Benzonatate: What to Know Before You Take It
Also known as Tessalon
A patient-focused safety profile with information from public regulatory sources.
In plain language
What Benzonatate is used for
INDICATIONS AND USAGE Benzonatate Capsule is indicated for the symptomatic relief of cough.
Read before you decide
Risks and precautions
Risks and warnings
WARNINGS Hypersensitivity Severe hypersensitivity reactions (including bronchospasm, laryngospasm and cardiovascular collapse) have been reported which are possibly related to local anesthesia from sucking or chewing the capsule instead of swallowing it. Severe reactions have required intervention with vasopressor agents and supportive measures. Psychiatric Effects Isolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking Benzonatate Capsule in combination with other prescribed drugs. Accidental Ingestion and Death in Children Keep Benzonatate Capsules out of reach of children. Accidental ingestion of Benzonatate Capsules resulting in death has been reported in children below age 10. Signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion. If accidental ingestion occurs, seek medical attention immediately (see OVERDOSAGE ).
Who should not take it
CONTRAINDICATIONS Hypersensitivity to benzonatate or related compounds.
FDA safety data
Most-reported side effects
Based on 15,958 FAERS reports. Reports do not prove the drug caused the effect.
Regulatory record
FDA recalls (4)
Superpotent drug: Assay results were slightly above specification at the time zero point.
Recalling firm: Amerisource Health Services LLC
Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
Recalling firm: Strides Pharma INC
Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules
Recalling firm: American Health Packaging
Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Recalling firm: Zydus Pharmaceuticals USA Inc
Common questions
Patient questions
What is Benzonatate prescribed for?
INDICATIONS AND USAGE Benzonatate Capsule is indicated for the symptomatic relief of cough.
What are the key warnings and safety precautions for Benzonatate?
WARNINGS Hypersensitivity Severe hypersensitivity reactions (including bronchospasm, laryngospasm and cardiovascular collapse) have been reported which are possibly related to local anesthesia from sucking or chewing the capsule instead of swallowing it. Severe reactions have required intervention with vasopressor agents and supportive measures. Psychiatric Effects Isolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking Benzonatate Capsule in combination with other prescribed drugs. Accidental Ingestion and Death in Children Keep Benzonatate Capsules out of reach of children. Accidental ingestion of Benzonatate Capsules resulting in death has been reported in children below age 10. Signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion. If accidental ingestion occurs, seek medical attention immediately (see OVERDOSAGE ).
Does Benzonatate interact with other medications or foods?
Benzonatate has 0 documented drug interaction(s) and 0 food interaction(s) in clinical databases. Always provide your complete medication list to your clinician.
This information is educational — not medical advice.
This page is provided for general educational purposes and summarizes publicly available data from sources such as the U.S. Food & Drug Administration. It is not a substitute for the judgment of a licensed clinician and should not be used to start, stop, or change any medication. It may be incomplete or out of date, and individual circumstances vary. Always talk with your prescriber or pharmacist about your specific medications and health conditions. If you think you may have a medical emergency, call 911.