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Tamofen Side Effects

Generic name: tamoxifen

Medically reviewed by Drugs.com. Last updated on Oct 25, 2023.

Note: This document contains side effect information about tamoxifen. Some dosage forms listed on this page may not apply to the brand name Tamofen.

Applies to tamoxifen: oral solution, oral tablet.

Warning

Oral route (Solution)

Serious, life-threatening, and fatal events from use of tamoxifen include uterine malignancies, stroke, and pulmonary embolism. Discuss risks and benefits of tamoxifen with women at high risk for breast cancer and women with ductal carcinoma in situ (DCIS) when considering tamoxifen use to reduce the risk of developing breast cancer. For most patients already diagnosed with breast cancer, the benefits of tamoxifen outweigh its risks.

Oral route (Tablet)

Serious and life-threatening uterine malignancies, stroke, and pulmonary embolism have been associated with tamoxifen use in the risk reduction setting (women with Ductal Carcinoma in Situ (DCIS) and women at high risk for breast cancer). Some of these adverse events were fatal. Health care providers should discuss the potential benefits versus the potential risks of these serious events with women at high risk of breast cancer and women with DCIS considering tamoxifen to reduce their risk of developing breast cancer. The benefits of tamoxifen outweigh its risks in women already diagnosed with breast cancer.

Serious side effects of Tamofen

Along with its needed effects, tamoxifen (the active ingredient contained in Tamofen) 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

Less common

Rare

Incidence not known

Other side effects of Tamofen

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

Less common

Incidence not known

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]

Frequently asked questions

References

1. Cerner Multum, Inc. UK Summary of Product Characteristics.

2. Product Information. Tamoxifen Citrate (tamoxifen). Mayne Pharma Inc. 2018.

3. Product Information. Soltamox (tamoxifen). Cytogen Corporation. 2018.

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.

Medical Disclaimer