Nolvadex Side Effects

Generic Name: Tamoxifen

Please note - some side effects for Nolvadex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Nolvadex - for the consumer

Nolvadex

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Nolvadex:

Bone pain; constipation; coughing; hot flashes; muscle pain; nausea; tiredness; vaginal discharge; weight loss.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unexplained hoarseness); abnormal menstrual periods; abnormal vaginal bleeding or bloody discharge; chest pain; coughing up blood; dark urine; decreased sexual desire or ability; depression; fever, chills, or persistent sore throat; groin or pelvic pain or pressure; loss of appetite; loss of balance or coordination; missed menstrual period; new or increased breast tumor or pain; new or unusual lumps; one-sided weakness; pain or swelling in one or both legs; red, swollen, blistered, or peeling skin; severe or persistent tiredness or weakness; shortness of breath; skin changes; stomach pain; sudden severe headache; swelling of the arms or the legs; unusual bleeding or bruising; vision or speech problems; yellowing of the eyes or skin.

For the professional

Nolvadex

Adverse reactions to Nolvadex are relatively mild and rarely severe enough to require discontinuation of treatment in breast cancer patients.

Continued clinical studies have resulted in further information which better indicates the incidence of adverse reactions with Nolvadex as compared to placebo.

Metastatic Breast Cancer:

Increased bone and tumor pain and, also, local disease flare have occurred, which are sometimes associated with a good tumor response. Patients with increased bone pain may require additional analgesics. 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 occur, the bone pain or disease flare are seen shortly after starting Nolvadex and generally subside rapidly.

In patients treated with Nolvadex for metastatic breast cancer, the most frequent adverse reaction to Nolvadex is hot flashes.

Other adverse reactions which are seen infrequently are hypercalcemia, peripheral edema, distaste for food, pruritus vulvae, depression, dizziness, light-headedness, headache, hair thinning and/or partial hair loss, and vaginal dryness.

Premenopausal Women:

The following table summarizes the incidence of adverse reactions reported at a frequency of 2% or greater from clinical trials (Ingle, Pritchard, Buchanan) which compared Nolvadex therapy to ovarian ablation in premenopausal patients with metastatic breast cancer.

Male Breast Cancer:

Nolvadex is well tolerated in males with breast cancer. Reports from the literature and case reports suggest that the safety profile of Nolvadex in males is similar to that seen in women. Loss of libido and impotence have resulted in discontinuation of tamoxifen therapy in male patients. Also, in oligospermic males treated with tamoxifen, LH, FSH, testosterone and estrogen levels were elevated. No significant clinical changes were reported.

Adjuvant Breast Cancer:

In the NSABP B-14 study, women with axillary node-negative breast cancer were randomized to 5 years of Nolvadex 20 mg/day or placebo following primary surgery. The reported adverse effects are tabulated below (mean follow-up of approximately 6.8 years) showing adverse events more common on Nolvadex than on placebo. The incidence of hot flashes (64% vs. 48%), vaginal discharge (30% vs. 15%), and irregular menses (25% vs. 19%) were higher with Nolvadex compared with placebo. All other adverse effects occurred with similar frequency in the 2 treatment groups, with the exception of thrombotic events; a higher incidence was seen in Nolvadex-treated patients (through 5 years, 1.7% vs. 0.4%). Two of the patients treated with Nolvadex who had thrombotic events died.

In the Eastern Cooperative Oncology Group (ECOG) adjuvant breast cancer trial, Nolvadex or placebo was administered for 2 years to women following mastectomy. When compared to placebo, Nolvadex showed a significantly higher incidence of hot flashes (19% vs. 8% for placebo). The incidence of all other adverse reactions was similar in the 2 treatment groups with the exception of thrombocytopenia where the incidence for Nolvadex was 10% vs. 3% for placebo, an observation of borderline statistical significance.

In other adjuvant studies, Toronto and Nolvadex Adjuvant Trial Organization (NATO), women received either Nolvadex or no therapy. In the Toronto study, hot flashes were observed in 29% of patients for Nolvadex vs. 1% in the untreated group. In the NATO trial, hot flashes and vaginal bleeding were reported in 2.8% and 2.0% of women, respectively, for Nolvadex vs. 0.2% for each in the untreated group.

Anastrozole Adjuvant Trial — Study of Anastrozole compared to Nolvadex for Adjuvant Treatment of Early Breast Cancer

See CLINICAL PHARMACOLOGY - Clinical Studies. At a median follow-up of 33 months, the combination of anastrozole and Nolvadex did not demonstrate any efficacy benefit when compared to Nolvadex therapy given alone, in all patients as well as in the hormone receptor positive subpopulation. This treatment arm was discontinued from the trial. The median duration of adjuvant treatment for safety evaluation was 59.8 months and 59.6 months for patients receiving anastrozole 1 mg and Nolvadex 20 mg, respectively.

Adverse events occurring with an incidence of at least 5% in either treatment group during treatment or within 14 days of the end of treatment are presented in the following table.

Certain adverse events and combinations of adverse events were prospectively specified for analysis, based on the known pharmacologic properties and side effect profiles of the two drugs.

Patients receiving anastrozole had an increase in joint disorders (including arthritis, arthrosis and arthralgia) compared with patients receiving Nolvadex. Patients receiving anastrozole had an increase in the incidence of all fractures (specifically fractures of spine, hip and wrist) [315 (10%)] compared with patients receiving Nolvadex [209 (7%)]. Patients receiving anastrozole had a decrease in hot flashes, vaginal bleeding, vaginal discharge, endometrial cancer, venous thromboembolic events and ischemic cerebrovascular events compared with patients receiving Nolvadex.

Patients receiving Nolvadex had a decrease in hypercholesterolemia (108 [3.5%]) compared to patients receiving anastrozole (278 [9%]). Angina pectoris was reported in 71 [2.3%] patients in the anastrozole arm and 51 [1.6%] patients in the Nolvadex arm; myocardial infarction was reported in 37 [1.2%] patients in the anastrozole arm and in 34 [1.1%] patients in the Nolvadex arm.

Results from the adjuvant trial bone substudy, at 12 and 24 months demonstrated that patients receiving anastrozole had a mean decrease in both lumbar spine and total hip bone mineral density (BMD) compared to baseline. Patients receiving Nolvadex had a mean increase in both lumbar spine and total hip BMD compared to baseline.

Ductal Carcinoma in Situ (DCIS):

The type and frequency of adverse events in the NSABP B-24 trial were consistent with those observed in the other adjuvant trials conducted with Nolvadex.

Reduction in Breast Cancer Incidence in High Risk Women:

In the NSABP P-1 Trial, there was an increase in five serious adverse effects in the Nolvadex group: endometrial cancer (33 cases in the Nolvadex group vs. 14 in the placebo group); pulmonary embolism (18 cases in the Nolvadex group vs. 6 in the placebo group); deep vein thrombosis (30 cases in the Nolvadex group vs. 19 in the placebo group); stroke (34 cases in the Nolvadex group vs. 24 in the placebo group); cataract formation (540 cases in the Nolvadex group vs. 483 in the placebo group) and cataract surgery (101 cases in the Nolvadex group vs. 63 in the placebo group).

The following table presents the adverse events observed in NSABP P-1 by treatment arm. Only adverse events more common on Nolvadex than placebo are shown.

In the NSABP P-1 trial, 15.0% and 9.7% of participants receiving Nolvadex and placebo therapy, respectively withdrew from the trial for medical reasons. The following are the medical reasons for withdrawing from Nolvadex and placebo therapy, respectively: Hot flashes (3.1% vs. 1.5%) and Vaginal Discharge (0.5% vs. 0.1%).

In the NSABP P-1 trial, 8.7% and 9.6% of participants receiving Nolvadex and placebo therapy, respectively withdrew for non-medical reasons.

On the NSABP P-1 trial, hot flashes of any severity occurred in 68% of women on placebo and in 80% of women on Nolvadex. Severe hot flashes occurred in 28% of women on placebo and 45% of women on Nolvadex. Vaginal discharge occurred in 35% and 55% of women on placebo and Nolvadex respectively; and was severe in 4.5% and 12.3% respectively. There was no difference in the incidence of vaginal bleeding between treatment arms.

Pediatric Patients - McCune-Albright Syndrome:

Mean uterine volume increased after 6 months of treatment and doubled at the end of the one-year study. A causal relationship has not been established; however, as an increase in the incidence of endometrial adenocarcinoma and uterine sarcoma has been noted in adults treated with Nolvadex, continued monitoring of McCune-Albright patients treated with Nolvadex for long-term effects is recommended. The safety and efficacy of Nolvadex for girls aged two to 10 years with McCune-Albright Syndrome and precocious puberty have not been studied beyond one year of treatment. The long-term effects of Nolvadex therapy in girls have not been established.

Postmarketing experience:

Less frequently reported adverse reactions are vaginal bleeding, vaginal discharge, menstrual irregularities, skin rash and headaches. Usually these have not been of sufficient severity to require dosage reduction or discontinuation of treatment. Very rare reports of erythema multiforme, Stevens-Johnson syndrome, bullous pemphigoid, interstitial pneumonitis, and rare reports of hypersensitivity reactions including angioedema have been reported with Nolvadex therapy. In some of these cases, the time to onset was more than one year. Rarely, elevation of serum triglyceride levels, in some cases with pancreatitis, may be associated with the use of Nolvadex.

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