Drug Safety Information for ACCOLATE (Zafirlukast)

Adverse Drug Reactions for ACCOLATE* (Zafirlukast)

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 ACCOLATE
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Dyspnoea	192
2	Asthma	166
3	Drug ineffective	117
4	Nausea	87
5	Malaise	79
6	Headache	74
7	Pain	73
8	Product quality issue	69
9	Drug dose omission	68
10	Pneumonia	68
11	Fatigue	66
12	Dizziness	61
13	Cough	58
14	Chest discomfort	54
15	Depression	52
16	Vomiting	51
17	Fall	50
18	Chest pain	50
19	Wheezing	47
20	Rash*	44

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

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

	Reason	# of FDA Reports
1	Asthma*	1115
2	Product used for unknown indication	476
3	Bronchitis	140
4	Chronic obstructive pulmonary disease	98
5	Hypersensitivity	45
6	Seasonal allergy	40
7	Respiratory disorder	26
8	Dyspnoea	25
9	Multiple allergies	23
10	Premedication	19

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

Types of Adverse Events for ACCOLATE

Total Reports Filed with FDA: 8059

Number of FDA Adverse Event Reports by Patient Age for ACCOLATE

Total Reports Filed with FDA: 8059*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Zafirlukast (Zafirlukast, Accolate)

Charts are based on 8059 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.