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Benzonatate Side Effects

Report Benzonatate Side Effects

If you experienced any harmful or unwanted effects of Benzonatate, please share your experience. This could help to raise awareness about Benzonatate side effects, identify uknown risks and inform health professionals and patients taking Benzonatate.

Examples: headache, dizziness


The most commonly reported Benzonatate side effects are:
Night Sweat (11 reports)
Anxiety/depression (7 reports)
Horrible Headache (5 reports)
Burning In Eyes (4 reports)
Rashes (4 reports)
Dizziness (3 reports)
Stomach Pain (2 reports)
Sweating (2 reports)
35 Yo Female...I Took Two As Prescribed For A Coug (1 reports)
Anxious (1 reports)
Cold Sweat (1 reports)
Cold Sweats (1 reports)

If you have experienced a side effect listed above, you can check a box to report it.


View a complete list of Benzonatate side effects or compare Benzonatate side effects

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 (eg, physician, pharmacist). Your health care provider can provide additional clinical information and complete a copy of the side effect reporting form.

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.

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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.
Feeling Abnormal, Presyncope, Urticaria, Hyperhidrosis
on Feb 03, 2012 Male from UNITED STATES , 37 years of age, weighting 210.0 lb, was diagnosed with and was treated with Benzonatate. Directly after, patient experienced the unwanted or unexpected Benzonatate side effects: feeling abnormal, presyncope, urticaria, hyperhidrosis. Benzonatate dosage: 1-2 Capsules.

Pleurisy, Muscle Strain, Hyperhidrosis, Patella Fracture, Tremor, Feeling Cold, Fall, Musculoskeletal Chest Pain
Patient was taking Benzonatate. Patient felt the following Benzonatate side effects: pleurisy, muscle strain, hyperhidrosis, patella fracture, tremor, feeling cold, fall, musculoskeletal chest pain on Dec 02, 2011 from UNITED STATES Additional patient health information: Female , 59 years of age, weighting 121.3 lb, . Benzonatate dosage: 100 Mg, Prn.
Multiple prescriptions taken:
  • Prochlorperazine Maleate (10 Mg, Prn)
  • Compazine
  • Midrin (100 Mg, Qd)
  • Hydroxyzine Hcl (25 Mg, Prn)
  • Albuterol Sulfate (Unk)
  • Seroquel (400 Mg, Qhs)
  • Reglan (10 Mg, Prn)
  • Zantac (300 Mg, Qd)


Paraesthesia, Hypoaesthesia
Adverse event was reported on Nov 30, 2011 by a Female taking Benzonatate (Dosage: N/A) . Location: UNITED STATES , 56 years of age, weighting 183.0 lb, After Benzonatate was administered, patient encountered several Benzonatate side effects: paraesthesia, hypoaesthesia.
Multiple concurrent drugs taken:
  • Advair Diskus 100/50
  • Albuterol
  • Vitamin B12
  • Zemaira
  • Zemaira
  • Folic Acid
  • Carvedilol
  • Ibuprofen
Patient was hospitalized.

Hypoaesthesia, Paraesthesia, Hypersensitivity
on Dec 08, 2011 Female from UNITED STATES , 55 years of age, weighting 153.0 lb, was diagnosed with and was treated with Benzonatate. Directly after, patient experienced the unwanted or unexpected Benzonatate side effects: hypoaesthesia, paraesthesia, hypersensitivity. Benzonatate dosage: 1 Capsule.
Associated medications used:
  • Ventolin Hfa
  • Acetaminophen W/ Codeine No. 3



Hallucination
on Dec 02, 2011 Male from UNITED STATES , weighting 208.0 lb, was diagnosed with and was treated with Benzonatate. Patient felt the following Benzonatate side effects: hallucination. Benzonatate dosage: 200 Mg 3x Day Oral 11-3, 11-4, 11-5.

Anaemia, Febrile Neutropenia, Platelet Count Decreased, White Blood Cell Count Decreased
Patient was taking Benzonatate. After Benzonatate was administered, patient encountered several Benzonatate side effects: anaemia, febrile neutropenia, platelet count decreased, white blood cell count decreased on Nov 16, 2011 from UNITED STATES Additional patient health information: Female , 44 years of age, weighting 263.6 lb, . Benzonatate dosage: N/A.
Multiple concurrent drugs taken:
  • Doxorubicin Hcl (10 Milligram/sq. Meter)
  • Guaifenesin
  • Cyclophosphamide (600 Milligram/sq. Meter)
  • Zolpidem
  • Cefepime
  • Bevacizumab (10 Milligram/kilogram)
  • Famotidine
  • Prochlorperazine
Patient was hospitalized.

Dyspnoea, Hypertension, Lung Disorder, Cough, Migraine
Adverse event was reported on Sep 09, 2011 by a Female taking Benzonatate (Dosage: 100 Mg, Unk) . Location: UNITED STATES , weighting 130.0 lb, Directly after, patient experienced the unwanted or unexpected Benzonatate side effects: dyspnoea, hypertension, lung disorder, cough, migraine.
Associated medications used:
  • Vitamin D (1000, Unk)
  • Cefpodoxime (100 Mg, Unk)
  • Calcium With Vitamin D (Unk)
  • Azithromycin (250 Mg, Unk)
  • Sutent (50 Mg, 1x/day (28 Days On, 14 Days Off))
  • Neurontin (100 Mg, Unk)
  • Oxycontin (10 Mg, Unk)


Emotional Distress, Gastrooesophageal Reflux Disease, Hyperkinesia, Fatigue, Dyslipidaemia, Blood Potassium Decreased, Dyskinesia, Pneumonia, Urinary Tract Infection
on Aug 25, 2011 Female from UNITED STATES , 63 years of age, weighting 125.0 lb, was treated with Benzonatate. Patient felt the following Benzonatate side effects: emotional distress, gastrooesophageal reflux disease, hyperkinesia, fatigue, dyslipidaemia, blood potassium decreased, dyskinesia, pneumonia, urinary tract infection. Benzonatate dosage: N/A.
Multiple prescriptions taken:
  • Glucophage
  • Neurontin
  • M.v.i.
  • Alphagan
  • Prednisone
  • Humulin R
  • Fluticasone Propionate
  • Metformin Hcl
Patient was hospitalized and became disabled.

Platelet Count Decreased
on Aug 25, 2011 Male from UNITED STATES , 54 years of age, weighting 211.6 lb, was treated with Benzonatate. After Benzonatate was administered, patient encountered several Benzonatate side effects: platelet count decreased. Benzonatate dosage: N/A.
Multiple concurrent drugs taken:
  • Compazine
  • Aspirin
  • Tylenol-500
  • Multi-vitamins
  • Ipilimumab (10 Mg/kg Iv Over On D1 Q12 Weeks No Of Course-4 Last Dose On 26jul2011)
Patient was hospitalized.

Product Substitution Issue, Confusional State, Hallucination
Patient was taking Benzonatate. Directly after, patient experienced the unwanted or unexpected Benzonatate side effects: product substitution issue, confusional state, hallucination on Aug 30, 2011 from UNITED STATES Additional patient health information: Male , weighting 167.0 lb, was diagnosed with and. Benzonatate dosage: 200mg.

Ventricular Fibrillation
Adverse event was reported on Aug 17, 2011 by a Female taking Benzonatate (Dosage: Unk) . Location: UNITED STATES , 27 years of age, Patient felt the following Benzonatate side effects: ventricular fibrillation. Patient was hospitalized.

Intentional Overdose, Convulsion, Cardiac Arrest, Pyrexia, Confabulation
on Aug 17, 2011 Female from UNITED STATES , 17 years of age, was diagnosed with and was treated with Benzonatate. After Benzonatate was administered, patient encountered several Benzonatate side effects: intentional overdose, convulsion, cardiac arrest, pyrexia, confabulation. Benzonatate dosage: Unk. Patient was hospitalized.

Anxiety, Pulmonary Embolism, Emotional Distress, Anhedonia, Injury, Pain
on Aug 09, 2011 Female from UNITED STATES , 39 years of age, weighting 119.0 lb, was treated with Benzonatate. Directly after, patient experienced the unwanted or unexpected Benzonatate side effects: anxiety, pulmonary embolism, emotional distress, anhedonia, injury, pain. Benzonatate dosage: Daily Dose 100 Mg.
Associated medications used:
  • Azithromycin (Daily Dose 250 Mg)
  • Yasmin (Unk)
  • Yaz (Unk)
  • Nsaid's (Unk Unk, Prn)
  • Xopenex
  • Yaz (Unk)
  • Yasmin (Unk)
Patient was hospitalized.

Dry Mouth, Dry Throat
Patient was taking Benzonatate. Patient felt the following Benzonatate side effects: dry mouth, dry throat on Jul 28, 2011 from UNITED STATES Additional patient health information: Female , 71 years of age, . Benzonatate dosage: Unk.
Multiple prescriptions taken:
  • Allegra (180 Mg, 1x/day)
  • Allegra (180 Mg, 1x/day)


Cough, Ear Infection, Fatigue
Adverse event was reported on Jul 21, 2011 by a Female taking Benzonatate (Dosage: N/A) was diagnosed with and. Location: UNITED STATES , 13 years of age, After Benzonatate was administered, patient encountered several Benzonatate side effects: cough, ear infection, fatigue.
Multiple concurrent drugs taken:
  • Abilify


Nausea, Weight Decreased, Confusional State, Chest Pain, Eating Disorder, Dizziness, Retching
on Jul 21, 2011 Female from UNITED STATES , 52 years of age, weighting 125.0 lb, was diagnosed with and was treated with Benzonatate. Directly after, patient experienced the unwanted or unexpected Benzonatate side effects: nausea, weight decreased, confusional state, chest pain, eating disorder, dizziness, retching. Benzonatate dosage: 1 Capsule.

Swelling, Pruritus
on May 26, 2011 Male from UNITED STATES , 71 years of age, weighting 225.0 lb, was treated with Benzonatate. Patient felt the following Benzonatate side effects: swelling, pruritus. Benzonatate dosage: 1 Capsule 3 Times A Day Mouth 4-23 - 4-24.
Multiple prescriptions taken:
  • Azithromycin (10mgc A Day For 3 Days Mouth 4-12-4 24)


Pain, Loss Of Consciousness, Fall, Pain In Extremity
Patient was taking Benzonatate. After Benzonatate was administered, patient encountered several Benzonatate side effects: pain, loss of consciousness, fall, pain in extremity on May 12, 2011 from UNITED STATES Additional patient health information: Female , 86 years of age, weighting 165.0 lb, was diagnosed with and. Benzonatate dosage: 1 2x Daily By Mouth 1 Time.
Multiple concurrent drugs taken:
  • Tessalon
Patient was hospitalized.

Tachycardia, Colitis, Lipase Increased, Chest Pain, Hypoxia
Adverse event was reported on May 12, 2011 by a Female taking Benzonatate (Dosage: Tid) was diagnosed with and. Location: INDIA , 59 years of age, Directly after, patient experienced the unwanted or unexpected Benzonatate side effects: tachycardia, colitis, lipase increased, chest pain, hypoxia.
Associated medications used:
  • 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
on Apr 14, 2011 Male from UNITED STATES , weighting 206.0 lb, was diagnosed with and was treated with Benzonatate. Patient felt the following Benzonatate side effects: angioedema. Benzonatate dosage: N/A. Patient was hospitalized.

Pain, Cerebral Infarction, Motor Dysfunction
on Sep 21, 2010 Female from UNITED STATES , weighting 170.0 lb, was diagnosed with and was treated with Benzonatate. After Benzonatate was administered, patient encountered several Benzonatate side effects: pain, cerebral infarction, motor dysfunction. Benzonatate dosage: N/A.
Multiple concurrent drugs taken:
  • 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
Patient was taking Benzonatate. Directly after, patient experienced the unwanted or unexpected Benzonatate side effects: respiratory arrest, cardiac arrest on Feb 17, 2011 from UNITED STATES Additional patient health information: Female , child 11 years of age, . Benzonatate dosage: N/A.

Pulmonary Function Test Decreased, Condition Aggravated
Adverse event was reported on Feb 11, 2011 by a Female taking Benzonatate (Dosage: N/A) . Location: UNITED STATES , 76 years of age, weighting 141.1 lb, Patient felt the following Benzonatate side effects: pulmonary function test decreased, condition aggravated.
Multiple prescriptions taken:
  • Coreg
  • Lasix
  • Potassium
  • Cozaar
  • Multaq
  • Amiodarone
  • Aspirin
  • Temazepam


Confusional State, Dizziness
on Feb 08, 2011 Female from UNITED STATES , 58 years of age, weighting 117.0 lb, was diagnosed with and was treated with Benzonatate. After Benzonatate was administered, patient encountered several Benzonatate side effects: confusional state, dizziness. Benzonatate dosage: N/A.

Quality Of Life Decreased, Pain In Extremity
on Feb 02, 2011 Female from UNITED STATES , weighting 178.0 lb, was treated with Benzonatate. Directly after, patient experienced the unwanted or unexpected Benzonatate side effects: quality of life decreased, pain in extremity. Benzonatate dosage: N/A.
Associated medications used:
  • Levaquin (1 Tablet Daily)
  • Levaquin (1 Tablet Daily)
  • Ventolin Hfa


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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?

    Yes, Severe
    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]

    Latest Benzonatate clinical trials