tobramycin Side Effects
Also known as: Tobi, Nebcin
Analysis of 23,287 adverse event reports submitted to the FDA from 2002 to 2025.
Total Reports
23,287
Death-Related
2,764
11.9% of reports
Hospitalizations
11,066
47.5% of reports
Top Indication
Cystic Fibrosis
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 2,764 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 1,661 |
| OFF LABEL USE | 217 |
| DRUG INEFFECTIVE | 160 |
| RESPIRATORY FAILURE | 155 |
| PNEUMONIA | 126 |
| RENAL FAILURE | 111 |
| CYSTIC FIBROSIS | 95 |
| DYSPNOEA | 85 |
| PYREXIA | 80 |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | 75 |
| SEPSIS | 74 |
| ACUTE KIDNEY INJURY | 72 |
| SEPTIC SHOCK | 70 |
| CONDITION AGGRAVATED | 69 |
| HYPOTENSION | 68 |
| PRODUCT USE ISSUE | 57 |
| CARDIAC ARREST | 53 |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 51 |
| MULTI-ORGAN FAILURE | 50 |
| CHRONIC KIDNEY DISEASE | 45 |
Reactions in Hospitalization Reports
Top reactions in 11,066 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS | 1,310 |
| PNEUMONIA | 1,202 |
| CYSTIC FIBROSIS | 1,016 |
| HOSPITALISATION | 938 |
| DYSPNOEA | 801 |
| OFF LABEL USE | 743 |
| CONDITION AGGRAVATED | 607 |
| INFECTION | 550 |
| COUGH | 511 |
| PYREXIA | 487 |
| ACUTE KIDNEY INJURY | 382 |
| MALAISE | 373 |
| PSEUDOMONAS INFECTION | 337 |
| DRUG INEFFECTIVE | 336 |
| PULMONARY FUNCTION TEST DECREASED | 329 |
| ILL-DEFINED DISORDER | 327 |
| FATIGUE | 285 |
| WEIGHT DECREASED | 283 |
| LUNG DISORDER | 280 |
| NAUSEA | 249 |
Nearby — Related Medications
What the FAERS Data Reveals About tobramycin Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 23,287 voluntary reports linked to tobramycin and its brand equivalents (Tobi, Nebcin), spanning 2002 through 2025. Of those, 2,764 (11.9%) listed death as an outcome and 11,066 (47.5%) involved hospitalization. The most common indication reported alongside adverse events was Cystic Fibrosis.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 55% were female and 45% male; age distribution skews toward 18-44, with 4,990 reports in that bracket. The single most reported reaction is off label use with 1,939 submissions, followed by death and infective pulmonary exacerbation of cystic fibrosis.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.