Antimycobacterial side effects compared: 4 drugs, 32,523 FDA adverse event reports
Members
| Drug | FAERS reports | Serious | Death outcome | Boxed warning | Top labeled signals | Unlabeled (unassessed) |
|---|---|---|---|---|---|---|
| Isoniazid | 16,105 | 91% | 2,199 | boxed | Immune reconstitution inflammatory syndrome associated tuberculosis; Tuberculosis of central nervous system; Sideroblastic anaemia | Paradoxical drug reaction; Immune reconstitution inflammatory syndrome |
| Pyrazinamide | 9,340 | 97% | 1,645 | – | – | – |
| Clofazimine (Lamprene) | 6,351 | 89% | 1,259 | – | Electrocardiogram qt prolonged; Anaemia; Aspartate aminotransferase increased | Neuropathy peripheral; Hepatotoxicity |
| Pretomanid | 727 | 98% | 286 | – | Neuropathy peripheral; Electrocardiogram qt prolonged; Hepatotoxicity | – |
Class-wide signals (flagged in at least 2 of 4 members)
| Reaction | Members flagged | Median PRR | Reports (sum) | In label |
|---|---|---|---|---|
| Tuberculoma of central nervous system | 2/4 | 1,981.2 | 193 | 0/2 members' labels |
| Immune reconstitution inflammatory syndrome associated tuberculosis | 2/4 | 1,792.4 | 331 | 1/2 members' labels |
| Serpiginous choroiditis | 2/4 | 1,749.3 | 48 | 0/2 members' labels |
| Tuberculosis of eye | 2/4 | 459.7 | 30 | 0/2 members' labels |
| Tuberculosis of central nervous system | 2/4 | 392.2 | 99 | 1/2 members' labels |
| Diaphragmatic injury | 2/4 | 344.1 | 24 | 0/2 members' labels |
| Meningitis tuberculous | 2/4 | 341.2 | 182 | 0/2 members' labels |
| Paradoxical drug reaction | 2/4 | 298.4 | 1,067 | 0/2 members' labels |
| Tuberculosis of genitourinary system | 2/4 | 243.1 | 21 | 0/2 members' labels |
| Sideroblastic anaemia | 2/4 | 214.2 | 30 | 1/2 members' labels |
| Splenic embolism | 2/4 | 204.8 | 23 | 0/2 members' labels |
| Tuberculosis gastrointestinal | 2/4 | 174.4 | 59 | 0/2 members' labels |
| Immune reconstitution syndrome | 2/4 | 166.5 | 226 | 0/2 members' labels |
| Acid fast bacilli infection | 2/4 | 160.6 | 27 | 0/2 members' labels |
| Cutaneous tuberculosis | 2/4 | 145.8 | 28 | 1/2 members' labels |
| Disseminated tuberculosis | 2/4 | 143.6 | 388 | 0/2 members' labels |
| Choroiditis | 2/4 | 142.7 | 58 | 0/2 members' labels |
| Peritoneal tuberculosis | 2/4 | 138.2 | 66 | 0/2 members' labels |
| Lymph node tuberculosis | 2/4 | 129.5 | 105 | 0/2 members' labels |
| Bone tuberculosis | 2/4 | 119.8 | 50 | 0/2 members' labels |
| Extrapulmonary tuberculosis | 2/4 | 119.6 | 40 | 0/2 members' labels |
| Pulmonary tuberculosis | 2/4 | 112.4 | 520 | 0/2 members' labels |
| Tuberculous pleurisy | 2/4 | 101.9 | 55 | 0/2 members' labels |
| Immune reconstitution inflammatory syndrome | 2/4 | 101.0 | 545 | 0/2 members' labels |
| Electrocardiogram qt prolonged | 2/4 | 56.2 | 813 | 2/2 members' labels |
| Tuberculosis | 2/4 | 55.4 | 550 | 0/2 members' labels |
| Drug reaction with eosinophilia and systemic symptoms | 2/4 | 38.1 | 794 | 1/2 members' labels |
| Hepatotoxicity | 2/4 | 28.3 | 208 | 1/2 members' labels |
| Polyneuropathy | 2/4 | 25.0 | 87 | 1/2 members' labels |
| Neuropathy peripheral | 2/4 | 18.6 | 461 | 1/2 members' labels |
Member-specific signals (flagged in exactly one drug)
| Reaction | Drug | Reports | PRR | Label screen |
|---|---|---|---|---|
| Vaginal flatulence | Isoniazid | 89 | 536.4 | Not in label — unassessed |
| Hepatitis toxic | Pyrazinamide | 77 | 67.8 | No label text to screen |
| Optic neuropathy | Pyrazinamide | 55 | 60.5 | No label text to screen |
| Drug-induced liver injury | Clofazimine | 143 | 15.4 | Not in label — unassessed |
| Electrolyte imbalance | Clofazimine | 50 | 14.4 | Not in label — unassessed |
| Haemoptysis | Clofazimine | 116 | 13.8 | Not in label — unassessed |
| Deafness | Clofazimine | 95 | 12.0 | Labeled (related wording) |
| Pneumothorax | Clofazimine | 54 | 11.3 | Not in label — unassessed |
| Transaminases increased | Clofazimine | 66 | 9.8 | Not in label — unassessed |
| Hypokalaemia | Clofazimine | 121 | 8.7 | Labeled adverse reaction |
| Skin discolouration | Clofazimine | 117 | 8.4 | Not in label — unassessed |
| Anaemia | Clofazimine | 474 | 8.2 | Labeled adverse reaction |
| Hepatitis | Clofazimine | 61 | 7.9 | Labeled adverse reaction |
| Respiratory failure | Clofazimine | 173 | 7.8 | Not in label — unassessed |
| Tinnitus | Clofazimine | 104 | 7.5 | Not in label — unassessed |
| Psychotic disorder | Clofazimine | 57 | 6.4 | Not in label — unassessed |
| Productive cough | Clofazimine | 87 | 6.1 | Not in label — unassessed |
| Hypothyroidism | Clofazimine | 58 | 6.0 | Not 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.