Drug Safety Information for PERFOROMIST (Formoterol fumarate)

Safety-related Labeling Changes for PERFOROMIST (FORMOTEROL FUMARATE) Rx Drug: FDA Link

Safety-related Labeling Changes for DULERA (FORMOTEROL FUMARATE; MOMETASONE FUROATE) Rx Drug: FDA Link

Adverse Drug Reactions for PERFOROMIST* (Formoterol fumarate)

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 PERFOROMIST
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea825
2Asthma414
3Pneumonia335
4Drug ineffective287
5Cough275
6Chronic obstructive pulmonary disease265
7Fatigue256
8Nausea241
9Death232
10Malaise208
11Dizziness186
12Headache168
13Asthenia165
14Diarrhoea162
15Vomiting147
16Hypertension147
17Condition aggravated146
18Pyrexia134
19Fall133
20Pain132

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

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

Reason # of FDA Reports
1Asthma3014
2Chronic obstructive pulmonary disease*2181
3Product used for unknown indication1707
4Emphysema605
5Dyspnoea404
6Bronchitis339
7Lung disorder168
8Bronchitis chronic99
9Respiratory disorder93
10Bronchospasm63

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


Types of Adverse Events for PERFOROMIST

Total Reports Filed with FDA: 23870


Number of FDA Adverse Event Reports by Patient Age for PERFOROMIST

Total Reports Filed with FDA: 23870*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Formoterol fumarate (Foradil certihaler, Eformoterol, Formoterol, Foradil, Perforomist)

Charts are based on 23870 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 PERFOROMIST Reviews and Review Summary .

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.