Is Tessalon (Benzonatate) safe during pregnancy?

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Last updated: February 21, 2025View editorial policy

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From the Guidelines

Tessalon (Benzonatate) should be avoided during pregnancy due to the lack of sufficient human studies and potential risks to the fetus, and safer alternatives should be considered first. The provided evidence does not directly address the safety of Benzonatate during pregnancy, but it emphasizes the importance of cautious medication use during pregnancy and lactation, as seen in the discussion of various antibiotics and their potential risks [ 1 ].

When considering medication use during pregnancy, it is crucial to weigh the potential benefits against the potential risks to the fetus. In the case of Benzonatate, its classification as FDA Pregnancy Category C indicates that potential risks cannot be ruled out, and animal studies have shown adverse effects at high doses [ 1 ].

Given the lack of strong evidence supporting the safety of Benzonatate during pregnancy, it is recommended that pregnant women try safer alternatives for cough relief, such as dextromethorphan, or simple home remedies before considering Benzonatate. If Benzonatate is deemed necessary by a physician, it should be used at the lowest effective dose for the shortest duration possible.

Some key points to consider when evaluating medication safety during pregnancy include:

  • The medication's FDA pregnancy category
  • The availability of human studies versus animal studies
  • The potential for the medication to cross the placenta and affect the fetus
  • The importance of consulting an obstetrician or healthcare provider for personalized advice

In general, the approach to medication use during pregnancy should prioritize caution and consider the potential long-term effects on the fetus, as highlighted by the discussions on antibiotics such as Azithromycin and Clarithromycin [ 1 ].

From the Research

Safety of Tessalon (Benzonatate) during Pregnancy

There are no research papers provided that directly address the safety of Tessalon (Benzonatate) during pregnancy.

General Considerations for Drug Use during Pregnancy

  • The use of drugs during pregnancy can have adverse effects on the fetus 2, 3.
  • It is essential to exercise caution when prescribing medications during pregnancy, as the development of knowledge in this area has been limited due to difficulties in testing new products in pregnant women and a lack of high-quality research 2.
  • When choosing a drug for use during pregnancy, it is recommended to select one for which there is accumulated experience and no known association with adverse effects 3.

Herbal Medicines and Pregnancy

  • The use of herbal medicines during pregnancy is common, but their safety has not been well established 4, 5, 6.
  • Some herbal medicines may have potent pharmacological actions and can be harmful to the fetus, while others may be safe for use during certain trimesters of pregnancy but not others 5.
  • It is crucial to approach the use of herbal medicines during pregnancy with caution and to consult with a healthcare provider before using any herbal products 6.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Drugs in pregnancy. Drugs to avoid.

Best practice & research. Clinical obstetrics & gynaecology, 2001

Research

Which drugs can be used during pregnancy?

Duodecim; laaketieteellinen aikakauskirja, 2016

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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