OpenClaim

Benzonatate Side Effects

The most commonly reported side effects of benzonatate include fatigue, cough, and dyspnoea, based on 20,468 FDA adverse event reports from 2004 to 2025. 3.3% of reports found the drug to be ineffective.

Benzonatate side effects

Percentages show how often each reaction appears relative to total reports for benzonatate.

1
Fatigue7.2%1,476
2
Cough6.9%1,419
3
Dyspnoea6.6%1,348
4
Chronic Kidney Disease6.5%1,338
5
Pneumonia6.5%1,322
6
Diarrhoea6.1%1,256
7
Nausea6.1%1,248
8
Pain5.0%1,015
9
Death4.9%1,006
10
Renal Failure4.7%964
11
Headache4.7%956
12
Acute Kidney Injury4.5%917
13
Off Label Use3.9%792
14
Dizziness3.5%725
15
Drug Ineffective3.3%680

These are voluntary reports and do not establish that benzonatate caused these reactions.

Report severity

66.0%Serious13,518 reports
35.8%Hospitalizations7,319 reports
12.1%Fatal2,486 reports

Seriousness is determined by the reporter, not by OpenClaim.

Benzonatate drug interactions

Other drugs that appear in adverse event reports alongside benzonatate. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Lenalidomide7.8%1,589
2
Esomeprazole5.6%1,150
3
Omeprazole5.4%1,107
4
Treprostinil4.2%851
5
Pantoprazole-sodium3.8%781
6
Dupilumab3.7%749
7
Sodium-oxybate3.5%709
8
Lansoprazole3.3%676
9
Pirfenidone2.3%469
10
Pomalidomide2.2%449
11
Dexlansoprazole1.5%316
12
Venetoclax1.3%268
13
Acetaminophen1.3%264
14
Tenofovir1.2%255
15
Adalimumab1.2%244

Taken alongside

1
Albuterol36.3%7,425
2
Acetaminophen30.9%6,323
3
Fluticasone24.8%5,072
4
Ergocalciferol22.8%4,665
5
Prednisone22.6%4,627
6
Aspirin22.4%4,581
7
Ondansetron19.5%3,989
8
Omeprazole19.0%3,882
9
Furosemide18.7%3,823
10
Gabapentin18.3%3,739
11
Atorvastatin-calcium17.0%3,482
12
Levothyroxine-sodium17.0%3,481
13
Azithromycin16.1%3,292
14
Amlodipine15.4%3,143
15
Metoprolol14.8%3,024

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports benzonatate side effects

62.4% of benzonatate adverse event reports involve female patients and 32.1% involve male patients. The largest age group is adult at 54%. These figures reflect who reports side effects, not underlying risk.

Sex

Female62.4%
Male32.1%
Unknown5.5%

Age group

< 20.1%
2–110.2%
12–171.4%
18–6454.2%
65+44.1%

What is benzonatate used for

Conditions and purposes for which patients were taking benzonatate when the adverse event was reported.

Abdominal DiscomfortAcneAcute SinusitisAdverse EventAllergic CoughAntiinflammatory TherapyAntitussive TherapyAsbestosisAsthmaAtypical PneumoniaAbdominal PainAccidental Exposure To Product By ChildAcute Myeloid LeukaemiaAcute SinusitisAdverse Event

Showing 15 of 208 indications

Benzonatate brand names and reporting trend

Benzonatate is sold under the brand name Tessalon.

Brand names

Tessalon16,266

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking benzonatate with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.