Isoniazid adverse reactions

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Isoniazid
ISONIAZID® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Overdosage
Dosage and Administration
How Supplied

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]

Adverse Reactions

The most frequent reactions are those affecting the nervous system and the liver.

Nervous System Reactions

Peripheral neuropathy is the most common toxic effect. It is dose-related, occurs most often in the malnourished and in those predisposed to neuritis (e.g., alcoholics and diabetics), and is usually preceded by paresthesias of the feet and hands. The incidence is higher in “slow inactivators”.

Other neurotoxic effects, which are uncommon with conventional doses, are convulsions, toxic encephalopathy, optic neuritis and atrophy, memory impairment and toxic psychosis.

Hepatic Reactions

See boxed warning. Elevated serum transaminase (SGOT; SGPT), bilirubinemia, bilirubinuria, jaundice and occasionally severe and sometimes fatal hepatitis. The common prodromal symptoms of hepatitis are anorexia, nausea, vomiting, fatigue, malaise and weakness. Mild hepatic dysfunction, evidenced by mild and transient elevation of serum transaminase levels occurs in 10 to 20 percent of patients taking isoniazid. This abnormality usually appears in the first 1 to 3 months of treatment but can occur at any time during therapy. In most instances, enzyme levels return to normal, and generally, there is no necessity to discontinue medication during the period of mild serum transaminase elevation. In occasional instances, progressive liver damage occurs, with accompanying symptoms. If the SGOT value exceeds three to five times the upper limit of normal, discontinuation of the isoniazid should be strongly considered. The frequency of progressive liver damage increases with age. It is rare in persons under 20, but occurs in up to 2.3 percent of those over 50 years of age.

Gastrointestinal Reactions

Nausea, vomiting and epigastric distress.

Hematologic Reactions

Agranulocytosis; hemolytic, sideroblastic or aplastic anemia; thrombocytopenia; and eosinophilia.

Hypersensitivity Reactions

Fever, skin eruptions (morbilliform, maculopapular, purpuric, or exfoliative), lymphadenopathy and vasculitis.

Metabolic And Endocrine Reactions

Pyridoxine deficiency, pellagra, hyperglycemia, metabolic acidosis and gynecomastia.

Miscellaneous Reactions

Rheumatic syndrome and systemic lupus erythematosus-like syndrome.[1]

References

  1. "ISONIAZID (ISONIAZID) TABLET [MIKART, INC.]".

Adapted from the FDA Package Insert.