TAMOXIFEN CITRATE

N/A

Manufactured by Mayne Pharma

11,158 FDA adverse event reports analyzed

Last updated: 2026-04-15

About TAMOXIFEN CITRATE

TAMOXIFEN CITRATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Mayne Pharma. The most commonly reported adverse reactions for TAMOXIFEN CITRATE include FATIGUE, NAUSEA, DIARRHOEA, ARTHRALGIA, MALIGNANT NEOPLASM PROGRESSION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TAMOXIFEN CITRATE.

Top Adverse Reactions

FATIGUE390 reports
NAUSEA336 reports
DIARRHOEA273 reports
ARTHRALGIA270 reports
MALIGNANT NEOPLASM PROGRESSION249 reports
PAIN242 reports
VOMITING224 reports
DYSPNOEA221 reports
BREAST CANCER217 reports
DIZZINESS211 reports
HEADACHE199 reports
HOT FLUSH198 reports
DRUG INEFFECTIVE189 reports
DISEASE PROGRESSION187 reports
ASTHENIA183 reports
METASTASES TO BONE177 reports
PAIN IN EXTREMITY174 reports
DEPRESSION162 reports
BACK PAIN156 reports
MALAISE153 reports
FALL151 reports
INSOMNIA148 reports
WEIGHT DECREASED137 reports
MYALGIA135 reports
OSTEONECROSIS135 reports
ANXIETY131 reports
WEIGHT INCREASED131 reports
RASH125 reports
ANAEMIA124 reports
OFF LABEL USE124 reports
NEUROPATHY PERIPHERAL123 reports
PYREXIA123 reports
BREAST CANCER METASTATIC122 reports
ALOPECIA119 reports
CHEST PAIN119 reports
DEATH115 reports
HYPERTENSION115 reports
GAIT DISTURBANCE114 reports
NEOPLASM PROGRESSION113 reports
PARAESTHESIA112 reports
PULMONARY EMBOLISM111 reports
CONSTIPATION108 reports
PRURITUS107 reports
OEDEMA PERIPHERAL106 reports
DRUG INTERACTION102 reports
BONE PAIN101 reports
MUSCLE SPASMS100 reports
URINARY TRACT INFECTION97 reports
BONE DISORDER96 reports
COUGH96 reports
OSTEONECROSIS OF JAW96 reports
BREAST CANCER RECURRENT93 reports
PNEUMONIA89 reports
DEEP VEIN THROMBOSIS87 reports
METASTASES TO LIVER87 reports
CONDITION AGGRAVATED81 reports
ABDOMINAL PAIN78 reports
FEELING ABNORMAL78 reports
HYPOAESTHESIA78 reports
DECREASED APPETITE77 reports
ERYTHEMA75 reports
CEREBROVASCULAR ACCIDENT74 reports
METASTASES TO LUNG70 reports
OSTEOARTHRITIS70 reports
HAEMOGLOBIN DECREASED69 reports
TREMOR69 reports
BREAST CANCER FEMALE68 reports
THROMBOSIS68 reports
WHITE BLOOD CELL COUNT DECREASED65 reports
IMPAIRED HEALING64 reports
MUSCULAR WEAKNESS64 reports
NEUTROPENIA64 reports
ABDOMINAL PAIN UPPER63 reports
PAIN IN JAW63 reports
TOOTH EXTRACTION62 reports
HYPOTENSION61 reports
CONFUSIONAL STATE60 reports
CATARACT59 reports
OSTEOMYELITIS59 reports
HYPERHIDROSIS58 reports
PLEURAL EFFUSION58 reports
UTERINE POLYP56 reports
VAGINAL HAEMORRHAGE56 reports
ASTHMA55 reports
DEHYDRATION55 reports
DRUG HYPERSENSITIVITY55 reports
NEOPLASM MALIGNANT55 reports
OSTEOPOROSIS55 reports
RENAL FAILURE55 reports
ACUTE MYELOID LEUKAEMIA54 reports
INFECTION54 reports
MEMORY IMPAIRMENT53 reports
METASTASES TO LYMPH NODES52 reports
PLATELET COUNT DECREASED51 reports
SWELLING50 reports
THROMBOCYTOPENIA50 reports
GASTROOESOPHAGEAL REFLUX DISEASE49 reports
VISION BLURRED49 reports
BALANCE DISORDER48 reports
MUSCULOSKELETAL STIFFNESS48 reports

Report Outcomes

Out of 5,615 classified reports for TAMOXIFEN CITRATE:

Serious 77.2%Non-Serious 22.8%

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

Female4,985 (96.0%)
Male202 (3.9%)
Unknown6 (0.1%)

Reports by Age

Age 54111 reports
Age 50106 reports
Age 52106 reports
Age 56106 reports
Age 70106 reports
Age 5198 reports
Age 4893 reports
Age 5393 reports
Age 6293 reports
Age 6890 reports
Age 6088 reports
Age 4587 reports
Age 4787 reports
Age 5787 reports
Age 6584 reports
Age 6383 reports
Age 4982 reports
Age 5582 reports
Age 6482 reports
Age 4481 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 TAMOXIFEN CITRATE?

This profile reflects 11,158 FDA FAERS reports that mention TAMOXIFEN CITRATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for TAMOXIFEN CITRATE?

Frequently reported terms in FAERS include FATIGUE, NAUSEA, DIARRHOEA, ARTHRALGIA, MALIGNANT NEOPLASM PROGRESSION, PAIN. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures TAMOXIFEN CITRATE?

Labeling and FAERS entries often list Mayne Pharma in connection with TAMOXIFEN CITRATE. 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.