Drug Safety Information for ANGELIQ (Drospirenone; estradiol)

FDA Safety-related Labeling Changes for ANGELIQ (DROSPIRENONE; ESTRADIOL) Rx Drug: Safety Information Link

Adverse Drug Reactions for ANGELIQ* (Drospirenone; estradiol)

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 ANGELIQ
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Vaginal haemorrhage	26
2	Metrorrhagia	24
3	Hot flush	20
4	Headache	19
5	Alopecia	15
6	Drug ineffective	14
7	Abdominal pain	13
8	Pain in extremity	13
9	Weight increased	11
10	Nausea	11
11	Anxiety	11
12	Fatigue	11
13	Dizziness	10
14	Muscle spasms	8
15	Breast tenderness	8
16	Night sweats	7
17	Malaise	7
18	Dyspnoea	7
19	Breast pain	7
20	Urticaria	7

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

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

	Reason	# of FDA Reports
1	Hormone replacement therapy	221
2	Product used for unknown indication	121
3	Menopause	109
4	Menopausal symptoms	76
5	Hot flush	60
6	Hormone therapy	25
7	Contraception	14
8	Blood calcium decreased	11
9	Menopausal symptoms prophylaxis	8
10	Oral contraception	8

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

Types of Adverse Events for ANGELIQ

Total Reports Filed with FDA: 905

Number of FDA Adverse Event Reports by Patient Age for ANGELIQ

Total Reports Filed with FDA: 905*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Drospirenone; estradiol (Angeliq)

Charts are based on 905 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.