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Raloxifene Side Effects

For the Consumer

Applies to raloxifene: oral tablet

Along with its needed effects, raloxifene may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need 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)

Check with your doctor as soon as possible if any of the following side effects occur while taking raloxifene:

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 side effects of raloxifene may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions 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

Cardiovascular

Very common (10% or more): Hot flashes/hot flushes/vasodilation (28.7%), increased blood pressure

Common (1% to 10%): Varicose vein, venous thromboembolism (VTE)

Postmarketing reports: Death related to VTE[Ref]

Other

Very common (10% or more): Flu syndrome (16.2%), infection (15.1%), peripheral edema (14.1%)

Common (1% to 10%): Chest pain, fever[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (15.5%), muscle spasms/leg cramps (12.1%)

Common (1% to 10%): Myalgia, arthritis, tendon disorder[Ref]

Respiratory

Very common (10% or more): Sinusitis (10.3%), rhinitis (10.2%)

Common (1% to 10%): Bronchitis, pharyngitis, increased cough, pneumonia, laryngitis[Ref]

Dermatologic

Common (1% to 10%): Rash, sweating[Ref]

Endocrine

Common (1% to 10%): Breast pain/tenderness/enlargement[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, diarrhea, dyspepsia, vomiting, flatulence, gastrointestinal disorder, gastroenteritis, abdominal pain[Ref]

Genitourinary

Common (1% to 10%): Vaginitis, urinary tract infection, cystitis, leukorrhea, uterine disorder, vaginal bleeding, endometrial disorder, vaginal hemorrhage, urinary tract disorder[Ref]

Hepatic

Common (1% to 10%): Cholelithiasis, cholecystectomy

Frequency not reported: Slightly decreased platelet counts, moderate increases in AST and/or ALT[Ref]

Metabolic

Common (1% to 10%): Weight gain[Ref]

Nervous system

Common (1% to 10%): Headache/migraine, syncope, vertigo, neuralgia, hypesthesia, stroke, death related to stroke[Ref]

Ocular

Common (1% to 10%): Conjunctivitis

Postmarketing reports: Retinal vein occlusion[Ref]

Psychiatric

Common (1% to 10%): Depression, insomnia[Ref]

Hematologic

Uncommon (0.1% to 1%): Thrombocytopenia[Ref]

Oncologic

Uncommon (0.1% to 1%): Benign endometrial polyps

Frequency not reported: Endometrial cancer, ovarian cancer, endometrial atrophy[Ref]

References

1. "Product Information. Raloxifene (raloxifene)." Prasco Laboratories, Cincinnati, OH.

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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