Drug Safety Information for SEREVENT (Salmeterol xinafoate)

Adverse Drug Reactions for SEREVENT* (Salmeterol xinafoate)

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 SEREVENT
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea1049
2Drug ineffective986
3Asthma728
4Product quality issue552
5Cough388
6Dizziness*355
7Pneumonia319
8Headache316
9Nausea314
10Chronic obstructive pulmonary disease308
11Fatigue292
12Chest pain261
13Malaise247
14Vomiting238
15Asthenia233
16Death233
17Diarrhoea223
18Pyrexia221
19Wheezing*213
20Chest discomfort*209

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

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

Reason # of FDA Reports
1Asthma*6672
2Product used for unknown indication3202
3Chronic obstructive pulmonary disease*1983
4Emphysema*386
5Ill-defined disorder365
6Dyspnoea218
7Bronchitis99
8Bronchitis chronic*72
9Hypersensitivity62
10Bronchospasm48

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


Types of Adverse Events for SEREVENT

Total Reports Filed with FDA: 36956


Number of FDA Adverse Event Reports by Patient Age for SEREVENT

Total Reports Filed with FDA: 36956*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Salmeterol xinafoate (Serevent accuhaler, Salmeterol, Salmeterol xinafoate, Serevent)

Charts are based on 36956 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 SEREVENT 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 SEREVENT's side effects.