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Drug class · FAERS comparison

Antimycobacterial side effects compared: 4 drugs, 32,523 FDA adverse event reports

Class as assigned in the FDA label (Established Pharmacologic Class) · data 2026-09-14
How to read this page. Report counts are not incidence rates: a drug with more reports is usually older, more widely used or more publicised, not more dangerous. Signals are screened against each product's FDA label on its own page; a term flagged across most of a class usually reflects the shared mechanism or the shared patient population.

Members

DrugFAERS reportsSeriousDeath outcomeBoxed warningTop labeled signalsUnlabeled (unassessed)
Isoniazid16,10591%2,199boxedImmune reconstitution inflammatory syndrome associated tuberculosis; Tuberculosis of central nervous system; Sideroblastic anaemiaParadoxical drug reaction; Immune reconstitution inflammatory syndrome
Pyrazinamide9,34097%1,645–––
Clofazimine (Lamprene)6,35189%1,259–Electrocardiogram qt prolonged; Anaemia; Aspartate aminotransferase increasedNeuropathy peripheral; Hepatotoxicity
Pretomanid72798%286–Neuropathy peripheral; Electrocardiogram qt prolonged; Hepatotoxicity–

Class-wide signals (flagged in at least 2 of 4 members)

ReactionMembers flaggedMedian PRRReports (sum)In label
Tuberculoma of central nervous system2/41,981.21930/2 members' labels
Immune reconstitution inflammatory syndrome associated tuberculosis2/41,792.43311/2 members' labels
Serpiginous choroiditis2/41,749.3480/2 members' labels
Tuberculosis of eye2/4459.7300/2 members' labels
Tuberculosis of central nervous system2/4392.2991/2 members' labels
Diaphragmatic injury2/4344.1240/2 members' labels
Meningitis tuberculous2/4341.21820/2 members' labels
Paradoxical drug reaction2/4298.41,0670/2 members' labels
Tuberculosis of genitourinary system2/4243.1210/2 members' labels
Sideroblastic anaemia2/4214.2301/2 members' labels
Splenic embolism2/4204.8230/2 members' labels
Tuberculosis gastrointestinal2/4174.4590/2 members' labels
Immune reconstitution syndrome2/4166.52260/2 members' labels
Acid fast bacilli infection2/4160.6270/2 members' labels
Cutaneous tuberculosis2/4145.8281/2 members' labels
Disseminated tuberculosis2/4143.63880/2 members' labels
Choroiditis2/4142.7580/2 members' labels
Peritoneal tuberculosis2/4138.2660/2 members' labels
Lymph node tuberculosis2/4129.51050/2 members' labels
Bone tuberculosis2/4119.8500/2 members' labels
Extrapulmonary tuberculosis2/4119.6400/2 members' labels
Pulmonary tuberculosis2/4112.45200/2 members' labels
Tuberculous pleurisy2/4101.9550/2 members' labels
Immune reconstitution inflammatory syndrome2/4101.05450/2 members' labels
Electrocardiogram qt prolonged2/456.28132/2 members' labels
Tuberculosis2/455.45500/2 members' labels
Drug reaction with eosinophilia and systemic symptoms2/438.17941/2 members' labels
Hepatotoxicity2/428.32081/2 members' labels
Polyneuropathy2/425.0871/2 members' labels
Neuropathy peripheral2/418.64611/2 members' labels

Member-specific signals (flagged in exactly one drug)

ReactionDrugReportsPRRLabel screen
Vaginal flatulenceIsoniazid89536.4Not in label — unassessed
Hepatitis toxicPyrazinamide7767.8No label text to screen
Optic neuropathyPyrazinamide5560.5No label text to screen
Drug-induced liver injuryClofazimine14315.4Not in label — unassessed
Electrolyte imbalanceClofazimine5014.4Not in label — unassessed
HaemoptysisClofazimine11613.8Not in label — unassessed
DeafnessClofazimine9512.0Labeled (related wording)
PneumothoraxClofazimine5411.3Not in label — unassessed
Transaminases increasedClofazimine669.8Not in label — unassessed
HypokalaemiaClofazimine1218.7Labeled adverse reaction
Skin discolourationClofazimine1178.4Not in label — unassessed
AnaemiaClofazimine4748.2Labeled adverse reaction
HepatitisClofazimine617.9Labeled adverse reaction
Respiratory failureClofazimine1737.8Not in label — unassessed
TinnitusClofazimine1047.5Not in label — unassessed
Psychotic disorderClofazimine576.4Not in label — unassessed
Productive coughClofazimine876.1Not in label — unassessed
HypothyroidismClofazimine586.0Not in label — unassessed

Common questions

Which antimycobacterial has the most FDA adverse event reports?

Isoniazid has the most FAERS co-reports in this class (16,105), followed by Pyrazinamide (9,340). Report volume tracks how widely and how long a drug has been used, and how much attention it has had, far more than its risk.

Which side effects are shared across antimycobacterial drugs?

Reaction terms flagged in at least half of the 4 members include tuberculoma of central nervous system, immune reconstitution inflammatory syndrome associated tuberculosis, serpiginous choroiditis, tuberculosis of eye, tuberculosis of central nervous system. A term shared across a class usually reflects the shared mechanism (or the shared patient population) rather than one product.

Does a FAERS signal mean the drug causes the reaction?

No. These are disproportionality signals from voluntary reports with no denominator. Each is screened against the FDA label (known vs unlabeled) on the drug pages; causality needs temporality, dose-response, plausibility and trial or cohort evidence.

Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, seriousness and death counts from openFDA count queries. Generated 2026-10-08. Not medical advice.