Drug Safety Information for OVRETTE (Norgestrel)

Safety-related Labeling Changes for OPILL (NORGESTREL) Over-the-counter Drug: FDA Link

The label has been updated from Ovrette® to the new proprietary name, Opill®.

Adverse Drug Reactions for OVRETTE* (Norgestrel)

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 OVRETTE
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Product quality issue	90
2	Drug ineffective	64
3	Unintended pregnancy	55
4	Metrorrhagia	36
5	Menorrhagia	16
6	Nausea	16
7	Headache	14
8	Vaginal haemorrhage	13
9	Abortion spontaneous	12
10	Vomiting	12
11	Depression*	12
12	Malaise	12
13	Pain	11
14	Anxiety	11
15	Abdominal pain upper	10
16	Muscle spasms	9
17	Abdominal pain	9
18	Pulmonary embolism	8
19	Feeling abnormal	8
20	Deep vein thrombosis	8

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

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

	Reason	# of FDA Reports
1	Contraception*	315
2	Oral contraception	43
3	Product used for unknown indication	31
4	Menorrhagia	25
5	Off label use	24
6	Metrorrhagia	23
7	Menstruation irregular	21
8	Menstrual cycle management	16
9	Iron deficiency anaemia	14
10	Polycystic ovaries	13

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

Types of Adverse Events for OVRETTE

Total Reports Filed with FDA: 1088

Number of FDA Adverse Event Reports by Patient Age for OVRETTE

Total Reports Filed with FDA: 1088*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Norgestrel (Low-ogestrel, Ovrette)

Charts are based on 1088 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.