Divigel

Divigel Adverse Reactions

estradiol

Manufacturer:

Orion Pharma

Distributor:

Apex
Full Prescribing Info
Adverse Reactions
Adverse drug reactions reported during clinical trials with Divigel and estrogen replacement therapy are usually mild and only seldom lead to discontinuation of the treatment. If they do occur, it will usually be during the first months of the treatment.
Very common (>1/10): Reproductive: Breast tenderness.
Common (>1/100, <1/10): Central nervous system: Headache.
Metabolic and nutritional: Oedema, increased weight.
Reproductive: Unscheduled vaginal bleeding or spotting.
Gastrointestinal: Nausea, vomiting, stomach cramps.
Application site: Skin irritation.
Rare (>1/10,000, <1/1,000): Ovarian Cancer: Use of oestrogen-only or combined oestrogen-progestagen HRT has been associated with a slightly increased risk of having ovarian cancer diagnosed.
A meta-analysis from 52 epidemiological studies reported an increased risk of ovarian cancer in women currently using HRT compared to women who have never used HRT (RR 1.43, 95% CI 1.31-1.56). For women aged 50 to 54 years taking 5 years of HRT, this results in about 1 extra case per 2000 users. In women aged 50 to 54 who are not taking HRT, about 2 women in 2000 will be diagnosed with ovarian cancer over a 5-year period.
Central nervous system: Migraine.
Psychic: Changes in libido and mood.
Cardiovascular: Venous thromboembolism.
Very rare (<1/10,000), including isolated reports: Cardiovascular: Hypertension.
Hepato-biliary: Alterations in liver function and biliary flow.
Skin and subcutaneous tissue: Rash.
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