pharmacopeia
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/api/v1/drug/pyrazinamide

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Unknown Cellular or Molecular Interaction.

Indications

Sourced from openFDA
  • & USAGE 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.ICD-10: A15.9

Contraindications

Sourced from openFDA
  • Pyrazinamide is contraindicated in persons: with severe hepatic damage. who have shown hypersensitivity to it.contraindicated

Dosage & administration

Sourced from openFDA

DOSAGE & ADMINISTRATION Pyrazinamide should always be administered with other effective antituberculous drugs. It is administered for the initial 2 months of a 6-month or longer treatment regimen for drug-susceptible patients. Patients who are known or suspected to have drug-resistant disease should be treated with regimens individualized to their situation. Pyrazinamide frequently will be an important component of such therapy. Patients with concomitant HIV infection may require longer courses of therapy. Physicians treating such patients should be alert to any revised recommendations from CDC for this group of patients. Usual dose: Pyrazinamide is administered orally, 15 to 30 mg/kg once daily. Older regimens employed 3 to 4 divided doses daily, but most current recommendations are for once a day. Three grams per day should not be exceeded. The CDC recommendations do not exceed 2 g per day when given as a daily regimen (see table). Alternatively, a twice weekly dosing regimen (50 to 70 mg/kg twice weekly based on lean body weight) has been developed to promote patient compliance with a regimen on an outpatient basis. In studies evaluating the twice weekly regimen, doses of pyrazinamide in excess of 3 g twice weekly have been administered. This exceeds the recommended maximum 3 g/daily dose. However, an increased incidence of adverse reactions has not been reported.

Warnings & precautions

Sourced from openFDA

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.

Adverse reactions

Sourced from openFDA

General Fever, porphyria and dysuria have rarely been reported. Gout (see PRECAUTIONS ). Gastrointestinal The principal adverse effect is a hepatic reaction (see WARNINGS ). Hepatotoxicity appears to be dose related, and may appear at any time during therapy. GI disturbances including nausea, vomiting and anorexia have also been reported. Hematologic and Lymphatic Thrombocytopenia and sideroblastic anemia with erythroid hyperplasia, vacuolation of erythrocytes and increased serum iron concentration have occurred rarely with this drug. Adverse effects on blood clotting mechanisms have also been rarely reported. Other Mild arthralgia and myalgia have been reported frequently. Hypersensitivity reactions including rashes, urticaria, and pruritus have been reported. Fever, acne, photosensitivity, porphyria, dysuria and interstitial nephritis have been reported rarely.

Use in specific populations

Sourced from openFDA

PREGNANCY Teratogenic Effects – Pregnancy Category C Animal reproduction studies have not been conducted with pyrazinamide. It is also not known whether pyrazinamide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pyrazinamide should be given to a pregnant woman only if clearly needed.

Overdosage

Sourced from openFDA

Overdosage experience is limited. In one case report of overdose, abnormal liver function tests developed. These spontaneously reverted to normal when the drug was stopped. Clinical monitoring and supportive therapy should be employed. Pyrazinamide is dialyzable. 13

Approval history

Sourced from openFDA
  • Jun 3, 1971ANDAANDA080157Novitium Pharma
  • Jun 30, 1992ANDAANDA081319Hikma
  • Jul 27, 2020ANDAANDA212541Macleods Pharms Ltd

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
9,209 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Reaction With Eosinophilia And Systemic Symptoms6687.3%
  2. 2Drug-induced Liver Injury6477.0%
  3. 3Pyrexia5966.5%
  4. 4Drug Interaction5866.4%
  5. 5Paradoxical Drug Reaction5125.6%
  6. 6Off Label Use5035.5%
  7. 7Drug Ineffective4815.2%
  8. 8Vomiting4805.2%
  9. 9Tuberculosis3954.3%
  10. 10Nausea3914.2%
  11. 11Anaemia3684.0%
  12. 12Hepatotoxicity3603.9%
  13. 13Drug Resistance3533.8%
  14. 14Condition Aggravated3273.6%
  15. 15Neuropathy Peripheral2753.0%

Literature

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Recent PubMed references pinned to Pyrazinamide as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 203 ClinicalTrials.gov registrations naming Pyrazinamide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Pyrazinamide work?
Mechanism-of-action class: Unknown Cellular or Molecular Interaction.
What is Pyrazinamide used for?
According to FDA labeling, Pyrazinamide carries indications including: & USAGE 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Pyrazinamide?
Pyrazinamide is classified as Other drugs for treatment of tuberculosis, Antimycobacterial, Unknown Cellular or Molecular Interaction, Unknown Physiological Effect.
What are the contraindications for Pyrazinamide?
Pyrazinamide labeling lists contraindications including: Pyrazinamide is contraindicated in persons: with severe hepatic damage. who have shown hypersensitivity to it.. Always consult the full prescribing information and a clinician.
Note. Data for pyrazinamide is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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