Nolvadex-D Adverse Reactions

Side effects can be classified as either due to the pharmacological action of the drug, e.g. hot flushes, vaginal bleeding, vaginal discharge, pruritus vulvae and tumour flare or as more general side effects, e.g. gastrointestinal intolerance, headache, light-headedness and occasionally, fluid retention and alopecia.
When side effects are severe, it may be possible to control them by a simple reduction of dosage (to not less than 20 mg/day) without loss of control of the disease. If side effects do not respond to this measure, it may be necessary to stop the treatment.
Skin rashes (including rare reports of erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, cutaneous vasculitis and bullous pemphigoid) and commonly hypersensitivity reactions, including angioedema have been reported.
Cases of exacerbation of angioedema have been reported in patients with hereditary angioedema receiving NOLVADEX.
Uncommonly, patients with bony metastases have developed hypercalcaemia on initiation of therapy.
Falls in platelet count, usually to 80,000 to 90,000 per cu mm but occasionally lower, have been reported in patients taking tamoxifen for breast cancer.
Cases of visual disturbances including rare reports of corneal changes and common reports of retinopathy have been described in patients receiving NOLVADEX. Cataracts have been reported commonly in association with the administration of NOLVADEX.
Cases of optic neuropathy and optic neuritis have been reported in patients receiving tamoxifen and, in a small number of cases, blindness has occurred.
Sensory disturbances (including paraesthesia and dysgeusia) have been reported commonly in patients receiving NOLVADEX.
Uterine fibroids, endometriosis and other endometrial changes including hyperplasia and polyps have been reported.
Cystic ovarian swellings have occasionally been observed in premenopausal women and have also been observed in postmenopausal women receiving NOLVADEX.
Vaginal polyps have rarely been observed in women receiving NOLVADEX.
Leucopenia has been observed following the administration of NOLVADEX, sometimes in association with anaemia and/or thrombocytopenia. Neutropenia has been reported on rare occasions; this can sometimes be severe, and rarely cases of agranulocytosis have been reported.
There is evidence of ischaemic cerebrovascular events and thromboembolic events, including deep vein thrombosis, microvascular thrombosis, and pulmonary embolism, occurring commonly during NOLVADEX therapy (see Contraindications, Precautions and Interactions). When NOLVADEX is used in combination with cytotoxic agents, there is an increased risk of thromboembolic events occurring.
Leg cramps and myalgia have been reported commonly in patients receiving NOLVADEX.
Uncommonly, cases of interstitial pneumonitis have been reported.
NOLVADEX has been associated with changes in liver enzyme levels and with a spectrum of more severe liver abnormalities which in some cases were fatal, including fatty liver, cholestasis and hepatitis, liver failure, cirrhosis, and, hepatocellular injury (including hepatic necrosis).
Commonly, elevation of serum triglyceride levels, in some cases with pancreatitis, may be associated with the use of NOLVADEX.
Depression has been reported with frequency very common in association with the use of NOLVADEX.
Uncommonly incidences of endometrial cancer and rare instances of uterine sarcoma (mostly malignant mixed Mullerian tumours) have been associated with NOLVADEX treatment.
Cutaneous lupus erythematosus has been observed very rarely in patients receiving NOLVADEX.
Porphyria cutanea tarda has been observed very rarely in patients receiving NOLVADEX.
Fatigue has been reported very commonly in patients taking NOLVADEX.
Radiation Recall (skin rash involving redness, swelling, and/or blistering of the skin after receiving radiation therapy) has been observed very rarely in patients receiving NOLVADEX.