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
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Women with Ductal Carcinoma in Situ (DCIS) and Women at High Risk for Breast Cancer
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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]
