What the label lists and what reports show
Raloxifene side effects
Raloxifene's FDA label: “Hot flashes occurred in about one in 10 patients on raloxifene hydrochloride and were most commonly reported during the first 6 months of treatment and were not different from placebo thereafter.” FAERS holds 16,046 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (848 reports).
- Generic listed
- Boxed warning
Check it at the source: the raloxifene FDA label on DailyMed (effective April 14, 2026, Amneal Pharmaceuticals LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of raloxifene hydrochloride?Serious and life-threatening side effects can occur while taking raloxifene hydrochloride. These include blood clots and dying from stroke: Increased risk of blood clots in the legs (deep vein thrombosis) and lungs (pulmonary embolism) have been reported with raloxifene hydrochloride. Women who have or have had blood clots in the legs, lungs, or eyes should not take raloxifene hydrochloride. Women who have had a heart attack or are at risk for a heart attack may have an increased risk of dying from stroke when taking raloxifene hydrochloride. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. […]
Source: FDA drug label, Amneal Pharmaceuticals LLC, effective April 14, 2026 (SPL set 3798c70b-a4b0-4811-9788-e4c9cff47ebe), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsHot flashes occurred in about one in 10 patients on raloxifene hydrochloride and were most commonly reported during the first 6 months of treatment and were not different from placebo thereafter.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Infection | Raloxifene Hydrochloride (N=2,557) % A | Placebo (N=2,576) % A | Raloxifene Hydrochloride (N=581) % 15.1 | Placebo (N=584) % 14.6 |
|---|---|---|---|---|
| Flu Syndrome | 13.5 | 11.4 | 14.6 | 13.5 |
| Headache | 9.2 | 8.5 | A | A |
| Leg Cramps | 7.0 | 3.7 | 5.9 | 1.9 |
| Fever | 3.9 | 3.8 | 3.1 | 2.6 |
| Hot Flashes | 9.7 | 6.4 | 24.6 | 18.3 |
| Syncope | 2.3 | 2.1 | B | B |
| Varicose Vein | 2.2 | 1.5 | A | A |
| Nausea | 8.3 | 7.8 | 8.8 | 8.6 |
| Diarrhea | 7.2 | 6.9 | A | A |
| Vomiting | 4.8 | 4.3 | 3.4 | 3.3 |
| Peripheral Edema | 5.2 | 4.4 | 3.3 | 1.9 |
| Arthralgia | 15.5 | 14.0 | 10.7 | 10.1 |
| Tendon Disorder | 3.6 | 3.1 | A | A |
| Vertigo | 4.1 | 3.7 | A | A |
| Neuralgia | 2.4 | 1.9 | B | B |
| Hypesthesia | 2.1 | 2.0 | B | B |
| Sinusitis | 7.9 | 7.5 | 10.3 | 6.5 |
| Rhinitis | 10.2 | 10.1 | A | A |
| Bronchitis | 9.5 | 8.6 | A | A |
| Pharyngitis | 5.3 | 5.1 | 7.6 | 7.2 |
| Cough Increased | 9.3 | 9.2 | 6.0 | 5.7 |
| Sweating | 2.5 | 2.0 | 3.1 | 1.7 |
| Conjunctivitis | 2.2 | 1.7 | A | A |
| Cystitis | 4.6 | 4.5 | 3.3 | 3.1 |
| Uterine Disorder b,c | 3.3 | 2.3 | A | A |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedAdverse reactions (> 2% and more common than with placebo) include: hot flashes, leg cramps, peripheral edema, flu syndrome, arthralgia, sweating. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to raloxifene hydrochloride in 8,429 patients who were enrolled in placebo-controlled trials, including 6,666 exposed for 1 year and 5,685 for at least 3 years. Osteoporosis Treatment Clinical Trial (MORE) – The safety of raloxifene in the treatment of osteoporosis was assessed in a large (7,705 patients) multinational, placebo-controlled trial. Duration of treatment was 36 months, and 5,129 postmenopausal women were exposed to raloxifene (2,557 received 60 mg/day, and 2,572 received 120 mg/day). The incidence of all-cause mortality was similar among groups: 23 (0.9%) placebo, 13 (0.5%) raloxifene hydrochloride-treated (raloxifene hydrochloride 60 mg), and 28 (1.1%) raloxifene hydrochloride 120 mg women died. …
Source: FDA drug label, Amneal Pharmaceuticals LLC, effective April 14, 2026 (SPL set 3798c70b-a4b0-4811-9788-e4c9cff47ebe), via openFDA; the full label on DailyMed
What do FAERS reports show?
16,046 reports list raloxifene among the medicines taken, each a report of something that happened, not proof the medicine caused it; 649 are coded as a death and 3,825 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 24 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Raloxifene: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions