Pyrazinamide Recall

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Questions & Answers

Side Effects & Adverse Reactions

Patients started on pyrazinamide should have baseline serum uric acid and liver function determinations. Those patients with preexisting liver disease or those at increased risk for drug related hepatitis (e.g., alcohol abusers) should be followed closely.

Pyrazinamide should be discontinued and not be resumed if signs of hepatocellular damage or hyperuricemia accompanied by an acute gouty arthritis appear.


Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


Pyrazinamide is indicated for the initial treatment of active tuberculosis in adults and children when combined with other antituberculous agents. (The current recommendation of the CDC for drug-susceptible disease is to use a six-month regimen for initial treatment of active tuberculosis, consisting of isoniazid, rifampin and pyrazinamide given for 2 months, followed by isoniazid and rifampin for 4 months.* 4)

(Patients with drug-resistant disease should be treated with regimens individualized to their situation. Pyrazinamide frequently will be an important component of such therapy.)

(In patients with concomitant HIV infection, the physician should be aware of current recommendations of CDC. It is possible these patients may require a longer course of treatment.)

It is also indicated after treatment failure with other primary drugs in any form of active tuberculosis.

Pyrazinamide should only be used in conjunction with other effective antituberculous agents.

*See recommendations of Center for Disease Control (CDC) and American Thoracic Society for complete regimen and dosage recommendations. 4



There is currently no drug history available for this drug.

Other Information

Pyrazinamide, the pyrazine analogue of nicotinamide, is an antituberculous agent. It is a white crystalline powder, stable at room temperature, and sparingly soluble in water. Pyrazinamide has the following structural formula:


C5H5N3O              M.W. 123.11

Each Pyrazinamide tablet for oral administration contains 500 mg of pyrazinamide and the following inactive ingredients: Corn Starch, Magnesium Stearate, Pregelatinized Starch and Stearic Acid.


Pyrazinamide Manufacturers

  • Remedyrepack Inc.
    Pyrazinamide Tablet [Remedyrepack Inc. ]
  • Mikart, Inc.
    Pyrazinamide Tablet [Mikart, Inc.]
  • Remedyrepack Inc.
    Pyrazinamide Tablet [Remedyrepack Inc. ]
  • Versapharm Incorporated
    Pyrazinamide Tablet [Versapharm Incorporated]
  • Remedyrepack Inc.
    Pyrazinamide Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Pyrazinamide Tablet [Remedyrepack Inc. ]
  • Dava Pharmaceuticals, Inc.
    Pyrazinamide Tablet [Dava Pharmaceuticals, Inc.]
  • American Health Packaging
    Pyrazinamide Tablet [American Health Packaging]

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