Drug Safety Information for OSPHENA (Ospemifene)

Safety-related Labeling Changes for OSPHENA (OSPEMIFENE) Rx Drug: FDA Link

Adverse Drug Reactions for OSPHENA* (Ospemifene)

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 OSPHENA
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Off label use	166
2	Hot flush	137
3	Muscle spasms	66
4	Vaginal haemorrhage	48
5	Vaginal discharge	46
6	Headache	45
7	Labelled drug-drug interaction medication error	45
8	Hyperhidrosis	34
9	Drug ineffective	34
10	Rash	26
11	Nausea	24
12	Fatigue	20
13	Diarrhoea	19
14	Pain in extremity	19
15	Dizziness	16
16	Insomnia	16
17	Night sweats	15
18	Abdominal pain	15
19	Therapeutic response unexpected	15
20	Anxiety	15

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

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

	Reason	# of FDA Reports
1	Dyspareunia	716
2	Product used for unknown indication	428
3	Off label use	264
4	Atrophic vulvovaginitis	228
5	Vulvovaginal dryness	28
6	Vulvovaginal pain	10
7	Vaginal lesion	9
8	Micturition urgency	8
9	Lichen sclerosus	8
10	Hormone replacement therapy	8

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

Types of Adverse Events for OSPHENA

Total Reports Filed with FDA: 1854

Number of FDA Adverse Event Reports by Patient Age for OSPHENA

Total Reports Filed with FDA: 1854*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Ospemifene (Osphena)

Charts are based on 1854 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.