Gentamicin side effects: what 13,004 FDA adverse event reports show
Drug class
Not stated in label
Who reports
13,004 reports · 94% serious · 2,405 with death outcome · 48% female
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.
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.
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.
Causality screen of the 40 strongest signals
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. 1,079 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Normal labour | 96 | 3,550.6 2,479.0–5,085.4ROR 3,577.0 · χ² 104,291 / p <1e-300 | 900.2 EB05 758.9 · IC025 +7.0 3/3 methods agree | Not in label — unassessed | serious n=96 · ♀ 100% (drug 48%) · 100% clinician | not reported in cached trials |
| Neonatal candida infection | 12 | 615.6 316.2–1,198.5ROR 616.2 · χ² 4,875 / p <1e-300 | 260.3 EB05 158.7 · IC025 +3.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=12 | not reported in cached trials |
| Bartter's syndrome | 10 | 568.0 276.0–1,169.1ROR 568.4 · χ² 3,763 / p <1e-300 | 233.0 EB05 135.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Haematopoietic stem cell mobilisation | 14 | 454.4 250.9–822.8ROR 454.9 · χ² 4,580 / p <1e-300 | 238.7 EB05 151.1 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Endocarditis candida | 13 | 338.9 186.3–616.6ROR 339.3 · χ² 3,337 / p <1e-300 | 198.5 EB05 123.4 · 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 |
| Polyglandular disorder | 11 | 312.4 163.7–596.1ROR 312.7 · χ² 2,599 / p <1e-300 | 180.2 EB05 107.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Delivery | 103 | 297.3 241.1–366.7ROR 299.7 · χ² 25,377 / p <1e-300 | 239.5 EB05 203.1 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=103 · ♀ 100% (drug 48%) · 100% clinician | not reported in cached trials |
| Delusion of grandeur | 61 | 254.6 194.4–333.5ROR 255.8 · χ² 13,066 / p <1e-300 | 205.5 EB05 165.8 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=61 · ♀ 0% (drug 48%) | not reported in cached trials |
| Persistent genital arousal disorder | 21 | 159.8 102.1–250.2ROR 160.1 · χ² 2,869 / p <1e-300 | 128.6 EB05 88.7 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=21 · ♀ 100% (drug 48%) · 100% clinician | not reported in cached trials |
| Aminoaciduria | 14 | 154.6 89.3–267.6ROR 154.8 · χ² 1,810 / p <1e-300 | 118.6 EB05 75.1 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Oropharyngeal oedema | 12 | 145.7 80.7–263.0ROR 145.8 · χ² 1,450 / p <1e-300 | 110.6 EB05 67.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Spinal muscular atrophy | 21 | 136.3 87.3–212.8ROR 136.5 · χ² 2,475 / p <1e-300 | 113.0 EB05 78.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=21 · ♀ 0% (drug 48%) · 100% clinician | not reported in cached trials |
| Antimicrobial susceptibility test resistant | 21 | 116.4 74.7–181.2ROR 116.6 · χ² 2,132 / p <1e-300 | 99.0 EB05 68.3 · IC025 +4.2 3/3 methods agree | Likely indication confounding term in indications | serious n=21 | not reported in cached trials |
| Oscillopsia | 16 | 105.6 63.7–175.1ROR 105.7 · χ² 1,458 / p <1e-300 | 88.9 EB05 58.0 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Intraventricular haemorrhage neonatal | 30 | 105.6 73.0–152.7ROR 105.8 · χ² 2,816 / p <1e-300 | 93.3 EB05 68.5 · IC025 +4.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=30 · 100% clinician | not reported in cached trials |
| Antibiotic level above therapeutic | 24 | 102.9 68.1–155.4ROR 103.1 · χ² 2,180 / p <1e-300 | 90.0 EB05 63.6 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious n=24 · 100% clinician | not reported in cached trials |
| Vestibular disorder | 72 | 100.6 79.3–127.6ROR 101.2 · χ² 6,586 / p <1e-300 | 92.4 EB05 75.9 · IC025 +5.5 3/3 methods agree | Labeled (related wording) related wording | serious n=59 | not reported in cached trials |
| Anaemia folate deficiency | 11 | 100.5 54.7–184.9ROR 100.6 · χ² 928 / p 4e-204 | 81.7 EB05 48.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Procedural hypertension | 11 | 99.4 54.1–182.7ROR 99.5 · χ² 918 / p 6e-202 | 80.9 EB05 48.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | NCT00600483: 1/743 (0.1%) on Gentamicin; 3/759 (0.4%) control |
| Geotrichum infection | 12 | 96.4 53.8–172.6ROR 96.5 · χ² 980 / p 2e-215 | 79.8 EB05 48.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Positive airway pressure therapy | 13 | 94.8 54.2–165.9ROR 94.9 · χ² 1,052 / p 4e-231 | 79.5 EB05 49.4 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=13 | not reported in cached trials |
| Ototoxicity | 94 | 86.1 70.0–105.9ROR 86.7 · χ² 7,422 / p <1e-300 | 80.5 EB05 67.7 · IC025 +5.5 3/3 methods agree | Labeled — boxed warning exact term | serious n=91 | not reported in cached trials |
| Cardiac valve vegetation | 24 | 84.6 56.2–127.6ROR 84.8 · χ² 1,805 / p <1e-300 | 75.7 EB05 53.6 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=24 | not reported in cached trials |
| Lymphocyte count abnormal | 49 | 73.1 54.9–97.3ROR 73.4 · χ² 3,263 / p <1e-300 | 68.2 EB05 53.6 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | serious n=49 · ♀ 0% (drug 48%) · 92% clinician | NCT00600483: 12/743 (1.6%) on Gentamicin; 7/759 (0.9%) control |
| Stoma closure | 13 | 72.5 41.6–126.4ROR 72.6 · χ² 810 / p 2e-178 | 63.3 EB05 39.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Necrotising enterocolitis neonatal | 17 | 71.1 43.8–115.6ROR 71.2 · χ² 1,059 / p 1e-232 | 63.5 EB05 42.0 · IC025 +3.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=17 | not reported in cached trials |
| Noninfectious peritonitis | 10 | 69.1 36.7–130.2ROR 69.2 · χ² 580 / p 2e-128 | 59.2 EB05 34.4 · IC025 +2.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=10 | not reported in cached trials |
| Respiratory tract infection bacterial | 20 | 67.1 42.9–104.9ROR 67.2 · χ² 1,187 / p 2e-260 | 60.9 EB05 41.6 · IC025 +3.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=20 | not reported in cached trials |
| Herpes zoster reactivation | 10 | 64.9 34.5–122.1ROR 65.0 · χ² 545 / p 9e-121 | 56.1 EB05 32.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Pneumococcal sepsis | 24 | 61.7 41.0–92.7ROR 61.8 · χ² 1,321 / p 2e-289 | 56.9 EB05 40.2 · IC025 +4.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=24 · ♀ 0% (drug 48%) · 100% clinician | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 39 | 60.6 44.1–83.4ROR 60.8 · χ² 2,146 / p <1e-300 | 56.9 EB05 43.4 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=39 | not reported in cached trials |
| Bacillus infection | 22 | 58.8 38.4–90.0ROR 58.9 · χ² 1,150 / p 2e-252 | 54.2 EB05 37.7 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=22 · 100% clinician | not reported in cached trials |
| Endocarditis bacterial | 27 | 57.1 38.9–83.8ROR 57.2 · χ² 1,383 / p <1e-300 | 53.2 EB05 38.4 · IC025 +4.2 3/3 methods agree | Likely indication confounding term in indications | serious n=27 · 100% clinician | not reported in cached trials |
| Fungal endocarditis | 10 | 56.8 30.2–106.7ROR 56.8 · χ² 477 / p 5e-106 | 50.0 EB05 29.0 · IC025 +2.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=10 | not reported in cached trials |
| Hypoprothrombinaemia | 10 | 55.0 29.3–103.3ROR 55.1 · χ² 462 / p 1e-102 | 48.6 EB05 28.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Motor neurone disease | 16 | 54.3 33.0–89.3ROR 54.3 · χ² 758 / p 3e-167 | 49.6 EB05 32.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Sepsis syndrome | 16 | 52.7 32.0–86.7ROR 52.7 · χ² 736 / p 2e-162 | 48.3 EB05 31.5 · IC025 +3.5 3/3 methods agree | Likely indication confounding term in indications | serious n=16 | NCT00600483: 5/743 (0.7%) on Gentamicin; 8/759 (1.1%) control (serious AE) |
| Pyroglutamic acidosis | 12 | 52.6 29.6–93.4ROR 52.6 · χ² 539 / p 2e-119 | 47.4 EB05 28.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Anisocytosis | 20 | 51.2 32.8–79.9ROR 51.3 · χ² 906 / p 2e-199 | 47.6 EB05 32.5 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=20 | not reported in cached trials |
| Cns ventriculitis | 10 | 50.8 27.1–95.3ROR 50.8 · χ² 426 / p 6e-95 | 45.3 EB05 26.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=10 | 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 (3 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) | 1,064 | 1.3 1.2–1.4ROR 1.3 · χ² 80 / p 2e-19 | 1.3 EB05 1.2 · IC025 +0.3 | Reporting / coding artifact | serious PRR 2.1 · 95% clinician | not reported in cached trials |
| Acute kidney injury (sudden kidney damage) | 1,030 | 11.0 10.3–11.6ROR 11.8 · χ² 9,331 / p <1e-300 | 10.9 EB05 10.3 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.7 · 93% clinician | not reported in cached trials |
| Pyrexia (fever) | 766 | 3.6 3.3–3.8ROR 3.7 · χ² 1,438 / p <1e-300 | 3.6 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.7 | NCT00600483: 2/743 (0.3%) on Gentamicin (serious AE) |
| Off label use (used outside approved label) | 705 | 1.3 1.2–1.4ROR 1.3 · χ² 54 / p 1e-13 | 1.3 EB05 1.2 · IC025 +0.3 | Reporting / coding artifact | serious PRR 1.3 · 91% clinician | not reported in cached trials |
| Renal failure (kidney failure) | 606 | 7.3 6.8–7.9ROR 7.6 · χ² 3,315 / p <1e-300 | 7.3 EB05 6.8 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.5 | NCT00600483: 1/743 (0.1%) on Gentamicin (serious AE) |
| Diarrhoea (diarrhea) | 475 | 1.2 1.1–1.3ROR 1.2 · χ² 15 / p 6e-5 | 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) | 437 | 6.3 5.8–6.9ROR 6.5 · χ² 1,961 / p <1e-300 | 6.3 EB05 5.8 · IC025 +2.5 3/3 methods agree | Likely indication confounding term in indications | serious PRR 3.9 · 91% clinician | NCT00600483: 5/743 (0.7%) on Gentamicin; 8/759 (1.1%) control (serious AE) |
| Condition aggravated | 424 | 2.3 2.1–2.5ROR 2.3 · χ² 303 / p 4e-68 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.0 · 92% clinician | not reported in cached trials |
| Hypotension (low blood pressure) | 413 | 3.3 3.0–3.7ROR 3.4 · χ² 676 / p 2e-149 | 3.3 EB05 3.1 · 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) |
| Chronic kidney disease | 403 | 8.5 7.7–9.4ROR 8.8 · χ² 2,662 / p <1e-300 | 8.4 EB05 7.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | not reported in cached trials |
| Nausea | 388 | 0.8 0.7–0.9ROR 0.8 · χ² 22 / p 2e-6 | 0.8 EB05 0.7 · IC025 -0.5 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) |
| Drug interaction | 383 | 3.9 3.5–4.3ROR 4.0 · χ² 827 / p 3e-182 | 3.9 EB05 3.6 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 2.6 · 90% clinician | not reported in cached trials |
| Foetal exposure during pregnancy | 359 | 7.2 6.5–7.9ROR 7.3 · χ² 1,893 / p <1e-300 | 7.1 EB05 6.5 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 · 97% clinician | not reported in cached trials |
| Renal failure acute | 359 | 13.6 12.2–15.0ROR 13.9 · χ² 4,136 / p <1e-300 | 13.4 EB05 12.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | NCT00600483: 1/743 (0.1%) on Gentamicin (serious AE) |
| Pneumonia (lung infection) | 345 | 1.7 1.6–1.9ROR 1.7 · χ² 105 / p 5e-25 | 1.7 EB05 1.6 · IC025 +0.6 | Likely indication confounding term in indications | serious PRR 1.1 · 90% clinician | NCT00600483: 1/759 (0.1%) control (serious AE) |
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=96, PRR 3,550.6
- Delivery — n=103, PRR 297.3
- Delusion of grandeur — n=61, PRR 254.6
- Persistent genital arousal disorder — n=21, PRR 159.8
- Spinal muscular atrophy — n=21, PRR 136.3
- Cardiac valve vegetation — n=24, PRR 84.6
- Chronic kidney disease-mineral and bone disorder — n=39, PRR 60.6
- Bacillus infection — n=22, PRR 58.8
- Anisocytosis — n=20, PRR 51.2
✓ 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, fieldpatient.drug.openfda.generic_name.exact, 1,119 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.