Drug Safety Information for FROVA (Frovatriptan succinate)

FDA Safety-related Labeling Changes for FROVA ( FROVATRIPTAN SUCCINATE) Rx Drug: Safety Information Link

Adverse Drug Reactions for FROVA* (Frovatriptan succinate)

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 FROVA
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Migraine*	82
2	Headache	69
3	Nausea*	50
4	Pain*	48
5	Drug ineffective*	39
6	Dyspnoea	30
7	Vomiting	29
8	Dizziness*	28
9	Fatigue	28
10	Chest pain	26
11	Depression	25
12	Deep vein thrombosis	20
13	Anxiety	19
14	Muscle spasms	18
15	Arthralgia	18
16	Injury	18
17	Insomnia	18
18	Asthenia	15
19	Gallbladder disorder	14
20	Tremor	14

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

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

	Reason	# of FDA Reports
1	Migraine*	860
2	Product used for unknown indication	123
3	Headache	93
4	Migraine prophylaxis	25
5	Pain	22
6	Cyclic vomiting syndrome	15
7	Migraine with aura*	8
8	Cluster headache	5
9	Multiple sclerosis	4
10	Mountain sickness acute	4

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

Types of Adverse Events for FROVA

Total Reports Filed with FDA: 2754

Number of FDA Adverse Event Reports by Patient Age for FROVA

Total Reports Filed with FDA: 2754*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Frovatriptan succinate (Frovatriptan, Allegro, Frova)

Charts are based on 2754 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.