Streptomycin side effects: what 1,145 FDA adverse event reports show

Streptomycin · 33 reaction terms · 734 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

1,145 reports · 92% serious · 183 with death outcome · 43% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Streptomycin is indicated for the treatment of individuals with moderate to severe infections caused by susceptibile strains of microorganisms in the specific conditions listed below: 1. Mycobacterium tuberculosis: The Advisory Council for the Eliminat.

FDA label, Indications and Usage

What it is

DESCRIPTION Streptomycin is a water-soluble aminoglycoside derived from Streptomyces griseus . It is marketed as the sulfate salt of streptomycin.

FDA label, Description section

Boxed warning

THE RISK OF SEVERE NEUROTOXIC REACTIONS IS SHARPLY INCREASED IN PATIENTS WITH IMPAIRED RENAL FUNCTION OR PRE-RENAL AZOTEMIA. THESE INCLUDE DISTURBANCES OF VESTIBULAR AND COCHLEAR FUNCTION, OPTIC NERVE DYSFUNCTION, PERIPHERAL NEURITIS, ARACHNOIDITIS, AND ENCEPHALOPATHY MAY ALSO OCCUR.

FDA 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 24 strongest signals

Labeled — boxed warning 2Labeled adverse reaction 1Labeled (related wording) 2Likely indication confounding 1Reporting / coding artifact 2Lab value / disease marker 1Not in label — unassessed 15

What the badges mean

Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
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.

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. 9 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Drug resistance	147	105.4 90.6–122.6ROR 120.8 · χ² 15,029 / p <1e-300	103.4 EB05 90.1 · IC025 +6.0 3/3 methods agree	Reporting / coding artifact	serious PRR 70.5 · 99% clinician	no trial data cached
Tuberculosis	54	77.2 59.5–100.2ROR 81.0 · χ² 3,972 / p <1e-300	74.9 EB05 59.6 · IC025 +5.1 3/3 methods agree	Likely indication confounding term in indications	serious PRR 49.2 · 94% clinician	no trial data cached
Drug reaction with eosinophilia and systemic symptoms	55	39.5 30.5–51.1ROR 41.4 · χ² 2,024 / p <1e-300	38.9 EB05 31.0 · IC025 +4.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 24.8 · 98% clinician	no trial data cached
Lymphopenia	23	30.0 20.0–45.0ROR 30.6 · χ² 615 / p 4e-136	29.3 EB05 20.6 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 20.3 · ♀ 0% (drug 43%) · 96% clinician	no trial data cached
Clostridium difficile colitis	17	29.4 18.3–47.1ROR 29.8 · χ² 437 / p 2e-97	28.5 EB05 18.8 · IC025 +3.2 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 18.8	no trial data cached
Drug-induced liver injury	47	27.9 21.1–37.0ROR 29.1 · χ² 1,194 / p 5e-262	27.6 EB05 21.6 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 17.7 · 96% clinician	no trial data cached
Hepatotoxicity (liver damage)	32	26.5 18.8–37.3ROR 27.2 · χ² 759 / p 2e-167	26.1 EB05 19.3 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 16.9 · ♀ 64% (drug 43%) · 94% clinician	no trial data cached
Acute hepatic failure	18	24.3 15.3–38.4ROR 24.6 · χ² 378 / p 1e-84	23.7 EB05 15.8 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 15.2	no trial data cached
Hepatitis (liver inflammation)	33	23.6 16.9–33.1ROR 24.3 · χ² 693 / p 5e-153	23.3 EB05 17.4 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 15.1 · 97% clinician	no trial data cached
Jaundice (yellowing of skin/eyes)	27	18.3 12.6–26.6ROR 18.8 · χ² 426 / p 7e-95	18.0 EB05 12.9 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 12.2 · 96% clinician	no trial data cached
Toxic epidermal necrolysis (severe skin peeling reaction)	14	17.0 10.1–28.6ROR 17.2 · χ² 195 / p 1e-44	16.2 EB05 9.6 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 10.7	no trial data cached
Blood bilirubin increased	23	15.6 10.4–23.3ROR 15.9 · χ² 299 / p 3e-67	15.1 EB05 10.3 · IC025 +2.9 3/3 methods agree	Lab value / disease marker	serious PRR 11.2 · 95% clinician	no trial data cached
Polyneuropathy	10	15.4 8.3–28.6ROR 15.5 · χ² 121 / p 2e-28	13.8 EB05 6.8 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.8	no trial data cached
Drug eruption	14	14.6 8.6–24.5ROR 14.7 · χ² 163 / p 1e-37	13.5 EB05 7.8 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 10.5	no trial data cached
Face oedema	10	10.8 5.8–20.0ROR 10.9 · χ² 80 / p 2e-19	8.7 EB05 4.6 · IC025 +1.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.3	no trial data cached
Tubulointerstitial nephritis	11	10.8 6.0–19.4ROR 10.9 · χ² 88 / p 3e-21	8.9 EB05 4.8 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 6.8	no trial data cached
Neurotoxicity	10	10.5 5.7–19.5ROR 10.6 · χ² 77 / p 8e-19	8.4 EB05 4.5 · IC025 +1.8 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 6.7	no trial data cached
Eosinophilia	10	10.5 5.7–19.4ROR 10.6 · χ² 77 / p 1e-18	8.4 EB05 4.4 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.9	no trial data cached
Lymphadenopathy	20	10.3 6.7–16.0ROR 10.5 · χ² 160 / p 7e-37	9.3 EB05 6.1 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 8.5 · ♀ 70% (drug 43%)	no trial data cached
Hepatic function abnormal	19	9.4 6.0–14.7ROR 9.5 · χ² 134 / p 2e-31	8.3 EB05 5.4 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 6.0	no trial data cached
Pancreatitis (pancreas inflammation)	27	9.3 6.4–13.6ROR 9.5 · χ² 193 / p 3e-44	8.6 EB05 6.0 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 6.0 · ♀ 4% (drug 43%) · 100% clinician	no trial data cached
Transaminases increased	10	8.2 4.4–15.3ROR 8.3 · χ² 57 / p 3e-14	6.4 EB05 3.6 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 5.5	no trial data cached
Stevens-johnson syndrome (severe blistering skin reaction)	10	8.2 4.4–15.2ROR 8.3 · χ² 56 / p 3e-14	6.4 EB05 3.6 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 5.2	no trial data cached
Treatment failure	31	6.9 4.9–9.8ROR 7.1 · χ² 152 / p 4e-35	6.4 EB05 4.7 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 8.3 · 100% 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 resistance	147	105.4 90.6–122.6ROR 120.8 · χ² 15,029 / p <1e-300	103.4 EB05 90.1 · IC025 +6.0 3/3 methods agree	Reporting / coding artifact	serious PRR 70.5 · 99% clinician	no trial data cached
Drug reaction with eosinophilia and systemic symptoms	55	39.5 30.5–51.1ROR 41.4 · χ² 2,024 / p <1e-300	38.9 EB05 31.0 · IC025 +4.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 24.8 · 98% clinician	no trial data cached
Tuberculosis	54	77.2 59.5–100.2ROR 81.0 · χ² 3,972 / p <1e-300	74.9 EB05 59.6 · IC025 +5.1 3/3 methods agree	Likely indication confounding term in indications	serious PRR 49.2 · 94% clinician	no trial data cached
Drug-induced liver injury	47	27.9 21.1–37.0ROR 29.1 · χ² 1,194 / p 5e-262	27.6 EB05 21.6 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 17.7 · 96% clinician	no trial data cached
Hepatitis (liver inflammation)	33	23.6 16.9–33.1ROR 24.3 · χ² 693 / p 5e-153	23.3 EB05 17.4 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 15.1 · 97% clinician	no trial data cached
Hepatotoxicity (liver damage)	32	26.5 18.8–37.3ROR 27.2 · χ² 759 / p 2e-167	26.1 EB05 19.3 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 16.9 · ♀ 64% (drug 43%) · 94% clinician	no trial data cached
Treatment failure	31	6.9 4.9–9.8ROR 7.1 · χ² 152 / p 4e-35	6.4 EB05 4.7 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 8.3 · 100% clinician	no trial data cached
Pancreatitis (pancreas inflammation)	27	9.3 6.4–13.6ROR 9.5 · χ² 193 / p 3e-44	8.6 EB05 6.0 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 6.0 · ♀ 4% (drug 43%) · 100% clinician	no trial data cached
Jaundice (yellowing of skin/eyes)	27	18.3 12.6–26.6ROR 18.8 · χ² 426 / p 7e-95	18.0 EB05 12.9 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 12.2 · 96% clinician	no trial data cached
Blood bilirubin increased	23	15.6 10.4–23.3ROR 15.9 · χ² 299 / p 3e-67	15.1 EB05 10.3 · IC025 +2.9 3/3 methods agree	Lab value / disease marker	serious PRR 11.2 · 95% clinician	no trial data cached
Lymphopenia	23	30.0 20.0–45.0ROR 30.6 · χ² 615 / p 4e-136	29.3 EB05 20.6 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 20.3 · ♀ 0% (drug 43%) · 96% clinician	no trial data cached
Lymphadenopathy	20	10.3 6.7–16.0ROR 10.5 · χ² 160 / p 7e-37	9.3 EB05 6.1 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 8.5 · ♀ 70% (drug 43%)	no trial data cached
Hepatic function abnormal	19	9.4 6.0–14.7ROR 9.5 · χ² 134 / p 2e-31	8.3 EB05 5.4 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 6.0	no trial data cached
Acute hepatic failure	18	24.3 15.3–38.4ROR 24.6 · χ² 378 / p 1e-84	23.7 EB05 15.8 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 15.2	no trial data cached
Clostridium difficile colitis	17	29.4 18.3–47.1ROR 29.8 · χ² 437 / p 2e-97	28.5 EB05 18.8 · IC025 +3.2 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 18.8	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Lymphopenia — n=23, PRR 30.0
Drug-induced liver injury — n=47, PRR 27.9
Hepatotoxicity — n=32, PRR 26.5
Hepatitis — n=33, PRR 23.6
Jaundice — n=27, PRR 18.3
Lymphadenopathy — n=20, PRR 10.3
Pancreatitis — n=27, PRR 9.3

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 Streptomycin?

In FDA FAERS, the most frequently co-reported reaction terms for Streptomycin are drug reaction with eosinophilia and systemic symptoms, tuberculosis, drug-induced liver injury, hepatitis, hepatotoxicity, pancreatitis. 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 Streptomycin have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: THE RISK OF SEVERE NEUROTOXIC REACTIONS IS SHARPLY INCREASED IN PATIENTS WITH IMPAIRED RENAL FUNCTION OR PRE-RENAL AZOTEMIA. THESE INCLUDE DISTURBANCES OF VESTIBULAR AND COCHLEAR FUNCTION, OPTIC NERVE DYSFUNCTION, PERIPHERAL NEURITIS, ARACHNOIDITIS, AND ENCEPHALOPATHY MAY ALSO OCCUR.

Do FAERS signals prove that Streptomycin 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 abd1f64e-4283-4370-aae8-3666316aa36e, effective 20260121; matched on openfda.generic_name.exact:"STREPTOMYCIN")
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, field patient.drug.openfda.generic_name.exact, 33 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.