Applies to estramustine: oral capsule.

Serious side effects of Estramustine

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

Check with your doctor immediately if any of the following side effects occur while taking estramustine:

Rare

• Black, tarry stools
• blood in urine or stools
• cough or hoarseness
• fever or chills
• headaches (severe or sudden)
• loss of coordination (sudden)
• lower back or side pain
• painful or difficult urination
• pains in chest, groin, or leg (especially calf of leg)
• pinpoint red spots on skin
• shortness of breath (sudden, for no apparent reason)
• slurred speech (sudden)
• unusual bleeding or bruising
• vision changes (sudden)
• weakness or numbness in arm or leg

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

More common

• Swelling of feet or lower legs

Rare

• Skin rash or fever
• unusual tiredness or weakness

Other side effects of Estramustine

Some side effects of estramustine 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

• Breast tenderness or enlargement
• decreased interest in sex
• diarrhea
• nausea

Less common

• Trouble in sleeping
• vomiting

For Healthcare Professionals

Applies to estramustine: oral capsule.

Endocrine

Very common (10% or more): Breast tenderness (66%), breast enlargement (60%), gynecomastia

Frequency not reported: Erectile dysfunction^[Ref]

Hepatic

Very common (10% or more): Abnormal LDH and/or AST (31%), abnormal hepatic function

Common (1% to 10%): Abnormal bilirubin^[Ref]

Other

Very common (10% or more): Edema (19%)

Common (1% to 10%): Chest pain

Frequency not reported: Injection site thrombosis^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (15%), diarrhea (12%), minor gastrointestinal upset (11%), vomiting

Common (1% to 10%): Flatulence, gastrointestinal bleeding^[Ref]

Respiratory

Very common (10% or more): Dyspnea (11%)

Common (1% to 10%): Pulmonary emboli, upper respiratory discharge, hoarseness, burning throat

Frequency not reported: Larynx edema^[Ref]

Cardiovascular

Very common (10% or more): Congestive heart failure

Common (1% to 10%): Myocardial infarction, thrombophlebitis

Frequency not reported: Myocardial ischemia, hypertension^[Ref]

Hematologic

Very common (10% or more): Anemia, leukopenia

Common (1% to 10%): Thrombocytopenia^[Ref]

Metabolic

Very common (10% or more): Fluid retention

Common (1% to 10%): Anorexia, thirst^[Ref]

Dermatologic

Common (1% to 10%): Pruritus, dry skin, rash, easy bruising, flushing, peeling skin on fingertip, thinning hair^[Ref]

Musculoskeletal

Common (1% to 10%): Leg cramps

Frequency not reported: Muscular weakness^[Ref]

Nervous system

Common (1% to 10%): Lethargy, cerebrovascular accident, headache^[Ref]

Ocular

Common (1% to 10%): Tearing of eyes^[Ref]

Psychiatric

Common (1% to 10%): Insomnia, emotional lability, anxiety

Frequency not reported: Confusional state, depression^[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions, allergic reactions, angioedema, allergic dermatitis^[Ref]