Drug Safety Information for DEMULEN 1/35-28 (Ethinyl estradiol; ethynodiol diacetate)

Adverse Drug Reactions for DEMULEN 1/35-28* (Ethinyl estradiol; ethynodiol diacetate)

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 DEMULEN 1/35-28
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea*21
2Vomiting14
3Depression*12
4Abdominal pain11
5Anxiety10
6Fatigue10
7Diarrhoea10
8Inflammatory bowel disease9
9Cholecystitis chronic9
10Abdominal pain upper8
11Pyrexia8
12Pain7
13Colitis7
14Headache*7
15Pulmonary embolism6
16Blood cholesterol increased6
17Gallbladder disorder6
18Migraine6
19Influenza like illness6
20Dyspnoea6

* This side effect also appears in "Top 10 Side Effects of DEMULEN 1/35-28 " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking DEMULEN 1/35-28
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Contraception*140
2Product used for unknown indication26
3Ovarian cyst15
4Menstruation irregular13
5Hormone replacement therapy13
6Skin disorder11
7Oral contraception10
8Uterine haemorrhage7
9Blood cholesterol increased7
10Menorrhagia2

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


Types of Adverse Events for DEMULEN 1/35-28

Total Reports Filed with FDA: 857


Number of FDA Adverse Event Reports by Patient Age for DEMULEN 1/35-28

Total Reports Filed with FDA: 857*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Ethinyl estradiol; ethynodiol diacetate (Zovia 1/50e-21, Zovia 1/35e-21, Demulen 1/50-21, Zovia 1/35e-28, Demulen 1/35-28, Kelnor, Demulen 1/50-28, Zovia 1/50e-28, Demulen 1/35-21)

Charts are based on 857 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.

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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.