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Benzonatate Side Effects

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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.

Benzonatate Side Effects Reported to FDA



Benzonatate Side Effect Report#9994978
Dizziness, Presyncope
This is a report of a 71-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: cough, who was treated with Benzonatate (dosage: NA, start time:
Jan 20, 2014), combined with:
  • Tramadol
  • Albuterol
  • Multivitamin
  • Salmon Oil
  • Saline Nasal Spray
  • Prilosec Otc
and developed a serious reaction and side effect(s): Dizziness, Presyncope after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Benzonatate treatment in female patients, resulting in Dizziness side effect.
Benzonatate Side Effect Report#9981089
Retching, Choking, Dyspnoea, Headache, Swollen Tongue, Local Swelling
This report suggests a potential Benzonatate Retching side effect(s) that can have serious consequences. A 68-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: cough and used Benzonatate (dosage: By Mouth, 1 Capsule) starting
Feb 14, 2014. After starting Benzonatate the patient began experiencing various side effects, including: Retching, Choking, Dyspnoea, Headache, Swollen Tongue, Local SwellingAdditional drugs used concurrently:
  • Vitamins
  • Oscal
Although Benzonatate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Retching, may still occur.
Benzonatate Side Effect Report#9835649
Toxicity To Various Agents
This Toxicity To Various Agents problem was reported by a health professional from US. A 49-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Benzonatate (dosage: Unk). The following drugs were being taken at the same time:
  • Lisinopril (Unk)
  • Amlodipine Besilate (Unk)
  • Trazodone (Unk)
  • Cocaine (Unk)
  • Benztropeine (Unk)
When using Benzonatate, the patient experienced the following unwanted symptoms/side effects: Toxicity To Various AgentsAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Toxicity To Various Agents, may become evident only after a product is in use by the general population.
Benzonatate Side Effect Report#9809259
Accidental Exposure To Product, Cardiac Arrest, Respiratory Arrest
This Accidental Exposure To Product side effect was reported by a pharmacist from US. A 4-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Benzonatate (drug dosage: Unk), which was initiated on NS. Concurrently used drugs: NA..After starting to take Benzonatate the consumer reported adverse symptoms, such as: Accidental Exposure To Product, Cardiac Arrest, Respiratory ArrestThese side effects may potentially be related to Benzonatate.
Benzonatate Side Effect Report#9711456
Visual Impairment, Nausea, Headache
This is a report of a 30-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: sinusitis,cough, who was treated with Benzonatate (dosage: 1-2 Pills, Up To 3 Times A Day, start time:
Nov 22, 2013), combined with: NA. and developed a serious reaction and side effect(s): Visual Impairment, Nausea, Headache after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Benzonatate treatment in female patients, resulting in Visual Impairment side effect.
Benzonatate Side Effect Report#9695926
Diarrhoea
This report suggests a potential Benzonatate Diarrhoea side effect(s) that can have serious consequences. A 82-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: cough and used Benzonatate (dosage: 30 Capsules Twice Daily By Mouth) starting
Nov 01, 2013. After starting Benzonatate the patient began experiencing various side effects, including: DiarrhoeaAdditional drugs used concurrently:
  • Mylan Patch(soy Estradiol)
  • Levothyroxine
  • Niacinamide
  • Acidophilus/bifidus
  • Omega 3
  • Lutein
  • Vitamin C
  • Green Tea
Although Benzonatate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Diarrhoea, may still occur.
Benzonatate Side Effect Report#9548979
Muscle Disorder, Abasia
This Muscle Disorder problem was reported by a consumer or non-health professional from US. A 76-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: cough. On
Sep 18, 2013 this consumer started treatment with Benzonatate (dosage: NA). The following drugs were being taken at the same time: NA. When using Benzonatate, the patient experienced the following unwanted symptoms/side effects: Muscle Disorder, AbasiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Muscle Disorder, may become evident only after a product is in use by the general population.
Benzonatate Side Effect Report#9536942
Hypoaesthesia, Pharyngeal Oedema, Dyspnoea
This Hypoaesthesia side effect was reported by a pharmacist from US. A 57-year-old female patient (weight:NA) experienced the following symptoms/conditions: cough.The patient was prescribed Benzonatate (drug dosage: 100 Mg Prn/as Needed Oral), which was initiated on NS. Concurrently used drugs:
  • Heparin
  • Triamcinolone
  • Furosemide
.After starting to take Benzonatate the consumer reported adverse symptoms, such as: Hypoaesthesia, Pharyngeal Oedema, DyspnoeaThese side effects may potentially be related to Benzonatate.
Benzonatate Side Effect Report#9476008
Dysphonia, Dysphonia, Dysphonia
This is a report of a 77-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: idiopathic pulmonary fibrosis,cough, who was treated with Benzonatate (dosage: NA, start time:
Aug 16, 2013), combined with: NA. and developed a serious reaction and side effect(s): Dysphonia, Dysphonia, Dysphonia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Benzonatate treatment in male patients, resulting in Dysphonia side effect.
Benzonatate Side Effect Report#9391016
Respiratory Distress, Hypersensitivity, Bronchospasm, Laryngospasm, Circulatory Collapse
This report suggests a potential Benzonatate Respiratory Distress side effect(s) that can have serious consequences. A 21-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: cough and used Benzonatate (dosage: 1-2 Capsules) starting
May 01, 2013. After starting Benzonatate the patient began experiencing various side effects, including: Respiratory Distress, Hypersensitivity, Bronchospasm, Laryngospasm, Circulatory CollapseAdditional drugs used concurrently: NA.The patient was hospitalized. Although Benzonatate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Respiratory Distress, may still occur.
Benzonatate Side Effect Report#9376311
Headache, Nausea, Facial Pain, Pain In Jaw, Toothache, Sneezing, Hypersensitivity
This Headache problem was reported by a consumer or non-health professional from US. A 63-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: cough. On
Jun 19, 2013 this consumer started treatment with Benzonatate (dosage: 1 Pill 3 X Daily Po). The following drugs were being taken at the same time: NA. When using Benzonatate, the patient experienced the following unwanted symptoms/side effects: Headache, Nausea, Facial Pain, Pain In Jaw, Toothache, Sneezing, HypersensitivityAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Headache, may become evident only after a product is in use by the general population.
Benzonatate Side Effect Report#9248841
Dyspnoea, Asthma, Panic Attack
This Dyspnoea side effect was reported by a consumer or non-health professional from US. A 30-year-old male patient (weight:NA) experienced the following symptoms/conditions: cough.The patient was prescribed Benzonatate (drug dosage: NA), which was initiated on
Aug 10, 2013. Concurrently used drugs: NA..After starting to take Benzonatate the consumer reported adverse symptoms, such as: Dyspnoea, Asthma, Panic AttackThese side effects may potentially be related to Benzonatate.
Benzonatate Side Effect Report#9171189
Throat Tightness, Hypoaesthesia Oral, Dysphagia, Speech Disorder, Dyspnoea, Unevaluable Event
This is a report of a 85-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: cough, who was treated with Benzonatate (dosage: As Needed, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Throat Tightness, Hypoaesthesia Oral, Dysphagia, Speech Disorder, Dyspnoea, Unevaluable Event after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Benzonatate treatment in female patients, resulting in Throat Tightness side effect. The patient was hospitalized.
Benzonatate Side Effect Report#9041143
Blood Pressure Increased, Insomnia, Somnambulism
This report suggests a potential Benzonatate Blood Pressure Increased side effect(s) that can have serious consequences. A 86-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: bronchitis,cough and used Benzonatate (dosage: 100 Mg Take 1 Or 2 3 Times Daily Mouth) starting
Dec 30, 2012. After starting Benzonatate the patient began experiencing various side effects, including: Blood Pressure Increased, Insomnia, SomnambulismAdditional drugs used concurrently: NA. Although Benzonatate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Blood Pressure Increased, may still occur.
Benzonatate Side Effect Report#9012294
Toxicity To Various Agents, Coma, Convulsion, Metabolic Acidosis
This Toxicity To Various Agents problem was reported by a consumer or non-health professional from US. A 13-year-old patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Benzonatate (dosage: NA). The following drugs were being taken at the same time:
  • Chlorpheniramine (chlorpheniramiramine)
  • Dextromethorphan (dextromethorphan)
When using Benzonatate, the patient experienced the following unwanted symptoms/side effects: Toxicity To Various Agents, Coma, Convulsion, Metabolic AcidosisThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Toxicity To Various Agents, may become evident only after a product is in use by the general population.
Benzonatate Side Effect Report#8816364
Hiccups
This Hiccups side effect was reported by a consumer or non-health professional from US. A male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Benzonatate (drug dosage: One Tab T.i.d.), which was initiated on
Aug 28, 2012. Concurrently used drugs: NA..After starting to take Benzonatate the consumer reported adverse symptoms, such as: HiccupsThese side effects may potentially be related to Benzonatate.
Benzonatate Side Effect Report#8790570
Rash, Pruritus, Skin Reaction
This is a report of a female patient (weight: NA) from US, suffering from the following health symptoms/conditions: cough, who was treated with Benzonatate (dosage: 200 Mg Asc 106 Every 8 Hours, start time:
Jul 26, 2012), combined with: NA. and developed a serious reaction and side effect(s): Rash, Pruritus, Skin Reaction after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Benzonatate treatment in female patients, resulting in Rash side effect.
Benzonatate Side Effect Report#8473548-0
Injury, Toothache, Pain, Decreased Appetite, Cardiac Murmur, Peptic Ulcer, Hepatic Pain, Blood Potassium Decreased, Tooth Infection
This report suggests a potential Benzonatate Injury side effect(s) that can have serious consequences. A female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Benzonatate (dosage: NA) starting
Mar 01, 2005. After starting Benzonatate the patient began experiencing various side effects, including: Injury, Toothache, Pain, Decreased Appetite, Cardiac Murmur, Peptic Ulcer, Hepatic Pain, Blood Potassium Decreased, Tooth InfectionAdditional drugs used concurrently:
  • Clonazepam
  • Hydrochlorothiazide
  • Klonopin
  • Aspirin
  • Lactulose
  • Lortab
  • Metoprolol Succinate
  • Paxil
The patient was hospitalized. Although Benzonatate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Injury, may still occur.
Benzonatate Side Effect Report#8392704-3
Skin Haemorrhage, Contusion, Dizziness
This Skin Haemorrhage problem was reported by a consumer or non-health professional from United States. A 76-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: bronchitis. On
Nov 30, 2011 this consumer started treatment with Benzonatate (dosage: 1 Capsule Every 8 Hours 20 Pills). The following drugs were being taken at the same time: NA. When using Benzonatate, the patient experienced the following unwanted symptoms/side effects: Skin Haemorrhage, Contusion, DizzinessThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Skin Haemorrhage, may become evident only after a product is in use by the general population.
Benzonatate Side Effect Report#8360760-4
Haemoglobin Decreased
This Haemoglobin Decreased side effect was reported by a pharmacist from United States. A 70-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Benzonatate (drug dosage: NA), which was initiated on
Jun 01, 2006. Concurrently used drugs:
  • Coreg Cr (carvedilol)
  • Procrit
  • Folic Acid
  • Prilosec
  • Azithromycin
  • Levothyroxine Sodium
  • Revlimid (10 Mg, 1 In 1 D, Po)
  • Prevacid
.After starting to take Benzonatate the consumer reported adverse symptoms, such as: Haemoglobin DecreasedThese side effects may potentially be related to Benzonatate.
Benzonatate Side Effect Report#8350125-3
Pulmonary Embolism, Headache, Pain In Extremity, Vomiting, Pain, Abdominal Discomfort, Dyspnoea, Nausea, Oedema Peripheral
This is a report of a 16-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: cough, who was treated with Benzonatate (dosage: 100 Mg, Tid, start time:
Sep 23, 2009), combined with:
  • 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)
and developed a serious reaction and side effect(s): Pulmonary Embolism, Headache, Pain In Extremity, Vomiting, Pain, Abdominal Discomfort, Dyspnoea, Nausea, Oedema Peripheral after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Benzonatate treatment in female patients, resulting in Pulmonary Embolism side effect. The patient was hospitalized.
Benzonatate Side Effect Report#8231122-5
Chest Pain, Dyspnoea, Feeling Hot
This report suggests a potential Benzonatate Chest Pain side effect(s) that can have serious consequences. A 39-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: cough and used Benzonatate (dosage: 100 Mg Capsules) starting
Mar 20, 2012. After starting Benzonatate the patient began experiencing various side effects, including: Chest Pain, Dyspnoea, Feeling HotAdditional drugs used concurrently: NA. Although Benzonatate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Chest Pain, may still occur.
Benzonatate Side Effect Report#8193125-9
Feeling Abnormal, Dysgeusia
This Feeling Abnormal problem was reported by a health professional from United States. A 30-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: cough. On
Mar 07, 2012 this consumer started treatment with Benzonatate (dosage: NA). The following drugs were being taken at the same time: NA. When using Benzonatate, the patient experienced the following unwanted symptoms/side effects: Feeling Abnormal, DysgeusiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Feeling Abnormal, may become evident only after a product is in use by the general population.
Benzonatate Side Effect Report#8179454-3
Completed Suicide
This Completed Suicide side effect was reported by a health professional from United States. A 39-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Benzonatate (drug dosage: Unk,unk), which was initiated on NS. Concurrently used drugs:
  • 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)
.After starting to take Benzonatate the consumer reported adverse symptoms, such as: Completed SuicideThese side effects may potentially be related to Benzonatate.
Benzonatate Side Effect Report#8133820-0
Insomnia, Headache, Hypersensitivity, No Therapeutic Response
This is a report of a 61-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: cough, who was treated with Benzonatate (dosage: One Capsule, start time:
Feb 09, 2012), combined with: NA. and developed a serious reaction and side effect(s): Insomnia, Headache, Hypersensitivity, No Therapeutic Response after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Benzonatate treatment in female patients, resulting in Insomnia side effect.

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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.


What are common Benzonatate Side Effects for Women?

Women Side EffectsReports
Dyspnoea 10
Nausea 8
Dizziness 7
Headache 7
Pain 5
Diarrhoea 4
Hypoaesthesia 4
Cardiac Arrest 3
Chest Pain 3
Confusional State 3

What are common Benzonatate Side Effects for Men?

Men Side EffectsReports
Dysphonia 3
Dyspnoea 3
Dizziness 2
Feeling Abnormal 2
Hallucination 2
Presyncope 2
Abnormal Behaviour 1
Accidental Exposure 1
Agitation 1
Angioedema 1

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health 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

    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.

    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 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.

    Discuss Benzonatate Side Effects

    Did You Have a Benzonatate Side Effect?

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    How Effective is Benzonatate for You?

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    Benzonatate Safety Alerts, Active Ingredients, Usage Information

    NDC0179-0066
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary Namebenzonatate
    Namebenzonatate
    Dosage FormCAPSULE
    RouteORAL
    On market since20100621
    LabelerKAISER FOUNDATION HOSPITALS
    Active Ingredient(s)BENZONATATE
    Strength(s)100
    Unit(s)mg/1
    Pharma ClassDecreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC]

    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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