TOBRAMYCIN SULFATE

N/A

Manufactured by Fresenius Kabi USA, LLC

20,334 FDA adverse event reports analyzed

Last updated: 2026-04-14

About TOBRAMYCIN SULFATE

TOBRAMYCIN SULFATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Fresenius Kabi USA, LLC. The most commonly reported adverse reactions for TOBRAMYCIN SULFATE 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 SULFATE.

Top Adverse Reactions

OFF LABEL USE739 reports
PNEUMONIA712 reports
ACUTE KIDNEY INJURY675 reports
DRUG INEFFECTIVE661 reports
DYSPNOEA641 reports
INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS611 reports
DEATH448 reports
INFECTION438 reports
HOSPITALISATION429 reports
COUGH428 reports
CONDITION AGGRAVATED423 reports
CYSTIC FIBROSIS418 reports
PYREXIA414 reports
FATIGUE379 reports
NAUSEA360 reports
DIARRHOEA355 reports
HEADACHE330 reports
RENAL FAILURE322 reports
CHRONIC KIDNEY DISEASE287 reports
VOMITING269 reports
PAIN267 reports
MALAISE258 reports
PRODUCT USE IN UNAPPROVED INDICATION257 reports
RASH254 reports
PSEUDOMONAS INFECTION242 reports
WEIGHT DECREASED240 reports
DRUG HYPERSENSITIVITY234 reports
EYE PAIN228 reports
DIZZINESS200 reports
ASTHMA190 reports
PRODUCTIVE COUGH178 reports
HYPOTENSION174 reports
DRUG RESISTANCE173 reports
SEPSIS173 reports
ASTHENIA171 reports
ARTHRALGIA170 reports
LUNG DISORDER168 reports
DRUG INTERACTION163 reports
HYPERSENSITIVITY161 reports
OXYGEN SATURATION DECREASED159 reports
PRODUCT DOSE OMISSION ISSUE158 reports
BACK PAIN157 reports
CHEST PAIN157 reports
RENAL IMPAIRMENT156 reports
RESPIRATORY FAILURE155 reports
HAEMOPTYSIS152 reports
ANXIETY151 reports
WHEEZING150 reports
INFLUENZA147 reports
RENAL TUBULAR NECROSIS141 reports
TOXICITY TO VARIOUS AGENTS141 reports
PRODUCT USE ISSUE140 reports
PRURITUS138 reports
CHEST DISCOMFORT136 reports
DECREASED APPETITE136 reports
SINUSITIS136 reports
RENAL FAILURE ACUTE134 reports
COVID 19133 reports
SEPTIC SHOCK129 reports
NEUTROPENIA128 reports
PULMONARY FUNCTION TEST DECREASED128 reports
THROMBOCYTOPENIA128 reports
NASOPHARYNGITIS127 reports
ABDOMINAL PAIN124 reports
CONSTIPATION124 reports
FALL116 reports
TREATMENT FAILURE114 reports
PAIN IN EXTREMITY112 reports
VISUAL ACUITY REDUCED112 reports
BLOOD CREATININE INCREASED110 reports
DEPRESSION109 reports
URINARY TRACT INFECTION109 reports
DRUG INTOLERANCE108 reports
VISION BLURRED108 reports
OCULAR HYPERAEMIA103 reports
END STAGE RENAL DISEASE100 reports
NEPHROPATHY TOXIC100 reports
STAPHYLOCOCCAL INFECTION100 reports
BRONCHITIS99 reports
FEBRILE NEUTROPENIA98 reports
NEUROPATHY PERIPHERAL97 reports
APLASTIC ANAEMIA96 reports
ANAEMIA95 reports
DRUG LEVEL INCREASED95 reports
ERYTHEMA95 reports
HYPERTENSION95 reports
ABDOMINAL PAIN UPPER94 reports
JOINT SWELLING94 reports
SEIZURE93 reports
TINNITUS93 reports
TOXIC EPIDERMAL NECROLYSIS93 reports
WEIGHT INCREASED92 reports
INTRAOCULAR PRESSURE INCREASED90 reports
EYE IRRITATION89 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES88 reports
CYSTIC FIBROSIS RESPIRATORY INFECTION SUPPRESSION87 reports
GENERAL PHYSICAL HEALTH DETERIORATION87 reports
CHILLS86 reports
DEHYDRATION86 reports
ENDOPHTHALMITIS86 reports

Report Outcomes

Out of 11,829 classified reports for TOBRAMYCIN SULFATE:

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

Female6,035 (54.3%)
Male5,038 (45.3%)
Unknown37 (0.3%)

Reports by Age

Age 16165 reports
Age 18143 reports
Age 70134 reports
Age 65131 reports
Age 17130 reports
Age 20130 reports
Age 71129 reports
Age 12125 reports
Age 69123 reports
Age 14121 reports
Age 67121 reports
Age 21120 reports
Age 22119 reports
Age 38119 reports
Age 60117 reports
Age 64117 reports
Age 13116 reports
Age 19116 reports
Age 15115 reports
Age 28115 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 SULFATE?

This profile reflects 20,334 FDA FAERS reports that mention TOBRAMYCIN SULFATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for TOBRAMYCIN SULFATE?

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 SULFATE?

Labeling and FAERS entries often list Fresenius Kabi USA, LLC in connection with TOBRAMYCIN SULFATE. 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.