RALOXIFENE HYDROCHLORIDE

N/A

Manufactured by Eli Lilly and Company

26,004 FDA adverse event reports analyzed

Last updated: 2026-04-14

About RALOXIFENE HYDROCHLORIDE

RALOXIFENE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Eli Lilly and Company. The most commonly reported adverse reactions for RALOXIFENE HYDROCHLORIDE include NAUSEA, FALL, DRUG INEFFECTIVE, PAIN IN EXTREMITY, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for RALOXIFENE HYDROCHLORIDE.

Top Adverse Reactions

NAUSEA773 reports
FALL769 reports
DRUG INEFFECTIVE748 reports
PAIN IN EXTREMITY716 reports
PAIN683 reports
ARTHRALGIA632 reports
DIZZINESS611 reports
MUSCLE SPASMS584 reports
FATIGUE559 reports
HEADACHE553 reports
BODY HEIGHT DECREASED530 reports
BACK PAIN467 reports
DIARRHOEA464 reports
BONE DENSITY DECREASED452 reports
DYSPNOEA449 reports
ASTHENIA448 reports
FEELING ABNORMAL378 reports
HOT FLUSH372 reports
INSOMNIA328 reports
VOMITING327 reports
MALAISE325 reports
PULMONARY EMBOLISM315 reports
ARTHRITIS314 reports
OEDEMA PERIPHERAL312 reports
DEEP VEIN THROMBOSIS308 reports
BREAST CANCER301 reports
HYPERTENSION300 reports
OSTEOPOROSIS290 reports
GAIT DISTURBANCE284 reports
ANXIETY283 reports
CONSTIPATION280 reports
RASH279 reports
CEREBROVASCULAR ACCIDENT269 reports
DEPRESSION269 reports
CHEST PAIN258 reports
WEIGHT DECREASED252 reports
WEIGHT INCREASED242 reports
COUGH238 reports
OFF LABEL USE237 reports
ALOPECIA232 reports
PRURITUS226 reports
THROMBOSIS221 reports
URINARY TRACT INFECTION215 reports
PNEUMONIA211 reports
GASTROOESOPHAGEAL REFLUX DISEASE205 reports
MYALGIA205 reports
BLOOD PRESSURE INCREASED203 reports
PYREXIA202 reports
ABDOMINAL PAIN UPPER200 reports
CONTUSION197 reports
ANAEMIA196 reports
FEMUR FRACTURE190 reports
BONE PAIN188 reports
CONDITION AGGRAVATED184 reports
DECREASED APPETITE184 reports
PARAESTHESIA181 reports
ABDOMINAL PAIN179 reports
FRACTURE178 reports
DYSPEPSIA176 reports
MYOCARDIAL INFARCTION176 reports
VISION BLURRED174 reports
INJECTION SITE HAEMORRHAGE172 reports
ABDOMINAL DISCOMFORT169 reports
HYPERHIDROSIS169 reports
OSTEOARTHRITIS166 reports
INJECTION SITE ERYTHEMA164 reports
PALPITATIONS164 reports
TRANSIENT ISCHAEMIC ATTACK164 reports
CATARACT160 reports
SPINAL FRACTURE160 reports
MUSCULAR WEAKNESS157 reports
HYPOAESTHESIA154 reports
JOINT SWELLING152 reports
HIP FRACTURE151 reports
SOMNOLENCE146 reports
INJECTION SITE PAIN145 reports
DEHYDRATION144 reports
TREMOR144 reports
DEATH143 reports
HYPERSENSITIVITY142 reports
ATRIAL FIBRILLATION141 reports
ERYTHEMA138 reports
PERIPHERAL SWELLING137 reports
PHARMACEUTICAL PRODUCT COMPLAINT133 reports
LOSS OF CONSCIOUSNESS132 reports
NASOPHARYNGITIS130 reports
MUSCULOSKELETAL STIFFNESS129 reports
DRY MOUTH127 reports
MUSCULOSKELETAL PAIN127 reports
HEART RATE INCREASED126 reports
LIMB INJURY126 reports
DRUG DOSE OMISSION124 reports
DRUG HYPERSENSITIVITY124 reports
SINUSITIS124 reports
FLUSHING119 reports
CONFUSIONAL STATE118 reports
BALANCE DISORDER116 reports
RENAL FAILURE116 reports
DRUG INTERACTION115 reports
ABDOMINAL DISTENSION114 reports

Report Outcomes

Out of 14,467 classified reports for RALOXIFENE HYDROCHLORIDE:

Serious 56.7%Non-Serious 43.3%

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

Female14,092 (99.5%)
Male61 (0.4%)
Unknown13 (0.1%)

Reports by Age

Age 65377 reports
Age 75344 reports
Age 70327 reports
Age 74312 reports
Age 73300 reports
Age 72295 reports
Age 68293 reports
Age 69293 reports
Age 67291 reports
Age 60273 reports
Age 64270 reports
Age 71266 reports
Age 66264 reports
Age 62257 reports
Age 76257 reports
Age 80248 reports
Age 63245 reports
Age 78245 reports
Age 61234 reports
Age 79232 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 RALOXIFENE HYDROCHLORIDE?

This profile reflects 26,004 FDA FAERS reports that mention RALOXIFENE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for RALOXIFENE HYDROCHLORIDE?

Frequently reported terms in FAERS include NAUSEA, FALL, DRUG INEFFECTIVE, PAIN IN EXTREMITY, PAIN, ARTHRALGIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures RALOXIFENE HYDROCHLORIDE?

Labeling and FAERS entries often list Eli Lilly and Company in connection with RALOXIFENE HYDROCHLORIDE. 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.