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.
Sustanon 250, 250mg/ml solution for injection
⚠ 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 Testosterone decanoate, Testosterone isocaproate, Testosterone phenylpropionate, Testosterone propionate 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
Sustanon 250 is a clear pale yellow solution for injection containing the active ingredient testosterone in 4 (250 mg/ml) separate forms. The active substances of Sustanon 250 (see section 6 "What Sustanon 250 contains") are turned into testosterone by your body. Testosterone is a natural male hormone known as an androgen. In men, testosterone is produced by the testicles. It is necessary for the normal growth, development and function of the male sex organs and for secondary male sex characteristics. It is necessary for the growth of body hair, the development of bones and muscles, and it stimulates the production of red blood cells. It also makes men's voices deepen. Sustanon 250 is used in adult men for testosterone replacement to treat various health problems caused by a lack of testosterone (male hypogonadism). This should be confirmed by two separate blood testosterone measurements and also include clinical symptoms such as impotence, infertility, low sex drive, tiredness, depressive moods and bone loss caused by low hormone levels. Sustanon 250 may also be used as supportive therapy for female-to-male transsexuals. 2.
What you need to know before Sustanon 250 is administered
Do not take Sustanon 250:
- If you are pregnant or think you may be pregnant (see "Pregnancy, breast-feeding and fertility").
- If you have or have had a tumour of your prostate or breast, or are suspected to have one of these tumours.
- In children under the age of 3 years.
- If you are allergic to testosterone or to any of the other ingredients of this medicine (listed in section 6)
- If you are allergic to peanuts or soya (see Section 2 "Important information about some of the ingredients of Sustanon 250"). Warnings and precautions If you notice any signs of masculinisation (for instance lowering of the voice or increase in body or facial hair), consult your doctor immediately. Treatment with male hormones like testosterone may increase the size of the prostate gland, especially in elderly men. Therefore your doctor will examine your prostate gland at regular intervals by digital rectal examination (DRE) and blood tests for prostate-specific antigen (PSA). Additionally, at regular intervals, blood tests will be done to check the oxygen-carrying substance in your red blood cells (haemoglobin). In very rare cases the number of red blood cells will increase too much leading to complications. The following blood checks should be carried out by your doctor before and during the treatment: testosterone blood level, full blood count. Medical checks may also be necessary in some other conditions. Talk to your doctor or pharmacist before you start using this medicine if you ever had, still have or are suspected to have:
- Breast cancer which has spread to the bones;
- Kidney or lung cancer;
- Heart disease;
- Kidney disease;
- Liver disease;
- High blood pressure;
- Diabetes mellitus;
- Epilepsy;
- Migraine, headaches;
- Prostatic complaints, such as problems with passing urine;
- Blood clotting problems – thrombophilia (an abnormality of blood coagulation that increases the risk of thrombosis – blood clots in blood vessels).
- Factors that increase your risk for blood clots in a vein: previous blood clots in a vein; smoking; obesity; cancer; immobility; if one of your immediate family has had a blood clot in the leg, lung or other organ at a young age (e.g. below the age of about 50); or as you get older.
- How to recognise a blood clot: painful swelling of one leg or sudden change in colour of the skin e.g. turning pale, red or blue, sudden breathlessness, sudden unexplained cough which may bring up blood; or sudden chest pain, severe light headedness or dizziness, severe pain in your stomach, sudden loss of vision. Seek urgent medical attention if you experience one of these symptoms. If you are suffering from severe heart, liver or kidney disease, treatment with Sustanon 250 may cause severe complications in the form of water retention in your body sometimes accompanied by (congestive) heart failure. Tell your doctor if you have high blood pressure or if you are treated for high blood pressure as testosterone may cause a rise in blood pressure. If you have sleep apnoea (temporarily stopping breathing during your sleep), it may get worse if you are using testosterone-containing products. Let your doctor know if you are worried about this. Extra supervision by your doctor may be necessary in case you are overweight or suffer from chronic lung disease.
During treatment you should also tell your doctor:
- if you are a female-to-male transsexual. You should have special assessments, including psychiatric assessment, before treatment is started.
- if you are a female-to-male transsexual and have a personal or family history of breast cancer and a personal history of endometrial cancer. Children and adolescents The safety and efficacy of this medicine has not been adequately determined in children and adolescents. Extra supervision by your doctor is necessary in the treatment of children and adolescents since testosterone administration in general may cause early sexual development and limits growth (see section 4 "Children and adolescents"). Blood tests may be affected. For female-to-male transsexuals, Sustanon 250 may be given as part of a programme of treatment, including surgery. Other medicines and Sustanon 250 Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines – even those not prescribed. Other medicines may influence the effects of Sustanon 250, or Sustanon 250 may affect other medicines. Therefore, you must tell your doctor or pharmacist if you are using, or are about to use:
- medicines used to treat diabetes. It may be necessary to adjust the dose of your blood sugar reducing medicine. Like other androgens, testosterone may increase the effect of insulin. Taking SGLT-2 inhibitors (such as empagliflozin, dapagliflozin or canagliflozin) together with testosterone may increase the number of red blood cells in your blood. Your doctor may need to monitor your blood more regularly.
- Medicines to reduce the clotting of your blood (anti-coagulants);
- Certain medicines that change the amount of enzymes to be made in the liver e.g. medicines used to treat epilepsy (phenobarbital). These drugs may affect the levels of testosterone in your body and your doctor may need to adjust the dose or frequency of your Sustanon 250. The use of androgens like Sustanon 250 may lead to a reduction of the doses of these medicines. Tell your doctor or pharmacist if you are using or about to use the hormone ACTH or corticosteroids (used to treat various conditions such as rheumatism, arthritis, allergic conditions and asthma). The use of androgens like Sustanon 250 may increase the risk of water retention especially if your heart and liver are not working properly. Androgens may also affect the results of some laboratory tests (e.g. thyroid gland). Therefore, you must tell your doctor or the laboratory staff performing the tests that you are using this medicine. Sustanon 250 with food and drink This medicine can be injected without taking consideration of meals and drinks. Pregnancy, breast-feeding and fertility Sustanon 250 must not be taken by women who are pregnant or think they are pregnant (see section 2 "Do not use Sustanon 250"), or by women who are breast-feeding. In men, treatment with Sustanon 250 can lead to fertility disorders by repressing sperm formation.
In women, treatment with this medicine can lead to an irregular or absent menstrual cycle. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines As far as is known this medicine has no influence on driving and using machines. Sustanon 250 contains Arachis oil (peanut oil) (refined) and Benzyl alcohol (E 1519) This medicine also contains:
- Arachis oil (peanut oil) (refined) – If you are allergic to peanut or soya, do not use this medicinal product (see "Do not use Sustanon 250").
- Benzyl alcohol (E 1519) (100 mg per ml of solution) – Products containing benzyl alcohol must not be given to premature babies or neonates. Benzyl alcohol may cause toxic reactions and allergic reactions in infants and children up to 3 years old. Improper use If you are a patient who participates in competitions governed by the World Anti-Doping Agency (WADA), then you should consult the WADA-code before using this medicine as Sustanon 250 can interfere with anti-doping testing. The misuse of this medicine to enhance ability in sports carries serious health risks and is discouraged. Drug abuse and dependence This medicine should only be given by a doctor or nurse and used exactly as your doctor has told you. Abuse of testosterone, especially if you use too much of this medicine alone or with other anabolic androgenic steroids, can cause serious health problems to your heart and blood vessels (that can lead to death), mental health and/or the liver. Individuals who have abused testosterone may become dependent and experience withdrawal symptoms when the dosage changes significantly or is stopped immediately. You should not abuse this medicine alone or with other anabolic androgenic steroids because it carries serious health risks. 3.
How Sustanon 250 is administered
This medicine should only be given by a doctor or a nurse. The injections are given deeply into a muscle (for instance in the buttock, upper leg or upper arm). The dose depends on your illness and how bad it is. Your doctor will decide the dose. Usually, the dosage is one injection of 1 ml every three weeks. If you have the impression that the effect of this medicine is too strong or too weak, talk to your doctor or nurse immediately. Use in children and adolescents The safety and efficacy of this medicine have not been adequately determined in children and adolescents. Pre-pubertal children using this medicine will be monitored by your doctor (see section 2 "Take special care with Sustanon 250"). If you use more Sustanon 250 than you should Your doctor or nurse will inject this medicine into you. If you have the impression that the effect of this medicine is too strong then please talk to your doctor or nurse immediately.
The following effects may happen:
- Frequent erections in men;
- Changes in your red blood cells (polycythaemia), which your doctor may monitor you for. If you forgot to get your injection of Sustanon 250 Your doctor or nurse will inject this medicine into you. Should you miss a scheduled injection then please talk to your doctor or nurse as soon as possible. No double dose should be injected to make up for forgotten individual doses. If you stop treatment with Sustanon 250 The effects of this medicine do not stop immediately after discontinuation, but gradually subside. When treatment with this medicine is stopped, complaints such as those experienced before treatment may re-occur within a few weeks. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. Adults (female-to-male transsexuals) Sustanon 250: Doses vary from one injection of 1 ml every two weeks to one injection of 1 ml every four weeks. 4.
Possible side effects
Like all medicines, this medicine can cause side effects although not everybody gets them. In general, the side effects which are reported with testosterone therapy include: Common (may affect up to 1 in 10 people) • •
Increase in red blood cell count (the cells which carry the oxygen in your blood); haematocrit (percentage of red blood cells in blood) and haemoglobin (the component of red blood cells that carries oxygen), identified by periodic blood tests. Weight gain.
Rare (may affect up to 1 in 1000 patients): The oily liquid Sustanon 250 may reach the lungs (pulmonary microembolism of oily solutions) which can in rare cases lead to signs and symptoms such as cough, shortness of breath, feeling generally unwell, excessive sweating, chest pain, dizziness, "pins and needles", or fainting. These reactions may occur during or immediately after the injection and are reversible. The patient should therefore be observed during and immediately after each injection in order to allow for early recognition of possible signs and symptoms of pulmonary oily microembolism. Not known (cannot be estimated from available data) • • • • • • •
Itching (pruritus); Acne; Nausea; Changes in liver function tests; Changes in cholesterol levels (changes in lipid metabolism); Depression, nervousness, mood alterations; Muscle pain (myalgia);
Fluid retention in the tissues, usually marked by swelling of ankles or feet; High blood pressure (hypertension); Changes in sexual desire; Prolonged abnormal, painful erection of the penis; Ejaculation disorder; Disturbed formation of sperm; Feminisation (gynaecomastia); Prostatic growth to a size representative for the concerned age group; Increased levels of a blood marker which is associated with prostate cancer (PSA increased); Increased growth of a small prostate cancer which has not been detected yet (progression of a subclinical prostatic cancer). Due to the nature of Sustanon 250, side effects cannot be quickly reversed by discontinuing medication. Injectables in general, may cause local reaction at the injection site.
• • • • • • • • • •
Possible side effects
in women: In women, this product may induce signs of masculinisation (for example, lowering of the voice, and increase in body or facial hair.) Children and adolescents: The following side effects have been reported in pre-pubertal children using androgens:
- Early sexual development;
- Penis enlargement;
- An increased frequency of erections;
- Growth limitation (limited body height) 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine. 5.
How to store it
Sustanon 250
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton or label after the term "exp" (expiry date). The expiry date refers to the last day of that month. Store below 30°C. Do not refrigerate or freeze. Store in the original package in order to protect from light. 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 to protect the environment. 6.
Contents of the pack and other information
What Sustanon 250 contains The active substance is:
Each milliliter of the oily solution contains the following − testosterone propionate, 30 mg − testosterone phenylpropionate, 60 mg − testosterone isocaproate, 60 mg − testosterone decanoate, 100 mg All four compounds are esters of the natural hormone testosterone. The total amount of testosterone per ml is 176 mg. The other ingredients are: The solution for injection contains Arachis oil (refined) and Benzyl Alcohol (E 1519). What Sustanon 250 looks like and contents of the pack Sustanon 250 is a clear, pale yellow solution for deep intramuscular injection. Each colourless glass ampoule is filled with 1 ml of Sustanon 250. A box of Sustanon 250 contains 1 ampoule. Not all pack sizes are marketed. If you have any further questions or require the full prescribing information for this medicine please consult your doctor or pharmacist. Marketing Authorisation Holder Aspen Pharma Trading Limited 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland Tel: +44 (0)1 748 828 391 Manufacturer: Ever Pharma Jena GmbH Otto-Schott-Str. 15 07745 Jena Germany Or
Ever Pharma Jena GmbH, Bruesseler Str. 18, 07747 Jena, Germany This leaflet was updated in December 2025
Frequently asked questions about Sustanon 250, 250mg/ml solution for injection
How do I take Sustanon 250, 250mg/ml solution for injection?
Sustanon 250, 250mg/ml solution for injection comes as injection containing 250mg/ml. 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 Sustanon 250, 250mg/ml solution for injection?
The active substance in Sustanon 250, 250mg/ml solution for injection is testosterone decanoate, testosterone isocaproate, testosterone phenylpropionate, testosterone propionate.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Sustanon 250, 250mg/ml solution for injection, 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 Sustanon 250, 250mg/ml solution for injection 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: testosterone decanoate, testosterone isocaproate, testosterone phenylpropionate, testosterone propionate
- 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
Testosterone replacement therapy for male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests.
Testosterone administration may also be used as supportive therapy for female-to-male transsexuals.
4.2. Posology and method of administration
Posology
In general, the dose should be adjusted to the response of the individual patient.
Adults (incl. elderly):
Usually, one injection of 1ml per 3 weeks is adequate.
Paediatric population
Safety and efficacy have not been adequately determined in children and adolescents. Pre-pubertal children treated with Sustanon 250 should be treated with caution (see section 4.4).
Female-to-male transsexuals:
Different specialist centres have used doses varying from one injection of 1ml every two weeks to one injection of 1ml every four weeks.
Method of administration
Sustanon 250 should be administered by deep intramuscular injection.
4.3. Contraindications
• Pregnancy (see section 4.6).
• Known or suspected carcinoma of the prostate or breast (see section 4.4.).
• Breast-feeding.
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, including arachis oil (refined). Sustanon 250 is therefore contraindicated in patients allergic to peanuts or soya (see section 4.4).
4.4. Special warnings and precautions for use
Medical examination:
Testosterone level should be monitored at baseline and at regular intervals during treatment. Clinicians should adjust the dosage individually to ensure maintenance of eugonadal testosterone levels.
Physicians should consider monitoring patients receiving Sustanon 250 before the start of treatment, at quarterly intervals for the first 12 months and yearly thereafter for the following parameters:
• Digital rectal examination (DRE) of the prostate and PSA to exclude benign prostate hyperplasia or a sub-clinical prostate cancer (see section 4.3),
• Haematocrit and haemoglobin to exclude polycythaemia.
In patients receiving long-term androgen therapy, the following laboratory parameters should also be monitored regularly: haemoglobin, and haematocrit, liver function tests and lipid profile.
Conditions that need supervision:
Patients, especially the elderly, with the following conditions should be monitored for:
• Tumours – Mammary carcinoma, hypernephroma, bronchial carcinoma and skeletal metastases. In these patients hypercalcaemia or hypercalciuria may develop spontaneously, also during androgen therapy. The latter can be indicative of a positive tumour response to the hormonal treatment. Nevertheless, the hypercalcaemia or hypercalciuria should first be treated appropriately and after restoration of normal calcium levels, hormone therapy can be resumed.
• Pre-existing conditions – In patients suffering from severe cardiac, hepatic or renal insufficiency or ischaemic heart disease, treatment with testosterone may cause severe complications characterised by oedema with or without congestive cardiac failure. In such cases treatment must be stopped immediately. Patients who experienced myocardial infarction, cardiac-, hepatic- or renal insufficiency, hypertension, epilepsy, or migraine should be monitored due to the risk of deterioration of or reoccurrence of disease. In such cases treatment must be stopped immediately.
Testosterone may cause a rise in blood pressure and Sustanon 250 should be used with caution in men with hypertension.
• Epilepsy or Migraine – (or a history of these conditions), since androgens may occasionally induce fluid and sodium retention.
• Diabetes mellitus – Androgens in general and Sustanon 250 can improve glucose tolerance in diabetic patients (see section 4.5).
• Anti-coagulant therapy – Androgens in general and Sustanon 250 can enhance the anti-coagulant action of coumarin-type agents (see also section 4.5).
Sleep apnoea – Caution should be applied when treating men with sleep apnoea. There have been reports that testosterone can cause or exacerbate pre-existing sleep apnoea. However, there is a lack of evidence regarding the safety of testosterone in men with the condition. Good clinical judgment and caution should be employed in patients with risk factors such as adiposity or chronic lung diseases.
Adverse events:
If androgen-associated adverse reactions occur (see section 4.8), treatment with Sustanon 250 should be discontinued and, upon resolution of complaints, resumed with a lower dose.
Virilisation:
Patients should be informed about the potential occurrence of signs of virilisation. In particular, singers and women with speech professions should be informed about the risk of deepening of the voice. The voice changes may be irreversible.
If signs of virilisation develop, the risk/benefit ratio has to be newly assessed with the individual patient.
(Mis)use in sports:
Patients who participate in competitions governed by the World Anti-Doping Agency (WADA) should consult the WADA-code before using this product as Sustanon 250 can interfere with anti-doping testing. The misuse of androgens to enhance ability in sports carries serious health risks and is to be discouraged.
Drug abuse and dependence:
Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication(s) and in combination with other anabolic androgenic steroids. Abuse of testosterone and other anabolic androgenic steroids can lead to serious adverse reactions including: cardiovascular (with fatal outcomes in some cases), hepatic and/or psychiatric events. Testosterone abuse may result in dependence and withdrawal symptoms upon significant dose reduction or abrupt discontinuation of use. The abuse of testosterone and other anabolic androgenic steroids carries serious health risks and is to be discouraged.
Excipients:
Sustanon 250 contains Arachis oil (peanut oil) (refined) and should not be taken / applied by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to soya, patients with soya allergy should also avoid Sustanon 250 (see section 4.3).
Sustanon 250 contains 100 mg benzyl alcohol per ml solution and must not be given to premature babies or neonates. Benzyl alcohol may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
Female-to-male transsexual supportive therapy:
Before initiating Sustanon 250 for female-to-male transsexuals, specialist assessment should be undertaken, including psychiatric assessment. A complete personal and medical history should be taken. During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual. The following should be monitored:
• signs of osteoporosis,
• changes in lipid profile.
In patients with a personal or family history of breast cancer and with a personal history of endometrial cancer, careful monitoring should be undertaken.
Subject to specialist advice, hysterectomy and bilateral oophorectomy should be considered after 18-24 months of testosterone treatment, to reduce the possible increased risk of endometrial and ovarian cancer.
Continued surveillance is required to detect osteoporosis in patients who have undergone oophorectomy, as testosterone may not fully reverse the decline in bone density in these patients.
Continued surveillance is required to detect endometrial and ovarian cancer in patients on long term treatment who have not proceeded to hysterectomy and bilateral oophorectomy.
Paediatric population
In pre-pubertal children statural growth and sexual development should be monitored since androgens in general and Sustanon 250 in high dosages may accelerate epiphyseal closure and sexual maturation.
Older People:
There is limited experience on the safety and efficacy of the use of Sustanon 250 in patients over 65 years of age. Currently, there is no consensus about age specific testosterone reference values. However, it should be taken into account that physiologically testosterone serum levels are lower with increasing age.
Clotting disorders:
Testosterone should be used with caution in patients with thrombophilia or risk factors for venous thromboembolism (VTE), as there have been post-marketing studies and reports of thrombotic events (e.g. deep-vein thrombosis, pulmonary embolism, ocular thrombosis) in these patients during testosterone therapy. In thrombophilic patients, VTE cases have been reported even under anticoagulation treatment, therefore continuing testosterone treatment after first thrombotic event should be carefully evaluated. In case of treatment continuation, further measures should be taken to minimise the individual VTE risk.
As with all oily solutions, Sustanon 250 must be injected strictly intramuscularly and very slowly. Pulmonary microembolism of oily solutions can in rare cases lead to signs and symptoms such as cough, dyspnoea, malaise, hyperhydrosis, chest pain, dizziness, paraesthesia, or syncope. These reactions may occur during or immediately after the injection and are reversible. The patient should therefore be observed during and immediately after each injection in order to allow for early recognition of possible signs and symptoms of pulmonary oily microembolism. Treatment is usually supportive, e.g. by administration of supplemental oxygen.
4.5. Interaction with other medicinal products and other forms of interaction
Enzyme-inducing agents may decrease and enzyme-inhibiting drugs may increase testosterone levels. Therefore, adjustment of the dose of Sustanon 250 may be required.
Insulin and other anti-diabetic medicines:
Androgens may improve glucose tolerance and decrease the need for insulin or other anti-diabetic medicines in diabetic patients (see section 4.4).
Patients with diabetes mellitus should therefore be monitored especially at the beginning or end of treatment and at periodic intervals during Sustanon 250 treatment.
Concomitant use of testosterone replacement therapy and sodium-glucose co-transporter 2 (SGLT-2) inhibitors has been associated with an increased risk of erythrocytosis. Since both substances may independently elevate haematocrit levels, a cumulative effect is possible (see also section 4.4). Monitoring of haematocrit and haemoglobin levels is recommended in patients receiving both treatments.
Anti-coagulant therapy:
High doses of androgens may enhance the anticoagulant action of coumarin type agents (see section 4.4). Therefore, close monitoring of prothrombin time and if necessary a dose reduction of the anti-coagulant is required during therapy.
ACTH or Corticosteroids:
The concurrent administration of testosterone with ACTH or corticosteroids may enhance oedema formation therefore these active substances should be administered cautiously, particularly in patients with cardiac or hepatic disease or in patients predisposed to oedema (see section 4.4).
Laboratory test interactions:
Androgens may decrease levels of thyroxine-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, and there is no clinical evidence of thyroid dysfunction.
4.6. Fertility, pregnancy and lactation
Sustanon 250 is contra-indicated in women who are pregnant (see section 4.3).
Pregnancy
There are no adequate data for the use of Sustanon 250 in pregnant women. In view of the risk of virilisation of the foetus, Sustanon 250 should not be used during pregnancy (see section 4.3). Treatment with Sustanon should be discontinued when pregnancy occurs.
Breastfeeding
There are no adequate data for the use of Sustanon 250 during lactation. Therefore, Sustanon 250 should not be used during lactation.
Fertility
In men treatment with androgens can lead to fertility disorders by repressing sperm-formation (see section 4.8).
In women treatment with androgens can lead to an infrequent or repressed menstrual cycle (see section 4.8).
4.7. Effects on ability to drive and use machines
Sustanon 250 has no influence on the ability to drive and use machines.
4.8. Undesirable effects
Due to the nature of Sustanon 250 side effects cannot be quickly reversed by discontinuing medication. Injectables in general, may cause a local reaction at the injection site.
The following adverse reactions have been associated with androgen therapy in general.
All adverse reactions are listed by system organ class and frequency; common (≥ 1/100 to < 1/10) and not known (cannot be estimated from the available data).
System Organ Class
MedDRA term
Frequency
Neoplasms benign, malignant and unspecified (incl. cysts and polyps)
Prostatic cancer1
Not known
Blood and lymphatic system disorders
Polycythaemia
Not known
Metabolism and nutrition disorders
Fluid retention
Not known
Weight increased
Common
Psychiatric disorders
Depression,
Nervousness
Mood altered
Libido increased,
Libido decreased
Not known
Vascular disorders
Hypertension
Not known
Respiratory, thoracic and mediastinal disorders
Pulmonary oil microembolism
Rare
Gastrointestinal disorders
Nausea
Not known
Hepatobiliary disorders
Hepatic function abnormal
Not known
Skin and subcutaneous tissue disorders
Pruritus
Acne
Not known
Musculoskeletal and connective tissue disorders
Myalgia
Not known
Reproductive system and breast disorders
Ejaculation disorder
Gynaecomastia
Oligospermia
Priapism
Benign prostatic hyperplasia2
Not known
Investigations
Lipids abnormal3
PSA increased
Haematocrit increased
Red blood cell count increased
Haemoglobin increased
Not known
Common
1 Progression of a sub-clinical prostatic cancer
2 Prostatic growth (to eugonadal state)
3 Decrease in serum LDL-C, HDL-C and triglycerides
The terms used to describe the undesirable effects above are also meant to include synonyms and related terms.
Description of selected adverse reactions:
Pulmonary microembolism of oily solutions can in rare cases lead to signs and symptoms such as cough, dyspnoea, malaise, hyperhydrosis, chest pain, dizziness, paresthesia, or syncope. These reactions may occur during or immediately after the injections and are reversible.
Treatment in women
Treatment with Sustanon 250 may induce signs of virilisation in women (see section 4.4). Symptoms of virilisation may include hoarseness, acne, hirsutism, menstrual irregularity and alopecia.
Paediatric population
The following undesirable effects have been reported in prepubertal children using androgens (see section 4.4): precocious sexual development, an increased frequency of erections, phallic enlargement and premature epiphyseal closure.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
The acute toxicity of testosterone is low.
If symptoms of chronic overdose occur (e.g. polycythaemia, priapism) treatment should be discontinued and after disappearance of the symptoms, be resumed at lower dosage.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Testosterone decanoate, Testosterone isocaproate, Testosterone phenylpropionate, Testosterone propionate. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- NEBIDO 1000 mg/4 ml prescription partial — not the same combinationTESTOSTERONUM · injection / infusion
- TESTOSTERON EVER PHARMA 1000 mg/4 ml prescription partial — not the same combinationTESTOSTERONUM · injection / infusion
- TESTOSTERON TEVA 1000 mg/4 ml prescription partial — not the same combinationTESTOSTERONUM · injection / infusion
- ANDROJECT 1000 mg/4ml prescription partial — not the same combinationTESTOSTERONUM · injection / infusion
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Not the same combination. This medicine contains Testosterone decanoate, Testosterone isocaproate, Testosterone phenylpropionate, Testosterone propionate. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- Androtop partial — not the same combinationTestosteronum · skin / topical
- Testavan partial — not the same combinationTestosteronum · skin / topical
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Sustanon 250, 250mg/ml solution for injection. 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.