BENZONATATE: 1,416 Adverse Event Reports & Safety Profile
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Drug Class: Decreased Tracheobronchial Stretch Receptor Activity [PE] · Route: ORAL · Manufacturer: RedPharm Drug, Inc. · FDA Application: 011210 · HUMAN PRESCRIPTION DRUG · FDA Label: Available
First Report: 2003 · Latest Report: 20250921
What Are the Most Common BENZONATATE Side Effects?
All BENZONATATE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Toxicity to various agents | 215 | 15.2% | 116 | 159 |
| Completed suicide | 192 | 13.6% | 192 | 70 |
| Drug hypersensitivity | 163 | 11.5% | 0 | 5 |
| Intentional product use issue | 117 | 8.3% | 13 | 115 |
| Drug ineffective | 106 | 7.5% | 1 | 11 |
| Cardiac arrest | 100 | 7.1% | 71 | 68 |
| Overdose | 87 | 6.1% | 17 | 65 |
| Seizure | 80 | 5.7% | 25 | 66 |
| Cough | 78 | 5.5% | 1 | 11 |
| Intentional product misuse | 70 | 4.9% | 15 | 47 |
| Dyspnoea | 67 | 4.7% | 1 | 17 |
| Coma | 57 | 4.0% | 19 | 48 |
| Electrocardiogram qt prolonged | 56 | 4.0% | 0 | 54 |
| Dizziness | 52 | 3.7% | 1 | 9 |
| Metabolic acidosis | 48 | 3.4% | 25 | 42 |
| Respiratory arrest | 48 | 3.4% | 46 | 23 |
| Nausea | 46 | 3.3% | 3 | 7 |
| Conduction disorder | 43 | 3.0% | 0 | 40 |
| Cardio-respiratory arrest | 38 | 2.7% | 38 | 17 |
| Death | 37 | 2.6% | 37 | 9 |
Who Reports BENZONATATE Side Effects? Age & Gender Data
Gender: 73.4% female, 26.6% male. Average age: 47.6 years. Most reports from: US. View detailed demographics →
Is BENZONATATE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2003 | 1 | 0 | 0 |
| 2006 | 1 | 0 | 0 |
| 2007 | 1 | 0 | 1 |
| 2009 | 1 | 0 | 1 |
| 2010 | 3 | 1 | 2 |
| 2011 | 8 | 7 | 7 |
| 2012 | 7 | 5 | 2 |
| 2013 | 16 | 10 | 3 |
| 2014 | 30 | 5 | 5 |
| 2015 | 32 | 3 | 7 |
| 2016 | 45 | 18 | 4 |
| 2017 | 30 | 7 | 9 |
| 2018 | 46 | 5 | 6 |
| 2019 | 39 | 12 | 14 |
| 2020 | 41 | 21 | 12 |
| 2021 | 33 | 21 | 11 |
| 2022 | 51 | 18 | 16 |
| 2023 | 62 | 21 | 13 |
| 2024 | 29 | 1 | 2 |
| 2025 | 11 | 0 | 1 |
What Is BENZONATATE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 530 |
| Cough | 339 |
| Bronchitis | 33 |
| Suicide attempt | 18 |
| Covid-19 | 13 |
| Upper respiratory tract infection | 13 |
| Influenza | 9 |
| Nasopharyngitis | 8 |
| Antitussive therapy | 7 |
| Sinusitis | 6 |
BENZONATATE vs Alternatives: Which Is Safer?
Official FDA Label for BENZONATATE
Official prescribing information from the FDA-approved drug label.
Drug Description
DESCRIPTION Benzonatate capsules, USP, a non-narcotic oral antitussive agent, is 2,5,8,11,14,17,20,23,26-nonaoxaoctacosan-28-yl p -(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsule for oral administration contains 100 mg or 200 mg of benzonatate. In addition, each capsule also contains the following inactive ingredients: gelatin, glycerin, noncrystallising sorbitol solution, methylparaben, propylparaben and purified water.
The
200 mg capsule is printed with black pharmaceutical ink which contains following ingredients: ammonium hydroxide, ferrosoferric oxide, ethanol, isopropyl alcohol, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol and purified water. Structure forluma for Benzonatate
FDA Approved Uses (Indications)
INDICATIONS AND USAGE Benzonatate capsules, USP are indicated for the symptomatic relief of cough.
Dosage & Administration
DOSAGE AND ADMINISTRATION Adults and Children over 10 years of age: Usual dose is one 100 mg, 150 mg or 200 mg capsule three times a day as needed for cough. If necessary to control cough, up to 600 mg daily in three divided doses may be given. B enzonatate capsules should be swallowed whole. Benzonatate capsules are not to be broken, chewed, dissolved, cut or crushed.
Contraindications
CONTRAINDICATIONS Hypersensitivity to benzonatate or related compounds.
Known Adverse Reactions
ADVERSE REACTIONS Potential Adverse Reactions to benzonatate may include: Hypersensitivity reactions including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule.
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. Deliberate or accidental overdose has resulted in death, particularly in children. Call your doctor for medical advice about side effects. You may report side effects to AvKARE at 1-855-361-3993 or go to www.avkare.com
Other Nasal congestion; sensation of burning in the eyes; vague "chilly" sensation; numbness of the chest; hypersensitivity. Deliberate or accidental overdose has resulted in death, particularly in children. Call your doctor for medical advice about side effects. You may report side effects to AvKARE at 1-855-361-3993 or go to www.avkare.com
FDA Boxed Warning
BOXED WARNING Hypersensitivity Severe hypersensitivity reactions (including bronchospasm, laryngospasm and cardiovascular collapse) have been reported which are possibly related to local anesthesia from sucking or chewing the capsule instead of swallowing it. Severe reactions have required intervention with vasopressor agents and supportive measures.
Psychiatric Effects
Isolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking benzonatate in combination with other prescribed drugs.
Accidental
Ingestion and Death in Children Keep benzonatate out of reach of children. Accidental ingestion of benzonatate resulting in death has been reported in children below age 10. Signs and symptoms of overdose have been reported within 15 to 20 minutes and death has been reported within one hour of ingestion. If accidental ingestion occurs, seek medical attention immediately (see OVERDOSAGE ).
Warnings
WARNINGS Hypersensitivity Severe hypersensitivity reactions (including bronchospasm, laryngospasm and cardiovascular collapse) have been reported which are possibly related to local anesthesia from sucking or chewing the capsule instead of swallowing it. Severe reactions have required intervention with vasopressor agents and supportive measures.
Psychiatric Effects
Isolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking benzonatate capsules in combination with other prescribed drugs.
Accidental
Ingestion and Death in Children Keep benzonatate capsules out of reach of children. Accidental ingestion of benzonatate capsules resulting in death has been reported in children below age 10. Signs and symptoms of overdose have been reported within 15 to 20 minutes and death has been reported within one hour of ingestion. If accidental ingestion occurs, seek medical attention immediately (see OVERDOSAGE ).
Precautions
PRECAUTIONS Benzonatate is chemically related to anesthetic agents of the para-amino-benzoic 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. Information for Patients: Swallow benzonatate capsules whole. Do not break, chew, dissolve, cut, or crush benzonatate capsules. Release of benzonatate from the capsule in the mouth can produce a temporary local anesthesia of the oral mucosa and choking could occur. If numbness or tingling of the tongue, mouth, throat, or face occurs, refrain from oral ingestion of food or liquids until the numbness has resolved. If the symptoms worsen or persist, seek medical attention. Keep benzonatate capsules out of reach of children. Accidental ingestion resulting in death has been reported in children. Signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion. Signs and symptoms may include restlessness, tremors, convulsions, coma and cardiac arrest. If accidental ingestion occurs, seek medical attention immediately. Overdosage resulting in death may occur in adults. Do not exceed a single dose of 200 mg and a total daily dosage of 600 mg. If you miss a dose of benzonatate capsules, skip that dose and take the next dose at the next scheduled time. Do not take 2 doses of benzonatate capsules at one time. Repackaged By / Distributed By: RemedyRepack Inc. 625 Kolter Drive, Indiana, PA 15701 (724) 465-8762 Usage in Pregnancy PREGNANCY CATEGORY C Animal reproduction studies have not been conducted with benzonatate capsules. It is also not known whether benzonatate capsules can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Benzonatate capsules 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 capsules are administered to a nursing woman. Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity, mutagenicity, and reproduction studies have not been conducted with benzonatate capsules..
Pediatric Use
Safety and effectiveness in children below the age of 10 have not been established. Accidental ingestion resulting in death has been reported in children below age 10. Keep out of reach of children.