Drug Safety Information for YAZ (Drospirenone; ethinyl estradiol)
Safety-related Labeling Changes for YASMIN (DROSPIRENONE; ETHINYL ESTRADIOL) Rx Drug: FDA Link
Safety-related Labeling Changes for YAZ (DROSPIRENONE; ETHINYL ESTRADIOL) Rx Drug: FDA Link
Safety-related Labeling Changes for BEYAZ (DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM) Rx Drug: FDA Link
Safety-related Labeling Changes for SAFYRAL (DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM) Rx Drug: FDA Link
Adverse Drug Reactions for YAZ* (Drospirenone; ethinyl 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 YAZ
(reported in FDA Medwatch/FAERS Reports)
Side Effect | # of FDA Reports | |
---|---|---|
1 | Pain | 13493 |
2 | Injury | 12683 |
3 | Pulmonary embolism | 8898 |
4 | Deep vein thrombosis | 8224 |
5 | Anxiety* | 6905 |
6 | Emotional distress | 6529 |
7 | Cholecystitis chronic | 5808 |
8 | Gallbladder disorder | 4864 |
9 | Cholelithiasis | 4509 |
10 | General physical health deterioration | 3295 |
11 | Cholecystectomy | 2824 |
12 | Abdominal pain | 2777 |
13 | Nausea* | 2628 |
14 | Gallbladder injury | 2509 |
15 | Anhedonia | 2281 |
16 | Thrombosis | 2219 |
17 | Dyspnoea | 2208 |
18 | Abdominal pain upper | 1882 |
19 | Vomiting | 1879 |
20 | Chest pain | 1847 |
* This side effect also appears in "Top 10 Side Effects of YAZ " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking YAZ
(associated with FDA Medwatch/FAERS Reports)
Reason | # of FDA Reports | |
---|---|---|
1 | Contraception* | 43481 |
2 | Product used for unknown indication | 34053 |
3 | Oral contraception* | 8763 |
4 | Acne* | 8625 |
5 | Premenstrual syndrome* | 6130 |
6 | Menstruation irregular* | 5681 |
7 | Menstrual cycle management | 4435 |
8 | Dysmenorrhoea* | 1960 |
9 | Menorrhagia* | 1686 |
10 | Polycystic ovaries | 1657 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for YAZ
Total Reports Filed with FDA: 179926
Number of FDA Adverse Event Reports by Patient Age for YAZ
Total Reports Filed with FDA: 179926*
* Reports for drugs with the same active ingredients have been aggregated in this analysis: Drospirenone; ethinyl estradiol (Yaela, Nikki, Yaz, Loryna, Yasmin, Syeda)
Charts are based on 179926 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.
Click to go back to search results and YAZ Reviews and Review Summary .
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.