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.
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.
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:
For Healthcare Professionals
Applies to tamoxifen: compounding powder, oral solution, oral tablet.
Very common (10% or more): Amenorrhea (16%), altered menses (13%), vaginal bleeding, vaginal discharge
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]
Very common (10% or more): Edema
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]
Common (1% to 10%): Anemia
Uncommon (0.1% to 1%): Thrombocytopenia, leukopenia
Common (1% to 10%): Cataracts, retinopathy
Uncommon (0.1% to 1%): Visual disturbances
Common (1% to 10%): Cough, thromboembolic events (including pulmonary embolism); risk is increased when used in combination with cytotoxic agents
Very common (10% or more): Fatigue
Common (1% to 10%): Pain[Ref]
Very common (10% or more): Skin rash
Common (1% to 10%): Alopecia
Very common (10% or more): Nausea
Common (1% to 10%): Hypersensitivity reactions[Ref]
Frequently asked questions
- How do you relieve joint pain associated with tamoxifen or Aromasin?
- Is it common to lose hair AFTER stopping tamoxifen?
More about Soltamox (tamoxifen)
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- FDA approval history
- Drug class: hormones/antineoplastics
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Related treatment guides
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.
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.