pyrazinamide

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: pyrazinamide
Generic name: PYRAZINAMIDE
Manufacturer: Hikma Pharmaceuticals USA Inc
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 566db230-3d73-482f-b67d-defd0b2dc46c
SPL ID: 05eb3847-557f-460c-951f-e614fb9f9045
Version: 2
Effective date: 2023-10-03
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:24:23

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 18 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	081319	derived:openfda.application_number
application number		ANDA081319	openfda.application_number
brand name		pyrazinamide	openfda.brand_name
generic name		PYRAZINAMIDE	openfda.generic_name
manufacturer name		Hikma Pharmaceuticals USA Inc	openfda.manufacturer_name
ndc	package	0054-0812-25	openfda.package_ndc
ndc	package	0054-0812-29	openfda.package_ndc
ndc	package	0054-0812-22	openfda.package_ndc
ndc	package	0054-0812-21	openfda.package_ndc
ndc	product	0054-0812	openfda.product_ndc
ndc11	package	00054081221	derived:openfda.package_ndc
ndc11	package	00054081229	derived:openfda.package_ndc
ndc11	package	00054081225	derived:openfda.package_ndc
ndc11	package	00054081222	derived:openfda.package_ndc
rxcui		198181	openfda.rxcui
spl id		05eb3847-557f-460c-951f-e614fb9f9045	id
spl set id		566db230-3d73-482f-b67d-defd0b2dc46c	set_id
unii		2KNI5N06TI	openfda.unii

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS 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 cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS 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 pruritis have been reported. Fever, acne, photosensitivity, porphyria, dysuria and interstitial nephritis have been reported rarely.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.