Drug · FAERS side-effect profile with label screen
Tobramycin side effects: what 23,907 FDA adverse event reports show
Drug class
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Bethkis
openFDA label
Who reports
23,907 reports · 77% serious · 2,819 with death outcome · 55% female
openFDA FAERS counts, all years, deduplication not applied
Used for
BETHKIS is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa . Safety and efficacy have not been demonstrated in patients under the age of six years, patients with FEV 1 less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia .
FDA label, Indications and Usage
What it is
BETHKIS is a sterile, clear, colorless to pale yellow, non-pyrogenic, aqueous solution with pH and salinity adjusted. BETHKIS is administered by a compressed air driven reusable nebulizer.
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
Labeled adverse reaction 2Labeled (related wording) 5Likely indication confounding 6Reporting / coding artifact 1Lab value / disease marker 2Not in label — unassessed 24
What the badges mean
- 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. 1,101 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 |
|---|---|---|---|---|---|---|
| Infective pulmonary exacerbation of cystic fibrosis | 1,576 | 355.1 335.3–376.0ROR 380.0 · χ² 394,273 / p <1e-300 | 251.2 EB05 241.0 · IC025 +7.8 3/3 methods agree | Labeled (related wording) related wording | serious n=1,433 | not reported in cached trials |
| Cystic fibrosis lung | 33 | 297.2 200.1–441.2ROR 297.6 · χ² 7,030 / p <1e-300 | 196.4 EB05 146.3 · IC025 +5.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=33 | not reported in cached trials |
| Cystic fibrosis | 1,278 | 262.2 246.6–278.8ROR 277.0 · χ² 255,035 / p <1e-300 | 200.8 EB05 191.8 · IC025 +7.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=1,237 | not reported in cached trials |
| Cystic fibrosis related diabetes | 26 | 192.1 125.6–293.8ROR 192.3 · χ² 3,889 / p <1e-300 | 141.2 EB05 101.3 · IC025 +4.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=24 | not reported in cached trials |
| Cystic fibrosis respiratory infection suppression | 158 | 187.1 157.6–222.1ROR 188.3 · χ² 23,891 / p <1e-300 | 151.2 EB05 132.4 · IC025 +6.4 3/3 methods agree | Labeled (related wording) related wording | serious n=157 · 73% consumer | not reported in cached trials |
| Choroiditis | 64 | 180.2 137.7–235.8ROR 180.7 · χ² 9,290 / p <1e-300 | 143.0 EB05 115.9 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=64 · ♀ 0% (drug 55%) | not reported in cached trials |
| Infective keratitis | 12 | 178.8 96.1–333.0ROR 178.9 · χ² 1,614 / p <1e-300 | 120.4 EB05 73.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Pseudomonas bronchitis | 10 | 160.1 81.5–314.3ROR 160.1 · χ² 1,203 / p 7e-264 | 108.0 EB05 62.7 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | not reported in cached trials |
| Infective exacerbation of bronchiectasis | 43 | 150.5 108.9–208.0ROR 150.8 · χ² 5,312 / p <1e-300 | 121.5 EB05 94.0 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=43 | not reported in cached trials |
| Acquired factor v deficiency | 14 | 126.1 72.0–220.8ROR 126.1 · χ² 1,409 / p <1e-300 | 96.1 EB05 60.8 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Tracheostomy infection | 15 | 121.2 70.6–208.0ROR 121.3 · χ² 1,464 / p <1e-300 | 94.0 EB05 60.5 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Pulmonary function test decreased | 425 | 93.8 84.9–103.6ROR 95.4 · χ² 35,113 / p <1e-300 | 84.4 EB05 77.9 · IC025 +6.1 3/3 methods agree | Labeled (related wording) related wording | serious n=381 | not reported in cached trials |
| Pelvic kidney | 10 | 83.9 43.9–160.6ROR 84.0 · χ² 673 / p 1e-148 | 67.2 EB05 39.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Distal intestinal obstruction syndrome | 29 | 81.7 55.8–119.5ROR 81.8 · χ² 2,038 / p <1e-300 | 71.3 EB05 52.1 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=27 | not reported in cached trials |
| Antibiotic level above therapeutic | 32 | 76.2 53.1–109.4ROR 76.3 · χ² 2,114 / p <1e-300 | 67.4 EB05 50.0 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious n=31 · ♀ 81% (drug 55%) · 90% clinician | not reported in cached trials |
| Lung infection pseudomonal | 42 | 70.4 51.4–96.3ROR 70.5 · χ² 2,592 / p <1e-300 | 63.4 EB05 48.8 · IC025 +4.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=39 | not reported in cached trials |
| Keratitis fungal | 15 | 69.7 41.2–118.0ROR 69.8 · χ² 878 / p 4e-193 | 59.9 EB05 38.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Ventilation perfusion mismatch | 20 | 68.3 43.4–107.7ROR 68.4 · χ² 1,168 / p 3e-256 | 60.0 EB05 41.0 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=20 · 100% clinician | not reported in cached trials |
| Keratitis bacterial | 11 | 64.7 35.1–119.4ROR 64.7 · χ² 584 / p 3e-129 | 54.8 EB05 32.7 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Pseudomonas infection | 548 | 60.7 55.7–66.1ROR 62.1 · χ² 30,015 / p <1e-300 | 56.7 EB05 52.8 · IC025 +5.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 41.4 | not reported in cached trials |
| Corneal infiltrates | 20 | 60.7 38.6–95.4ROR 60.7 · χ² 1,042 / p 8e-229 | 54.0 EB05 36.9 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=19 · 100% clinician | not reported in cached trials |
| Pancreatic insufficiency | 23 | 59.0 38.7–90.0ROR 59.1 · χ² 1,174 / p 1e-257 | 53.0 EB05 37.2 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=23 | not reported in cached trials |
| Burkholderia cepacia complex infection | 18 | 58.1 36.0–93.6ROR 58.1 · χ² 893 / p 2e-196 | 51.7 EB05 34.6 · 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 |
| Pseudomonas test positive | 50 | 56.6 42.5–75.3ROR 56.7 · χ² 2,510 / p <1e-300 | 52.2 EB05 41.1 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious n=38 | not reported in cached trials |
| Sle arthritis | 16 | 52.0 31.4–86.1ROR 52.0 · χ² 707 / p 4e-156 | 46.6 EB05 30.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Corneal neovascularisation | 13 | 51.5 29.5–90.2ROR 51.6 · χ² 561 / p 2e-124 | 45.7 EB05 28.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Increased viscosity of bronchial secretion | 34 | 49.8 35.3–70.4ROR 49.9 · χ² 1,492 / p <1e-300 | 46.0 EB05 34.4 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=32 | not reported in cached trials |
| Ototoxicity | 96 | 47.9 39.0–58.8ROR 48.0 · χ² 4,129 / p <1e-300 | 45.0 EB05 38.0 · IC025 +4.9 3/3 methods agree | Labeled adverse reaction exact term | serious n=94 | not reported in cached trials |
| Corneal thinning | 13 | 47.2 27.0–82.5ROR 47.2 · χ² 515 / p 3e-114 | 42.3 EB05 26.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Sputum increased | 101 | 43.9 36.0–53.6ROR 44.1 · χ² 3,993 / p <1e-300 | 41.6 EB05 35.2 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=84 | not reported in cached trials |
| Vitamin k deficiency | 19 | 43.9 27.7–69.6ROR 43.9 · χ² 718 / p 2e-158 | 40.3 EB05 27.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Tracheitis | 36 | 43.6 31.2–60.9ROR 43.6 · χ² 1,386 / p <1e-300 | 40.7 EB05 30.7 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=34 | not reported in cached trials |
| Elbow deformity | 16 | 42.2 25.5–69.6ROR 42.2 · χ² 574 / p 3e-127 | 38.6 EB05 25.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Pneumonia pseudomonal | 69 | 41.7 32.7–53.1ROR 41.8 · χ² 2,575 / p <1e-300 | 39.4 EB05 32.2 · IC025 +4.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=67 | not reported in cached trials |
| Respiratory tract irritation | 47 | 41.4 30.9–55.5ROR 41.5 · χ² 1,731 / p <1e-300 | 39.0 EB05 30.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=33 | not reported in cached trials |
| Corneal epithelium defect | 25 | 39.9 26.7–59.5ROR 39.9 · χ² 869 / p 3e-191 | 37.2 EB05 26.5 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 76% (drug 55%) · 100% clinician | not reported in cached trials |
| Mycobacterium chelonae infection | 32 | 39.8 27.9–56.7ROR 39.9 · χ² 1,120 / p 6e-246 | 37.3 EB05 27.7 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=30 · 100% clinician | not reported in cached trials |
| Corneal perforation | 26 | 38.3 25.9–56.7ROR 38.3 · χ² 869 / p 3e-191 | 35.8 EB05 25.7 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=26 · 100% clinician | not reported in cached trials |
| Forced expiratory volume decreased | 115 | 37.0 30.7–44.6ROR 37.2 · χ² 3,831 / p <1e-300 | 35.4 EB05 30.3 · IC025 +4.6 3/3 methods agree | Labeled adverse reaction exact term | serious n=107 | not reported in cached trials |
| Bacterial disease carrier | 29 | 36.3 25.1–52.7ROR 36.4 · χ² 923 / p 6e-203 | 34.2 EB05 25.0 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious n=24 | 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 Tobramycin 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 (0 of 40 signal terms matched).
- NCT03739528 — Levo-Dexa vs. Tobra+Dexa for Prevention and Treatment of Inflammation and Prevention of Infection in Cataract (N=808, PHASE3; 3 AE terms posted; arms: Levofloxacin + Dexamethasone Followed by; Tobramycin + Dexamethasone)
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 |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 2,003 | 2.0 1.9–2.1ROR 2.1 · χ² 1,083 / p 8e-238 | 2.0 EB05 2.0 · IC025 +0.9 | Reporting / coding artifact | serious PRR 1.9 | not reported in cached trials |
| Death | 1,699 | 1.7 1.7–1.8ROR 1.8 · χ² 546 / p 5e-121 | 1.7 EB05 1.7 · IC025 +0.7 | Outcome field, not a reaction | serious PRR 1.3 | not reported in cached trials |
| Infective pulmonary exacerbation of cystic fibrosis | 1,576 | 355.1 335.3–376.0ROR 380.0 · χ² 394,273 / p <1e-300 | 251.2 EB05 241.0 · IC025 +7.8 3/3 methods agree | Labeled (related wording) related wording | serious n=1,433 | not reported in cached trials |
| Pneumonia (lung infection) | 1,504 | 4.1 3.9–4.3ROR 4.3 · χ² 3,554 / p <1e-300 | 4.1 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.1 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 1,407 | 2.2 2.1–2.3ROR 2.3 · χ² 925 / p 1e-203 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 1.8 | not reported in cached trials |
| Cough | 1,283 | 4.0 3.8–4.3ROR 4.2 · χ² 2,952 / p <1e-300 | 4.0 EB05 3.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | not reported in cached trials |
| Cystic fibrosis | 1,278 | 262.2 246.6–278.8ROR 277.0 · χ² 255,035 / p <1e-300 | 200.8 EB05 191.8 · IC025 +7.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=1,237 | not reported in cached trials |
| Hospitalisation | 1,036 | 6.0 5.6–6.4ROR 6.2 · χ² 4,311 / p <1e-300 | 5.9 EB05 5.6 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.3 | not reported in cached trials |
| Condition aggravated | 960 | 2.8 2.6–3.0ROR 2.9 · χ² 1,117 / p 4e-245 | 2.8 EB05 2.6 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 | not reported in cached trials |
| Infection | 865 | 5.3 5.0–5.6ROR 5.4 · χ² 3,005 / p <1e-300 | 5.2 EB05 5.0 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | not reported in cached trials |
| Drug ineffective (drug did not work) | 855 | 0.6 0.5–0.6ROR 0.6 · χ² 297 / p 8e-67 | 0.6 EB05 0.5 · IC025 -0.9 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.0 | not reported in cached trials |
| Acute kidney injury (sudden kidney damage) | 732 | 4.2 3.9–4.5ROR 4.3 · χ² 1,807 / p <1e-300 | 4.2 EB05 4.0 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | not reported in cached trials |
| Malaise (feeling unwell) | 689 | 1.4 1.3–1.5ROR 1.4 · χ² 72 / p 1e-17 | 1.4 EB05 1.3 · IC025 +0.3 | Not in label — unassessed | serious PRR 1.3 | not reported in cached trials |
| Pyrexia (fever) | 684 | 1.7 1.6–1.9ROR 1.8 · χ² 215 / p 6e-49 | 1.7 EB05 1.6 · IC025 +0.7 | Not in label — unassessed | serious PRR 1.5 | not reported in cached trials |
| Fatigue (tiredness) | 627 | 0.7 0.7–0.8ROR 0.7 · χ² 78 / p 4e-19 | 0.7 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC | Labeled (related wording) related wording | serious PRR 0.7 | 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.
- Choroiditis — n=64, PRR 180.2
- Infective exacerbation of bronchiectasis — n=43, PRR 150.5
- Distal intestinal obstruction syndrome — n=29, PRR 81.7
- Ventilation perfusion mismatch — n=20, PRR 68.3
- Corneal infiltrates — n=20, PRR 60.7
- Pancreatic insufficiency — n=23, PRR 59.0
- Increased viscosity of bronchial secretion — n=34, PRR 49.8
- Sputum increased — n=101, PRR 43.9
- Tracheitis — n=36, PRR 43.6
- Respiratory tract irritation — n=47, PRR 41.4
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 Tobramycin?
In FDA FAERS, the most frequently co-reported reaction terms for Tobramycin are infective pulmonary exacerbation of cystic fibrosis, pneumonia, dyspnoea, cough, cystic fibrosis, infection. 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 Tobramycin have an FDA boxed warning?
No. The FDA label retrieved for Tobramycin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Tobramycin 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 1cd3d47b-025f-4705-9daf-cf07725ec223, effective 20230224; matched on
openfda.generic_name.exact:"TOBRAMYCIN") - 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, 1,141 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
TOBRAMYCIN, 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.