TOBRAMYCIN SOLUTION

N/A

Manufactured by Amneal Pharmaceuticals LLC

19,799 FDA adverse event reports analyzed

Last updated: 2026-04-14

About TOBRAMYCIN SOLUTION

TOBRAMYCIN SOLUTION is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals LLC. The most commonly reported adverse reactions for TOBRAMYCIN SOLUTION include OFF LABEL USE, PNEUMONIA, ACUTE KIDNEY INJURY, DRUG INEFFECTIVE, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TOBRAMYCIN SOLUTION.

Top Adverse Reactions

OFF LABEL USE722 reports
PNEUMONIA692 reports
ACUTE KIDNEY INJURY670 reports
DRUG INEFFECTIVE641 reports
DYSPNOEA621 reports
INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS597 reports
DEATH441 reports
COUGH417 reports
HOSPITALISATION417 reports
CONDITION AGGRAVATED416 reports
INFECTION413 reports
CYSTIC FIBROSIS406 reports
PYREXIA401 reports
FATIGUE365 reports
NAUSEA357 reports
DIARRHOEA346 reports
HEADACHE320 reports
RENAL FAILURE315 reports
CHRONIC KIDNEY DISEASE284 reports
VOMITING267 reports
PAIN263 reports
MALAISE257 reports
RASH249 reports
PRODUCT USE IN UNAPPROVED INDICATION248 reports
PSEUDOMONAS INFECTION235 reports
WEIGHT DECREASED234 reports
DRUG HYPERSENSITIVITY227 reports
EYE PAIN225 reports
DIZZINESS193 reports
ASTHMA183 reports
DRUG RESISTANCE173 reports
PRODUCTIVE COUGH172 reports
HYPOTENSION168 reports
SEPSIS167 reports
ARTHRALGIA166 reports
ASTHENIA163 reports
LUNG DISORDER163 reports
DRUG INTERACTION161 reports
OXYGEN SATURATION DECREASED158 reports
HYPERSENSITIVITY156 reports
RENAL IMPAIRMENT154 reports
CHEST PAIN153 reports
RESPIRATORY FAILURE152 reports
BACK PAIN151 reports
PRODUCT DOSE OMISSION ISSUE151 reports
HAEMOPTYSIS150 reports
ANXIETY145 reports
WHEEZING141 reports
INFLUENZA140 reports
TOXICITY TO VARIOUS AGENTS140 reports
RENAL TUBULAR NECROSIS137 reports
PRODUCT USE ISSUE135 reports
CHEST DISCOMFORT132 reports
PRURITUS132 reports
DECREASED APPETITE130 reports
RENAL FAILURE ACUTE130 reports
SINUSITIS130 reports
NEUTROPENIA127 reports
PULMONARY FUNCTION TEST DECREASED126 reports
NASOPHARYNGITIS124 reports
SEPTIC SHOCK123 reports
THROMBOCYTOPENIA122 reports
ABDOMINAL PAIN121 reports
COVID 19121 reports
CONSTIPATION118 reports
TREATMENT FAILURE114 reports
FALL113 reports
PAIN IN EXTREMITY109 reports
VISUAL ACUITY REDUCED109 reports
URINARY TRACT INFECTION108 reports
DRUG INTOLERANCE107 reports
BLOOD CREATININE INCREASED105 reports
DEPRESSION103 reports
VISION BLURRED103 reports
END STAGE RENAL DISEASE100 reports
OCULAR HYPERAEMIA100 reports
BRONCHITIS99 reports
NEPHROPATHY TOXIC98 reports
STAPHYLOCOCCAL INFECTION97 reports
APLASTIC ANAEMIA96 reports
DRUG LEVEL INCREASED95 reports
NEUROPATHY PERIPHERAL95 reports
FEBRILE NEUTROPENIA93 reports
JOINT SWELLING93 reports
ANAEMIA92 reports
HYPERTENSION92 reports
ERYTHEMA91 reports
WEIGHT INCREASED91 reports
TOXIC EPIDERMAL NECROLYSIS90 reports
ABDOMINAL PAIN UPPER89 reports
SEIZURE89 reports
EYE IRRITATION88 reports
TINNITUS88 reports
CYSTIC FIBROSIS RESPIRATORY INFECTION SUPPRESSION87 reports
INTRAOCULAR PRESSURE INCREASED87 reports
ENDOPHTHALMITIS86 reports
DEHYDRATION85 reports
PATHOGEN RESISTANCE85 reports
CHILLS84 reports
GENERAL PHYSICAL HEALTH DETERIORATION84 reports

Report Outcomes

Out of 11,472 classified reports for TOBRAMYCIN SOLUTION:

Serious 81.0%Non-Serious 19.0%

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

Female5,860 (54.4%)
Male4,876 (45.3%)
Unknown37 (0.3%)

Reports by Age

Age 16162 reports
Age 18141 reports
Age 70130 reports
Age 20129 reports
Age 17128 reports
Age 65127 reports
Age 71123 reports
Age 12122 reports
Age 14121 reports
Age 67118 reports
Age 21117 reports
Age 38116 reports
Age 60116 reports
Age 64116 reports
Age 19115 reports
Age 69114 reports
Age 28113 reports
Age 15112 reports
Age 6111 reports
Age 13111 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 SOLUTION?

This profile reflects 19,799 FDA FAERS reports that mention TOBRAMYCIN SOLUTION. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for TOBRAMYCIN SOLUTION?

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

Who manufactures TOBRAMYCIN SOLUTION?

Labeling and FAERS entries often list Amneal Pharmaceuticals LLC in connection with TOBRAMYCIN SOLUTION. 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.