Drug side effects
tobramycin Side Effects
The reactions most often reported to the FDA for tobramycin (also sold as Tobi, Nebcin), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 23,287
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2002 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.
The most commonly reported side effects of tobramycin come from 23,287 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 23,287 reports to the FDA Adverse Event Reporting System (FAERS) for tobramycin (Tobi): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.
Total Reports
23,287
Reports Mentioning Death
2,764
11.9% of reports — not proof the medicine caused the death
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 |
| 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 |
| 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 |
| CONDITION AGGRAVATED | 607 |
| INFECTION | 550 |
| COUGH | 511 |
| PYREXIA | 487 |
| ACUTE KIDNEY INJURY | 382 |
| MALAISE | 373 |
| PSEUDOMONAS INFECTION | 337 |
| 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 death with 1,667 submissions, followed by infective pulmonary exacerbation of cystic fibrosis and pneumonia.
How to read these numbers
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.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to tobramycin's 23,287.
Read our methodology - how this data is sourced, computed, and verified.