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Aminosalicylic acid Side Effects

In Summary

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 tablet

Along with its needed effects, aminosalicylic acid may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking aminosalicylic acid:

More Common

  • Fever
  • joint pains
  • skin rash or itching
  • unusual tiredness or weakness

Less Common

Check with your doctor as soon as possible if any of the following side effects occur while taking aminosalicylic acid:

Less Common

- with long-term, high-dose therapy
  • Changes in menstrual periods
  • decreased sexual ability in males
  • dry, puffy skin
  • swelling of front part of neck
  • weight gain (unusual)

Some side effects of aminosalicylic acid may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

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

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]

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]

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]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Paser Granules (aminosalicylic acid)." Jacobus Pharmaceutical Company, Princeton, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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