Oestrogel Adverse Reactions

Skin: Irritation, reddening of the skin or mild and transient erythema at the site of application have been occasionally reported. In this instance a different site of application should be used, but if the topical side-effects continue, consideration should be given to discontinuation of treatment.
CNS: headache, migraine and mood changes.
Gastrointestinal tract: nausea.
Genito-urinary tract: increase in the size of uterine fibromyomata, excessive production of cervical mucus.
Breast: pain, enlargement and secretion.
Coronary Heart disease: see Cardiovascular Disorders: Coronary Heart disease and Stroke under Precautions.
Stroke: See Cardiovascular Disorders: Coronary Heart Disease and Stroke under Precautions. One large randomised clinical trial (WHI-trial) found, as a secondary outcome, an increased risk of ischaemic stroke in healthy women during treatment with continuous combined conjugated estrogens and MPA. For women who do not use HRT, it is estimated that the number of cases of stroke that will occur over a 5 year period is about 3 per 1000 women aged 50-59 years and 11 per 1000 women aged 60-69 years. It is estimated that for women who use conjugated estrogens and MPA for 5 years, the number of additional cases will be between 0 and 3 (best estimate = 1) per 1000 users aged 50-59 years and between 1 and 9 (best estimate = 4) per 1000 users aged 60-69 years. It is unknown whether the increased risk also extends to other HRT products.
Venous Thromboembolism (VTE): see Venous Thromboembolism (VTE) under Precautions.
Pulmonary embolus: Breast cancer (see Carcinoma under Precautions): For estrogen-only HRT, estimates of relative risk (RR) from a reanalysis of original data from 51 epidemiological studies (in which >80% of HRT use was estrogen-only HRT) and from the epidemiological Million Women Study (MWS) are similar at 1.35 (95%CI 1.21 - 1.49) and 1.30 (95%CI 1.21 - 1.40).
For estrogen plus progestagen combined HRT, several epidemiological studies have reported an overall higher risk for breast cancer than with estrogens alone. In the recent cohort E3N study, the risk was significantly greater (p<0.01) with HRT containing synthetic progestagens than with HRT containing micronized progesterone, the RRs being 1.4 (1.2-1.7).
The WHI trial reported a risk estimate of 1.26 (95%CI 1.00-1.59) after 5.6 years of use of estrogen-progestagen combined HRT (CEE + MPA) in all users compared with placebo. The WHI trial estimated that after 5.6 years of follow-up of women between the ages of 50 and 79 years, an additional 8 cases of invasive breast cancer would be due to estrogen-progestagen combined HRT (CEE + MPA) per 10,000 women years. The number of additional cases of breast cancer in women who use HRT is broadly similar for women who start HRT irrespective of age at start of use (between the ages of 45-65).
Endometrial cancer: According to data from epidemiological studies, the best estimate of the risk is that for women not using HRT. About 5 in every 1000 are expected to have endometrial cancer diagnosed between the ages of 50 and 65. Most studies show no significant increased risk associated with use of estrogens for less than one year. The greatest risk appears associated with prolonged use, with increased risks of 15- to 24-fold for 5 to 10 years or more, and this risk has been shown to persist for at least 8 to 15 years after estrogen therapy is discontinued.
Ovarian cancer: Long-term (at least 5-10 years) use of estrogen-only HRT products in hysterectomised women has been associated with an increased risk of ovarian cancer in some epidemiological studies. It is uncertain whether long-term use of combined HRTs confers to a different risk than estrogen-only products.
Dementia: There is some evidence from the WHI trial of increased risk of probable dementia in women who start using continuous combined oral CEE and MPA after the age of 65.