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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
This is a report of a 71-year-old female patient (weight: NA) from US, suffering from the following 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). The consumer presented with:
  • Dizziness
  • Presyncope
which developed 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.

Retching, Choking, Dyspnoea, Headache, Swollen Tongue, Local Swelling
This report suggests a potential Benzonatate Retching, Choking, Dyspnoea, Headache, Swollen Tongue, Local Swelling 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. Soon after starting Benzonatate the patient began experiencing various side effects, including:
  • Retching
  • Choking
  • Dyspnoea
  • Headache
  • Swollen Tongue
  • Local Swelling
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.

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 commencing Benzonatate, the patient experienced the following unwanted symptoms/side effects:
  • Toxicity To Various Agents
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.

Accidental Exposure To Product, Cardiac Arrest, Respiratory Arrest
This is a report of a 4-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: NA and was treated with Benzonatate (dosage: Unk) starting NS. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Accidental Exposure To Product
  • Cardiac Arrest
  • Respiratory Arrest
This opens a possibility that Benzonatate treatment could cause the above reactions, including accidental exposure to product, and some female subjects may be more susceptible.


Visual Impairment, Nausea, Headache
A 30-year-old female patient (weight: NA) from US with the following symptoms/conditions: sinusitis,cough started Benzonatate treatment (dosage: 1-2 Pills, Up To 3 Times A Day) on Nov 22, 2013. Soon after starting Benzonatate treatment, the subject experienced various side effects, including:
  • Visual Impairment
  • Nausea
  • Headache
Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Benzonatate.

Diarrhoea
A 82-year-old female patient from US (weight: NA) experienced symptoms, such as: cough and was treated with Benzonatate(dosage: 30 Capsules Twice Daily By Mouth). The treatment was initiated on Nov 01, 2013. After that a consumer reported the following side effect(s):
  • Diarrhoea
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Benzonatate efficacy:
  • Mylan Patch(soy Estradiol)
  • Levothyroxine
  • Niacinamide
  • Acidophilus/bifidus
  • Omega 3
  • Lutein
  • Vitamin C
  • Green Tea


Muscle Disorder, Abasia
In this report, Benzonatate was administered for the following condition: cough.A 76-year-old female consumer from US (weight: NA) started Benzonatate treatment (dosage: NA) on Sep 18, 2013.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Muscle Disorder
  • Abasia
A possible interaction with other drugs could have contributed to this reaction: NA.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Benzonatate treatment could be related to the listed above side effect(s).

Hypoaesthesia, Pharyngeal Oedema, Dyspnoea
This is a report of the following Benzonatate side effect(s):
  • Hypoaesthesia
  • Pharyngeal Oedema
  • Dyspnoea
A 57-year-old female patient from US (weight: NA) presented with the following condition: cough and received a treatment with Benzonatate (dosage: 100 Mg Prn/as Needed Oral) starting: NS.The following concurrently used drugs could have generated interactions:
  • Heparin
  • Triamcinolone
  • Furosemide
This report suggests that a Benzonatate treatment could be associated with the listed above side effect(s).

Dysphonia
This Benzonatate report was submitted by a 77-year-old male consumer from US (weight: NA). The patient was diagnosed with: idiopathic pulmonary fibrosis,cough and Benzonatate was administered (dosage: NA) starting: Aug 16, 2013. The consumer developed a set of symptoms:
  • Dysphonia
Other drugs used simultaneously: NA.Those unexpected symptoms could be linked to a Benzonatate treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Respiratory Distress, Hypersensitivity, Bronchospasm, Laryngospasm, Circulatory Collapse
This is a report of a possible correlation between Benzonatate use and the following symptoms/side effect(s):
  • Respiratory Distress
  • Hypersensitivity
  • Bronchospasm
  • Laryngospasm
  • Circulatory Collapse
which could contribute to an assessment of Benzonatate risk profile.A 21-year-old male consumer from US (weight: NA) was suffering from cough and was treated with Benzonatate (dosage: 1-2 Capsules) starting May 01, 2013.Other concurrent medications: NA.The patient was hospitalized.

Headache, Nausea, Facial Pain, Pain In Jaw, Toothache, Sneezing, Hypersensitivity
A 63-year-old female patient from US (weight: NA) presented with the following symptoms: cough and after a treatment with Benzonatate (dosage: 1 Pill 3 X Daily Po) experienced the following side effect(s):
  • Headache
  • Nausea
  • Facial Pain
  • Pain In Jaw
  • Toothache
  • Sneezing
  • Hypersensitivity
The treatment was started on Jun 19, 2013. Benzonatate was used in combination with the following drugs: NA.This report could alert potential Benzonatate consumers.

Dyspnoea, Asthma, Panic Attack
In this report, a 30-year-old male patient from US (weight: NA) was affected by a possible Benzonatate side effect.The patient was diagnosed with cough. After a treatment with Benzonatate (dosage: NA, start date: Aug 10, 2013), the patient experienced the following side effect(s):
  • Dyspnoea
  • Asthma
  • Panic Attack
The following simultaneously used drugs could have led to this reaction: NA.The findings here stress that side effects should be taken into consideration when evaluating a Benzonatate treatment.

Throat Tightness, Hypoaesthesia Oral, Dysphagia, Speech Disorder, Dyspnoea, Unevaluable Event
This is a report of a 85-year-old female patient from US (weight: NA), who used Benzonatate (dosage: As Needed) for a treatment of cough. After starting a treatment on NS, the patient experienced the following side effect(s):
  • Throat Tightness
  • Hypoaesthesia Oral
  • Dysphagia
  • Speech Disorder
  • Dyspnoea
  • Unevaluable Event
The following drugs could possibly have interacted with the Benzonatate treatment NA.The patient was hospitalized.Taken together, these observations suggest that a Benzonatate treatment could be related to side effect(s), such as Throat Tightness, Hypoaesthesia Oral, Dysphagia, Speech Disorder, Dyspnoea, Unevaluable Event.

Blood Pressure Increased, Insomnia, Somnambulism
This blood pressure increased side effect was reported by a consumer or non-health professional from US. A 86-year-old female patient (weight:NA) experienced the following symptoms/conditions: bronchitis,cough. The patient was prescribed Benzonatate (dosage: 100 Mg Take 1 Or 2 3 Times Daily Mouth), which was started on Dec 30, 2012. Concurrently used drugs: NA. When starting to take Benzonatate the consumer reported the following symptoms:
  • Blood Pressure Increased
  • Insomnia
  • Somnambulism
These side effects may potentially be related to Benzonatate.

Toxicity To Various Agents, Coma, Convulsion, Metabolic Acidosis
This is a Benzonatate side effect report of a 13-year-old patient (weight:NA) from US, suffering from the following symptoms/conditions: NA, who was treated with Benzonatate (dosage:NA, start time: NS), combined with:
  • Chlorpheniramine (chlorpheniramiramine)
  • Dextromethorphan (dextromethorphan)
, and developed a serious reaction and a toxicity to various agents side effect. The patient presented with:
  • Toxicity To Various Agents
  • Coma
  • Convulsion
  • Metabolic Acidosis
which developed after the beginning of treatment. The patient was hospitalized. This side effect report can indicate a possible existence of increased vulnerability to Benzonatate treatment in patients suffering from NA, resulting in toxicity to various agents.

Hiccups
This report suggests a potential Benzonatate hiccups side effect(s) that can have serious consequences. A male patient from US (weight:NA) was diagnosed with the following health condition(s): NA and used Benzonatate (dosage: One Tab T.i.d.) starting Aug 28, 2012. Soon after starting Benzonatate the patient began experiencing various side effects, including:
  • Hiccups
Drugs used concurrently:NA. Although Benzonatate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as hiccups, may still occur.

Rash, Pruritus, Skin Reaction
This rash problem was reported by a consumer or non-health professional from US. A female patient (weight: NA) was diagnosed with the following medical condition(s): cough.On Jul 26, 2012 a consumer started treatment with Benzonatate (dosage: 200 Mg Asc 106 Every 8 Hours). The following drugs/medications were being taken at the same time: NA. When commencing Benzonatate, the patient experienced the following unwanted symptoms /side effects:
  • Rash
  • Pruritus
  • Skin Reaction
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as rash, may become evident only after a product is in use by the general population.

Injury, Toothache, Pain, Decreased Appetite, Cardiac Murmur, Peptic Ulcer, Hepatic Pain, Blood Potassium Decreased, Tooth Infection
This is a Benzonatate side effect report of a female patient (weight: NA) from UNITED STATES. The patient developed the following symptoms/conditions: NA and was treated with Benzonatate (dosage: NA) starting Mar 01, 2005. Concurrently used drugs:
  • Clonazepam
  • Hydrochlorothiazide
  • Klonopin
  • Aspirin
  • Lactulose
  • Lortab
  • Metoprolol Succinate
  • Paxil
Soon after that, the consumer experienced the following of symptoms:
  • Injury
  • Toothache
  • Pain
  • Decreased Appetite
  • Cardiac Murmur
  • Peptic Ulcer
  • Hepatic Pain
  • Blood Potassium Decreased
  • Tooth Infection
The patient was hospitalized. This opens a possibility that Benzonatate could cause injury and that some female patients may be more susceptible.

Skin Haemorrhage, Contusion, Dizziness
A 76-year-old female patient (weight: NA) from UNITED STATES with the following symptoms: bronchitis started Benzonatate treatment (dosage: 1 Capsule Every 8 Hours 20 Pills) on Nov 30, 2011. Soon after starting Benzonatate treatment, the consumer experienced several side effects, including:
  • Skin Haemorrhage
  • Contusion
  • Dizziness
. Concurrently used drugs: NA.The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Benzonatate side effects, such as skin haemorrhage.

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 (dosage: NA), which was started 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
.When starting to take Benzonatate the consumer reported symptoms, such as:
  • Haemoglobin Decreased
These side effects may potentially be related to Benzonatate.

Pulmonary Embolism, Headache, Pain In Extremity, Vomiting, 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 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). The consumer presented with:
  • Pulmonary Embolism
  • Headache
  • Pain In Extremity
  • Vomiting
  • Abdominal Discomfort
  • Dyspnoea
  • Nausea
  • Oedema Peripheral
which developed 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.

Chest Pain, Dyspnoea, Feeling Hot
This report suggests a potential Benzonatate Chest Pain, Dyspnoea, Feeling Hot 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. Soon after starting Benzonatate the patient began experiencing various side effects, including:
  • Chest Pain
  • Dyspnoea
  • Feeling Hot
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.

Feeling Abnormal, Dysgeusia
This Feeling Abnormal, Dysgeusia 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 commencing Benzonatate, the patient experienced the following unwanted symptoms/side effects:
  • Feeling Abnormal
  • Dysgeusia
Although 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.

Completed Suicide
This is a report of a 39-year-old female patient (weight: NA) from UNITED STATES. The patient developed the following symptoms/conditions: NA and was treated with Benzonatate (dosage: Unk,unk) starting 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)
Soon after that, the consumer experienced the following side effects:
  • Completed Suicide
This opens a possibility that Benzonatate treatment could cause the above reactions, including completed suicide, and some female subjects may be more susceptible.

Insomnia, Headache, Hypersensitivity, No Therapeutic Response
A 61-year-old female patient (weight: NA) from UNITED STATES with the following symptoms/conditions: cough started Benzonatate treatment (dosage: One Capsule) on Feb 09, 2012. Soon after starting Benzonatate treatment, the subject experienced various side effects, including:
  • Insomnia
  • Headache
  • Hypersensitivity
  • No Therapeutic Response
Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Benzonatate.

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Top 10 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

Top 10 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

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

    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
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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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