Raloxifene side effects: what 2,405 FDA adverse event reports show

Raloxifene · Raloxifene Hydrochloride · 84 reaction terms · 1,080 drug–reaction co-reports · data 2026-09-14

Drug class

Estrogen agonist/ antagonist

FDA label, Indications wording

Brand names

Raloxifene Hydrochloride

openFDA label

Who reports

2,405 reports · 60% serious · 161 with death outcome · 98% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Raloxifene hydrochloride tablet, USP is an estrogen agonist/ antagonist indicated for: Treatment and prevention of osteoporosis in postmenopausal women. ( 1.1 ) Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis. ( 1.2 ). Reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer.

FDA label, Indications and Usage

What it is

Raloxifene hydrochloride, USP is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds.

FDA label, Description section

Boxed warning

INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE Increased risk of deep vein thrombosis and pulmonary embolism have been reported with raloxifene hydrochloride tablets [see Warnings and Precautions ( 5.1 )].

FDA label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 38 strongest signals

Labeled adverse reaction 3Labeled (related wording) 3Likely indication confounding 2Reporting / coding artifact 2Lab value / disease marker 1Not in label — unassessed 27

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 46 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Foot deformity	28	22.0 15.2–31.9ROR 22.3 · χ² 540 / p 9e-120	21.7 EB05 15.7 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 22.8	no trial data cached
Body height decreased	21	17.0 11.1–26.0ROR 17.1 · χ² 299 / p 3e-67	16.5 EB05 11.1 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=17	no trial data cached
Nephropathy	18	16.7 10.6–26.5ROR 16.9 · χ² 250 / p 1e-56	16.2 EB05 10.4 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 17.1	no trial data cached
Hepatic steatosis	28	13.1 9.1–19.0ROR 13.3 · χ² 301 / p 8e-68	12.6 EB05 8.9 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 14.3	no trial data cached
Osteonecrosis of jaw (jawbone death)	37	13.0 9.4–17.8ROR 13.1 · χ² 396 / p 2e-88	12.6 EB05 9.3 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 12.5 · 92% clinician	no trial data cached
Ischaemic stroke	24	11.7 7.9–17.4ROR 11.8 · χ² 224 / p 5e-51	11.0 EB05 7.4 · IC025 +2.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 11.2	no trial data cached
Joint range of motion decreased	17	11.1 6.9–17.8ROR 11.2 · χ² 146 / p 6e-34	9.9 EB05 6.1 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 13.6	no trial data cached
Synovitis	21	10.1 6.6–15.5ROR 10.2 · χ² 164 / p 7e-38	9.2 EB05 6.0 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 10.2	no trial data cached
Sciatica	18	9.9 6.2–15.7ROR 10.0 · χ² 135 / p 2e-31	8.7 EB05 5.6 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 12.0	no trial data cached
Osteoporosis	39	8.3 6.0–11.3ROR 8.4 · χ² 242 / p 8e-55	7.7 EB05 5.8 · IC025 +2.4 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 7.3	no trial data cached
Cholelithiasis	27	7.2 4.9–10.4ROR 7.2 · χ² 138 / p 5e-32	6.5 EB05 4.7 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.3	no trial data cached
Bone density decreased	26	7.2 4.9–10.5ROR 7.2 · χ² 132 / p 9e-31	6.5 EB05 4.6 · IC025 +2.0 3/3 methods agree	Lab value / disease marker	serious PRR 5.9	no trial data cached
Photosensitivity reaction (sun sensitivity)	13	6.9 4.0–11.8ROR 6.9 · χ² 60 / p 6e-15	5.7 EB05 3.5 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 8.9	no trial data cached
Limb injury	21	6.8 4.4–10.3ROR 6.8 · χ² 97 / p 3e-23	6.0 EB05 4.1 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 7.6	no trial data cached
Movement disorder	25	6.8 4.6–10.0ROR 6.8 · χ² 117 / p 1e-27	6.1 EB05 4.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 8.0	no trial data cached
Cardiomyopathy	11	6.5 3.6–11.7ROR 6.5 · χ² 46 / p 7e-12	5.2 EB05 3.1 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 6.3	no trial data cached
Femur fracture	23	6.5 4.3–9.7ROR 6.5 · χ² 101 / p 5e-24	5.8 EB05 4.0 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 6.2	no trial data cached
Dysstasia	21	6.2 4.1–9.6ROR 6.3 · χ² 87 / p 4e-21	5.6 EB05 3.8 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 7.9	no trial data cached
Joint stiffness	17	5.6 3.5–9.1ROR 5.7 · χ² 60 / p 4e-15	4.9 EB05 3.3 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 8.7	no trial data cached
Osteoarthritis	27	5.5 3.8–8.1ROR 5.6 · χ² 96 / p 5e-23	5.1 EB05 3.7 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 5.7	no trial data cached
Fracture	12	5.5 3.1–9.7ROR 5.5 · χ² 40 / p 1e-10	4.6 EB05 2.8 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 5.3	no trial data cached
Rib fracture	12	5.1 2.9–9.0ROR 5.1 · χ² 36 / p 1e-9	4.3 EB05 2.7 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 4.9	no trial data cached
Osteomyelitis	10	4.8 2.6–8.9ROR 4.8 · χ² 27 / p 1e-7	4.0 EB05 2.4 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 4.7	no trial data cached
Spinal fracture	11	4.8 2.7–8.7ROR 4.8 · χ² 29 / p 3e-8	4.1 EB05 2.5 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 4.4	no trial data cached
Skin disorder	18	4.7 3.0–7.5ROR 4.7 · χ² 49 / p 1e-12	4.2 EB05 2.9 · IC025 +1.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.9	no trial data cached
Flatulence (gas)	30	4.6 3.2–6.6ROR 4.7 · χ² 82 / p 8e-20	4.3 EB05 3.2 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.5 · 77% consumer	no trial data cached
Psoriatic arthropathy	21	4.6 3.0–7.0ROR 4.6 · χ² 55 / p 7e-14	4.2 EB05 2.9 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 5.5	no trial data cached
Rash macular	18	4.5 2.8–7.1ROR 4.5 · χ² 46 / p 7e-12	4.1 EB05 2.7 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 7.1	no trial data cached
Musculoskeletal pain	26	4.3 2.9–6.3ROR 4.3 · χ² 62 / p 1e-15	4.0 EB05 2.9 · IC025 +1.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.8	no trial data cached
Arthritis	38	4.2 3.1–5.8ROR 4.3 · χ² 90 / p 1e-21	4.0 EB05 3.1 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.3	no trial data cached
Hip fracture	15	4.1 2.5–6.7ROR 4.1 · χ² 32 / p 9e-9	3.7 EB05 2.4 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 4.0	no trial data cached
Dementia	12	3.8 2.1–6.6ROR 3.8 · χ² 22 / p 2e-6	3.3 EB05 2.1 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 3.2	no trial data cached
Disease recurrence	20	3.7 2.4–5.7ROR 3.7 · χ² 36 / p 1e-9	3.4 EB05 2.3 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 0.7 · 85% consumer	no trial data cached
Arthropathy	23	3.6 2.4–5.4ROR 3.6 · χ² 41 / p 9e-11	3.4 EB05 2.4 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 4.0	no trial data cached
Hot flush (hot flashes)	30	3.5 2.4–4.9ROR 3.5 · χ² 50 / p 6e-13	3.3 EB05 2.4 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 3.4	no trial data cached
Psoriasis	41	2.7 2.0–3.7ROR 2.8 · χ² 44 / p 2e-11	2.7 EB05 2.1 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 4.4	no trial data cached
Breast cancer	24	2.2 1.5–3.3ROR 2.2 · χ² 15 / p 5e-5	2.2 EB05 1.5 · IC025 +0.4	Likely indication confounding term in indications; also in warnings	serious PRR 2.1	no trial data cached
Product substitution issue	14	2.1 1.3–3.6ROR 2.1 · χ² 7 / p 0.004	2.0 EB05 1.3 · IC025 +0.1	Reporting / coding artifact	serious PRR 1.5	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Psoriasis	41	2.7 2.0–3.7ROR 2.8 · χ² 44 / p 2e-11	2.7 EB05 2.1 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 4.4	no trial data cached
Osteoporosis	39	8.3 6.0–11.3ROR 8.4 · χ² 242 / p 8e-55	7.7 EB05 5.8 · IC025 +2.4 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 7.3	no trial data cached
Arthritis	38	4.2 3.1–5.8ROR 4.3 · χ² 90 / p 1e-21	4.0 EB05 3.1 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.3	no trial data cached
Osteonecrosis of jaw (jawbone death)	37	13.0 9.4–17.8ROR 13.1 · χ² 396 / p 2e-88	12.6 EB05 9.3 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 12.5 · 92% clinician	no trial data cached
Hot flush (hot flashes)	30	3.5 2.4–4.9ROR 3.5 · χ² 50 / p 6e-13	3.3 EB05 2.4 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 3.4	no trial data cached
Flatulence (gas)	30	4.6 3.2–6.6ROR 4.7 · χ² 82 / p 8e-20	4.3 EB05 3.2 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.5 · 77% consumer	no trial data cached
Hepatic steatosis	28	13.1 9.1–19.0ROR 13.3 · χ² 301 / p 8e-68	12.6 EB05 8.9 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 14.3	no trial data cached
Foot deformity	28	22.0 15.2–31.9ROR 22.3 · χ² 540 / p 9e-120	21.7 EB05 15.7 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 22.8	no trial data cached
Osteoarthritis	27	5.5 3.8–8.1ROR 5.6 · χ² 96 / p 5e-23	5.1 EB05 3.7 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 5.7	no trial data cached
Cholelithiasis	27	7.2 4.9–10.4ROR 7.2 · χ² 138 / p 5e-32	6.5 EB05 4.7 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.3	no trial data cached
Musculoskeletal pain	26	4.3 2.9–6.3ROR 4.3 · χ² 62 / p 1e-15	4.0 EB05 2.9 · IC025 +1.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.8	no trial data cached
Bone density decreased	26	7.2 4.9–10.5ROR 7.2 · χ² 132 / p 9e-31	6.5 EB05 4.6 · IC025 +2.0 3/3 methods agree	Lab value / disease marker	serious PRR 5.9	no trial data cached
Movement disorder	25	6.8 4.6–10.0ROR 6.8 · χ² 117 / p 1e-27	6.1 EB05 4.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 8.0	no trial data cached
Breast cancer	24	2.2 1.5–3.3ROR 2.2 · χ² 15 / p 5e-5	2.2 EB05 1.5 · IC025 +0.4	Likely indication confounding term in indications; also in warnings	serious PRR 2.1	no trial data cached
Ischaemic stroke	24	11.7 7.9–17.4ROR 11.8 · χ² 224 / p 5e-51	11.0 EB05 7.4 · IC025 +2.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 11.2	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Foot deformity — n=28, PRR 22.0
Body height decreased — n=21, PRR 17.0
Hepatic steatosis — n=28, PRR 13.1
Osteonecrosis of jaw — n=37, PRR 13.0
Synovitis — n=21, PRR 10.1
Limb injury — n=21, PRR 6.8
Movement disorder — n=25, PRR 6.8
Femur fracture — n=23, PRR 6.5
Dysstasia — n=21, PRR 6.2
Osteoarthritis — n=27, PRR 5.5

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Raloxifene?

In FDA FAERS, the most frequently co-reported reaction terms for Raloxifene are psoriasis, osteoporosis, arthritis, osteonecrosis of jaw, hot flush, flatulence. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Raloxifene have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE Increased risk of deep vein thrombosis and pulmonary embolism have been reported with raloxifene hydrochloride tablets [see Warnings and Precautions ( 5.1 )].

Do FAERS signals prove that Raloxifene causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 53a2db10-4af8-4032-b598-b7c7a0969801, effective 20210317; matched on openfda.generic_name.exact:"RALOXIFENE")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 84 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.