LEVONORGESTREL AND ETHINYL ESTRADIOL

N/A

Manufactured by Teva Pharmaceuticals USA, Inc.

4,908 FDA adverse event reports analyzed

Last updated: 2026-04-15

About LEVONORGESTREL AND ETHINYL ESTRADIOL

LEVONORGESTREL 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 LEVONORGESTREL AND ETHINYL ESTRADIOL include NAUSEA, HEADACHE, FATIGUE, DRUG INEFFECTIVE, VOMITING. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LEVONORGESTREL AND ETHINYL ESTRADIOL.

Top Adverse Reactions

NAUSEA231 reports
HEADACHE174 reports
FATIGUE169 reports
DRUG INEFFECTIVE152 reports
VOMITING119 reports
PAIN112 reports
ANXIETY104 reports
DIZZINESS104 reports
DIARRHOEA102 reports
DEPRESSION100 reports
OFF LABEL USE95 reports
RASH86 reports
DYSPNOEA81 reports
MALAISE73 reports
WEIGHT INCREASED73 reports
PRURITUS70 reports
ARTHRALGIA68 reports
BACK PAIN64 reports
PULMONARY EMBOLISM64 reports
ABDOMINAL PAIN UPPER63 reports
VAGINAL HAEMORRHAGE63 reports
CONDITION AGGRAVATED62 reports
PRODUCT DOSE OMISSION ISSUE61 reports
FEELING ABNORMAL58 reports
INSOMNIA57 reports
WEIGHT DECREASED56 reports
PYREXIA54 reports
MUSCLE SPASMS53 reports
MIGRAINE52 reports
ABDOMINAL PAIN49 reports
INJECTION SITE PAIN48 reports
METRORRHAGIA47 reports
SOMNOLENCE47 reports
ALOPECIA46 reports
COUGH46 reports
PRODUCT USE IN UNAPPROVED INDICATION46 reports
HYPERSENSITIVITY45 reports
COVID 1944 reports
SUICIDAL IDEATION44 reports
MENSTRUATION IRREGULAR43 reports
DRUG DOSE OMISSION42 reports
PAIN IN EXTREMITY42 reports
URTICARIA42 reports
ASTHENIA39 reports
NASOPHARYNGITIS39 reports
PRODUCT SUBSTITUTION ISSUE39 reports
CHEST PAIN38 reports
DECREASED APPETITE38 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION38 reports
MENORRHAGIA38 reports
SINUSITIS38 reports
PARAESTHESIA37 reports
HYPOAESTHESIA36 reports
INJECTION SITE ERYTHEMA34 reports
INJURY34 reports
HYPERHIDROSIS33 reports
SEIZURE33 reports
CHEST DISCOMFORT32 reports
DRY SKIN32 reports
HYPERTENSION32 reports
TREMOR32 reports
ASTHMA31 reports
LOSS OF CONSCIOUSNESS31 reports
SYNCOPE31 reports
ABDOMINAL DISTENSION30 reports
ACNE30 reports
DERMATITIS ATOPIC30 reports
PSORIASIS30 reports
DEEP VEIN THROMBOSIS29 reports
INCORRECT DOSE ADMINISTERED29 reports
PALPITATIONS29 reports
VISION BLURRED29 reports
MATERNAL EXPOSURE DURING PREGNANCY28 reports
URINARY TRACT INFECTION28 reports
FALL27 reports
PRODUCT USE ISSUE27 reports
ABDOMINAL DISCOMFORT26 reports
CONSTIPATION26 reports
DRUG INTERACTION26 reports
ERYTHEMA26 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION26 reports
ECZEMA25 reports
FLUSHING25 reports
INTENTIONAL PRODUCT USE ISSUE25 reports
MUSCULAR WEAKNESS25 reports
CROHN^S DISEASE24 reports
EMOTIONAL DISTRESS24 reports
INJECTION SITE PRURITUS24 reports
NO ADVERSE EVENT24 reports
PELVIC PAIN24 reports
PNEUMONIA24 reports
CONTUSION23 reports
MYALGIA23 reports
PRODUCT QUALITY ISSUE23 reports
SWELLING23 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS23 reports
DEHYDRATION22 reports
UNEVALUABLE EVENT22 reports
VISUAL IMPAIRMENT22 reports
BLOOD PRESSURE INCREASED21 reports

Report Outcomes

Out of 2,771 classified reports for LEVONORGESTREL AND ETHINYL ESTRADIOL:

Serious 45.5%Non-Serious 54.5%

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

Female2,484 (98.9%)
Male21 (0.8%)
Unknown6 (0.2%)

Reports by Age

Age 2066 reports
Age 2165 reports
Age 3163 reports
Age 2360 reports
Age 2659 reports
Age 2858 reports
Age 1957 reports
Age 3355 reports
Age 1854 reports
Age 2453 reports
Age 3253 reports
Age 3452 reports
Age 3951 reports
Age 3049 reports
Age 3749 reports
Age 1747 reports
Age 3647 reports
Age 2245 reports
Age 2544 reports
Age 2943 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 LEVONORGESTREL AND ETHINYL ESTRADIOL?

This profile reflects 4,908 FDA FAERS reports that mention LEVONORGESTREL 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 LEVONORGESTREL AND ETHINYL ESTRADIOL?

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

Who manufactures LEVONORGESTREL AND ETHINYL ESTRADIOL?

Labeling and FAERS entries often list Teva Pharmaceuticals USA, Inc. in connection with LEVONORGESTREL 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.