Raloxifene Side Effects

It is possible that some side effects of raloxifene may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to raloxifene: oral tablet

As well as its needed effects, raloxifene may cause unwanted side effects that require medical attention.

Stop taking raloxifene and get emergency help immediately if any of the following effects occur:

Rare
  • Coughing blood
  • headache or migraine headache
  • loss of or change in speech, coordination, or vision
  • pain or numbness in chest, arm, or leg
  • shortness of breath (unexplained)

If any of the following side effects occur while taking raloxifene, check with your doctor or nurse as soon as possible:

More common
  • Bloody or cloudy urine
  • chest pain
  • difficult, burning, or painful urination
  • fever
  • frequent urge to urinate
  • infection, including body aches or pain, congestion in throat, cough, dryness or soreness of throat, runny nose, and loss of voice
  • leg cramping
  • skin rash
  • swelling of hands, ankles, or feet
  • vaginal itching
Less common
  • Abdominal pain (severe)
  • aching body pains
  • congestion in lungs
  • decreased vision or other changes in vision
  • diarrhea
  • difficulty in breathing
  • hoarseness
  • loss of appetite
  • nausea
  • trouble in swallowing
  • weakness

Some raloxifene side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Hot flashes, including sudden sweating and feelings of warmth (especially common during the first 6 months of treatment)
  • increased white vaginal discharge
  • joint or muscle pain
  • mental depression
  • problems of stomach or intestines, including passing of gas, upset stomach, or vomiting
  • swollen joints
  • trouble in sleeping
  • weight gain (unexplained)

For Healthcare Professionals

Applies to raloxifene: oral tablet

General

General side effects have included infection (11% to 15%), flu syndrome (15%), and abdominal pain (7%). The most common general side effects were hot flashes (25%) and leg cramps (6%). Hot flashes or flushes tended to occur during the first six months of therapy.[Ref]

Cardiovascular

Raloxifene should be discontinued at least 72 hours prior to and during periods of immobilization. Therapy should be resumed only after the patient is fully ambulatory. Patients should be advised to avoid prolonged restrictions of movement during travel. The use of raloxifene in women predisposed to thromboembolic disease, such as women with congestive heart failure and malignancy, should be carefully considered.

A large (7,705 women), 3.3 year study reported raloxifene was associated with an increased risk for venous thromboembolism (relative risk 2.1, 95% confidence interval 1.2-3.8)[Ref]

Cardiovascular side effects have included decreased fibrinogen 12% (versus 2% with estrogen) and Plasminogen Activator Inhibitor-1 2% (versus 9% with estrogen). However, analysis of clinical study data revealed an increased risk of venous thromboembolic events, such as deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis associated with use of raloxifene. The greatest risk of these events occurs within the first four months of treatment.

Chest pain occurred in 4% of raloxifene treated patients.[Ref]

Genitourinary

Genitourinary side effects have included vaginal bleeding (6% versus HRT 64%), vaginitis (4%), UTI (4%), cystitis (3%), leukorrhea (3%), endometrial disorder (uterine-related) (3%), and breast pain (4% versus HRT 38%).

Endometrial proliferation or an increased risk of breast cancer has not been reported with raloxifene.[Ref]

Dermatologic

Dermatologic side effects have included rash (6%) and sweating (3%).[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea (9%), vomiting (3%), dyspepsia (6%), flatulence (2% to 3%), GI disorder (3%), and gastroenteritis (3%).[Ref]

Metabolic

Metabolic effects of raloxifene therapy have resulted in a less positive effect on lipids than conjugated estrogen. High density lipoprotein (HDL) is increased 15% (versus 33% with estrogen). Lipoprotein (a) is decreased 7% (versus 19% with estrogen). Low density lipoprotein (LDL) is decreased 12% (versus 14% with estrogen.

Limited clinical data suggest that women with a history of marked hypertriglyceridemia (>5.6 mmol/L or >500 mg/dL) in response to treatment with oral estrogen or estrogen plus progestin may develop increased levels of triglycerides when treated with raloxifene.[Ref]

Metabolic side effects have included weight gain (9%) and peripheral edema (3%).[Ref]

Musculoskeletal

Musculoskeletal side effects have included arthralgia (11%), myalgia (8%), leg cramps (6%), and arthritis (4%).[Ref]

Nervous system

Nervous system side effects have included depression (6%), insomnia (6%) and fever (3%), hot flashes (25% to 29% versus HRT 3% and placebo 18%), and migraine headaches (2%).[Ref]

Respiratory

Respiratory side effects have included sinusitis (10%), pharyngitis (8%), cough increased (6%), pneumonia (3%), and laryngitis (2%).[Ref]

Ocular

Ocular side effects have included very rare reports of retinal vein occlusion.[Ref]

References

1. Willhite SL, Goebel SR, Scoggin JA "Raloxifene provides an alternative for osteoporosis prevention." Ann Pharmacother 32 (1998): 834-7

2. Davies GC, Huster WJ, Lu YL, Plouffe L, Lakshmanan M "Adverse events reported by postmenopausal women in controlled trials with raloxifene." Obstet Gynecol 93 (1999): 558-65

3. "Product Information. Evista (raloxifene)." Lilly, Eli and Company, Indianapolis, IN.

4. Cummings SR, Eckert S, Krueger KA, et al. "The effect of raloxifene on risk of breast cancer in postmenopausal women: results from the MORE Randomized Trial." JAMA 281 (1999): 2189-97

5. Delmas PD, Bjarnason NH, Mitlak BH, Ravoux AC, Shah AS, Huster WJ, Draper M, Christiansen C "Effects of raloxifene on bone mineral density, serum cholesterol concentrations, and uterine endometrium in postmenopausal women." N Engl J Med 337 (1997): 1641-7

6. Grady D, Ettinger B, Moscarelli E, et al. "Safety and adverse effects associated with raloxifene: multiple outcomes of raloxifene evaluation." Obstet Gynecol 104 (2004): 837-44

7. Brinker A, Beitz J "Spontaneous reports of pulmonary embolism in association with raloxifene." Obstet Gynecol 98 (2001): 1151

8. Walsh BW, Paul S, Wild RA, Dean RA, Tracy RP, Cox DA, Anderson PW "The effects of hormone replacement therapy and raloxifene on C-reactive protein and homocysteine in healthy postmenopausal women: A randomized, controlled trial." J Clin Endocrinol Metab 85 (2000): 214-8

9. Walsh BW, Kuller LH, Wild RA, et al. "Effects of raloxifene on serum lipids and coagulation factors in healthy postmenopausal women." JAMA 279 (1998): 1445-51

10. Fugere P, Scheele WH, Shah A, Strack TR, Glant MD, Jolly E "Uterine effects of raloxifene in comparison with continuous-combined hormone replacement therapy in postmenopausal women." Am J Obstet Gynecol 182 (2000): 568-74

11. Baker VL, Draper M, Paul S, Allerheiligen S, Glant M, Shifren J, Jaffe RB "Reproductive endocrine and endometrial effects of raloxifene hydrochloride, a selective estrogen receptor modulator, in women with regular menstrual cycles." J Clin Endocrinol Metab 83 (1998): 6-13

12. Goldstein SR, Neven P, Zhou LF, Taylor YL, Ciaccia AV, Plouffe L "Raloxifene effect on frequency of surgery for pelvic floor relaxation." Obstet Gynecol 98 (2001): 91-6

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