BENZONATATE

N/A

Manufactured by Amneal Pharmaceuticals LLC

35,213 FDA adverse event reports analyzed

Last updated: 2026-04-14

About BENZONATATE

BENZONATATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals LLC. The most commonly reported adverse reactions for BENZONATATE include CHRONIC KIDNEY DISEASE, FATIGUE, COUGH, DYSPNOEA, PNEUMONIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BENZONATATE.

Top Adverse Reactions

CHRONIC KIDNEY DISEASE1,229 reports
FATIGUE1,182 reports
COUGH1,123 reports
DYSPNOEA1,097 reports
PNEUMONIA1,070 reports
DIARRHOEA1,033 reports
NAUSEA1,014 reports
PAIN890 reports
RENAL FAILURE871 reports
DEATH812 reports
ACUTE KIDNEY INJURY792 reports
HEADACHE773 reports
OFF LABEL USE610 reports
DIZZINESS606 reports
ANXIETY566 reports
DRUG INEFFECTIVE556 reports
VOMITING540 reports
FALL530 reports
ASTHENIA526 reports
COVID 19478 reports
MALAISE465 reports
RASH433 reports
PRODUCT DOSE OMISSION ISSUE432 reports
CONSTIPATION416 reports
ARTHRALGIA407 reports
WEIGHT DECREASED407 reports
BRONCHITIS401 reports
DECREASED APPETITE393 reports
NASOPHARYNGITIS393 reports
END STAGE RENAL DISEASE371 reports
BACK PAIN356 reports
PAIN IN EXTREMITY353 reports
PYREXIA347 reports
DEPRESSION344 reports
EMOTIONAL DISTRESS313 reports
PRURITUS303 reports
SINUSITIS301 reports
URINARY TRACT INFECTION297 reports
HYPERTENSION288 reports
ASTHMA284 reports
CHEST PAIN282 reports
HYPOTENSION279 reports
INFLUENZA270 reports
GASTROOESOPHAGEAL REFLUX DISEASE268 reports
ABDOMINAL PAIN UPPER267 reports
INSOMNIA262 reports
TOXICITY TO VARIOUS AGENTS260 reports
CONDITION AGGRAVATED257 reports
MUSCLE SPASMS246 reports
PERIPHERAL SWELLING240 reports
ABDOMINAL PAIN236 reports
NEPHROGENIC ANAEMIA231 reports
RENAL INJURY230 reports
ABDOMINAL DISCOMFORT228 reports
PRODUCTIVE COUGH227 reports
ANHEDONIA224 reports
COMPLETED SUICIDE219 reports
UPPER RESPIRATORY TRACT INFECTION219 reports
DEHYDRATION218 reports
ILLNESS216 reports
FEELING ABNORMAL213 reports
INFECTION212 reports
ANAEMIA207 reports
WEIGHT INCREASED202 reports
BLOOD PRESSURE INCREASED197 reports
INTENTIONAL PRODUCT USE ISSUE193 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE192 reports
DRUG HYPERSENSITIVITY192 reports
GAIT DISTURBANCE192 reports
CARDIAC ARREST183 reports
HYPOAESTHESIA181 reports
OEDEMA PERIPHERAL180 reports
ATRIAL FIBRILLATION176 reports
OXYGEN SATURATION DECREASED176 reports
TREMOR173 reports
OROPHARYNGEAL PAIN172 reports
SEPSIS169 reports
SOMNOLENCE169 reports
HOSPITALISATION168 reports
PRODUCT USE IN UNAPPROVED INDICATION167 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION162 reports
ALOPECIA161 reports
CHEST DISCOMFORT160 reports
DYSPEPSIA160 reports
CONTUSION158 reports
CONFUSIONAL STATE155 reports
MYALGIA155 reports
SEIZURE155 reports
CARDIAC FAILURE CONGESTIVE153 reports
PULMONARY EMBOLISM151 reports
WHITE BLOOD CELL COUNT DECREASED150 reports
CEREBROVASCULAR ACCIDENT149 reports
OSTEOPOROSIS149 reports
RESPIRATORY FAILURE146 reports
MEMORY IMPAIRMENT145 reports
WHEEZING143 reports
CHILLS142 reports
ECONOMIC PROBLEM142 reports
MUSCULAR WEAKNESS142 reports
NASAL CONGESTION140 reports

Report Outcomes

Out of 15,492 classified reports for BENZONATATE:

Serious 65.4%Non-Serious 34.6%

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

Female9,550 (65.4%)
Male5,053 (34.6%)
Unknown6 (0.0%)

Reports by Age

Age 66296 reports
Age 62280 reports
Age 63276 reports
Age 65275 reports
Age 61263 reports
Age 71261 reports
Age 60249 reports
Age 70249 reports
Age 72248 reports
Age 68239 reports
Age 64233 reports
Age 67233 reports
Age 59222 reports
Age 73222 reports
Age 75220 reports
Age 74211 reports
Age 56204 reports
Age 69202 reports
Age 57199 reports
Age 77197 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 BENZONATATE?

This profile reflects 35,213 FDA FAERS reports that mention BENZONATATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BENZONATATE?

Frequently reported terms in FAERS include CHRONIC KIDNEY DISEASE, FATIGUE, COUGH, DYSPNOEA, PNEUMONIA, DIARRHOEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures BENZONATATE?

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