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Raloxifene Side Effects

The most commonly reported side effects of raloxifene include pain in extremity, nausea, and pain, based on 16,635 FDA adverse event reports from 2004 to 2025. 3.0% of reports found the drug to be ineffective.

Raloxifene side effects

Percentages show how often each reaction appears relative to total reports for raloxifene.

1
Drug Ineffective3.0%502
2
Pain In Extremity2.9%480
3
Nausea2.8%472
4
Pain2.8%471
5
Body Height Decreased2.7%446
6
Arthralgia2.7%442
7
Fall2.6%438
8
Fall2.5%416
9
Fatigue2.5%411
10
Nausea2.4%404
11
Muscle Spasms2.4%393
12
Headache2.2%358
13
Dizziness2.1%356
14
Diarrhoea2.1%348
15
Drug Ineffective2.1%347

These are voluntary reports and do not establish that raloxifene caused these reactions.

Report severity

57.2%Serious9,511 reports
24.2%Hospitalizations4,024 reports
4.2%Fatal694 reports

Seriousness is determined by the reporter, not by OpenClaim.

Raloxifene drug interactions

Other drugs that appear in adverse event reports alongside raloxifene. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Teriparatide6.2%1,032
2
Adalimumab3.1%514
3
Alendronate-sodium1.9%321
4
Lenalidomide1.6%264
5
Esomeprazole1.1%177
6
Etanercept1.0%173
7
Denosumab1.0%165
8
Varenicline0.8%140
9
Infliximab0.8%138
10
Atorvastatin-calcium0.8%136
11
Fluticasone0.8%135
12
Omeprazole0.8%128
13
Dalfampridine0.7%122
14
Sodium-oxybate0.7%118
15
Salmeterol-xinafoate0.7%117

Taken alongside

1
Levothyroxine-sodium12.9%2,138
2
Calcium11.5%1,905
3
Aspirin11.2%1,866
4
Ergocalciferol10.7%1,788
5
Atorvastatin-calcium7.6%1,266
6
Acetaminophen7.2%1,206
7
Omeprazole6.6%1,093
8
Hydrochlorothiazide5.8%962
9
Metoprolol5.6%933
10
Simvastatin5.5%912
11
Amlodipine5.4%895
12
Furosemide5.0%838
13
Lisinopril4.6%766
14
Folic-acid4.4%726
15
Fluticasone4.3%714

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports raloxifene side effects

96.5% of raloxifene adverse event reports involve female patients and 0.6% involve male patients. The largest age group is elderly at 69%. These figures reflect who reports side effects, not underlying risk.

Sex

Female96.5%
Male0.6%
Unknown2.8%

Age group

< 2<0.1%
2–110.0%
12–17<0.1%
18–6431.3%
65+68.7%

What is raloxifene used for

Conditions and purposes for which patients were taking raloxifene when the adverse event was reported.

Adverse ReactionAffective DisorderAntioestrogen TherapyAnxietyArthralgiaArthritisAcromegalyArthritisAsthmaBack PainBenign Ovarian TumourBiopsy Breast AbnormalBipolar DisorderBlood Calcium AbnormalBlood Calcium Decreased

Showing 15 of 195 indications

Raloxifene brand names and reporting trend

Raloxifene is sold under the brand name Evista.

Brand names

Evista5

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking raloxifene with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.