Benzonatate (Tessalon Perles) in Pregnancy
Benzonatate is not contraindicated in pregnancy, but should only be used when clearly needed, as it is classified as FDA Pregnancy Category C with no adequate human studies to establish safety. 1
FDA Classification and Official Guidance
The FDA drug label explicitly states that benzonatate is Pregnancy Category C, meaning:
- Animal reproduction studies have not been conducted with benzonatate 1
- It is unknown whether benzonatate can cause fetal harm when administered to pregnant women 1
- It is unknown whether benzonatate affects reproductive capacity 1
- Benzonatate should be given to a pregnant woman only if clearly needed 1
This is distinctly different from Category X drugs (like warfarin), which are explicitly contraindicated in pregnancy due to documented fetal abnormalities. 2
Clinical Decision Framework
When considering benzonatate use in pregnancy:
First trimester exposure should be avoided when possible, as this is the period of organogenesis when risk of congenital malformations is highest, consistent with general principles for medications with limited safety data 2
Risk-benefit assessment must weigh:
If benzonatate must be used:
Key Distinction: Category C vs. Contraindicated
Important caveat: Category C designation means "use with caution and only if benefits outweigh risks," which is fundamentally different from contraindication. 1 Truly contraindicated medications in pregnancy (Category X) include:
- ACE inhibitors and ARBs (cause renal dysgenesis and fetal death) 2
- Warfarin (causes embryopathy and CNS abnormalities) 2
- Statins (remain contraindicated despite limited evidence) 2
Benzonatate does not carry this level of documented risk, but the absence of safety data necessitates cautious use. 1