"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"...
Benzonatate Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Benzonatate is a nonnarcotic antitussive (anti-cough) drug used to relieve cough symptoms. Benzonatate is available in generic form. Common side effects of benzonatate include drowsiness, dizziness, headache, stomach upset, constipation, and stuffy nose.
The usual dose of benzonatate for adults and children over 10 years of age is one 100 mg softgel three times daily as required. If necessary, up to 6 softgels daily may be given. Benzonatate may interact with other medications that cause drowsiness including, cough and cold medications, antihistamines, anti-seizure drugs, medicine for sleep or anxiety, muscle relaxants, narcotics, or psychiatric medicines. Tell your doctor all medications and supplements you use. During pregnancy, benzonatate should be used only if prescribed. It is unknown if this drug is excreted in breast milk. Consult your doctor before breastfeeding.
Our Benzonatate Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Benzonatate FDA Prescribing Information: Side Effects
Potential Adverse Reactions to benzonatate (benzonatate softgels) may include: Hypersensitivity reactions including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from chewing or sucking the softgel.
CNS: sedation; headache; dizziness; mental confusion; visual hallucinations.
GI: constipation; nausea; GI upset.
Dermatologic: pruritus; skin eruptions.
Other: nasal congestion; sensation of burning in the eyes; vague 'chilly' sensation; numbness of the chest; hypersensitivity. Rare instances of deliberate or accidental overdose have resulted in death.
Read the entire FDA prescribing information for Benzonatate (Benzonatate Softgels)
Additional Benzonatate Information
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.
Find out what women really need.