Drug · FAERS side-effect profile with label screen
Tobramycin Sulfate side effects: what 12,308 FDA adverse event reports show
Drug class
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Bethkis
openFDA label
Who reports
12,308 reports · 81% serious · 1,279 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 1Labeled (related wording) 5Likely indication confounding 5Lab value / disease marker 1Not in label — unassessed 28
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.
- 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. 1,048 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 |
|---|---|---|---|---|---|---|
| Choroiditis | 64 | 350.2 267.7–458.2ROR 352.0 · χ² 18,154 / p <1e-300 | 266.9 EB05 216.4 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=64 · ♀ 0% (drug 55%) | no trial data cached |
| Infective keratitis | 11 | 313.2 164.6–596.1ROR 313.5 · χ² 2,628 / p <1e-300 | 181.5 EB05 108.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Acquired factor v deficiency | 14 | 245.0 139.9–429.1ROR 245.3 · χ² 2,760 / p <1e-300 | 166.0 EB05 105.1 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Infective pulmonary exacerbation of cystic fibrosis | 621 | 217.7 200.6–236.2ROR 229.2 · χ² 118,429 / p <1e-300 | 191.7 EB05 179.4 · IC025 +7.3 3/3 methods agree | Labeled (related wording) related wording | serious n=560 | no trial data cached |
| Cystic fibrosis respiratory infection suppression | 90 | 189.5 152.5–235.4ROR 190.9 · χ² 14,994 / p <1e-300 | 164.5 EB05 137.9 · IC025 +6.1 3/3 methods agree | Labeled (related wording) related wording | serious n=89 · 81% consumer | no trial data cached |
| Cystic fibrosis lung | 12 | 172.3 95.1–312.0ROR 172.5 · χ² 1,701 / p <1e-300 | 125.6 EB05 76.6 · IC025 +3.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=12 | no trial data cached |
| Ventilation perfusion mismatch | 23 | 154.6 100.9–236.8ROR 154.8 · χ² 3,074 / p <1e-300 | 126.9 EB05 89.1 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 100% (drug 55%) · 100% clinician | no trial data cached |
| Cystic fibrosis | 426 | 141.3 128.2–155.7ROR 146.3 · χ² 54,624 / p <1e-300 | 129.7 EB05 119.7 · IC025 +6.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=417 | no trial data cached |
| Antibiotic level above therapeutic | 30 | 138.1 95.2–200.3ROR 138.4 · χ² 3,647 / p <1e-300 | 118.2 EB05 86.8 · IC025 +4.8 3/3 methods agree | Lab value / disease marker | serious n=29 · ♀ 79% (drug 55%) | no trial data cached |
| Keratitis fungal | 15 | 135.5 80.1–229.2ROR 135.6 · χ² 1,730 / p <1e-300 | 108.5 EB05 69.8 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Cystic fibrosis related diabetes | 10 | 126.3 66.4–240.1ROR 126.4 · χ² 1,043 / p 5e-229 | 96.5 EB05 56.0 · IC025 +3.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=9 | no trial data cached |
| Keratitis bacterial | 11 | 125.7 68.1–231.9ROR 125.8 · χ² 1,153 / p 6e-253 | 97.7 EB05 58.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Sle arthritis | 16 | 101.1 61.0–167.3ROR 101.2 · χ² 1,402 / p <1e-300 | 85.9 EB05 56.1 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Corneal infiltrates | 16 | 93.0 56.2–153.8ROR 93.1 · χ² 1,294 / p 1e-283 | 80.0 EB05 52.2 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Infective exacerbation of bronchiectasis | 14 | 85.2 49.8–145.7ROR 85.3 · χ² 1,030 / p 2e-226 | 73.4 EB05 46.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Corneal neovascularisation | 11 | 84.0 45.9–153.9ROR 84.1 · χ² 782 / p 2e-172 | 70.6 EB05 42.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Elbow deformity | 16 | 81.9 49.6–135.3ROR 82.1 · χ² 1,144 / p 5e-251 | 71.8 EB05 46.8 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Vitamin k deficiency | 18 | 80.6 50.3–129.4ROR 80.8 · χ² 1,276 / p 1e-279 | 71.4 EB05 47.8 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Ototoxicity | 83 | 79.8 64.1–99.4ROR 80.4 · χ² 6,092 / p <1e-300 | 75.0 EB05 62.4 · IC025 +5.4 3/3 methods agree | Labeled adverse reaction exact term | serious n=81 · 94% clinician | no trial data cached |
| Corneal perforation | 27 | 77.4 52.6–113.8ROR 77.6 · χ² 1,874 / p <1e-300 | 70.5 EB05 50.9 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=27 · ♀ 100% (drug 55%) · 100% clinician | no trial data cached |
| Mycobacterium chelonae infection | 32 | 77.4 54.3–110.2ROR 77.5 · χ² 2,233 / p <1e-300 | 71.0 EB05 52.6 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=30 · 100% clinician | no trial data cached |
| Corneal thinning | 11 | 77.0 42.1–140.9ROR 77.1 · χ² 718 / p 2e-158 | 65.7 EB05 39.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Corneal epithelium defect | 21 | 64.6 41.8–99.9ROR 64.7 · χ² 1,206 / p 2e-264 | 59.1 EB05 40.8 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=21 | no trial data cached |
| Trichosporon infection | 13 | 57.8 33.2–100.4ROR 57.8 · χ² 647 / p 4e-143 | 51.9 EB05 32.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Restrictive cardiomyopathy | 10 | 57.5 30.6–108.0ROR 57.6 · χ² 484 / p 2e-107 | 50.6 EB05 29.4 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Hypotony of eye | 13 | 54.6 31.4–94.8ROR 54.7 · χ² 612 / p 3e-135 | 49.3 EB05 30.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Tracheitis | 23 | 53.1 35.1–80.5ROR 53.2 · χ² 1,091 / p 2e-239 | 49.6 EB05 34.8 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=22 | no trial data cached |
| Increased viscosity of bronchial secretion | 19 | 52.8 33.4–83.3ROR 52.8 · χ² 886 / p 6e-195 | 48.8 EB05 33.0 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Pseudomonas infection | 251 | 52.0 46.0–58.9ROR 53.1 · χ² 12,143 / p <1e-300 | 50.3 EB05 45.3 · IC025 +5.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 34.6 | no trial data cached |
| Pulmonary function test decreased | 130 | 51.8 43.6–61.7ROR 52.4 · χ² 6,240 / p <1e-300 | 50.0 EB05 43.2 · IC025 +5.1 3/3 methods agree | Labeled (related wording) related wording | serious n=119 | no trial data cached |
| Hypopyon | 24 | 50.6 33.7–75.9ROR 50.7 · χ² 1,085 / p 3e-238 | 47.4 EB05 33.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=24 · 100% clinician | no trial data cached |
| Lung infection pseudomonal | 16 | 49.6 30.2–81.5ROR 49.7 · χ² 694 / p 4e-153 | 45.8 EB05 29.9 · IC025 +3.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=14 | no trial data cached |
| Respiratory tract infection bacterial | 14 | 49.0 28.8–83.3ROR 49.1 · χ² 594 / p 2e-131 | 44.9 EB05 28.4 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious n=14 | no trial data cached |
| Retinopathy of prematurity | 15 | 47.7 28.6–79.7ROR 47.8 · χ² 623 / p 1e-137 | 44.0 EB05 28.3 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Pneumonia pseudomonal | 38 | 43.7 31.7–60.2ROR 43.8 · χ² 1,503 / p <1e-300 | 41.8 EB05 31.8 · IC025 +4.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=37 | no trial data cached |
| Glomerulonephritis membranoproliferative | 13 | 43.2 24.9–74.8ROR 43.2 · χ² 482 / p 5e-107 | 39.8 EB05 24.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Overlap syndrome | 16 | 40.4 24.6–66.3ROR 40.5 · χ² 563 / p 1e-124 | 37.9 EB05 24.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Respiratory tract irritation | 24 | 40.2 26.8–60.2ROR 40.2 · χ² 857 / p 1e-188 | 38.2 EB05 27.0 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=19 · ♀ 33% (drug 55%) | no trial data cached |
| Bronchopulmonary aspergillosis allergic | 20 | 38.0 24.4–59.1ROR 38.0 · χ² 668 / p 1e-147 | 36.0 EB05 24.6 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Mycobacterium abscessus infection | 15 | 37.0 22.2–61.7ROR 37.0 · χ² 480 / p 1e-106 | 34.8 EB05 22.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=14 | 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 |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 771 | 1.5 1.4–1.6ROR 1.5 · χ² 140 / p 2e-32 | 1.5 EB05 1.4 · IC025 +0.5 | Reporting / coding artifact | serious PRR 1.7 | no trial data cached |
| Pneumonia (lung infection) | 757 | 4.0 3.7–4.3ROR 4.2 · χ² 1,720 / p <1e-300 | 4.0 EB05 3.7 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.9 | no trial data cached |
| Drug ineffective (drug did not work) | 694 | 0.9 0.8–1.0ROR 0.9 · χ² 8 / p 0.002 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.5 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 686 | 7.7 7.2–8.3ROR 8.1 · χ² 4,005 / p <1e-300 | 7.6 EB05 7.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 · 90% clinician | no trial data cached |
| Dyspnoea (shortness of breath) | 669 | 2.0 1.9–2.2ROR 2.1 · χ² 351 / p 2e-78 | 2.0 EB05 1.9 · IC025 +0.9 | Not in label — unassessed | serious PRR 1.7 | no trial data cached |
| Infective pulmonary exacerbation of cystic fibrosis | 621 | 217.7 200.6–236.2ROR 229.2 · χ² 118,429 / p <1e-300 | 191.7 EB05 179.4 · IC025 +7.3 3/3 methods agree | Labeled (related wording) related wording | serious n=560 | no trial data cached |
| Death | 476 | 0.9 0.9–1.0ROR 0.9 · χ² 2 / p 0.093 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 0.7 | no trial data cached |
| Infection | 459 | 5.4 5.0–5.9ROR 5.6 · χ² 1,664 / p <1e-300 | 5.4 EB05 5.0 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 | no trial data cached |
| Hospitalisation | 451 | 5.1 4.6–5.5ROR 5.2 · χ² 1,469 / p <1e-300 | 5.0 EB05 4.6 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 3.5 | no trial data cached |
| Cough | 445 | 2.7 2.5–3.0ROR 2.8 · χ² 485 / p 9e-108 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.4 | no trial data cached |
| Condition aggravated | 440 | 2.5 2.3–2.7ROR 2.5 · χ² 394 / p 6e-88 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.4 | no trial data cached |
| Pyrexia (fever) | 426 | 2.1 1.9–2.3ROR 2.1 · χ² 247 / p 5e-56 | 2.1 EB05 1.9 · IC025 +0.9 | Not in label — unassessed | serious PRR 1.7 | no trial data cached |
| Cystic fibrosis | 426 | 141.3 128.2–155.7ROR 146.3 · χ² 54,624 / p <1e-300 | 129.7 EB05 119.7 · IC025 +6.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=417 | no trial data cached |
| Fatigue (tiredness) | 392 | 0.9 0.8–0.9ROR 0.9 · χ² 9 / p 0.001 | 0.9 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Labeled (related wording) related wording | serious PRR 0.9 | no trial data cached |
| Nausea | 369 | 0.8 0.7–0.9ROR 0.8 · χ² 20 / p 5e-6 | 0.8 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 0.9 · ♀ 77% (drug 55%) | 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.
- Choroiditis — n=64, PRR 350.2
- Ventilation perfusion mismatch — n=23, PRR 154.6
- Corneal perforation — n=27, PRR 77.4
- Mycobacterium chelonae infection — n=32, PRR 77.4
- Corneal epithelium defect — n=21, PRR 64.6
- Tracheitis — n=23, PRR 53.1
- Hypopyon — n=24, PRR 50.6
- Respiratory tract irritation — n=24, PRR 40.2
- Bronchopulmonary aspergillosis allergic — n=20, PRR 38.0
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 pneumonia, acute kidney injury, dyspnoea, infective pulmonary exacerbation of cystic fibrosis, infection, cough. 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, 1,088 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.