Asacol

Asacol Adverse Reactions

mesalazine

Manufacturer:

Tillotts

Distributor:

Associated Medical Supplies
Full Prescribing Info
Adverse Reactions
Dose-dependent hypersensitivity reactions such as fever1, bronchospasm1 or alopecia1 can occur rarely1. Alopecia can also be a rare extra-intestinal manifestation of chronic inflammatory bowel disease. Other rare1 adverse reactions are predominantly gastrointestinal, including diarrhoea and abdominal pain.
Adverse reactions which occur rarely very rarely2 are listed by system organ class.
Blood and lymphatic: Blood dyscrasia, bone marrow depression with leukopenia, neutropenia, thrombocytopenia, pancytopenia up to aplastic anemia.
Nervous system: Headache, vertigo, arthralgia.
Cardiac: Myocarditis, pericarditis.
Muscles: Myalgia.
Respiratory: Allergic lung reactions, bronchospasm, eosinophilic penumonia.
Digestive: Nausea, vomiting, pancreatitis, hepatitis, exacerbation of the symptoms of colitis.
Skin and appendages: Mesalazine-induced lupus-erythematodes-like symptoms with pericarditis and pleuroperi-carditis as prominent symptoms as well as rash and arthralgia.
Renal & urinary: Interstitial nephritis, nephrotic syndrome. Renal failure, which may be reversible on withdrawal.
Patients should immediately inform their physician if they experience any of these changes or other signs of illness.
1rare: one adverse reaction in 1000 to 10,000 treatment years.
2very rare: less than one adverse reaction per 10,000 treatment years.
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