Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Diethylstilbestrol 1mg film-coated tablet
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Diethylstilbestrol may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Diethylstilbestrol 1 mg film-coated tablets, referred to as Diethylstilbestrol in this leaflet, is a synthetic non-steroidal oestrogen hormone used specifically for men with prostate cancer who have not responded to other drug or surgery forms of castration and for whom alternative treatments are not suitable.
What you need to know before you take it
e Diethylstilbestrol Do NOT take Diethylstilbestrol if you:
- are allergic to diethylstilbestrol or any of the other ingredients of this medicine (listed in section 6)
- are currently suffering from liver disease
- have moderate or severe high blood pressure
- have any heart problems
- have a history of blood clots
- have any disorder of the blood vessels in the brain
- have hyperlipoproteinaemia (an excess of lipoproteins in the blood)
- untreated polycythaemia (increased production of red blood cells), or sickle cell anaemia (altered shape of red blood cells) which causes anaemia
- have porphyria (a deficiency of specific enzymes within the body, causing an increase of substances called porphyrins). Warnings and precautions Talk to your doctor before taking this medicine if you:
- suffer from kidney problems
- have ever had any liver problems or have suffered from jaundice (yellowing of the skin or whites of the eyes)
- suffer from mild high blood pressure
- have diabetes
• • • • • •
suffer from epilepsy suffer from migraine suffer from depression wear contact lenses suffer from gallstones suffer from thyroid problems.
If you have a thyroid function test while you are taking this medicine, make sure you have told the doctor that you are taking Diethylstilbestrol, as this may affect the results. Children Diethylstilbestrol should NOT be used in children (see section 3). Other medicines and Diethylstilbestrol Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. In particular, talk to your doctor if you are taking any of the following:
- diuretics or water tablets
- medicines used for high blood pressure. Pregnancy Diethylstilbestrol should NOT be used by women of childbearing age. Driving and using machines Diethylstilbestrol is not known to affect your ability to drive or operate machinery. Diethylstilbestrol contains lactose and E110 (sunset yellow)
- Patients who are intolerant to lactose should note that Diethylstilbestrol tablets contain a small amount of lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
- Your medicine contains the colouring agent (sunset yellow) which may cause allergic reactions.
How to take it
Diethylstilbestrol Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The tablets should be swallowed preferably with a drink of water. In some patients, the doctor may consider prescribing a blood thinning agent such as low dose aspirin to prevent clots forming. Before taking diethylstilbestrol, your doctor may offer you breast bud radiation to minismise some of the side effects associated with diethylstilbestrol How much to take The recommended dose is: Adults, including the elderly Prostate cancer – One to three 1 mg tablets per day. Use in children Diethylstilbestrol should NOT be used in children. If you take more Diethylstilbestrol than you should
If you (or someone else) take too many tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. The most common symptoms of overdose are feeling or being sick (nausea or vomiting). Please take this leaflet, any remaining tablets, and the container with you to the hospital or doctor so that they know which tablets were consumed. If you forget to take Diethylstilbestrol If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. DO NOT take a double dose to make up for a forgotten dose. If you stop taking Diethylstilbestrol You should continue to take these tablets for as long as your doctor tells you to. DO NOT stop taking your medicine without talking to your doctor first even if you feel better. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, Diethylstilbestrol can cause side effects, although not everybody gets them. Stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital if the following happens:
- an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives)
- blood clots (causing redness, swelling and pain in the affected area). These are very serious but rare side effects. You may need urgent medical attention or hospitalisation. Tell your doctor immediately if the following happens:
- gallstones and associated jaundice (causing yellowing of the skin or whites of the eyes). The following side effects have been reported:
- aches and pains
- darkening/discoloration of the skin
- fluid retention
- headache
- increased incidence of migraine
- high blood pressure
- feeling sick (nausea) and being sick (vomiting)
- skin rashes
- weight gain
- sodium retention causing symptoms such as increased thirst, dry mouth, loss of skin elasticity, irritability, muscle twitching
- above normal glucose levels in the blood, which may increase the risk of diabetes
- fluctuating moods (both elation and depression)
- tender inflamed skin marked by red nodules
- discomfort of the eyes in patients wearing contact lenses
- breast discomfort, breast tenderness, breast enlargement and secretion of milk-like fluid from the breasts in both men and women
- in women, withdrawal bleeding, excessive production of cervical mucous, thickening of the lining of the uterus and uterine tumours. With prolonged use there may be an increased risk of malignant tumours in the lining of the uterus.
- in women, high calcium levels in the blood causing nausea, vomiting, loss of appetite, weakness, headache, bone pain, sleepiness or apathy
- in men, increased size of male breasts, reduction in size of testes, inability to get or maintain an erection. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
How to store it
Diethylstilbestrol Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Diethylstilbestrol tablet contains The active substance is diethylstilbestrol. Each 1 mg tablet contains 1mg of diethylstilbestrol. The other ingredients are lactose monohydrate, magnesium stearate (E572), maize starch, ethanol, opadry II pink 85F24252 consists of: polyvinyl alcohol, titanium dioxide (E171) polyethylene glycol/macrogol, talc, eryhtrosine alumnium lake (E127), sunset yellow FCF aluminium lake (E110) and indigo carmine aluminium lake (E132). What Diethylstilbestrol tablets looks like and contents of the pack Diethylstilbestrol 1 mg film-coated tablets are pink, biconvex, film-coated tablets, plain on one side and inscribed D1on the reverse for oral administration. The tablets are available in blister packs of 10, 28, 30, 56, 60 and 100 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Brown & Burk UK Ltd. 5 Marryat Close, Hounslow West Middlesex, TW4 5DQ, United Kingdom
This leaflet was last revised in 08/2021
Frequently asked questions about Diethylstilbestrol 1mg film-coated tablet
How do I take Diethylstilbestrol 1mg film-coated tablet?
Diethylstilbestrol 1mg film-coated tablet comes as tablet containing 1mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Diethylstilbestrol 1mg film-coated tablet?
The active substance in Diethylstilbestrol 1mg film-coated tablet is diethylstilbestrol.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Diethylstilbestrol 1mg film-coated tablet, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Diethylstilbestrol 1mg film-coated tablet without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: diethylstilbestrol
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Diethylstilbestrol tablets are indicated for the treatment of castration-resistant carcinoma of the prostate in patients for whom alternative forms of therapy are not suitable (see Section 5.1).
4.2. Posology and method of administration
Posology
Adults:
Management of prostatic carcinoma: 1 - 3 mg daily.
Paediatric population
Children:
Diethylstilbestrol should not be used in children.
Special populations
Elderly: The recommended adult dose is appropriate.
Thromboembolic complications are frequent and patients treated with diethylstilbestrol should be considered for treatment with aspirin See 4.4 below.
Diethylstilbestrol stimulates breast tissue in males, breast bud irradiation may be offered before treatment. See 4.4 below
Method of administration
For oral administration.
4.3. Contraindications
Diethylstilbestrol is a synthetic non-steroidal oestrogen hormone which due to its carcinogenic potential is only justified in the management of malignant disease.
Diethylstilbestrol should not be used in children or young adults because of its carcinogenic potential.
Diethylstilbestrol is strongly contra-indicated in those who are pregnant (it is not suitable for pre-menopausal women). It is also contra-indicated in the following conditions; oestrogen dependent neoplasms especially of the genital tract; premenopausal carcinoma of the breast; endometrial hyperplasia or uterine fibromyomata (fibroids). Diethylstilbestrol should not be given where there is undiagnosed vaginal bleeding; a history of herpes gestationis; porphyria; moderate to severe hypertension; severe or active liver disease; hyperlipoproteinaemia; any cardiovascular or cerebrovascular disorder or a history of thrombo-embolism or conditions predisposing to it such as sickle cell anaemia, untreated polycythaemia and pulmonary hypertension.
4.4. Special warnings and precautions for use
Thromboembolic complications are frequent and patients treated with diethylstilbestrol should be given prophylaxis with aspirin (75 mg daily).
The use of diethylstilbestrol may cause tenderness, pain, enlargement and secretion of milk-like fluid from the breast. Breast bud irradiation should be considered before treatment with diethylstilbestrol.
Care should be taken when administering diethylstilbestrol preparations to patients with cardiac failure; hypertension; diabetes; epilepsy; migraine; depression; contact lenses; cholelithiasis; or if there are any evidence of renal impairment, hepatic impairment; a history of, or with cholestatic jaundice from any cause.
During treatment with diethylstilbestrol blood pressure should be monitored at regular intervals and if hypertension develops treatment should be stopped. In addition, if surgery is contemplated or signs or symptoms of thrombosis develop treatment should be discontinued. This is because of the significant increase in risk of deep vein thrombosis in the presence of high oestrogen activity.
In patients who suffer from diabetes, glucose tolerance may be lowered, and the need for insulin or other anti-diabetic drugs may be increased.
In thyroid disease or investigations of thyroid function, thyroid hormone binding globulin may be increased leading to increased circulating total thyroid hormone, which may lead to difficulty in interpreting thyroid function tests.
Patient with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.
4.5. Interaction with other medicinal products and other forms of interaction
Oestrogens may antagonise diuretics and reduce the effect of anti-hypertensives.
4.6. Fertility, pregnancy and lactation
Diethylstilbestrol is contra-indicated in pre-menopausal women.
Diethylstilbestrol is a known human teratogen. Diethylstilbestrol is thus contraindicated in pregnancy. In the first trimester, high doses are associated with vaginal carcinoma, urogenital abnormalities, and reduced fertility in female offspring. Increased risk of hypospadias in male offspring.
4.7. Effects on ability to drive and use machines
None known
4.8. Undesirable effects
Diethylstilbestrol has been used for many years and has been found to cause serious adverse effects which have greatly limited its use. There is limited clinical trial data on adverse reactions relating to the use of diethylstilbestrol in men with carcinoma of the prostate.
The following adverse reactions have been reported from post-marketing experience over many years. Many of the reactions are dose related and, from the data available, it is not possible to indicate their frequency (see table below).
System Organ Class
Adverse reactions (frequency unknown)
Metabolism and nutrition disorders
sodium retention, fluid retention
Eye disorders
corneal irritation in patients wearing contact lenses
Psychiatric disorders
mood altered
Nervous system disorders
headache, migraine
Vascular disorders
thrombosis, cerebral thrombosis, coronary artery thrombosis, embolism, hypertension
Gastrointestinal disorders
nausea, vomiting
Hepatobiliary disorders
cholelithiasis, jaundice cholestatic
Skin and subcutaneous tissue disorders
rash, erythema nodosum, chloasma
Reproductive system and breast disorders
in both sexes, breast discomfort, breast tenderness, breast pain, breast enlargement, breast discharge. In men, gynaecomastia, testicular atrophy, impotence
Investigations
glucose tolerance decreased, weight increased
As high doses of diethylstilbestrol in early pregnancy have caused vaginal carcinoma in female offspring 16-20 years later, it should not be used in premenopausal women.
As with other oestrogens the following hormonal disturbances may occur in women, diethylstilbestrol may cause an increase in the size of uterine fibromyomata, endometrial proliferation and/or an aggravation or recurrence of endometriosis and an excessive production of cervical mucous. The risk of endometrial neoplasia is increased significantly.
Other effects may be withdrawal bleeding in women. In the event of prolonged usage there is an increased risk of endometrial carcinoma. Hypercalcaemia and bone pain may occur in women treated for breast cancer.
In a clinical study of 231 patients with advanced prostatic cancer the following adverse effects requiring cessation of treatment were noted, where the patients either stopped or had the dose of DES reduced:
System Organ Class
Adverse reactions
Incidence
Nervous system disorders
lethargy
0.9 %
transient ischaemic attack
0.4 %
Vascular disorders
embolism
4.8 %
Cardiac disorders
cardiac failure congestive
0.4 %
Respiratory, thoracic and mediastinal disorders
pulmonary oedema
0.4 %
Gastrointestinal disorders
nausea
4.8 %
gastrooesophageal reflux disease
0.4 %
General disorders and administration site conditions
oedema peripheral
0.9 %
Chest pain
0.4 %
Investigations
liver function test abnormal
0.9 %
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9. Overdose
There is no specific antidote to Diethylstilbestrol. The commonest symptoms of over dosage are nausea and vomiting. Management may include gastric lavage associated with special care of plasma electrolytes and any other appropriate symptomatic relief. Should the overdose (abuse) be in female children, an oestrogen-withdrawal bleed may be induced.
💬 Ask about this leaflet
Ask anything about Diethylstilbestrol 1mg film-coated tablet. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.