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What the label lists and what reports show

Benzonatate side effects

Benzonatate's FDA label lists its adverse reactions in its own words. FAERS holds 16,446 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (1,263 reports).

  • Generic listed

Check it at the source: the benzonatate FDA label on DailyMed (effective August 3, 2026, Epic Pharma LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Potential Adverse Reactions to benzonatate capsules may include: Hypersensitivity reactions including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule. CNS sedation; headache; dizziness; mental confusion; visual hallucinations. GI constipation; nausea; GI upset. Dermatologic pruritus; skin eruptions. Other nasal congestion; sensation of burning in the eyes; vague “chilly” sensation; numbness of the chest; hypersensitivity. Deliberate or accidental overdose has resulted in death, particularly in children. Hypersensitivity reactions including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule.

Source: FDA drug label, Epic Pharma LLC, effective August 3, 2026 (SPL set 9b35e9d5-7d72-4f51-a245-ad2467ab40e9), via openFDA; the full label on DailyMed

What do FAERS reports show?

16,446 reports list benzonatate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,952 are coded as a death and 5,621 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 4 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Fatigue1,263
  • Cough (a use or a product term, not a reaction)1,237
  • Chronic Kidney Disease1,234
  • Dyspnoea1,180
  • Diarrhoea1,126
  • Pneumonia1,120
  • Nausea (named in the label)1,100
  • Pain940
  • Renal Failure871
  • Headache (named in the label)845
  • Death (an outcome recorded in the report)839
  • Acute Kidney Injury804
  • Off Label Use (a use or a product term, not a reaction)667
  • Dizziness (named in the label)655
  • Drug Ineffective (a use or a product term, not a reaction)599
  • Vomiting592
  • Anxiety578
  • Fall561
  • Asthenia558
  • Covid-19489
  • Malaise479
  • Product Dose Omission Issue (a use or a product term, not a reaction)477
  • Rash465
  • Constipation (named in the label)448
  • Weight Decreased443

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Benzonatate: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions