Paser Side Effects

Generic Name: aminosalicylic acid

Note: This page contains side effects data for the generic drug aminosalicylic acid. It is possible that some of the dosage forms included below may not apply to the brand name Paser.

It is possible that some side effects of Paser may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to aminosalicylic acid: oral tablet

As well as its needed effects, aminosalicylic acid (the active ingredient contained in Paser) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking aminosalicylic acid, check with your doctor immediately:

More common
  • Fever
  • joint pains
  • skin rash or itching
  • unusual tiredness or weakness
Less common
  • Abdominal pain (severe)
  • backache
  • headache
  • lower back pain
  • pain or burning while urinating
  • paleness of skin
  • sore throat
  • yellow eyes or skin

If any of the following side effects occur while taking aminosalicylic acid, check with your doctor or nurse as soon as possible:

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 aminosalicylic acid side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • 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.[Ref]

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

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.[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]

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%.[Ref]

Endocrine

A reduction in thyroxine synthesis has been associated with the administration of the sodium salt of aminosalicylic acid (the active ingredient contained in Paser) The development of goiter can be prevented by the administration of thyroxine but not iodide.[Ref]

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

Hematologic

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

References

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

2. American Thoracic Society, CDC, Infectious Diseases Society of America "Treatment of tuberculosis." MMWR Morb Mortal Wkly Rep 53 (2005): 1203

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