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Soltamox Side Effects

Generic name: tamoxifen

Medically reviewed by Drugs.com. Last updated on Oct 25, 2022.

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

Summary

Common side effects of Soltamox 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. Continue reading for a comprehensive list of adverse effects.

Applies to tamoxifen: oral solution, oral tablets.

Warning

    Women with Ductal Carcinoma in Situ (DCIS) and Women at High Risk for Breast Cancer
  • Serious and life-threatening events associated with tamoxifen in the risk reduction setting include uterine malignancies, stroke, and pulmonary embolism.128 Incidence rates for these events have been estimated from the Breast Cancer Prevention Trial (BCPT; also known as the National Surgical Adjuvant Breast and Bowel Project [NSABP] P-1 trial) (median length of follow-up 6.9 years).128

    Uterine malignancies consist of both endometrial adenocarcinoma (incidence rate per 1000 women-years of 2.2 for tamoxifen versus 0.71 for placebo) and uterine sarcoma (incidence rate per 1000 women-years of 0.17 for tamoxifen versus 0.04 for placebo).128

    For stroke, the incidence rate per 1000 women-years was 1.43 for tamoxifen versus 1 for placebo.128

    For pulmonary embolism, the incidence rate per 1000 women-years was 0.75 for tamoxifen versus 0.25 for placebo.128

  • Discuss potential benefits versus potential risks of these serious, sometimes fatal, events with women at high risk of breast cancer and women with DCIS considering tamoxifen to reduce their risk of developing breast cancer.128

  • The benefits of tamoxifen outweigh its risks in women already diagnosed with breast cancer.128

Side effects include:

Hot flushes (flashes), mood disturbances, vaginal discharge, vaginal bleeding, menstrual irregularities, nausea, fluid retention, weight loss.

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.

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