Benzonatate Safety in Pregnancy
Benzonatate should be avoided during pregnancy unless the benefit clearly outweighs the risk, as it is FDA Pregnancy Category C with no human safety data and unknown fetal effects. 1
FDA Classification and Available Evidence
The FDA classifies benzonatate as Pregnancy Category C, meaning animal reproduction studies have not been conducted, and it is unknown whether benzonatate can cause fetal harm or affect reproductive capacity. 1
No human pregnancy data exists for benzonatate—the FDA label explicitly states "it is not known whether benzonatate can cause fetal harm when administered to a pregnant woman." 1
The FDA recommends benzonatate "should be given to a pregnant woman only if clearly needed." 1
Clinical Context: Cough Management in Pregnancy
When managing cough in pregnant women, the lack of safety data for benzonatate becomes particularly concerning:
For respiratory conditions like asthma during pregnancy, maintaining adequate maternal oxygenation is critical, as uncontrolled symptoms increase risks of perinatal mortality, pre-eclampsia, preterm birth, and low-birth-weight infants. 2
Albuterol is the preferred short-acting beta-agonist during pregnancy due to extensive human safety data, demonstrating that medications with established safety profiles should be prioritized. 2
The principle that "it is safer for pregnant women to be treated with medications that have established safety records than to withhold necessary therapy" applies broadly—but benzonatate lacks this safety record. 2
Additional Safety Concerns
Beyond pregnancy category considerations:
Benzonatate carries significant overdose risks, including cardiac arrest, seizures, and death within 15-20 minutes of ingestion, with fatalities reported within one hour. 1, 3
The drug is chemically related to para-amino-benzoic acid anesthetic agents (procaine, tetracaine) and can cause serious CNS effects. 1
Accidental ingestion in children has resulted in death, highlighting the drug's narrow safety margin. 1
Lactation Considerations
- It is unknown whether benzonatate is excreted in human milk, and the FDA recommends caution when administering to nursing women. 1
Practical Recommendation
Given the complete absence of human pregnancy data, FDA Category C classification, and availability of alternative cough management strategies, benzonatate should not be used during pregnancy. If cough suppression is essential, consider non-pharmacologic measures first or consult with maternal-fetal medicine regarding safer alternatives with established human safety profiles. 1