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Benzonatate Side Effects

Common Benzonatate Side Effects

The most commonly reported Benzonatate side effects (click to view or check a box to report):

Dyspnoea (13)
Nausea (9)
Dizziness (9)
Headache (7)
Pain (5)
Dysphagia (4)
Confusional State (4)
Convulsion (4)
Diarrhoea (4)
Hypoaesthesia (4)
Hypersensitivity (4)
Feeling Abnormal (4)
Dysphonia (3)
Chest Pain (3)
Fatigue (3)
Cough (3)
Pain In Extremity (3)
Vomiting (3)
Presyncope (3)
Hallucination (3)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Benzonatate Side Effects Reported to FDA

The following Benzonatate reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Benzonatate on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Dizziness, Presyncope
on Mar 07, 2014 Female from US , 71 years of age, weighting 173.0 lb, was diagnosed with and was treated with Benzonatate. Directly after, patient experienced the unwanted or unexpected Benzonatate side effects: dizziness, presyncope. Benzonatate dosage: N/A.
Associated medications used:
  • Tramadol
  • Albuterol
  • Multivitamin
  • Salmon Oil
  • Saline Nasal Spray
  • Prilosec Otc


Retching, Choking, Dyspnoea, Headache, Swollen Tongue, Local Swelling
Patient was taking Benzonatate. Patient felt the following Benzonatate side effects: retching, choking, dyspnoea, headache, swollen tongue, local swelling on Mar 06, 2014 from US Additional patient health information: Female , 68 years of age, weighting 170.0 lb, was diagnosed with and. Benzonatate dosage: By Mouth, 1 Capsule.
Multiple prescriptions taken:
  • Vitamins
  • Oscal


Toxicity To Various Agents
Adverse event was reported on Jan 22, 2014 by a Male taking Benzonatate (Dosage: Unk) . Location: US , 49 years of age, After Benzonatate was administered, patient encountered several Benzonatate side effects: toxicity to various agents.
Multiple concurrent drugs taken:
  • Lisinopril (Unk)
  • Amlodipine Besilate (Unk)
  • Trazodone (Unk)
  • Cocaine (Unk)
  • Benztropeine (Unk)


Accidental Exposure To Product, Cardiac Arrest, Respiratory Arrest
on Jan 10, 2014 Female from US , child 4 years of age, was treated with Benzonatate. Directly after, patient experienced the unwanted or unexpected Benzonatate side effects: accidental exposure to product, cardiac arrest, respiratory arrest. Benzonatate dosage: Unk.


Visual Impairment, Nausea, Headache
on Nov 25, 2013 Female from US , 30 years of age, weighting 175.0 lb, was diagnosed with and was treated with Benzonatate. Patient felt the following Benzonatate side effects: visual impairment, nausea, headache. Benzonatate dosage: 1-2 Pills, Up To 3 Times A Day.

Diarrhoea
Patient was taking Benzonatate. After Benzonatate was administered, patient encountered several Benzonatate side effects: diarrhoea on Nov 18, 2013 from US Additional patient health information: Female , 82 years of age, weighting 123.0 lb, was diagnosed with and. Benzonatate dosage: 30 Capsules Twice Daily By Mouth.
Multiple concurrent drugs taken:
  • Mylan Patch(soy Estradiol)
  • Levothyroxine
  • Niacinamide
  • Acidophilus/bifidus
  • Omega 3
  • Lutein
  • Vitamin C
  • Green Tea


Muscle Disorder, Abasia
Adverse event was reported on Sep 23, 2013 by a Female taking Benzonatate (Dosage: N/A) was diagnosed with and. Location: US , 76 years of age, Directly after, patient experienced the unwanted or unexpected Benzonatate side effects: muscle disorder, abasia.

Hypoaesthesia, Pharyngeal Oedema, Dyspnoea
on Sep 18, 2013 Female from US , 57 years of age, weighting 143.3 lb, was diagnosed with and was treated with Benzonatate. Patient felt the following Benzonatate side effects: hypoaesthesia, pharyngeal oedema, dyspnoea. Benzonatate dosage: 100 Mg Prn/as Needed Oral.
Multiple prescriptions taken:
  • Heparin
  • Triamcinolone
  • Furosemide


Dysphonia
on Aug 22, 2013 Male from US , 77 years of age, weighting 195.0 lb, was diagnosed with and was treated with Benzonatate. After Benzonatate was administered, patient encountered several Benzonatate side effects: dysphonia. Benzonatate dosage: N/A.

Respiratory Distress, Hypersensitivity, Bronchospasm, Laryngospasm, Circulatory Collapse
Patient was taking Benzonatate. Directly after, patient experienced the unwanted or unexpected Benzonatate side effects: respiratory distress, hypersensitivity, bronchospasm, laryngospasm, circulatory collapse on Jul 05, 2013 from US Additional patient health information: Male , 21 years of age, was diagnosed with and. Benzonatate dosage: 1-2 Capsules. Patient was hospitalized.

Headache, Nausea, Facial Pain, Pain In Jaw, Toothache, Sneezing, Hypersensitivity
Adverse event was reported on Jun 28, 2013 by a Female taking Benzonatate (Dosage: 1 Pill 3 X Daily Po) was diagnosed with and. Location: US , 63 years of age, weighting 178.0 lb, Patient felt the following Benzonatate side effects: headache, nausea, facial pain, pain in jaw, toothache, sneezing, hypersensitivity.

Dyspnoea, Asthma, Panic Attack
on Apr 19, 2013 Male from US , 30 years of age, weighting 250.0 lb, was diagnosed with and was treated with Benzonatate. After Benzonatate was administered, patient encountered several Benzonatate side effects: dyspnoea, asthma, panic attack. Benzonatate dosage: N/A.

Throat Tightness, Hypoaesthesia Oral, Dysphagia, Speech Disorder, Dyspnoea, Unevaluable Event
on Mar 18, 2013 Female from US , 85 years of age, weighting 110.0 lb, was diagnosed with and was treated with Benzonatate. Directly after, patient experienced the unwanted or unexpected Benzonatate side effects: throat tightness, hypoaesthesia oral, dysphagia, speech disorder, dyspnoea, unevaluable event. Benzonatate dosage: As Needed. Patient was hospitalized.

Blood Pressure Increased, Insomnia, Somnambulism
Patient was taking Benzonatate. Patient felt the following Benzonatate side effects: blood pressure increased, insomnia, somnambulism on Jan 24, 2013 from US Additional patient health information: Female , 86 years of age, weighting 170.0 lb, was diagnosed with and. Benzonatate dosage: 100 Mg Take 1 Or 2 3 Times Daily Mouth.

Toxicity To Various Agents, Coma, Convulsion, Metabolic Acidosis
Adverse event was reported on Dec 31, 2012 by a Patient taking Benzonatate (Dosage: N/A) . Location: US , 13 years of age, After Benzonatate was administered, patient encountered several Benzonatate side effects: toxicity to various agents, coma, convulsion, metabolic acidosis.
Multiple concurrent drugs taken:
  • Chlorpheniramine (chlorpheniramiramine)
  • Dextromethorphan (dextromethorphan)
Patient was hospitalized.

Hiccups
on Sep 28, 2012 Male from US , weighting 182.0 lb, was treated with Benzonatate. Directly after, patient experienced the unwanted or unexpected Benzonatate side effects: hiccups. Benzonatate dosage: One Tab T.i.d..

Rash, Pruritus, Skin Reaction
on Sep 12, 2012 Female from US , weighting 110.0 lb, was diagnosed with and was treated with Benzonatate. Patient felt the following Benzonatate side effects: rash, pruritus, skin reaction. Benzonatate dosage: 200 Mg Asc 106 Every 8 Hours.

Injury, Toothache, Pain, Decreased Appetite, Cardiac Murmur, Peptic Ulcer, Hepatic Pain, Blood Potassium Decreased, Tooth Infection
Patient was taking Benzonatate. After Benzonatate was administered, patient encountered several Benzonatate side effects: injury, toothache, pain, decreased appetite, cardiac murmur, peptic ulcer, hepatic pain, blood potassium decreased, tooth infection on Jun 06, 2012 from UNITED STATES Additional patient health information: Female , weighting 148.0 lb, . Benzonatate dosage: N/A.
Multiple concurrent drugs taken:
  • Clonazepam
  • Hydrochlorothiazide
  • Klonopin
  • Aspirin
  • Lactulose
  • Lortab
  • Metoprolol Succinate
  • Paxil
Patient was hospitalized.

Skin Haemorrhage, Contusion, Dizziness
Adverse event was reported on May 25, 2012 by a Female taking Benzonatate (Dosage: 1 Capsule Every 8 Hours 20 Pills) was diagnosed with and. Location: UNITED STATES , 76 years of age, weighting 123.0 lb, Directly after, patient experienced the unwanted or unexpected Benzonatate side effects: skin haemorrhage, contusion, dizziness. Patient was hospitalized.

Haemoglobin Decreased
on Jan 25, 2011 Male from UNITED STATES , 70 years of age, was treated with Benzonatate. Patient felt the following Benzonatate side effects: haemoglobin decreased. Benzonatate dosage: N/A.
Multiple prescriptions taken:
  • Coreg Cr (carvedilol)
  • Procrit
  • Folic Acid
  • Prilosec
  • Azithromycin
  • Levothyroxine Sodium
  • Revlimid (10 Mg, 1 In 1 D, Po)
  • Prevacid


Pulmonary Embolism, Headache, Pain In Extremity, Vomiting, Abdominal Discomfort, Dyspnoea, Nausea, Oedema Peripheral
on May 03, 2012 Female from UNITED STATES , 16 years of age, weighting 249.1 lb, was diagnosed with and was treated with Benzonatate. After Benzonatate was administered, patient encountered several Benzonatate side effects: pulmonary embolism, headache, pain in extremity, vomiting, abdominal discomfort, dyspnoea, nausea, oedema peripheral. Benzonatate dosage: 100 Mg, Tid.
Multiple concurrent drugs taken:
  • Clindamycin (1 Percent, Apply 2 Times A Day)
  • Yaz (Unk)
  • Yaz
  • Ritalin La
  • Midrin (65-325-100 Mg, Take 1 Every 4 Hours As Needed)
  • Mucinex
  • Yaz
  • Albuterol (90 Mcg/act Inhaler, 2 Puffs Every 4 Hours As Needed)
Patient was hospitalized.

Chest Pain, Dyspnoea, Feeling Hot
Patient was taking Benzonatate. Directly after, patient experienced the unwanted or unexpected Benzonatate side effects: chest pain, dyspnoea, feeling hot on Mar 22, 2012 from UNITED STATES Additional patient health information: Female , 39 years of age, weighting 180.0 lb, was diagnosed with and. Benzonatate dosage: 100 Mg Capsules.

Feeling Abnormal, Dysgeusia
Adverse event was reported on Mar 08, 2012 by a Female taking Benzonatate (Dosage: N/A) was diagnosed with and. Location: UNITED STATES , 30 years of age, weighting 195.0 lb, Patient felt the following Benzonatate side effects: feeling abnormal, dysgeusia.

Completed Suicide
on Feb 27, 2012 Female from UNITED STATES , 39 years of age, was treated with Benzonatate. After Benzonatate was administered, patient encountered several Benzonatate side effects: completed suicide. Benzonatate dosage: Unk,unk.
Multiple concurrent drugs taken:
  • Gabapentin (Unk,unk)
  • Omeprazole (Unk,unk)
  • Tramadol Hcl (Unk,unk)
  • Ferrous Sulfate Tab (Unk,unk)
  • Fluoxetine (Unk,unk)
  • Ethanol (Unk,unk)
  • Vitamin D (Unk,unk)
  • Acetaminophen And Hydrocodone Bitartrate (Unk,unk)


Insomnia, Headache, Hypersensitivity, No Therapeutic Response
on Feb 13, 2012 Female from UNITED STATES , 61 years of age, weighting 170.0 lb, was diagnosed with and was treated with Benzonatate. Directly after, patient experienced the unwanted or unexpected Benzonatate side effects: insomnia, headache, hypersensitivity, no therapeutic response. Benzonatate dosage: One Capsule.

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:

     

    Side Effects

    Scale

    Date & Time

    Other Medicine(s) or Treatment(s)

     

     

     

     

    Scale: 1 = very mild to 10 = very bad


    Track Online

  • User Sign In
  • Register to track your side effects

  • 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.

    Discuss Benzonatate Side Effects

    Did You Have a Benzonatate Side Effect?

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    Yes, Moderate
    Yes, Minor
    No

    How Effective is Benzonatate for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Safety Alerts, Active Ingredients, Usage Information

    Alternative BENZONATATE Names:BENZONATA

    Active Ingredient: BENZONATA

    More About Benzonatate

    Side Effects reported to FDA: 80

    Benzonatate safety alerts: 2010

    Reported deaths: 7

    Reported hospitalizations: 21

    Tessalon (benzonatate): Drug Safety Communication - Potential for Accidental Ingestion by Children

    [Posted 12/14/2010]

    AUDIENCE: Patients, Pediatrics, Pharmacy

    ISSUE: FDA is warning the public that accidental ingestion of benzonatate by children under the age of 10 years can result in death from overdose. Overdose with benzonatate in children less than 2 years of age has been reported following accidental ingestion of as few as 1 or 2 capsules. Benzonatate may be attractive to children because of the drug's appearance (it is a round-shaped liquid-filled gelatin capsule). 

    BACKGROUND: Benzonatate is a prescription drug approved for relief of cough in patients over 10 years of age. The safety and effectiveness of benzonatate in children under 10 years of age have not been established. Benzonatate is sold under the brand-name Tessalon and is also sold in generic preparations. Individuals who experience overdose of benzonatate may exhibit restlessness, tremors, convulsions, coma, and cardiac arrest. Signs and symptoms of overdose can occur rapidly after ingestion (within 15-20 minutes). Deaths in children have been reported within hours of the accidental ingestion.

    RECOMMENDATION: Patients who are taking benzonatate should keep the medication in a child-resistant container and store it out of reach of children. If a child accidentally ingests benzonatate, seek medical attention immediately. Signs and symptoms of benzonatate overdose can occur rapidly after ingestion (within 15-20 minutes) and may include restlessness, tremors, convulsions, coma, and cardiac arrest.

    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178


    [12/14/2010 - Drug Safety Communication - FDA]

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