Drug Safety Information for ALTAVERA (Ethinyl estradiol; levonorgestrel)

Safety-related Labeling Changes for NORDETTE-21 (ETHINYL ESTRADIOL; LEVONORGESTREL) Rx Drug: FDA Link

Safety-related Labeling Changes for NORDETTE-28 (ETHINYL ESTRADIOL; LEVONORGESTREL) Rx Drug: FDA Link

Safety-related Labeling Changes for ALESSE (ETHINYL ESTRADIOL; LEVONORGESTREL) Brand name discontinued; available as generic: FDA Link

Safety-related Labeling Changes for SEASONALE (ETHINYL ESTRADIOL; LEVONORGESTREL) Rx Drug: FDA Link

Safety-related Labeling Changes for SEASONIQUE (ETHINYL ESTRADIOL; LEVONORGESTREL) Rx Drug: FDA Link

Safety-related Labeling Changes for LYBREL (ETHINYL ESTRADIOL; LEVONORGESTREL) Rx Drug: FDA Link

Safety-related Labeling Changes for LOSEASONIQUE (ETHINYL ESTRADIOL; LEVONORGESTREL) Rx Drug: FDA Link

Safety-related Labeling Changes for QUARTETTE (ETHINYL ESTRADIOL; LEVONORGESTREL) Rx Drug: FDA Link

Adverse Drug Reactions for ALTAVERA* (Ethinyl estradiol; levonorgestrel)

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 ALTAVERA
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea*218
2Pain182
3Drug ineffective170
4Headache*156
5Pulmonary embolism148
6Anxiety147
7Vomiting134
8Depression*131
9Fatigue129
10Dizziness126
11Metrorrhagia122
12Abdominal pain117
13Dyspnoea113
14Deep vein thrombosis103
15Diarrhoea95
16Cholecystitis chronic81
17Abdominal pain upper78
18Injury77
19Weight increased*71
20Menorrhagia68

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

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

Reason # of FDA Reports
1Contraception*2935
2Oral contraception*834
3Product used for unknown indication731
4Dysmenorrhoea*171
5Endometriosis*163
6Menstruation irregular*161
7Menorrhagia*92
8Menstrual disorder65
9Menstrual cycle management40
10Migraine39

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


Types of Adverse Events for ALTAVERA

Total Reports Filed with FDA: 12229


Number of FDA Adverse Event Reports by Patient Age for ALTAVERA

Total Reports Filed with FDA: 12229*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Ethinyl estradiol; levonorgestrel (Amethyst, Triphasil-21, Triphasil-28, Lessina-21, Levora 0.15/30-21, Aviane-28, Levonest, Enpresse-21, Levora 0.15/30-28, Ashlyna, Setlakin, Vienva, Altavera, Marlissa, Kurvelo, Trivora-21, Myzilra, Aviane-21, Loseasonique, Introvale, Lessina, Alesse, Levlite, Portia, Daysee, Enpresse-28, Lessina-28, Portia-21, Falmina, Portia-28, Orsythia, Trivora-28, Nordette-28, Quasense, Seasonale, Nordette-21, Seasonique, Lybrel, Quartette)

Charts are based on 12229 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 ALTAVERA Reviews and Review Summary .

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.

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