NORGESTIMATE AND ETHINYL ESTRADIOL

N/A

Manufactured by Teva Pharmaceuticals USA, Inc.

7,959 FDA adverse event reports analyzed

Last updated: 2026-04-15

About NORGESTIMATE AND ETHINYL ESTRADIOL

NORGESTIMATE AND ETHINYL ESTRADIOL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Teva Pharmaceuticals USA, Inc.. The most commonly reported adverse reactions for NORGESTIMATE AND ETHINYL ESTRADIOL include NAUSEA, HEADACHE, DRUG INEFFECTIVE, FATIGUE, VOMITING. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for NORGESTIMATE AND ETHINYL ESTRADIOL.

Top Adverse Reactions

NAUSEA404 reports
HEADACHE279 reports
DRUG INEFFECTIVE249 reports
FATIGUE237 reports
VOMITING220 reports
ANXIETY207 reports
PAIN203 reports
DEPRESSION175 reports
DIZZINESS155 reports
RASH152 reports
PRURITUS135 reports
OFF LABEL USE133 reports
DIARRHOEA125 reports
PRODUCT SUBSTITUTION ISSUE116 reports
ABDOMINAL PAIN UPPER111 reports
PRODUCT DOSE OMISSION ISSUE109 reports
ABDOMINAL PAIN106 reports
PULMONARY EMBOLISM106 reports
DYSPNOEA102 reports
MALAISE102 reports
VAGINAL HAEMORRHAGE102 reports
INJECTION SITE PAIN98 reports
MENSTRUATION IRREGULAR98 reports
FEELING ABNORMAL90 reports
DRUG DOSE OMISSION89 reports
PRODUCT USE IN UNAPPROVED INDICATION89 reports
METRORRHAGIA86 reports
INJURY79 reports
WEIGHT INCREASED79 reports
URTICARIA78 reports
MUSCLE SPASMS77 reports
PREGNANCY ON ORAL CONTRACEPTIVE75 reports
PRODUCT QUALITY ISSUE75 reports
CONDITION AGGRAVATED74 reports
MATERNAL EXPOSURE DURING PREGNANCY74 reports
PRODUCT DOSE OMISSION71 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION70 reports
SOMNOLENCE69 reports
MENORRHAGIA68 reports
DERMATITIS ATOPIC67 reports
NO ADVERSE EVENT67 reports
ABDOMINAL DISCOMFORT65 reports
ARTHRALGIA65 reports
ACNE64 reports
CHEST PAIN63 reports
ALOPECIA62 reports
INSOMNIA62 reports
MIGRAINE62 reports
DEEP VEIN THROMBOSIS61 reports
HYPERSENSITIVITY61 reports
BACK PAIN60 reports
DECREASED APPETITE59 reports
PAIN IN EXTREMITY58 reports
ABDOMINAL DISTENSION57 reports
NASOPHARYNGITIS57 reports
PARAESTHESIA57 reports
SUICIDAL IDEATION55 reports
ASTHENIA54 reports
ERYTHEMA54 reports
COUGH53 reports
COVID 1953 reports
THROMBOSIS53 reports
DRUG INTERACTION52 reports
WEIGHT DECREASED52 reports
HYPOAESTHESIA51 reports
MOOD SWINGS51 reports
PYREXIA51 reports
CHOLELITHIASIS50 reports
PALPITATIONS50 reports
VISION BLURRED49 reports
FLUSHING48 reports
DRY SKIN47 reports
DYSMENORRHOEA47 reports
EXPOSURE DURING PREGNANCY47 reports
INJECTION SITE ERYTHEMA47 reports
EMOTIONAL DISTRESS45 reports
PSORIASIS45 reports
CHOLECYSTITIS CHRONIC44 reports
CONSTIPATION44 reports
INCORRECT DOSE ADMINISTERED44 reports
URINARY TRACT INFECTION44 reports
STRESS43 reports
BLOOD PRESSURE INCREASED42 reports
INJECTION SITE SWELLING42 reports
PANIC ATTACK41 reports
SINUSITIS41 reports
PRODUCT USE ISSUE40 reports
LOSS OF CONSCIOUSNESS39 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION38 reports
MEMORY IMPAIRMENT38 reports
FALL37 reports
HEART RATE INCREASED37 reports
HYPERHIDROSIS37 reports
HYPERTENSION37 reports
ILLNESS36 reports
DEVICE ISSUE35 reports
DRUG HYPERSENSITIVITY33 reports
ECZEMA33 reports
INFECTION33 reports
MOOD ALTERED33 reports

Report Outcomes

Out of 4,433 classified reports for NORGESTIMATE AND ETHINYL ESTRADIOL:

Serious 40.8%Non-Serious 59.2%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female3,994 (99.4%)
Male21 (0.5%)
Unknown5 (0.1%)

Reports by Age

Age 20133 reports
Age 21113 reports
Age 25108 reports
Age 24107 reports
Age 23106 reports
Age 19105 reports
Age 30105 reports
Age 28104 reports
Age 29100 reports
Age 2297 reports
Age 2797 reports
Age 2689 reports
Age 3184 reports
Age 1882 reports
Age 3382 reports
Age 1677 reports
Age 1777 reports
Age 3273 reports
Age 3473 reports
Age 3571 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with NORGESTIMATE AND ETHINYL ESTRADIOL?

This profile reflects 7,959 FDA FAERS reports that mention NORGESTIMATE AND ETHINYL ESTRADIOL. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for NORGESTIMATE AND ETHINYL ESTRADIOL?

Frequently reported terms in FAERS include NAUSEA, HEADACHE, DRUG INEFFECTIVE, FATIGUE, VOMITING, ANXIETY. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures NORGESTIMATE AND ETHINYL ESTRADIOL?

Labeling and FAERS entries often list Teva Pharmaceuticals USA, Inc. in connection with NORGESTIMATE AND ETHINYL ESTRADIOL. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.