Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following serious adverse reactions are discussed below and elsewhere in the labeling: Uterine malignancies [see Boxed Warning , Warnings and Precautions (5.1) , and Clinical Studies (14.4) ] Thromboembolic events [see Boxed Warning , Warnings and Precautions (5.2) , and Clinical Studies (14.4) ] Embryo-Fetal Toxicity [see Warnings and Precautions (5.3) , and Use in Specific Populations (8.1 , 8.3) ] Liver cancer [see Warnings and Precautions (5.4) ] Most common adverse reactions: hot flashes, mood disturbances, vaginal discharge, vaginal bleeding, nausea, and fluid retention ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse Reactions in Patients with Metastatic Breast Cancer In patients treated with tamoxifen for metastatic breast cancer, the most frequent adverse reaction was hot flashes.
Other adverse reactions which were seen less commonly are hypercalcemia, peripheral edema, distaste for food, pruritus vulvae, depression, dizziness, lightheadedness, headache, hair thinning and/or partial hair loss, and vaginal dryness.
Increased bone, tumor pain and local disease flare have occurred.
Patients with soft tissue disease may have sudden increases in the size of preexisting lesions, sometimes associated with marked erythema within and surrounding the lesions and/or the development of new lesions.
When they occurred, the bone pain or disease flares were seen shortly after starting tamoxifen and generally subsided rapidly.
Premenopausal Women with Metastatic Breast Cancer Table 1 summarizes the incidence of adverse reactions reported at a frequency of 2% or greater from clinical trials that compared tamoxifen therapy to ovarian ablation in premenopausal patients with metastatic breast cancer.
Table 1: Adverse Reactions (frequency ≥2% in either arm) from Trials Comparing Tamoxifen to Ovarian Ablation in Premenopausal Women with Metastatic Breast Cancer % of Women Tamoxifen N=104 Ovarian Ablation N=100 Adverse Reactions Some women had more than one adverse reaction.
5 WARNINGS AND PRECAUTIONS Uterine malignancies: Promptly evaluate abnormal vaginal bleeding in a woman with current or past tamoxifen use.
( 5.1 ) Thromboembolic events: Risk increases with coadministered chemotherapy.
For treatment of breast cancer, consider risks and benefits in patients with a history of thromboembolic events.
( 5.2 ) Embryo-fetal toxicity: Can cause fetal harm.
Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.
Like all medications, Soltamox can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: