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
1	Dyspnoea*	344
2	Nausea	257
3	Pneumonia	244
4	Pain	237
5	Cough*	221
6	Diarrhoea	202
7	Fatigue	199
8	Vomiting	192
9	Anxiety	182
10	Asthenia	162
11	Dizziness*	153
12	Headache*	153
13	Pyrexia	151
14	Chest pain	144
15	Pulmonary embolism	139
16	Fall	133
17	Depression	133
18	Injury	129
19	Death	125
20	Bronchitis	123

* 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
1	Cough*	2651
2	Product used for unknown indication	1727
3	Bronchitis*	118
4	Asthma*	50
5	Pneumonia*	48
6	Antitussive therapy	44
7	Upper respiratory tract infection*	28
8	Foetal exposure during pregnancy	27
9	Suicide attempt	27
10	Ill-defined disorder	20

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

Types of Adverse Events for TESSALON

Total Reports Filed with FDA: 22282

Number of FDA Adverse Event Reports by Patient Age for TESSALON

Total Reports Filed with FDA: 22282*

* 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.

Historical 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.