Drug Safety Information for MODICON 21 (Ethinyl estradiol; norethindrone)

Safety-related Labeling Changes for LOESTRIN FE 1/20 (ETHINYL ESTRADIOL; NORETHINDRONE ACETATE) Rx Drug: FDA Link

Safety-related Labeling Changes for LOESTRIN FE 1.5/30 (ETHINYL ESTRADIOL; NORETHINDRONE ACETATE) Rx Drug: FDA Link

Safety-related Labeling Changes for NORINYL 1+35 21-DAY (ETHINYL ESTRADIOL; NORETHINDRONE) Rx Drug: FDA Link

Safety-related Labeling Changes for BREVICON 21-DAY (ETHINYL ESTRADIOL; NORETHINDRONE) Discontinued Drug: FDA Link

Safety-related Labeling Changes for MODICON 28 (ETHINYL ESTRADIOL; NORETHINDRONE) Discontinued Drug: FDA Link

Safety-related Labeling Changes for BREVICON 28-DAY (ETHINYL ESTRADIOL; NORETHINDRONE) Rx Drug: FDA Link

Safety-related Labeling Changes for LOESTRIN 21 1.5/30 (ETHINYL ESTRADIOL; NORETHINDRONE ACETATE) Rx Drug: FDA Link

Safety-related Labeling Changes for LOESTRIN 21 1/20 (ETHINYL ESTRADIOL; NORETHINDRONE ACETATE) Rx Drug: FDA Link

Safety-related Labeling Changes for ORTHO-NOVUM 1/35-28 (ETHINYL ESTRADIOL; NORETHINDRONE) Rx Drug: FDA Link

Safety-related Labeling Changes for TRI-NORINYL 21-DAY (ETHINYL ESTRADIOL; NORETHINDRONE; NORETHINDRONE) Rx Drug: FDA Link

Safety-related Labeling Changes for ORTHO-NOVUM 7/7/7-21 (ETHINYL ESTRADIOL; NORETHINDRONE; NORETHINDRONE; NORETHINDRONE) Rx Drug: FDA Link

Safety-related Labeling Changes for FEMHRT (ETHINYL ESTRADIOL; NORETHINDRONE ACETATE) Rx Drug: FDA Link

Safety-related Labeling Changes for FEMCON FE (ETHINYL ESTRADIOL; NORETHINDRONE) Discontinued Drug: FDA Link

Safety-related Labeling Changes for LOESTRIN 24 FE (ETHINYL ESTRADIOL; NORETHINDRONE ACETATE) Rx Drug: FDA Link

Safety-related Labeling Changes for LO LOESTRIN FE (ETHINYL ESTRADIOL; NORETHINDRONE ACETATE) Rx Drug: FDA Link

Safety-related Labeling Changes for MINASTRIN 24 FE (ETHINYL ESTRADIOL; NORETHINDRONE ACETATE) Rx Drug: FDA Link

Adverse Drug Reactions for MODICON 21* (Ethinyl estradiol; norethindrone)

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 MODICON 21
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pain80
2Nausea*79
3Pulmonary embolism61
4Deep vein thrombosis55
5Headache*45
6Injury43
7Anxiety40
8Metrorrhagia36
9Drug ineffective34
10Dizziness33
11Vomiting32
12Abdominal pain upper31
13Abdominal pain30
14Cholecystitis chronic28
15Depression*28
16Emotional distress28
17Fatigue27
18Insomnia27
19Off label use27
20Diarrhoea27

* This side effect also appears in "Top 10 Side Effects of MODICON 21 " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking MODICON 21
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Contraception*796
2Oral contraception235
3Product used for unknown indication161
4Ovarian cyst*77
5Menstruation irregular*77
6Menorrhagia*46
7Endometriosis*31
8Dysmenorrhoea*27
9Amenorrhoea27
10Metrorrhagia18

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


Types of Adverse Events for MODICON 21

Total Reports Filed with FDA: 3499


Number of FDA Adverse Event Reports by Patient Age for MODICON 21

Total Reports Filed with FDA: 3499*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Ethinyl estradiol; norethindrone (Nortrel 0.5/35-28, Ortho-novum 7/14-21, N.e.e. 1/35 28, Norcept-e 1/35 21, Ortho-novum 7/14-28, Ortho-novum 10/11-28, Norethin 1/35e-28, Modicon 21, Gencept 10/11-28, Gencept 10/11-21, Norinyl 1+35 21-day, Brevicon 28-day, Balziva-28, Ortho-novum 1/35-21, Norcept-e 1/35 28, Brevicon 21-day, N.e.e. 1/35 21, Tri-norinyl 28-day, Norethin 1/35e-21, Ortho-novum 10/11-21, Tri-norinyl 21-day, Ovcon-50, Cyclafem 1/35, Wera, Alyacen 7/7/7, Dasetta 7/7/7, Pirmella 7/7/7, Philith, Ortho-novum 7/7/7-28, Ortho-novum 1/35-28, Femcon fe, Vyfemla, Balziva-21, Nortrel 1/35-28, Cyclafem 7/7/7, Nortrel, Pirmella 1/35, Nortrel 7/7/7, Modicon 28, Gildagia, Nortrel 1/35-21, Norinyl 1+35 28-day, Alyacen 1/35, Dasetta 1/35, Ortho-novum 7/7/7-21, Nortrel 0.5/35-21, Briellyn, Aranelle, Ovcon-35)

Charts are based on 3499 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 MODICON 21 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.