TOBRAMYCIN

N/A

Manufactured by Viatris Specialty LLC

37,207 FDA adverse event reports analyzed

Last updated: 2026-04-14

About TOBRAMYCIN

TOBRAMYCIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Viatris Specialty LLC. The most commonly reported adverse reactions for TOBRAMYCIN include OFF LABEL USE, DEATH, INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS, PNEUMONIA, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TOBRAMYCIN.

Top Adverse Reactions

OFF LABEL USE1,939 reports
DEATH1,668 reports
INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS1,560 reports
PNEUMONIA1,452 reports
DYSPNOEA1,373 reports
CYSTIC FIBROSIS1,263 reports
COUGH1,257 reports
HOSPITALISATION996 reports
CONDITION AGGRAVATED942 reports
INFECTION832 reports
DRUG INEFFECTIVE818 reports
ACUTE KIDNEY INJURY721 reports
MALAISE674 reports
PYREXIA672 reports
FATIGUE608 reports
HEADACHE543 reports
PSEUDOMONAS INFECTION538 reports
NAUSEA537 reports
DIARRHOEA504 reports
WEIGHT DECREASED435 reports
HAEMOPTYSIS425 reports
PULMONARY FUNCTION TEST DECREASED422 reports
PRODUCT USE ISSUE406 reports
LUNG DISORDER386 reports
RENAL FAILURE385 reports
VOMITING380 reports
PRODUCTIVE COUGH378 reports
PRODUCT USE IN UNAPPROVED INDICATION375 reports
ILL DEFINED DISORDER364 reports
PAIN363 reports
CHEST DISCOMFORT356 reports
RASH343 reports
DIZZINESS321 reports
CHRONIC KIDNEY DISEASE308 reports
DRUG HYPERSENSITIVITY303 reports
ASTHMA302 reports
WHEEZING301 reports
INFLUENZA299 reports
DYSPHONIA293 reports
LUNG INFECTION286 reports
ASTHENIA280 reports
PRODUCT DOSE OMISSION ISSUE275 reports
CHEST PAIN264 reports
HYPERSENSITIVITY264 reports
EYE PAIN262 reports
RESPIRATORY FAILURE251 reports
OXYGEN SATURATION DECREASED248 reports
NASOPHARYNGITIS233 reports
ANXIETY232 reports
DECREASED APPETITE226 reports
SINUSITIS219 reports
ABDOMINAL PAIN213 reports
ARTHRALGIA212 reports
SEPSIS208 reports
UPPER RESPIRATORY TRACT INFECTION207 reports
DRUG RESISTANCE204 reports
STAPHYLOCOCCAL INFECTION203 reports
CONSTIPATION202 reports
ABDOMINAL PAIN UPPER200 reports
BACK PAIN199 reports
BRONCHIECTASIS198 reports
PRURITUS197 reports
HYPOTENSION194 reports
DRUG INTERACTION192 reports
RENAL IMPAIRMENT192 reports
OROPHARYNGEAL PAIN190 reports
DRUG INTOLERANCE189 reports
TINNITUS189 reports
DEPRESSION182 reports
WEIGHT INCREASED178 reports
FEELING ABNORMAL174 reports
BRONCHITIS172 reports
COVID 19167 reports
FALL164 reports
CYSTIC FIBROSIS RESPIRATORY INFECTION SUPPRESSION155 reports
TOXICITY TO VARIOUS AGENTS155 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE154 reports
BRONCHOSPASM153 reports
OCULAR HYPERAEMIA152 reports
URINARY TRACT INFECTION152 reports
GENERAL PHYSICAL HEALTH DETERIORATION149 reports
VISION BLURRED149 reports
RESPIRATORY DISORDER147 reports
PRODUCT DOSE OMISSION145 reports
INSOMNIA144 reports
RENAL FAILURE ACUTE143 reports
URTICARIA141 reports
SPUTUM DISCOLOURED140 reports
VIRAL INFECTION139 reports
PAIN IN EXTREMITY138 reports
BLOOD CREATININE INCREASED137 reports
RENAL TUBULAR NECROSIS137 reports
THROMBOCYTOPENIA137 reports
NEUTROPENIA136 reports
DEHYDRATION135 reports
SEIZURE135 reports
SEPTIC SHOCK134 reports
LOWER RESPIRATORY TRACT INFECTION132 reports
APHONIA130 reports
NEPHROLITHIASIS130 reports

Report Outcomes

Out of 23,281 classified reports for TOBRAMYCIN:

Serious 76.9%Non-Serious 23.1%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female11,536 (54.7%)
Male9,511 (45.1%)
Unknown52 (0.2%)

Reports by Age

Age 16341 reports
Age 18341 reports
Age 17306 reports
Age 20288 reports
Age 19274 reports
Age 21271 reports
Age 14263 reports
Age 15263 reports
Age 22260 reports
Age 13245 reports
Age 12239 reports
Age 25221 reports
Age 23219 reports
Age 28216 reports
Age 24214 reports
Age 11206 reports
Age 32205 reports
Age 26190 reports
Age 10189 reports
Age 27185 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with TOBRAMYCIN?

This profile reflects 37,207 FDA FAERS reports that mention TOBRAMYCIN. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for TOBRAMYCIN?

Frequently reported terms in FAERS include OFF LABEL USE, DEATH, INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS, PNEUMONIA, DYSPNOEA, CYSTIC FIBROSIS. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures TOBRAMYCIN?

Labeling and FAERS entries often list Viatris Specialty LLC in connection with TOBRAMYCIN. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.