Aminosalicylic acid Side Effects
Medically reviewed by Drugs.com. Last updated on July 15, 2020.
More frequently reported side effects include: eosinophilia and leukocytosis. See below for a comprehensive list of adverse effects.
For the Consumer
Applies to aminosalicylic acid: oral delayed-release granules
Side effects include:
For Healthcare Professionals
Applies to aminosalicylic acid: compounding powder, oral granule enteric coated
Gastrointestinal intolerance was manifested by abdominal pain, diarrhea, nausea, and vomiting.[Ref]
Common (1% to 10%): Abdominal pain, bloating, diarrhea, gastrointestinal intolerance, nausea, soft stools, vomiting
Common (1% to 10%): Giddiness, vestibular syndrome
Rare (0.01% to 0.1%): Metallic taste
Common (1% to 10%): Cutaneous hypersensitivity, skin rash
Rare (0.01% to 0.1%): Urticaria
Very rare (less than 0.01%): Purpura
Frequency not reported: Exfoliative dermatitis, skin eruptions of various types[Ref]
Hypothyroidism most commonly occurred in patients with HIV, especially when this drug was given with ethionamide or prothionamide. When patients without HIV were given this drug, hypothyroidism rarely occurred.[Ref]
Common (1% to 10%): Hypothyroidism[Ref]
Uncommon (0.1% to 1%): Anorexia
Patients should be closely monitored during the first three months of therapy and treatment must be discontinued immediately at the first signs of rash, fever, jaundice, or other sign of intolerance.[Ref]
Rare (0.01% to 0.1%): Jaundice
Very rare (less than 0.01%): Hepatocytolysis, increased blood alkaline phosphatase, increased transaminases
Frequency not reported: Hepatitis[Ref]
Very rare (less than 0.01%): Crystalluria[Ref]
Very rare (less than 0.01%): Visual abnormalities[Ref]
Very rare (less than 0.01%): Tendon pain[Ref]
Frequency not reported: Hypersensitivity reactions[Ref]
Frequency not reported: Loeffler's syndrome[Ref]
Frequency not reported: Fever[Ref]
1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
2. "Product Information. Paser Granules (aminosalicylic acid)." Jacobus Pharmaceutical Company, Princeton, NJ.
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Some side effects may not be reported. You may report them to the FDA.