Benzonatate (Tessalon Perles) Safety Profile
Benzonatate is safe to prescribe for cough suppression in adults when used as directed, but requires careful patient counseling about the critical risk of fatal overdose, particularly in children, and the importance of swallowing capsules whole without chewing or dissolving them.
Critical Safety Concerns
Fatal Toxicity Risk
- Benzonatate has documented fatal toxicity in both accidental pediatric ingestion and intentional overdose 1
- Two fatal cases have been reported: one involving an infant who chewed the capsules and another involving an 18-year-old who consumed a "handful" of benzonatate with phenytoin, resulting in death within 1 hour 1
- The medication poses extreme danger when capsules are chewed, sucked, or dissolved in the mouth, as this releases the full dose immediately and can cause severe local anesthetic effects 1
Essential Prescribing Precautions
Patient counseling must emphasize:
- Capsules must be swallowed whole—never chewed, crushed, or dissolved 1
- Keep completely out of reach of children due to fatal ingestion risk 1
- Seek immediate medical attention if accidental chewing occurs or if overdose is suspected 1
Appropriate Clinical Use
Legitimate Medical Application
- Benzonatate provides rapid and effective oropharyngeal anesthesia when used appropriately 2
- In controlled settings, benzonatate achieved loss of gag response in approximately 55 seconds compared to 339 seconds with nerve blocks 2
- The medication demonstrated 90% "no response" rates during awake intubation procedures with minimal patient discomfort 2
Distinction from Dietary Supplements
Benzonatate is an FDA-approved prescription medication, not a dietary supplement 3
- Unlike unregulated dietary supplements that lack FDA oversight and have variable active ingredient content 3, benzonatate is a regulated pharmaceutical agent
- Dietary supplements generally should be discouraged when they lack strong scientific evidence and third-party certification 3
- The evidence against routine dietary supplement use is particularly strong in vulnerable populations 3
Risk-Benefit Assessment
When prescribed appropriately for cough suppression:
- Benefits include effective symptom relief with established pharmacologic mechanism 2
- Risks are manageable with proper patient selection and education 1, 2
- Contraindications include households with young children who might access the medication 1
The key to safe prescribing is rigorous patient education about the fatal consequences of improper use, particularly capsule integrity and secure storage away from children.