Summary

More frequently reported side effects include: eosinophilia and leukocytosis. Continue reading for a comprehensive list of adverse effects.

Applies to aminosalicylic acid: oral delayed-release granules.

Side effects include:

GI effects (nausea, vomiting, abdominal pain, diarrhea).

For Healthcare Professionals

Applies to aminosalicylic acid: compounding powder, oral granule enteric coated.

Gastrointestinal

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

Rare (0.01% to 0.1%): Gastrointestinal bleeding, malabsorption syndrome, peptic ulcer^[Ref]

Nervous system

Common (1% to 10%): Giddiness, vestibular syndrome

Rare (0.01% to 0.1%): Metallic taste

Very rare (less than 0.01%): Dizziness, headache, peripheral neuropathy

Frequency not reported: Encephalopathy, optic neuritis^[Ref]

Dermatologic

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]

Endocrine

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]

Metabolic

Uncommon (0.1% to 1%): Anorexia

Very rare (less than 0.01%): Hypoglycemia, weight loss^[Ref]

Hepatic

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]

Hematologic

Very rare (less than 0.01%): Agranulocytosis, anemia, decreased prothrombin level, leukopenia, methemoglobinemia, thrombocytopenia

Frequency not reported: Coombs' positive hemolytic anemia, lymphoma-like syndrome^[Ref]

Genitourinary

Very rare (less than 0.01%): Crystalluria^[Ref]

Ocular

Very rare (less than 0.01%): Visual abnormalities^[Ref]

Musculoskeletal

Very rare (less than 0.01%): Tendon pain^[Ref]

Cardiovascular

Frequency not reported: Pericarditis, vasculitis^[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions^[Ref]

Immunologic

Frequency not reported: Infectious mononucleosis-like skin eruptions^[Ref]

Respiratory

Frequency not reported: Loeffler's syndrome^[Ref]

Other

Frequency not reported: Fever^[Ref]