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Night Sweat (9)
Anxiety/depression (7)
Horrible Headache (5)
Burning In Eyes (4)
Rashes (4)
Dizziness (3)
Stomach Pain (2)
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Benzonatate Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 62 

Pain, Loss Of Consciousness, Fall, Pain In Extremity (7481313-6)
on May 12, 2011 Female from UNITED STATES , 86 years of age, weighting 165.0 lb, was diagnosed with
  • cough
and was treated with Benzonatate. Directly after, patient experienced the unwanted or unexpected Benzonatate side effects: pain, loss of consciousness, fall, pain in extremity. Benzonatate dosage: 1 2x Daily By Mouth 1 Time.
Associated medications used:
  • Tessalon
Patient was hospitalized.

Tachycardia, Colitis, Lipase Increased, Chest Pain, Hypoxia (7481011-9)
Patient was taking Benzonatate. Patient felt the following Benzonatate side effects: tachycardia, colitis, lipase increased, chest pain, hypoxia on May 12, 2011 from INDIA Additional patient health information: Female , 59 years of age, was diagnosed with
  • cough
and. Benzonatate dosage: Tid.
Multiple prescriptions taken:
  • Celexa (30days Tabs)
  • Calcium + Vitamin D (Tabs 1df=600mg Plus 400iu)
  • Atenolol (Also 100mg)
  • Zantac
  • Amiloride Hcl And Hydrochlorothiazide (1 Df: 5/50 5mg-50mg Tabs)
  • Remeron (Tabs)
  • Leukine
  • Guaifenesin (Q4h)
Patient was hospitalized.

Angioedema (7422741-4)
Adverse event was reported on Apr 14, 2011 by a Male taking Benzonatate (Dosage: N/A) was diagnosed with
  • cough
and. Location: UNITED STATES , weighting 206.0 lb, After Benzonatate was administered, patient encountered several Benzonatate side effects: angioedema. Patient was hospitalized.

Pain, Cerebral Infarction, Motor Dysfunction (7356229-6)
on Sep 21, 2010 Female from UNITED STATES , weighting 170.0 lb, was diagnosed with
  • cough
and was treated with Benzonatate. Directly after, patient experienced the unwanted or unexpected Benzonatate side effects: pain, cerebral infarction, motor dysfunction. Benzonatate dosage: N/A.
Associated medications used:
  • Uncodeable ^unclassifiable^
  • Loratadine
  • Cholesterol
  • Uncodeable ^unclassifiable^
  • Verapamil
  • Uncodeable ^unclassifiable^ (400 Mg, Unk)
  • Ferrous Sulfate Tab (325 Mg, Unk)
  • Yasmin (Unk)
Patient was hospitalized.


Respiratory Arrest, Cardiac Arrest (7341339-X)
on Feb 17, 2011 Female from UNITED STATES , child 11 years of age, was treated with Benzonatate. Patient felt the following Benzonatate side effects: respiratory arrest, cardiac arrest. Benzonatate dosage: N/A.

Pulmonary Function Test Decreased, Condition Aggravated (7309393-9)
Patient was taking Benzonatate. After Benzonatate was administered, patient encountered several Benzonatate side effects: pulmonary function test decreased, condition aggravated on Feb 11, 2011 from UNITED STATES Additional patient health information: Female , 76 years of age, weighting 141.1 lb, . Benzonatate dosage: N/A.
Multiple concurrent drugs taken:
  • Coreg
  • Lasix
  • Potassium
  • Cozaar
  • Multaq
  • Amiodarone
  • Aspirin
  • Temazepam


Confusional State, Dizziness (7287367-4)
Adverse event was reported on Feb 08, 2011 by a Female taking Benzonatate (Dosage: N/A) was diagnosed with
  • cough
and. Location: UNITED STATES , 58 years of age, weighting 117.0 lb, Directly after, patient experienced the unwanted or unexpected Benzonatate side effects: confusional state, dizziness.

Quality Of Life Decreased, Pain In Extremity (7274820-2)
on Feb 02, 2011 Female from UNITED STATES , weighting 178.0 lb, was treated with Benzonatate. Patient felt the following Benzonatate side effects: quality of life decreased, pain in extremity. Benzonatate dosage: N/A.
Multiple prescriptions taken:
  • Levaquin (1 Tablet Daily)
  • Levaquin (1 Tablet Daily)
  • Ventolin Hfa


Cold Sweat, Headache, Unevaluable Event (7132653-1)
on Nov 30, 2010 Female from UNITED STATES , 61 years of age, weighting 248.0 lb, was diagnosed with
  • cough
  • sinusitis
and was treated with Benzonatate. After Benzonatate was administered, patient encountered several Benzonatate side effects: cold sweat, headache, unevaluable event. Benzonatate dosage: 1 Fill 2x Po.

Accidental Exposure, Convulsion (7074476-8)
Patient was taking Benzonatate. Directly after, patient experienced the unwanted or unexpected Benzonatate side effects: accidental exposure, convulsion on Oct 06, 2010 from UNITED STATES Additional patient health information: Male , 30 years of age, . Benzonatate dosage: (600 Mg, Once).

Rash Pruritic (7027193-4)
Adverse event was reported on Oct 01, 2010 by a Female taking Benzonatate (Dosage: 200 Mg 3 Times/day Prn Po) was diagnosed with
  • cough
and. Location: UNITED STATES , 42 years of age, weighting 210.0 lb, Patient felt the following Benzonatate side effects: rash pruritic.

Eye Discharge, Ocular Hyperaemia (6714354-4)
on Apr 23, 2010 Female from UNITED STATES , 50 years of age, was diagnosed with
  • cough
and was treated with Benzonatate. After Benzonatate was administered, patient encountered several Benzonatate side effects: eye discharge, ocular hyperaemia. Benzonatate dosage: 1 Cap - Q 8 Hours - Po.

Eye Discharge, Eye Haemorrhage (6694300-2)
on Apr 12, 2010 Female from UNITED STATES , 50 years of age, was diagnosed with
  • cough
and was treated with Benzonatate 200mg Capsule (zydus). Directly after, patient experienced the unwanted or unexpected Benzonatate side effects: eye discharge, eye haemorrhage. Benzonatate 200mg Capsule (zydus) dosage: 1 Cap, Q8 Hours; Po.

Dissociation, Dizziness, Fear, Feeling Abnormal, Somnolence (6667168-8)
Patient was taking Benzonatate. Patient felt the following Benzonatate side effects: dissociation, dizziness, fear, feeling abnormal, somnolence on Apr 01, 2010 from UNITED STATES Additional patient health information: Female , 40 years of age, weighting 183.0 lb, was diagnosed with
  • bronchitis
  • pneumonia
and. Benzonatate dosage: 200 Mg 3x Per Day Po.

Abdominal Pain Lower, Diarrhoea, Faecal Incontinence, Headache (6656211-8)
Adverse event was reported on Mar 26, 2010 by a Female taking Benzonatate (Dosage: One Capsule By Mouth Three Tmes Daily Po 6 -1/3 Days) . Location: UNITED STATES , 64 years of age, weighting 200.0 lb, After Benzonatate was administered, patient encountered several Benzonatate side effects: abdominal pain lower, diarrhoea, faecal incontinence, headache.

Abdominal Discomfort, Activities Of Daily Living Impaired, Aggression, Dizziness, Fatigue, Suicidal Ideation (6645750-1)
on Mar 18, 2010 Female from UNITED STATES , 59 years of age, weighting 173.0 lb, was diagnosed with
  • cough
and was treated with Benzonatate. Directly after, patient experienced the unwanted or unexpected Benzonatate side effects: abdominal discomfort, activities of daily living impaired, aggression, dizziness, fatigue, suicidal ideation. Benzonatate dosage: 200 Mg Bid Po.
Associated medications used:
  • Levothyroxine Sodium
  • Calcium
  • Multi-vitamin
  • Paroxetine Hcl
  • Abilify
  • Oxaprozin
  • Divalproex Sodium
  • Ranitidine


Dizziness, Nasal Congestion, Nausea, Presyncope, Somnolence (6500109-2)
on Dec 14, 2009 Male from UNITED STATES , weighting 162.0 lb, was diagnosed with
  • cough
and was treated with Benzonatate 100mg Cap Rx # 21560481. Patient felt the following Benzonatate side effects: dizziness, nasal congestion, nausea, presyncope, somnolence. Benzonatate 100mg Cap Rx # 21560481 dosage: 1 3 Times Oral.

Arthralgia, Feeling Abnormal, Myalgia (6409083-0)
Patient was taking Benzonatate. After Benzonatate was administered, patient encountered several Benzonatate side effects: arthralgia, feeling abnormal, myalgia on Oct 19, 2009 from UNITED STATES Additional patient health information: Male , 45 years of age, weighting 145.0 lb, was diagnosed with
  • cough
and. Benzonatate dosage: 1 To 3 Caps 3 Times Daily Po.

Product Contamination, Product Odour Abnormal (6356037-9)
Adverse event was reported on Sep 10, 2009 by a Female taking Benzonatate (Dosage: 1 3 Times Daily Po) was diagnosed with
  • cough
and. Location: UNITED STATES , 44 years of age, weighting 189.0 lb, Directly after, patient experienced the unwanted or unexpected Benzonatate side effects: product contamination, product odour abnormal.

Heart Rate Decreased (6303943-7)
on Aug 10, 2009 Female from UNITED STATES , 31 years of age, weighting 160.0 lb, was diagnosed with
  • sinusitis
and was treated with Benzonatate. Patient felt the following Benzonatate side effects: heart rate decreased. Benzonatate dosage: 1 Pill Once Po. Patient was hospitalized.

Nausea (6289711-3)
on Jul 29, 2009 Female from UNITED STATES , 79 years of age, weighting 109.0 lb, was diagnosed with
  • cough
and was treated with Benzonatate. After Benzonatate was administered, patient encountered several Benzonatate side effects: nausea. Benzonatate dosage: One 3x A Day Only Took 2 Pills.

Choking, Dysphagia, Dyspnoea, Fear, Throat Tightness (6265199-3)
Patient was taking Benzonatate. Directly after, patient experienced the unwanted or unexpected Benzonatate side effects: choking, dysphagia, dyspnoea, fear, throat tightness on Jul 09, 2009 from UNITED STATES Additional patient health information: Male , 53 years of age, weighting 140.0 lb, was diagnosed with
  • cough
and. Benzonatate dosage: 1 Or 2 Caps By Mouth - 4 To 6 Hours As Needed For Cough Only 1 Time.

Flat Affect, Psychomotor Retardation, Visual Impairment (6258376-9)
Adverse event was reported on Jul 02, 2009 by a Female taking Benzonatate (Dosage: Po) was diagnosed with
  • cough
and. Location: UNITED STATES , weighting 185.0 lb, Patient felt the following Benzonatate side effects: flat affect, psychomotor retardation, visual impairment.
Multiple prescriptions taken:
  • Nyquil (Po)


Cough, Dysphagia, Pharyngeal Hypoaesthesia, Regurgitation (6256422-X)
on Jul 01, 2009 Female from UNITED STATES , 49 years of age, weighting 172.0 lb, was diagnosed with
  • cough
and was treated with Benzonatate. After Benzonatate was administered, patient encountered several Benzonatate side effects: cough, dysphagia, pharyngeal hypoaesthesia, regurgitation. Benzonatate dosage: 2 Capsules Po.

Depressed Level Of Consciousness, Diarrhoea, Feeling Of Despair, Nausea, Vomiting (6245058-2)
on Jun 23, 2009 Female from UNITED STATES , weighting 120.0 lb, was diagnosed with
  • cough
  • pyrexia
and was treated with Benzonatate. Directly after, patient experienced the unwanted or unexpected Benzonatate side effects: depressed level of consciousness, diarrhoea, feeling of despair, nausea, vomiting. Benzonatate dosage: 1 Tablet Every 12 Hours Po; Once. Patient was hospitalized.

Showing 1-25 of 62 

Benzonatate Health Episodes

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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.

Benzonatate Information

Alternative BENZONATATE Names:BENZONATA

Active Ingredient: BENZONATA

More About Benzonatate

Side Effects reported to FDA: 62. View Benzonatate Adverse Reports

Benzonatate safety alerts: 2010

Reported deaths: 3

Reported hospitalizations: 17

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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