Drug · FAERS side-effect profile with label screen
Tobramycin and Dexamethasone side effects: what 3,280 FDA adverse event reports show
Drug class
Aminoglycoside Antibacterial
FDA label (Established Pharmacologic Class) of the closest related product
Label matched
Tobramycin (Bethkis)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
3,280 reports · 69% serious · 149 with death outcome · 63% 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 (related wording) 3Reporting / coding artifact 2Lab value / disease marker 2Not in label — unassessed 33
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- 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. 142 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 |
|---|---|---|---|---|---|---|
| Intraocular pressure increased (raised eye pressure) | 100 | 50.1 41.3–60.8ROR 51.7 · χ² 4,729 / p <1e-300 | 49.3 EB05 41.7 · IC025 +5.0 3/3 methods agree | Lab value / disease marker | serious PRR 54.5 | no trial data cached |
| Retinal detachment | 48 | 33.5 25.3–44.4ROR 34.0 · χ² 1,474 / p <1e-300 | 32.9 EB05 25.8 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 28.4 · 91% clinician | no trial data cached |
| Eye infection | 49 | 28.0 21.2–37.0ROR 28.4 · χ² 1,245 / p 6e-273 | 27.6 EB05 21.7 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious n=24 | no trial data cached |
| Eye pain | 241 | 28.0 24.8–31.6ROR 30.1 · χ² 6,232 / p <1e-300 | 27.8 EB05 25.0 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 33.1 | no trial data cached |
| Photophobia (light sensitivity) | 81 | 27.8 22.4–34.5ROR 28.5 · χ² 2,060 / p <1e-300 | 27.5 EB05 22.9 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 27.0 | no trial data cached |
| Eye inflammation | 38 | 25.8 18.8–35.4ROR 26.1 · χ² 879 / p 2e-193 | 25.4 EB05 19.3 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=26 | no trial data cached |
| Conjunctivitis | 73 | 25.5 20.3–32.0ROR 26.0 · χ² 1,686 / p <1e-300 | 25.2 EB05 20.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 32.5 | no trial data cached |
| Uveitis | 53 | 25.1 19.2–32.9ROR 25.5 · χ² 1,201 / p 2e-263 | 24.9 EB05 19.7 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 22.4 | no trial data cached |
| Ocular hyperaemia | 167 | 22.9 19.8–26.6ROR 24.1 · χ² 3,471 / p <1e-300 | 22.8 EB05 20.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 30.4 | no trial data cached |
| Eye discharge | 34 | 21.3 15.2–29.8ROR 21.5 · χ² 636 / p 1e-140 | 21.0 EB05 15.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Ocular discomfort | 36 | 21.2 15.3–29.4ROR 21.5 · χ² 672 / p 2e-148 | 21.0 EB05 15.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=24 | no trial data cached |
| Eye irritation | 168 | 19.3 16.6–22.4ROR 20.3 · χ² 2,895 / p <1e-300 | 19.2 EB05 16.9 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 31.2 | no trial data cached |
| Lacrimation increased | 85 | 18.2 14.8–22.5ROR 18.7 · χ² 1,364 / p 8e-299 | 18.1 EB05 15.1 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 23.8 | no trial data cached |
| Glaucoma | 51 | 16.9 12.9–22.3ROR 17.2 · χ² 748 / p 6e-165 | 16.8 EB05 13.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 15.3 · ♀ 43% (drug 63%) | no trial data cached |
| Eye swelling | 89 | 15.4 12.5–18.9ROR 15.8 · χ² 1,184 / p 1e-259 | 15.3 EB05 12.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 14.7 | no trial data cached |
| Visual acuity reduced | 76 | 14.5 11.6–18.1ROR 14.8 · χ² 943 / p 3e-207 | 14.4 EB05 11.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 14.3 | no trial data cached |
| Osteopenia | 34 | 14.3 10.2–19.9ROR 14.4 · χ² 405 / p 2e-90 | 13.9 EB05 10.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 14.1 | no trial data cached |
| Economic problem | 32 | 13.3 9.4–18.8ROR 13.4 · χ² 351 / p 1e-78 | 12.9 EB05 9.3 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 11.8 | no trial data cached |
| Eyelid oedema | 24 | 13.1 8.8–19.5ROR 13.2 · χ² 256 / p 6e-58 | 12.5 EB05 8.5 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 | no trial data cached |
| Eyelid ptosis | 20 | 12.6 8.1–19.5ROR 12.6 · χ² 201 / p 5e-46 | 11.7 EB05 7.6 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Eye pruritus | 64 | 12.4 9.7–15.8ROR 12.6 · χ² 660 / p 7e-146 | 12.2 EB05 9.8 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 21.8 | no trial data cached |
| Eye disorder | 57 | 11.1 8.6–14.4ROR 11.3 · χ² 515 / p 3e-114 | 10.8 EB05 8.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 | no trial data cached |
| Ear discomfort | 17 | 10.6 6.6–17.1ROR 10.7 · χ² 139 / p 3e-32 | 9.4 EB05 5.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Blindness unilateral | 23 | 10.4 6.9–15.7ROR 10.5 · χ² 187 / p 8e-43 | 9.6 EB05 6.4 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Vitreous floaters | 15 | 9.8 5.9–16.3ROR 9.9 · χ² 110 / p 4e-26 | 8.4 EB05 5.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Cataract | 91 | 9.8 8.0–12.0ROR 10.1 · χ² 712 / p 3e-157 | 9.6 EB05 8.0 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Hyperlipidaemia | 18 | 9.6 6.1–15.2ROR 9.6 · χ² 130 / p 2e-30 | 8.4 EB05 5.4 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 | no trial data cached |
| Dry eye | 72 | 9.5 7.6–11.9ROR 9.7 · χ² 540 / p 1e-119 | 9.2 EB05 7.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 15.1 | no trial data cached |
| Toxic skin eruption | 15 | 9.5 5.7–15.7ROR 9.5 · χ² 105 / p 5e-25 | 8.1 EB05 4.9 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Intervertebral disc degeneration | 13 | 8.9 5.2–15.4ROR 9.0 · χ² 84 / p 3e-20 | 7.4 EB05 4.4 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 | no trial data cached |
| Madarosis | 16 | 8.7 5.4–14.2ROR 8.8 · χ² 102 / p 3e-24 | 7.5 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Vision blurred (blurred vision) | 180 | 8.4 7.3–9.7ROR 8.9 · χ² 1,176 / p 4e-258 | 8.3 EB05 7.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Impaired quality of life | 18 | 8.0 5.0–12.7ROR 8.0 · χ² 103 / p 1e-24 | 6.9 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Mitral valve incompetence | 14 | 7.9 4.7–13.3ROR 7.9 · χ² 78 / p 6e-19 | 6.6 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Ejection fraction decreased | 19 | 7.8 5.0–12.2ROR 7.8 · χ² 106 / p 4e-25 | 6.8 EB05 4.5 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 7.2 | no trial data cached |
| Seasonal allergy | 17 | 7.7 4.8–12.4ROR 7.7 · χ² 92 / p 4e-22 | 6.6 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Eye haemorrhage | 16 | 7.6 4.7–12.5ROR 7.7 · χ² 86 / p 1e-20 | 6.5 EB05 4.2 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Tooth abscess | 12 | 7.5 4.3–13.2ROR 7.5 · χ² 61 / p 2e-15 | 6.1 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Arteriosclerosis | 11 | 7.5 4.1–13.5ROR 7.5 · χ² 55 / p 6e-14 | 5.9 EB05 3.5 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Product use complaint | 18 | 7.4 4.7–11.8ROR 7.5 · χ² 94 / p 2e-22 | 6.4 EB05 4.2 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious n=11 | 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 |
|---|---|---|---|---|---|---|
| Eye pain | 241 | 28.0 24.8–31.6ROR 30.1 · χ² 6,232 / p <1e-300 | 27.8 EB05 25.0 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 33.1 | no trial data cached |
| Vision blurred (blurred vision) | 180 | 8.4 7.3–9.7ROR 8.9 · χ² 1,176 / p 4e-258 | 8.3 EB05 7.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Eye irritation | 168 | 19.3 16.6–22.4ROR 20.3 · χ² 2,895 / p <1e-300 | 19.2 EB05 16.9 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 31.2 | no trial data cached |
| Ocular hyperaemia | 167 | 22.9 19.8–26.6ROR 24.1 · χ² 3,471 / p <1e-300 | 22.8 EB05 20.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 30.4 | no trial data cached |
| Visual impairment | 119 | 6.2 5.2–7.4ROR 6.4 · χ² 514 / p 4e-114 | 6.0 EB05 5.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 100 | 50.1 41.3–60.8ROR 51.7 · χ² 4,729 / p <1e-300 | 49.3 EB05 41.7 · IC025 +5.0 3/3 methods agree | Lab value / disease marker | serious PRR 54.5 | no trial data cached |
| Hypersensitivity (allergic reaction) | 94 | 3.2 2.7–4.0ROR 3.3 · χ² 144 / p 1e-33 | 3.2 EB05 2.7 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 | no trial data cached |
| Cataract | 91 | 9.8 8.0–12.0ROR 10.1 · χ² 712 / p 3e-157 | 9.6 EB05 8.0 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Eye swelling | 89 | 15.4 12.5–18.9ROR 15.8 · χ² 1,184 / p 1e-259 | 15.3 EB05 12.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 14.7 | no trial data cached |
| Lacrimation increased | 85 | 18.2 14.8–22.5ROR 18.7 · χ² 1,364 / p 8e-299 | 18.1 EB05 15.1 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 23.8 | no trial data cached |
| Photophobia (light sensitivity) | 81 | 27.8 22.4–34.5ROR 28.5 · χ² 2,060 / p <1e-300 | 27.5 EB05 22.9 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 27.0 | no trial data cached |
| Chronic kidney disease | 80 | 6.7 5.4–8.3ROR 6.8 · χ² 381 / p 4e-85 | 6.4 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Visual acuity reduced | 76 | 14.5 11.6–18.1ROR 14.8 · χ² 943 / p 3e-207 | 14.4 EB05 11.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 14.3 | no trial data cached |
| Conjunctivitis | 73 | 25.5 20.3–32.0ROR 26.0 · χ² 1,686 / p <1e-300 | 25.2 EB05 20.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 32.5 | no trial data cached |
| Dry eye | 72 | 9.5 7.6–11.9ROR 9.7 · χ² 540 / p 1e-119 | 9.2 EB05 7.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 15.1 | 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.
- Retinal detachment — n=48, PRR 33.5
- Photophobia — n=81, PRR 27.8
- Eye inflammation — n=38, PRR 25.8
- Conjunctivitis — n=73, PRR 25.5
- Uveitis — n=53, PRR 25.1
- Ocular hyperaemia — n=167, PRR 22.9
- Eye discharge — n=34, PRR 21.3
- Ocular discomfort — n=36, PRR 21.2
- Eye irritation — n=168, PRR 19.3
- Lacrimation increased — n=85, PRR 18.2
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 and Dexamethasone?
In FDA FAERS, the most frequently co-reported reaction terms for Tobramycin and Dexamethasone are eye pain, vision blurred, eye irritation, ocular hyperaemia, visual impairment, intraocular pressure increased. 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 and Dexamethasone have an FDA boxed warning?
No. The FDA label retrieved for Tobramycin and Dexamethasone has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Tobramycin and Dexamethasone 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, 182 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.