NORETHINDRONE

N/A

Manufactured by Amneal Pharmaceuticals LLC

11,560 FDA adverse event reports analyzed

Last updated: 2026-04-15

About NORETHINDRONE

NORETHINDRONE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals LLC. The most commonly reported adverse reactions for NORETHINDRONE include NAUSEA, HEADACHE, HOT FLUSH, FATIGUE, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for NORETHINDRONE.

Top Adverse Reactions

NAUSEA449 reports
HEADACHE424 reports
HOT FLUSH370 reports
FATIGUE322 reports
DRUG INEFFECTIVE320 reports
PAIN308 reports
OFF LABEL USE291 reports
VAGINAL HAEMORRHAGE277 reports
ABDOMINAL PAIN267 reports
ARTHRALGIA228 reports
DIARRHOEA224 reports
DIZZINESS221 reports
ANXIETY204 reports
MIGRAINE202 reports
DEPRESSION199 reports
VOMITING199 reports
PELVIC PAIN181 reports
DYSPNOEA175 reports
INSOMNIA175 reports
WEIGHT INCREASED170 reports
MENORRHAGIA164 reports
BACK PAIN158 reports
PRODUCT DOSE OMISSION ISSUE154 reports
MOOD SWINGS152 reports
ENDOMETRIOSIS144 reports
MUSCLE SPASMS142 reports
PYREXIA131 reports
PRURITUS127 reports
FEELING ABNORMAL123 reports
ABDOMINAL PAIN UPPER118 reports
METRORRHAGIA117 reports
ABDOMINAL DISTENSION115 reports
ALOPECIA111 reports
MALAISE111 reports
PAIN IN EXTREMITY111 reports
INJECTION SITE PAIN108 reports
HYPOAESTHESIA107 reports
PRODUCT USE IN UNAPPROVED INDICATION107 reports
RASH107 reports
WEIGHT DECREASED101 reports
COVID 1996 reports
NIGHT SWEATS95 reports
CONDITION AGGRAVATED91 reports
ABDOMINAL DISCOMFORT89 reports
COUGH88 reports
DYSMENORRHOEA87 reports
MENSTRUATION IRREGULAR87 reports
CHEST PAIN84 reports
BREAST CANCER83 reports
HAEMORRHAGE81 reports
NASOPHARYNGITIS81 reports
PALPITATIONS81 reports
MENSTRUAL DISORDER80 reports
MEMORY IMPAIRMENT79 reports
DECREASED APPETITE76 reports
PARAESTHESIA76 reports
ASTHENIA75 reports
HYPERHIDROSIS75 reports
MYALGIA72 reports
HYPERTENSION71 reports
FALL68 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION67 reports
URTICARIA67 reports
ACNE65 reports
BLOOD PRESSURE INCREASED64 reports
SINUSITIS63 reports
TREMOR63 reports
CRYING62 reports
DRUG DOSE OMISSION62 reports
SOMNOLENCE62 reports
URINARY TRACT INFECTION62 reports
MATERNAL EXPOSURE DURING PREGNANCY61 reports
CONSTIPATION60 reports
ERYTHEMA60 reports
ILLNESS59 reports
SUICIDAL IDEATION59 reports
HYPERSENSITIVITY57 reports
INFLUENZA57 reports
PNEUMONIA57 reports
PULMONARY EMBOLISM57 reports
MOOD ALTERED56 reports
OVARIAN CYST55 reports
SEIZURE54 reports
VISION BLURRED53 reports
HAEMOGLOBIN DECREASED51 reports
IRRITABILITY51 reports
AMENORRHOEA50 reports
SWELLING50 reports
FLUSHING48 reports
HEART RATE INCREASED48 reports
ANAEMIA47 reports
HEAVY MENSTRUAL BLEEDING47 reports
UTERINE LEIOMYOMA47 reports
PRODUCT USE ISSUE46 reports
RASH ERYTHEMATOUS46 reports
DRUG HYPERSENSITIVITY44 reports
DYSPEPSIA44 reports
NO ADVERSE EVENT44 reports
DRUG INTERACTION43 reports
GASTROOESOPHAGEAL REFLUX DISEASE43 reports

Report Outcomes

Out of 5,341 classified reports for NORETHINDRONE:

Serious 46.8%Non-Serious 53.2%

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

Female4,688 (98.8%)
Male40 (0.8%)
Unknown19 (0.4%)

Reports by Age

Age 34124 reports
Age 29115 reports
Age 33102 reports
Age 3098 reports
Age 3694 reports
Age 2793 reports
Age 3592 reports
Age 3790 reports
Age 4890 reports
Age 3288 reports
Age 4088 reports
Age 3985 reports
Age 2684 reports
Age 4482 reports
Age 2881 reports
Age 4181 reports
Age 2378 reports
Age 1877 reports
Age 2277 reports
Age 4677 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 NORETHINDRONE?

This profile reflects 11,560 FDA FAERS reports that mention NORETHINDRONE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for NORETHINDRONE?

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

Who manufactures NORETHINDRONE?

Labeling and FAERS entries often list Amneal Pharmaceuticals LLC in connection with NORETHINDRONE. 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.