Drug Safety Information for TESSALON (Benzonatate)

Adverse Drug Reactions for TESSALON* (Benzonatate)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with TESSALON
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea*344
2Nausea257
3Pneumonia244
4Pain237
5Cough*221
6Diarrhoea202
7Fatigue199
8Vomiting192
9Anxiety182
10Asthenia162
11Dizziness*153
12Headache*153
13Pyrexia151
14Chest pain144
15Pulmonary embolism139
16Fall133
17Depression133
18Injury129
19Death125
20Bronchitis123

* This side effect also appears in "Top 10 Side Effects of TESSALON " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking TESSALON
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Cough*2651
2Product used for unknown indication1727
3Bronchitis*118
4Asthma*50
5Pneumonia*48
6Antitussive therapy44
7Upper respiratory tract infection*28
8Foetal exposure during pregnancy27
9Suicide attempt27
10Ill-defined disorder20

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for TESSALON

Total Reports Filed with FDA: 22282

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Male Patients
Male
Female Patients
Female
Unknown Patients
Unknown


Number of FDA Adverse Event Reports by Patient Age for TESSALON

Total Reports Filed with FDA: 22282*

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Note: * Reports include 4,033 reports of unknown age.


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Benzonatate (Zonatuss, Tessalon, Benzonatate)

Charts are based on 22282 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and TESSALON Reviews and Review Summary .

Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.

Visit   DrugInformer.com more on TESSALON's side effects.