Nolvadex-D Adverse Reactions

Tabulated list of adverse reactions: The following definitions apply to the incidence of undesirable effects: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Unless specified, the following frequency categories were calculated from the number of adverse events reported in a large phase III study conducted in 9366 postmenopausal women patients with operable breast cancer treated for 5 years and unless specified, no account was taken of the frequency within the comparative treatment group or whether the investigator considered it to be related to study medication. (See table.)

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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-D.
Uncommonly patients with bony metastases have developed hypercalcaemia on initiation of therapy.
Cases of visual disturbances, including rare reports of corneal changes and common reports of retinopathy have been described in patients receiving Nolvadex-D therapy. Cataracts have been reported commonly in association with the administration of Nolvadex-D.
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-D.
Uterine fibroids, endometriosis and other endometrial changes including hyperplasia and polyps have been reported.
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.
Leucopenia has been observed following the administration of Nolvadex-D, 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 tamoxifen therapy (see Contraindications, Precautions and Interactions). When Nolvadex-D 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-D.
Uncommonly, cases of interstitial pneumonitis have been reported.
Nolvadex-D 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-D.
Depression has been reported with frequency very common in association with the use of Nolvadex-D.
Cystic ovarian swellings have rarely been observed in women receiving Nolvadex-D.
Vaginal polyps have rarely been observed in women receiving Nolvadex-D.
Cutaneous lupus erythematosus has been observed very-rarely in patients receiving Nolvadex-D.
Porphyria cutanea tarda has been observed very-rarely in patients receiving Nolvadex-D.
Fatigue has been reported very commonly in patients taking Nolvadex-D.
Radiation Recall has been observed very rarely in patients receiving Nolvadex-D.
Uncommonly incidences of endometrial cancer and rare instances of uterine sarcoma (mostly malignant mixed Mullerian tumours) has been reported in association with Nolvadex-D treatment.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via local reporting system.