Gentamicin Sulfate side effects: what 15,708 FDA adverse event reports show

Gentamicin Sulfate · 1,159 reaction terms · 60,401 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

15,708 reports · 92% serious · 2,829 with death outcome · 49% female

openFDA FAERS counts, all years, deduplication not applied

Used for

To reduce the development of drug-resistant bacteria and maintain the effectiveness of gentamicin injection and other antibacterial drugs, gentamicin injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

FDA label, Indications and Usage

What it is

DESCRIPTION Gentamicin sulfate, a water-soluble antibiotic of the aminoglycoside group, is derived by the growth of Micromonospora purpurea , an actinomycete. It has the following structural formula. Structural Formula Gentamicin Injection, USP is a sterile, nonpyrogenic aqueous solution for parenteral administration.

FDA label, Description section

Boxed warning

Patients treated with aminoglycosides should be under close clinical observation because of the potential toxicity associated with their use. As with other aminoglycosides, gentamicin injection is potentially nephrotoxic. The risk of nephrotoxicity is greater in patients with impaired renal function and in those who receive high dosage of prolonged therapy.

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 40 strongest signals

Labeled — boxed warning 1Labeled (related wording) 1Likely indication confounding 11Reporting / coding artifact 1Lab value / disease marker 2Not in label — unassessed 24

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 (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. 1,119 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
Normal labour	122	9,446.6 5,688.7–15,686.9ROR 9,520.6 · χ² 139,769 / p <1e-300	977.4 EB05 840.3 · IC025 +7.4 3/3 methods agree	Not in label — unassessed	serious n=122 · ♀ 100% (drug 49%) · 90% clinician	not reported in cached trials
Bartter's syndrome	14	767.9 397.3–1,484.1ROR 768.5 · χ² 6,296 / p <1e-300	291.9 EB05 184.8 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=14	not reported in cached trials
Neonatal candida infection	13	570.4 297.6–1,093.3ROR 570.9 · χ² 4,765 / p <1e-300	251.4 EB05 156.3 · IC025 +3.7 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=13	not reported in cached trials
Umbilical erythema	15	438.8 244.7–786.9ROR 439.2 · χ² 4,591 / p <1e-300	232.2 EB05 149.4 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=15	not reported in cached trials
Haematopoietic stem cell mobilisation	14	376.1 207.7–681.0ROR 376.4 · χ² 3,787 / p <1e-300	209.5 EB05 132.6 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=14	not reported in cached trials
Delivery	126	314.1 258.8–381.3ROR 316.7 · χ² 31,500 / p <1e-300	244.4 EB05 210.6 · IC025 +6.7 3/3 methods agree	Not in label — unassessed	serious n=126 · ♀ 100% (drug 49%)	not reported in cached trials
Endocarditis candida	13	280.5 154.2–510.4ROR 280.8 · χ² 2,759 / p <1e-300	173.1 EB05 107.6 · IC025 +3.7 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=13	not reported in cached trials
Delusion of grandeur	61	210.8 160.9–276.0ROR 211.6 · χ² 10,797 / p <1e-300	172.1 EB05 138.8 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious n=61 · ♀ 0% (drug 49%)	not reported in cached trials
Aminoaciduria	16	148.3 88.5–248.6ROR 148.5 · χ² 1,974 / p <1e-300	115.4 EB05 75.3 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=16	not reported in cached trials
Persistent genital arousal disorder	21	132.3 84.5–207.1ROR 132.4 · χ² 2,368 / p <1e-300	108.6 EB05 75.0 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=21 · ♀ 100% (drug 49%) · 100% clinician	not reported in cached trials
Spinal muscular atrophy	24	130.5 85.8–198.5ROR 130.7 · χ² 2,690 / p <1e-300	108.8 EB05 76.9 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=24 · ♀ 0% (drug 49%) · 100% clinician	not reported in cached trials
Congenital multiplex arthrogryposis	18	127.4 78.5–206.6ROR 127.5 · χ² 1,944 / p <1e-300	103.7 EB05 69.4 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=18	not reported in cached trials
Antibiotic level above therapeutic	34	124.0 87.3–176.2ROR 124.2 · χ² 3,679 / p <1e-300	106.7 EB05 79.9 · IC025 +4.9 3/3 methods agree	Lab value / disease marker	serious n=34	not reported in cached trials
Oropharyngeal oedema	12	120.6 66.8–217.7ROR 120.7 · χ² 1,196 / p 2e-262	94.4 EB05 57.5 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=12	not reported in cached trials
Oscillopsia	21	117.1 75.0–183.0ROR 117.3 · χ² 2,115 / p <1e-300	98.3 EB05 67.8 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious n=18	not reported in cached trials
Hypotensive crisis	11	113.1 61.1–209.4ROR 113.2 · χ² 1,025 / p 4e-225	88.7 EB05 52.8 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=11	not reported in cached trials
Vestibular disorder	91	107.0 86.5–132.5ROR 107.7 · χ² 8,744 / p <1e-300	97.1 EB05 81.5 · IC025 +5.7 3/3 methods agree	Labeled (related wording) related wording	serious n=78	not reported in cached trials
Ototoxicity	137	106.5 89.6–126.7ROR 107.4 · χ² 13,152 / p <1e-300	97.3 EB05 84.4 · IC025 +5.9 3/3 methods agree	Labeled — boxed warning exact term	serious n=132	not reported in cached trials
Antimicrobial susceptibility test resistant	21	96.3 61.9–150.0ROR 96.4 · χ² 1,758 / p <1e-300	83.2 EB05 57.4 · IC025 +4.1 3/3 methods agree	Likely indication confounding term in indications	serious n=21	not reported in cached trials
Intraventricular haemorrhage neonatal	32	93.6 65.4–133.9ROR 93.8 · χ² 2,651 / p <1e-300	83.3 EB05 61.7 · IC025 +4.6 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=32 · 100% clinician	not reported in cached trials
Conductive deafness	19	83.4 52.4–132.5ROR 83.5 · χ² 1,378 / p <1e-300	72.9 EB05 49.4 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=19	not reported in cached trials
Anaemia folate deficiency	11	83.2 45.3–153.0ROR 83.3 · χ² 765 / p 1e-168	69.3 EB05 41.3 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=11	not reported in cached trials
Cardiac valve vegetation	28	82.5 56.3–120.8ROR 82.6 · χ² 2,044 / p <1e-300	73.9 EB05 53.6 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=29	not reported in cached trials
Geotrichum infection	12	79.8 44.6–142.8ROR 79.8 · χ² 807 / p 7e-178	67.5 EB05 41.2 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=12	not reported in cached trials
Positive airway pressure therapy	13	78.5 44.9–137.3ROR 78.6 · χ² 867 / p 8e-191	67.1 EB05 41.8 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious n=13	not reported in cached trials
Stoma closure	15	69.8 41.5–117.2ROR 69.8 · χ² 901 / p 2e-198	61.4 EB05 39.5 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=15	not reported in cached trials
Respiratory tract infection bacterial	23	64.3 42.3–97.7ROR 64.4 · χ² 1,306 / p 2e-286	58.5 EB05 41.1 · IC025 +4.0 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=23 · ♀ 0% (drug 49%) · 100% clinician	not reported in cached trials
Necrotising enterocolitis neonatal	18	62.5 39.0–100.3ROR 62.6 · χ² 982 / p 6e-216	56.4 EB05 37.7 · IC025 +3.7 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=18	not reported in cached trials
Lymphocyte count abnormal	49	60.5 45.5–80.5ROR 60.7 · χ² 2,685 / p <1e-300	56.7 EB05 44.6 · IC025 +4.7 3/3 methods agree	Lab value / disease marker	serious n=49 · ♀ 0% (drug 49%) · 92% clinician	NCT00600483: 12/743 (1.6%) on Gentamicin; 7/759 (0.9%) control
Pneumococcal sepsis	27	57.7 39.3–84.8ROR 57.8 · χ² 1,387 / p <1e-300	53.4 EB05 38.5 · IC025 +4.2 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=27 · ♀ 0% (drug 49%) · 100% clinician	not reported in cached trials
Fungal endocarditis	12	56.8 31.9–101.2ROR 56.9 · χ² 578 / p 4e-128	50.4 EB05 30.7 · IC025 +3.1 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=13	not reported in cached trials
Splenic abscess	16	55.3 33.5–91.1ROR 55.3 · χ² 767 / p 4e-169	50.1 EB05 32.7 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=16	not reported in cached trials
Cns ventriculitis	13	55.2 31.7–96.1ROR 55.2 · χ² 613 / p 1e-135	49.4 EB05 30.7 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=13	not reported in cached trials
Chronic kidney disease-mineral and bone disorder	41	52.9 38.7–72.2ROR 53.0 · χ² 1,956 / p <1e-300	49.8 EB05 38.2 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=41	not reported in cached trials
Bacillus infection	23	51.0 33.6–77.3ROR 51.0 · χ² 1,037 / p 8e-228	47.3 EB05 33.2 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=23 · 100% clinician	not reported in cached trials
Motor neurone disease	18	50.7 31.7–81.2ROR 50.8 · χ² 798 / p 8e-176	46.6 EB05 31.2 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=18	not reported in cached trials
Endocarditis bacterial	28	49.1 33.7–71.5ROR 49.2 · χ² 1,225 / p 9e-269	46.0 EB05 33.4 · IC025 +4.1 3/3 methods agree	Likely indication confounding term in indications	serious n=28 · 100% clinician	not reported in cached trials
Sepsis syndrome	17	46.4 28.6–75.3ROR 46.5 · χ² 687 / p 1e-151	42.9 EB05 28.4 · IC025 +3.5 3/3 methods agree	Likely indication confounding term in indications	serious n=17	NCT00600483: 5/743 (0.7%) on Gentamicin; 8/759 (1.1%) control (serious AE)
Pyroglutamic acidosis	12	43.5 24.5–77.3ROR 43.5 · χ² 442 / p 2e-98	39.7 EB05 24.2 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=12	not reported in cached trials
Sepsis neonatal	25	42.8 28.7–63.7ROR 42.9 · χ² 948 / p 2e-208	40.3 EB05 28.7 · IC025 +3.9 3/3 methods agree	Likely indication confounding term in indications	serious n=24 · 100% clinician	not reported in cached trials

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Gentamicin as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (2 of 40 signal terms matched).

NCT00600483 — Safety and Efficacy of an Antibiotic Implant in Cardiac Surgical Subjects at Higher Risk for Sternal Wound Inf (N=1502, PHASE3; 1076 AE terms posted; arms: Gentamicin Group; Control Group)
NCT00926796 — Efficacy of Combination Therapies for Gonorrhea Treatment (N=614, PHASE4; 3 AE terms posted; arms: Regimen A: Gentamicin Plus Azithromycin; Regimen B: Gemifloxacin Plus Azithromyci)

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

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 ineffective (drug did not work)	1,248	1.3 1.2–1.3ROR 1.3 · χ² 74 / p 4e-18	1.3 EB05 1.2 · IC025 +0.2	Reporting / coding artifact	serious PRR 2.1 · 93% clinician	not reported in cached trials
Acute kidney injury (sudden kidney damage)	1,204	10.6 10.1–11.2ROR 11.4 · χ² 10,486 / p <1e-300	10.5 EB05 10.0 · IC025 +3.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.6 · 93% clinician	not reported in cached trials
Pyrexia (fever)	897	3.5 3.3–3.7ROR 3.6 · χ² 1,593 / p <1e-300	3.5 EB05 3.3 · IC025 +1.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 2.6	NCT00600483: 2/743 (0.3%) on Gentamicin (serious AE)
Off label use (used outside approved label)	870	1.3 1.3–1.4ROR 1.4 · χ² 77 / p 7e-19	1.3 EB05 1.3 · IC025 +0.3	Reporting / coding artifact	serious PRR 1.4	not reported in cached trials
Renal failure (kidney failure)	705	7.1 6.6–7.6ROR 7.4 · χ² 3,670 / p <1e-300	7.0 EB05 6.6 · IC025 +2.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.4	NCT00600483: 1/743 (0.1%) on Gentamicin (serious AE)
Diarrhoea (diarrhea)	562	1.2 1.1–1.3ROR 1.2 · χ² 14 / p 1e-4	1.2 EB05 1.1 · IC025 +0.1	Not in label — unassessed	serious PRR 1.2	NCT00600483: 1/759 (0.1%) control (serious AE)
Sepsis (blood infection)	507	6.1 5.6–6.6ROR 6.3 · χ² 2,152 / p <1e-300	6.0 EB05 5.6 · IC025 +2.4 3/3 methods agree	Likely indication confounding term in indications	serious PRR 3.8 · 91% clinician	NCT00600483: 5/743 (0.7%) on Gentamicin; 8/759 (1.1%) control (serious AE)
Condition aggravated	504	2.2 2.0–2.4ROR 2.3 · χ² 345 / p 2e-77	2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 2.0 · 90% clinician	not reported in cached trials
Hypotension (low blood pressure)	492	3.3 3.0–3.6ROR 3.4 · χ² 785 / p 4e-173	3.3 EB05 3.0 · IC025 +1.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.3	NCT00600483: 1/743 (0.1%) on Gentamicin; 1/759 (0.1%) control (serious AE)
Nausea	484	0.8 0.8–0.9ROR 0.8 · χ² 20 / p 4e-6	0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC	Labeled adverse reaction exact term	serious PRR 0.9	NCT00600483: 1/743 (0.1%) on Gentamicin (serious AE)
Renal failure acute	463	14.5 13.3–15.9ROR 14.9 · χ² 5,757 / p <1e-300	14.3 EB05 13.3 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 8.7	NCT00600483: 1/743 (0.1%) on Gentamicin (serious AE)
Rash	455	1.4 1.3–1.5ROR 1.4 · χ² 53 / p 2e-13	1.4 EB05 1.3 · IC025 +0.3	Labeled adverse reaction exact term	serious PRR 1.7	NCT00600483: 1/743 (0.1%) on Gentamicin
Pneumonia (lung infection)	441	1.8 1.7–2.0ROR 1.8 · χ² 165 / p 4e-38	1.8 EB05 1.7 · IC025 +0.7	Likely indication confounding term in indications	serious PRR 1.2	NCT00600483: 1/759 (0.1%) control (serious AE)
Product use in unapproved indication	426	2.3 2.1–2.6ROR 2.4 · χ² 325 / p 5e-73	2.3 EB05 2.1 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 2.9 · ♀ 76% (drug 49%)	not reported in cached trials
Chronic kidney disease	423	7.4 6.7–8.1ROR 7.6 · χ² 2,331 / p <1e-300	7.3 EB05 6.7 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 4.7	not reported in cached trials

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.

Normal labour — n=122, PRR 9,446.6
Delivery — n=126, PRR 314.1
Delusion of grandeur — n=61, PRR 210.8
Persistent genital arousal disorder — n=21, PRR 132.3
Spinal muscular atrophy — n=24, PRR 130.5
Oscillopsia — n=21, PRR 117.1
Cardiac valve vegetation — n=28, PRR 82.5
Chronic kidney disease-mineral and bone disorder — n=41, PRR 52.9
Bacillus infection — n=23, PRR 51.0

✓ A hand-written Bradford Hill causality assessment exists for this drug: Gentamicin (aminoglycosides) ↔ Ototoxicity (hearing/balance).

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 Gentamicin?

In FDA FAERS, the most frequently co-reported reaction terms for Gentamicin are acute kidney injury, pyrexia, renal failure, diarrhoea, sepsis, hypotension. 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 Gentamicin have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: Patients treated with aminoglycosides should be under close clinical observation because of the potential toxicity associated with their use. As with other aminoglycosides, gentamicin injection is potentially nephrotoxic. The risk of nephrotoxicity is greater in patients with impaired renal function and in those who receive high dosage of prolonged therapy.

Do FAERS signals prove that Gentamicin 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 51fffac8-fb6e-4f7f-b2de-440252781a42, effective 20230907; matched on openfda.generic_name.exact:"GENTAMICIN")
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, 1,159 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
ClinicalTrials.gov API v2 (query GENTAMICIN, results-bearing studies sorted by enrollment)

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.