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Raloxifene Side Effects

In Summary

Commonly reported side effects of raloxifene include: infection, flu-like symptoms, hot flash, and sinusitis. Other side effects include: leg cramps. See below for a comprehensive list of adverse effects.

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)

Severity: Moderate

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

Minor Side Effects

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

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. "UK Summary of Product Characteristics." O 0

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

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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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