmarketing																	x
Tongue disorder	Tongue oedema	postmarketing																	x
Tongue oedema	Tongue oedema	postmarketing																	x
Kidney fibrosis	Kidney fibrosis	postmarketing																	x
Hypomagnesaemia	Hypomagnesaemia	postmarketing																	x
Blood lactate dehydrogenase increased	Lactic dehydrogenase activity increased	postmarketing																x		x	x	x
Liver injury	Hepatocellular injury	postmarketing													x	x	x	x			x	x
Hepatic necrosis	Hepatic necrosis	postmarketing										x		x	x	x	x	x			x	x
Skin necrosis	Skin necrosis	postmarketing																	x
Skin exfoliation	Skin necrosis	postmarketing																	x
Eye pain	Eye pain	postmarketing																x		x	x	x	x
Blood alkaline phosphatase increased	Phosphatase alkaline increased	postmarketing													x	x	x	x		x	x	x	x
Aspartate aminotransferase increased	Aspartate aminotransferase increased	postmarketing																x		x	x	x	x
Skin discolouration	Skin discolouration	postmarketing																	x
Dry skin	Dry skin	postmarketing													x	x	x	x		x	x	x	x
Interstitial lung disease	Interstitial pneumonia	very rare, postmarketing										x		x				x		x	x	x	x
	Interstitial lung disease												x
	Lung fibrosis interstitial														x	x	x
Rectal discharge	Rectal discharge	postmarketing												x					x
Increased appetite	Increased appetite	postmarketing																x		x	x	x	x
Abdominal discomfort	Abdominal discomfort	postmarketing																	x
Abdominal discomfort	Upset stomach	postmarketing												x
Rash erythematous	Rash erythematous	postmarketing											x						x
Faeces discoloured	Faeces discoloured	postmarketing												x					x
Hepatotoxicity	Hepatotoxicity	postmarketing											x			x	x	x			x	x
Condition aggravated	Condition aggravated	postmarketing, uncommon																	x
Dyschezia	Dyschezia	postmarketing												x					x
Frequent bowel movements	Frequent bowel movements	postmarketing												x
Mucous stools	Mucous stools	postmarketing												x
Rectal haemorrhage	Rectal haemorrhage	postmarketing, 2% - 4%	5%									x			x	x	x	x	x	x	x	x	x
Eye swelling	Eye swelling	postmarketing												x
Blood bilirubin increased	Blood bilirubin increased	postmarketing																x		x	x	x
Blood bilirubin increased	Bilirubin total increased								x
Vision blurred	Vision blurred	postmarketing																x	x	x	x	x	x
Defaecation urgency	Defaecation urgency	postmarketing														x	x		x
Musculoskeletal stiffness	Stiffness	postmarketing																	x
Lymphadenopathy	Lymphadenopathy	postmarketing																x		x	x	x	x
Rash generalised	Rash generalised	postmarketing																	x
Chromaturia	Chromaturia	postmarketing																	x
Chromaturia	Urine color abnormal												x
Face oedema	Face oedema	postmarketing							x									x		x	x	x	x
Ear congestion	Ear congestion	postmarketing																			x	x	x
Blood creatinine abnormal	Blood creatinine abnormal	postmarketing																	x
Rectal spasm	Rectal cramps	postmarketing																	x
Lupus-like syndrome	Lupus-like syndrome	postmarketing								x		x		x				x		x	x	x	x
Medication residue present	Medication residue	postmarketing												x					x
Rhinorrhoea	Rhinorrhoea	postmarketing																	x
Lichenoid keratosis	Lichenoid keratosis	postmarketing																	x
Parosmia	Parosmia	postmarketing																	x
Eosinophilic pneumonia	Eosinophilic pneumonia	very rare, postmarketing								x		x						x	x	x	x	x	x
Somnolence	Somnolence	postmarketing, 0% - 2%	3%						x						x	x	x	x		x	x	x	x
Feeling hot	Feeling hot	postmarketing																	x
Dyspnoea	Dyspnoea	very rare, postmarketing										x	x		x	x	x		x				x
Blood disorder	Blood disorder	very rare, postmarketing												x
Neutropenia	Neutropenia	very rare, postmarketing				x	x				x		x						x
Lung infiltration	Lung infiltration	very rare, postmarketing											x		x	x	x		x
Pancreatitis acute	Pancreatitis acute	very rare						x					x
Bronchospasm	Bronchospasm	very rare								x			x
Cholestasis	Cholestasis	very rare											x
Hypersensitivity	Hypersensitivity	very rare					x	x		x			x	x	x	x	x		x		x	x	x
Lung disorder	Lung disorder	very rare, 0% - 3%	0%																				x
Nephrotic syndrome	Nephrotic syndrome	very rare								x			x		x	x	x
Pancytopenia	Pancytopenia	very rare				x					x		x		x	x	x
Pancytopenia	Bone marrow depression	very rare								x
Pneumonia	Pneumonia	very rare											x		x	x	x						x
Hepatitis cholestatic	Hepatitis cholestatic	very rare										x	x
Systemic lupus erythematosus	Lupus erythematosus	very rare											x
Systemic lupus erythematosus	Systemic lupus erythematosus														x	x	x
Alveolitis	Alveolitis	very rare
Dermatitis atopic	Allergic exanthema	very rare
Dermatitis atopic	Dermatitis atopic									x
Renal impairment	Renal impairment	very rare											x	x							x	x
Adenovirus infection	Adenovirus infection																			x
Albuminuria	Albuminuria														x	x	x
Amenorrhoea	Amenorrhoea														x	x	x
Blister	Blister
Dermatitis bullous	Blister
Bone disorder	Bone disorder												x
Breast disorder	Breast disorder
Obliterative bronchiolitis	Obliterative bronchiolitis														x	x	x
Candida infection	Oral candidiasis														x	x	x
Oral candidiasis	Oral candidiasis														x	x	x
Vulvovaginal candidiasis	Vaginal moniliasis																						x
Vulvovaginal mycotic infection	Vaginal moniliasis																						x
Cholangitis sclerosing	Cholangitis sclerosing																			x
Cholelithiasis	Cholelithiasis
Deafness	Deafness																						x
Dysphagia	Dysphagia														x	x	x
Duodenal ulcer	Duodenal ulcer														x	x	x
Ecchymosis	Ecchymosis														x	x	x
Eczema	Eczema														x	x	x
Faecal incontinence	Faecal incontinence														x	x	x
Haemorrhage	Haemorrhage
Haemoglobin	Haemorrhage
Hirsutism	Hirsutism
Hypomenorrhoea	Hypomenorrhoea														x	x	x
Orthostatic hypotension	Orthostatic hypotension
Infertility	Infertility					x					x
Intestinal obstruction	Intestinal obstruction
Lethargy	Lethargy																			x
Leukocytosis	Leukocytosis					x					x
Lichen planus	Lichen planus														x	x	x
Breast pain	Breast pain														x	x	x
Melaena	Melaena															x	x
Metrorrhagia	Metrorrhagia														x	x	x
Myelitis	Myelitis
Nail disorder	Nail disorder														x	x	x
Nephritis	Nephritis												x
Pleural effusion	Pleural effusion							x											x
Proteinuria	Proteinuria
Protein urine present	Proteinuria
Prurigo	Prurigo								x
Rectal polyp	Rectal polyp								x
Scotoma	Scotoma
Shock	Shock
Shock	Syncope																			x
Syncope	Syncope																			x
Loss of consciousness	Syncope																			x
Tachycardia	Tachycardia								x
Thirst	Thirst														x	x	x
Upper respiratory tract infection	Upper respiratory tract infection							x											x
Urinary tract infection	Urinary tract infection																		x				x
Micturition disorder	Micturition disorder
Urethral disorder	Urinary tract disorder									x			x
Urinary tract disorder	Urinary tract disorder									x			x
Angiopathy	Angiopathy
Weight increased	Weight increased
Acute interstitial pneumonitis	Hamman-Rich syndrome			x	x	x					x
Idiopathic pulmonary fibrosis	Hamman-Rich syndrome			x	x	x					x
Amylase increased	Amylase increased												x							x
Amylase increased	Serum amylase increased
Creatinine renal clearance decreased	Creatinine renal clearance decreased											x
Red blood cell sedimentation rate increased	Red blood cell sedimentation rate increased
Gamma-glutamyltransferase increased	Gamma-glutamyltransferase increased														x	x	x
Oesophageal ulcer	Oesophageal ulcer														x	x	x
Skin disorder	Unspecified disorder of skin and subcutaneous tissue									x			x						x
Body mass index decreased	Body mass index decreased																			x
Abdominal pain lower	Abdominal pain lower											x
Disorientation	Disorientation																			x
Abnormal dreams	Abnormal dreams
Blood creatinine increased	Blood creatinine increased
Urine abnormality	Urine abnormality																						x
Urine analysis abnormal	Urine abnormality																						x
Hepatic enzyme increased	Hepatic enzyme increased			x	x	x					x				x	x	x
Hepatobiliary disease	Hepatobiliary disease								x	x			x
Dry eye	Dry eye
Photosensitivity reaction	Photosensitivity														x	x	x
Platelet count decreased	Platelet count decreased								x
Transaminases increased	Transaminases increased											x
Nephropathy toxic	Nephrotoxicity			x	x	x					x
Haematocrit decreased	Haematocrit decreased											x
Thrombocytosis	Thrombocytosis					x					x				x	x	x
Infestation	Infestation NOS																		x
Administration site reaction	Administration site reaction																		x
Sperm concentration decreased	Sperm count decreased						x
Local reaction	Local reaction												x
Laryngeal pain	Pharyngolaryngeal pain								x										x
Blood methaemoglobin present	Blood methaemoglobin present									x
Pleuropericarditis	Pleuropericarditis									x

Indication	Labels
Acute ulcerative colitis				x
Alopecia	x	x	x					x
Aphagia																		x
Colitis									x
Colitis ulcerative			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Crohn's disease							x		x	x	x	x
Generalized illness														x
Inflammatory bowel disease													x
Proctitis			x					x
Proctitis ulcerative	x	x			x				x
Proctosigmoiditis			x					x
Ulcerative (chronic) proctosigmoiditis									x

Side effects:	10
Source:	FDA

Side effects:	14
Source:	FDA Structured Product Label

Side effects:	15
Source:	FDA Structured Product Label

Side effects:	19
Source:	Health Canada

Search results :

5-ASA

Side effects

Indications

MESALAMINE / CANASA

MESALAMINE

MESALAMINE

MESALAZINE / MESASAL

MESALAZINE / SALOFALK (R) 5-ASA SUPPOSITORIES - 500MG

MESALAMINE / LIALDA

Mesalazine (5-aminosalicylic acid) gastro-resistant tablets / Asamax 500, Enteric coated tablet

Mesalamine

MESALAMINE

mesalazine / Pentasa, Suppository

MESALAMINE

MESALAMINE

MESALAMINE

MESALAMINE

MESALAMINE

MESALAZINE / SALOFALK (R) 2GM/60GM RECTAL SUSPENSION

MESALAMINE

MESALAMINE / ASACOL HD

MESALAMINE

MESALAZINE / ASACOL 800

Color scheme:

		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