Aminosalicylic acid Side Effects

Some side effects of aminosalicylic acid may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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:

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

• Abdominal pain (severe)
• backache
• headache
• lower back pain
• pain or burning while urinating
• paleness of skin
• sore throat
• yellow eyes or skin

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

• 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:

• Diarrhea
• loss of appetite
• nausea and vomiting
• stomach pain (mild)

For Healthcare Professionals

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

Gastrointestinal

Gastrointestinal side effects have been reported the most frequently. These have included nausea, vomiting, and abdominal pain.

The incidence of gastrointestinal side effects is reduced with lower doses (8 g daily) and with the granular formulation of the drug.

Hypersensitivity

Hypersensitivity side effects have been reported rarely. The first signs have included rash, often followed by fever, and much less frequently, anorexia, nausea or diarrhea. The drug has been restarted in small but gradually increasing doses under a closely followed desensitization protocol.

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.

Hepatic side effects have included jaundice and hepatitis. In patients diagnosed with hepatitis, hepatomegaly was invariably present with lymphadenopathy (45%), leukocytosis (79%), and eosinophilia (55%). Prompt recognition of symptoms with discontinuation of therapy led to recovery. Failure to recognize symptoms of liver injury can result in a mortality of up to 21%.

Endocrine

A reduction in thyroxine synthesis has been associated with the administration of the sodium salt of aminosalicylic acid. The development of goiter can be prevented by the administration of thyroxine but not iodide.

Endocrine side effects have included hypothyroidism, especially with prolonged administration. It may be accompanied by goiter development.

Hematologic

Hematologic side effects have included leukopenia, agranulocytosis, thrombocytopenia, Coombs' positive hemolytic anemia, and reduction in prothrombin.

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