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Tamoxifen Side Effects

In Summary

Commonly reported side effects of tamoxifen include: amenorrhea, fluid retention, hot flash, nausea, vaginal discharge, vaginal hemorrhage, weight loss, and skin changes. Other side effects include: infection, sepsis, alopecia, constipation, cough, diarrhea, edema, increased serum aspartate aminotransferase, infrequent uterine bleeding, menstrual disease, ostealgia, vomiting, and weight gain. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to tamoxifen: oral solution, oral tablet

Along with its needed effects, tamoxifen 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 tamoxifen:

More Common

  • Absent, missed, or irregular menstrual periods
  • bladder pain
  • blindness
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody or cloudy urine
  • blurred vision
  • chills
  • confusion
  • cough
  • decrease in the amount of urine
  • decrease in height
  • decreased vision
  • difficult or labored breathing
  • difficult, burning, or painful urination
  • dizziness
  • fainting
  • fast heartbeat
  • fever
  • frequent urge to urinate
  • heavy non-menstrual vaginal bleeding
  • hoarseness
  • increased clear or white vaginal discharge
  • lower back or side pain
  • noisy, rattling breathing
  • pain in the back, ribs, arms, or legs
  • painful or difficult urination
  • pale skin
  • rapid weight gain
  • rapid, shallow breathing
  • stopping of menstrual bleeding
  • tightness in the chest
  • tingling of the hands or feet
  • troubled breathing at rest
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss

Less Common

  • Abnormal growth filled with fluid or semisolid material
  • black, tarry stools
  • bleeding gums
  • bloating
  • blurred vision
  • breast pain, redness, or swelling
  • chest pain
  • clear or bloody discharge from the nipple
  • cough producing mucus
  • dimpling of the breast skin
  • feeling of warmth or heat
  • flushing or redness of the skin, especially on the face and neck headache
  • inverted nipple
  • joint pain or stiffness
  • large amount of cholesterol in the blood
  • lump in the breast or under the arm
  • nervousness
  • persistent crusting or scaling of the nipple
  • pinpoint red spots on the skin
  • pounding in the ears
  • skin rash or itching over the entire body
  • slow heartbeat
  • sore on the skin of the breast that does not heal
  • stomach or pelvic discomfort, aching, or heaviness

Rare

  • Anxiety
  • bluish color of the skin
  • tenderness

Incidence Not Known

  • Blistering, peeling, loosening of the skin
  • constipation
  • dark urine
  • diarrhea
  • general feeling of discomfort or illness
  • indigestion
  • muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  • loss of appetite
  • nausea
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • thickening of bronchial secretions
  • vomiting
  • yellow eyes or skin

Some side effects of tamoxifen 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

  • Back pain
  • belching
  • body aches or pain
  • bone pain
  • congestion
  • depression
  • difficulty in moving
  • dryness of the throat
  • hair loss or thinning of hair
  • heartburn
  • joint swelling
  • lack or loss of strength
  • mood changes
  • muscle cramps or stiffness
  • passing of gas
  • redness of the face, neck, arms, and occasionally, upper chest
  • runny nose
  • shivering
  • skin changes
  • stomach upset, fullness, or pain
  • sudden sweating
  • tender, swollen glands in the neck
  • trouble in swallowing
  • trouble sleeping
  • voice changes

Less Common

  • Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • itching of the vagina or genital area
  • pain during sexual intercourse

Incidence Not Known

  • Decreased interest in sexual intercourse
  • inability to have or keep an erection
  • loss in sexual ability, desire, drive, or performance

For Healthcare Professionals

Applies to tamoxifen: compounding powder, oral solution, oral tablet

Genitourinary

Very common (10% or more): Amenorrhea (16%), altered menses (13%), vaginal bleeding, vaginal discharge

Common (1% to 10%): Oligomenorrhea, menstrual disorder, ovarian cysts, uterine fibroids, pruritus vulvae, endometrial changes (including hyperplasia and polyps)

Uncommon (0.1% to 1%): Endometrial cancer

Rare (less than 0.1%): Suppression of menstruation in premenopausal women, endometriosis, cystic ovarian swelling, vaginal polyps, uterine sarcoma (mostly malignant mixed Mullerian tumors), tumor flare[Ref]

Musculoskeletal

Common (1% to 10%): Bone pain, myalgia, leg cramps[Ref]

Metabolic

Very common (10% or more): Edema

Uncommon (0.1% to 1%): Hypercalcemia (in patients with bone metastases) on initiation of therapy[Ref]

Hepatic

Common (1% to 10%): Changes in liver enzymes, fatty liver

Uncommon (0.1% to 1%): Cirrhosis of the liver

Rare (less than 0.1%): Cholestasis, hepatitis, hepatic failure, hepatocellular injury, hepatic necrosis[Ref]

Hematologic

Common (1% to 10%): Anemia

Uncommon (0.1% to 1%): Thrombocytopenia, leukopenia

Rare (less than 0.1%): Neutropenia, agranulocytosis[Ref]

Ocular

Common (1% to 10%): Cataracts, retinopathy

Uncommon (0.1% to 1%): Visual disturbances

Rare (less than 0.1%): Corneal changes, optic neuropathy[Ref]

Cardiovascular

Common (1% to 10%): Thromboembolic events (including deep vein thrombosis and microvascular thrombosis); risks are increased when used in combination with cytotoxic agents[Ref]

Respiratory

Common (1% to 10%): Cough, thromboembolic events (including pulmonary embolism); risk is increased when used in combination with cytotoxic agents

Uncommon (0.1% to 1%): Interstitial pneumonitis[Ref]

Psychiatric

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

Other

Very common (10% or more): Fatigue

Common (1% to 10%): Pain[Ref]

Dermatologic

Very common (10% or more): Skin rash

Common (1% to 10%): Alopecia

Rare (0.01% to 0.1%): Angioedema, Stevens-Johnson syndrome, cutaneous vasculitis, bullous pemphigoid, erythema multiforme

Very rare (less than 0.01%): Cutaneous lupus erythematosus[Ref]

Nervous system

Common (1% to 10%): Ischemic cerebrovascular events, headache, sensory disturbances (including paresthesia and dysgeusia), light-headedness[Ref]

Gastrointestinal

Very common (10% or more): Nausea

Common (1% to 10%): Vomiting, diarrhea, constipation, abdominal cramps, anorexia

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

Hypersensitivity

Common (1% to 10%): Hypersensitivity reactions[Ref]

References

1. "Product Information. Tamoxifen Citrate (tamoxifen)." Mayne Pharma Inc, Paramus, NJ.

2. "Product Information. Soltamox (tamoxifen)." Cytogen Corporation, Princeton, NJ.

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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