Drug · FAERS side-effect profile with label screen
Pyrazinamide side effects: what 9,340 FDA adverse event reports show
Who reports
9,340 reports · 97% serious · 1,645 with death outcome · 45% female
openFDA FAERS counts, all years, deduplication not applied
Used for
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 in.
FDA label, Indications and Usage
What it is
DESCRIPTION: Pyrazinamide, USP the pyrazine analogue of nicotinamide, is an antituberculous agent. It is a white crystalline powder, stable at room temperature, and sparingly soluble in water..
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Lab value / disease marker 2No label text to screen 38
What the badges mean
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 970 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Tuberculoma of central nervous system | 95 | 2,446.8 1,828.9–3,273.3ROR 2,471.9 · χ² 109,194 / p <1e-300 | 940.8 EB05 792.4 · IC025 +7.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=95 · 97% clinician | no trial data cached |
| Immune reconstitution inflammatory syndrome associated tuberculosis | 169 | 2,339.6 1,886.5–2,901.4ROR 2,382.7 · χ² 190,987 / p <1e-300 | 1,007.3 EB05 886.1 · IC025 +7.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=169 · 97% clinician | no trial data cached |
| Serpiginous choroiditis | 24 | 2,215.0 1,258.3–3,898.8ROR 2,220.7 · χ² 25,460 / p <1e-300 | 586.6 EB05 414.9 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=24 · 100% clinician | no trial data cached |
| Tuberculosis of eye | 12 | 466.3 250.3–868.7ROR 466.9 · χ² 4,226 / p <1e-300 | 239.1 EB05 145.7 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | no trial data cached |
| Tuberculosis of central nervous system | 44 | 445.0 322.1–614.8ROR 447.1 · χ² 15,864 / p <1e-300 | 319.2 EB05 247.6 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=44 · ♀ 15% (drug 45%) · 91% clinician | no trial data cached |
| Diaphragmatic injury | 12 | 435.7 234.7–808.9ROR 436.3 · χ² 3,993 / p <1e-300 | 230.8 EB05 140.7 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | no trial data cached |
| Meningitis tuberculous | 90 | 427.8 341.7–535.6ROR 431.9 · χ² 31,762 / p <1e-300 | 333.3 EB05 279.4 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=90 · 96% clinician | no trial data cached |
| Paradoxical drug reaction | 513 | 365.2 333.4–400.1ROR 386.4 · χ² 159,683 / p <1e-300 | 310.1 EB05 288.2 · IC025 +7.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=507 · 99% clinician | no trial data cached |
| Tuberculosis of genitourinary system | 10 | 295.3 152.7–571.1ROR 295.6 · χ² 2,335 / p <1e-300 | 174.5 EB05 101.3 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Sideroblastic anaemia | 16 | 285.8 169.9–480.9ROR 286.3 · χ² 3,774 / p <1e-300 | 194.7 EB05 127.1 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=16 | no trial data cached |
| Splenic embolism | 12 | 268.5 147.5–488.6ROR 268.8 · χ² 2,618 / p <1e-300 | 173.8 EB05 106.0 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | no trial data cached |
| Immune reconstitution syndrome | 110 | 206.3 169.9–250.6ROR 208.8 · χ² 20,373 / p <1e-300 | 182.9 EB05 155.9 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=109 | no trial data cached |
| Tuberculosis gastrointestinal | 25 | 192.3 127.8–289.2ROR 192.8 · χ² 4,203 / p <1e-300 | 156.1 EB05 111.2 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=25 · 92% clinician | no trial data cached |
| Acid fast bacilli infection | 12 | 184.6 102.5–332.5ROR 184.8 · χ² 1,857 / p <1e-300 | 134.5 EB05 82.0 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | no trial data cached |
| Cutaneous tuberculosis | 14 | 184.6 107.0–318.3ROR 184.9 · χ² 2,193 / p <1e-300 | 138.7 EB05 87.8 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=14 | no trial data cached |
| Disseminated tuberculosis | 181 | 171.9 148.0–199.7ROR 175.3 · χ² 28,386 / p <1e-300 | 157.0 EB05 138.7 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=180 · 94% clinician | no trial data cached |
| Choroiditis | 25 | 160.0 106.7–240.0ROR 160.5 · χ² 3,538 / p <1e-300 | 134.2 EB05 95.6 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=25 · 100% clinician | no trial data cached |
| Peritoneal tuberculosis | 27 | 148.4 100.6–219.0ROR 148.8 · χ² 3,568 / p <1e-300 | 126.9 EB05 91.6 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=27 · 96% clinician | no trial data cached |
| Lymph node tuberculosis | 45 | 144.7 107.1–195.4ROR 145.4 · χ² 5,893 / p <1e-300 | 128.6 EB05 100.0 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=46 · 93% clinician | no trial data cached |
| Bone tuberculosis | 22 | 136.9 89.0–210.4ROR 137.2 · χ² 2,668 / p <1e-300 | 116.2 EB05 80.9 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=22 · ♀ 15% (drug 45%) · 90% clinician | no trial data cached |
| Pulmonary tuberculosis | 238 | 132.7 116.6–151.0ROR 136.2 · χ² 29,236 / p <1e-300 | 124.0 EB05 111.4 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=238 | no trial data cached |
| Immune reconstitution inflammatory syndrome | 262 | 124.0 109.7–140.2ROR 127.6 · χ² 30,168 / p <1e-300 | 116.5 EB05 105.2 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=262 · 97% clinician | no trial data cached |
| Pancreatitis haemorrhagic | 24 | 121.6 80.7–183.4ROR 122.0 · χ² 2,609 / p <1e-300 | 105.9 EB05 74.9 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=24 · ♀ 100% (drug 45%) · 100% clinician | no trial data cached |
| Extrapulmonary tuberculosis | 15 | 119.5 71.1–200.9ROR 119.7 · χ² 1,562 / p <1e-300 | 99.4 EB05 64.0 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=15 | no trial data cached |
| Vitamin b1 decreased | 12 | 113.1 63.3–202.0ROR 113.2 · χ² 1,164 / p 2e-255 | 92.3 EB05 56.3 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious n=12 | no trial data cached |
| Oedematous kidney | 12 | 106.3 59.6–189.7ROR 106.5 · χ² 1,096 / p 1e-240 | 87.8 EB05 53.5 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | no trial data cached |
| Toxic optic neuropathy | 19 | 103.7 65.5–164.1ROR 103.9 · χ² 1,749 / p <1e-300 | 90.3 EB05 61.1 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=19 | no trial data cached |
| Tuberculous pleurisy | 21 | 103.6 66.9–160.4ROR 103.8 · χ² 1,942 / p <1e-300 | 91.0 EB05 62.8 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=21 | no trial data cached |
| Urinary tract inflammation | 14 | 91.5 53.6–156.1ROR 91.6 · χ² 1,118 / p 2e-245 | 78.8 EB05 49.9 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=14 | no trial data cached |
| Dandy-walker syndrome | 10 | 89.7 47.7–168.7ROR 89.8 · χ² 760 / p 2e-167 | 74.4 EB05 43.2 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Tuberculosis | 402 | 72.5 65.7–79.9ROR 75.7 · χ² 27,377 / p <1e-300 | 70.0 EB05 64.4 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 42.7 | no trial data cached |
| Conductive deafness | 10 | 71.7 38.2–134.5ROR 71.8 · χ² 608 / p 1e-134 | 61.7 EB05 35.8 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Granulomatous liver disease | 21 | 69.0 44.7–106.5ROR 69.2 · χ² 1,300 / p 6e-285 | 63.3 EB05 43.7 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=21 · ♀ 19% (drug 45%) | no trial data cached |
| Jarisch-herxheimer reaction | 21 | 68.0 44.1–104.9ROR 68.2 · χ² 1,281 / p 8e-281 | 62.4 EB05 43.1 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=19 · 100% clinician | no trial data cached |
| Hepatitis toxic | 77 | 67.8 54.1–85.0ROR 68.4 · χ² 4,856 / p <1e-300 | 64.8 EB05 53.6 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=77 · 99% clinician | no trial data cached |
| Oedematous pancreatitis | 15 | 62.0 37.1–103.5ROR 62.1 · χ² 817 / p 5e-180 | 56.2 EB05 36.2 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=15 | no trial data cached |
| Central nervous system vasculitis | 13 | 61.4 35.4–106.5ROR 61.5 · χ² 694 / p 3e-153 | 55.2 EB05 34.3 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 679 | 61.3 56.9–66.0ROR 66.0 · χ² 39,175 / p <1e-300 | 59.6 EB05 55.9 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.5 · 98% clinician | no trial data cached |
| Antipsychotic drug level decreased | 14 | 60.7 35.7–103.2ROR 60.8 · χ² 743 / p 7e-164 | 54.9 EB05 34.8 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious n=14 | no trial data cached |
| Optic neuropathy | 55 | 60.5 46.3–79.0ROR 60.8 · χ² 3,073 / p <1e-300 | 57.8 EB05 46.0 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=55 · 98% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug reaction with eosinophilia and systemic symptoms | 679 | 61.3 56.9–66.0ROR 66.0 · χ² 39,175 / p <1e-300 | 59.6 EB05 55.9 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.5 · 98% clinician | no trial data cached |
| Drug-induced liver injury | 655 | 48.7 45.2–52.5ROR 52.3 · χ² 29,948 / p <1e-300 | 47.6 EB05 44.6 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.7 · 96% clinician | no trial data cached |
| Drug interaction | 600 | 8.5 7.9–9.2ROR 9.0 · χ² 3,990 / p <1e-300 | 8.5 EB05 7.9 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 5.5 · 97% clinician | no trial data cached |
| Pyrexia (fever) | 599 | 3.9 3.6–4.2ROR 4.1 · χ² 1,303 / p 2e-285 | 3.9 EB05 3.6 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.9 · 93% clinician | no trial data cached |
| Off label use (used outside approved label) | 524 | 1.4 1.2–1.5ROR 1.4 · χ² 51 / p 5e-13 | 1.4 EB05 1.3 · IC025 +0.3 | Reporting / coding artifact | serious PRR 1.4 · 95% clinician | no trial data cached |
| Paradoxical drug reaction | 513 | 365.2 333.4–400.1ROR 386.4 · χ² 159,683 / p <1e-300 | 310.1 EB05 288.2 · IC025 +7.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=507 · 99% clinician | no trial data cached |
| Drug ineffective (drug did not work) | 490 | 0.8 0.8–0.9ROR 0.8 · χ² 17 / p 2e-5 | 0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.4 · 96% clinician | no trial data cached |
| Vomiting | 485 | 2.3 2.1–2.5ROR 2.4 · χ² 373 / p 3e-83 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.0 | no trial data cached |
| Nausea | 402 | 1.1 1.0–1.3ROR 1.2 · χ² 7 / p 0.003 | 1.1 EB05 1.1 · IC025 +0.0 | No label text to screen label has no adverse-reaction text | serious PRR 1.3 · 93% clinician | no trial data cached |
| Tuberculosis | 402 | 72.5 65.7–79.9ROR 75.7 · χ² 27,377 / p <1e-300 | 70.0 EB05 64.4 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 42.7 | no trial data cached |
| Anaemia (low red blood cells) | 373 | 4.4 4.0–4.9ROR 4.5 · χ² 982 / p 7e-216 | 4.4 EB05 4.0 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.8 | no trial data cached |
| Hepatotoxicity (liver damage) | 366 | 37.7 34.1–41.7ROR 39.2 · χ² 12,830 / p <1e-300 | 37.0 EB05 33.9 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.2 · 98% clinician | no trial data cached |
| Drug resistance | 355 | 31.5 28.4–34.9ROR 32.7 · χ² 10,306 / p <1e-300 | 31.0 EB05 28.4 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious PRR 20.5 · 99% clinician | no trial data cached |
| Condition aggravated | 332 | 2.5 2.2–2.7ROR 2.5 · χ² 293 / p 5e-66 | 2.5 EB05 2.2 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 2.2 · 96% clinician | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 287 | 6.8 6.1–7.7ROR 7.0 · χ² 1,426 / p <1e-300 | 6.8 EB05 6.1 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.7 · 95% clinician | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
✓ A hand-written Bradford Hill causality assessment exists for this drug: Pyrazinamide ↔ Drug-induced liver injury.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Pyrazinamide?
In FDA FAERS, the most frequently co-reported reaction terms for Pyrazinamide are drug reaction with eosinophilia and systemic symptoms, drug-induced liver injury, pyrexia, paradoxical drug reaction, vomiting, nausea. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Pyrazinamide have an FDA boxed warning?
No. The FDA label retrieved for Pyrazinamide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Pyrazinamide causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID a8b7ba02-8509-475b-8a3b-39d205af3f1e, effective 20221206; matched on
openfda.generic_name.exact:"PYRAZINAMIDE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,010 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.