December 2, 2015
Recommended Topic Related To:


"The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended restricting the use of codeine for cough and cold in children because there is a risk for serious adverse effects, including respiratory"...




Severe hypersensitivity reactions (including bronchospasm, laryngospasm and cardiovascular collapse) have been reported which are possibly related to local anesthesia from sucking or chewing the softgel instead of swallowing it. Severe reactions have required intervention with vasopressor agents and supportive measures. Isolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking benzonatate (benzonatate softgels) in combination with other prescribed drugs.


Benzonatate (benzonatate softgels) is chemically related to anesthetic agents of the para-aminobenzoic acid class (e.g., procaine; tetracaine) and has been associated with adverse CNS effects possibly related to a prior sensitivity to related agents or interaction with concomitant medication.

Usage in Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with benzonatate (benzonatate softgels) . It is also not known whether benzonatate (benzonatate softgels) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Benzonatate (benzonatate softgels) should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk caution should be exercised when benzonatate (benzonatate softgels) is administered to a nursing woman.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity, and reproduction studies have not been conducted with benzonatate (benzonatate softgels) .

Pediatric Use

Safety and effectiveness in children below the age of 10 has not been established.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 12/8/2004


Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Women's Health

Find out what women really need.