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.
Testosterone Enantate 250 mg/ ml Solution for Injection Ampoules
⚠ 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 enantate 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 Testosterone Enantate is a manufactured version of the naturally occurring male sex hormone, testosterone. It 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
- Bone loss caused by low hormone levels.
Testosterone PIL UK 011
What you need to know before you take it
e Testosterone Enantate Do not use Testosterone Enantate:
- if you are allergic to Testosterone Enantate or any of the other ingredients of this medicine (listed in section 6)
- if you suffer from androgen (steroid hormone) dependent prostate cancer or breast cancer
- if you have high calcium levels in your blood
- if you have or have had tumours of the liver
- if you have kidney disease (nephrosis) Warnings and precautions Talk to your doctor before using Testosterone Enantate if you:
- have liver problems including severe upper abdominal complaints
- have a tendency to retain fluid causing, for example, swelling of the ankles
- suffer from sleep apnoea (interrupted breathing during sleep), as this may get worse
- are suffering from severe heart, liver or kidney disease; treatment with Testosterone Enantate may cause severe complications in the form of water retention in your body sometimes accompanied by (congestive) heart failure
- have high blood pressure or if you are being treated for high blood pressure as testosterone may cause a rise in blood pressure
- have or have ever had 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. have epilepsy, migraine, diabetes mellitus or cancerous bone disease.
Testosterone Enantate should not be used in women because they may develop signs of virilisation, e.g. acne, increased hair growth on the face or body and voice changes. Male hormones such as Testosterone Enantate are not suitable for increasing muscular development in healthy people or for increasing physical ability. Medical examination/consultation
Testosterone PIL UK 011
Male hormones may increase the growth of prostate cancer and enlarged prostate glands (benign prostatic hypertrophy). Before your doctor injects Testosterone Enantate, s/he will examine you to check that you do not have prostate cancer. If you are older, you may be at an increased risk for the development of prostate enlargement when using Testosterone Enantate. Although there is no clear evidence that sex hormones such as Testosterone Enantate actually generate cancer of the prostate, they can enhance the growth of any existing cancer of the prostate. As a precaution, regular examinations of the prostate are recommended in men, especially if you are elderly. If you are on long-term androgen therapy blood tests should be carried out periodically (see section "Possible side effects"). The following blood checks should be carried out by your doctor before and during the treatment:
- testosterone blood level and
- full blood count Following the use of hormonal substances such as androgen compounds, cases of benign (non-cancerous) and malignant (cancerous) liver tumours have been observed to occur. Although it is improbable that a tumour will occur, these would present a health concern. In isolated cases, internal bleeding could occur from these tumours, which might endanger life. Thus you should always seek the immediate emergency attention of a doctor when you suffer severe abdominal pains. Not all unusual sensations you might feel in your upper abdomen can be counted as a possible sign of tumour or bleeding. Those that do not disappear within a short time should however better be brought to your doctor's attention. Additional information on special populations Children and adolescents Testosterone Enantate is not indicated for use in children and adolescents (see "Warnings and precautions"). In children and adolescents, earlier development of male secondary sex characteristics (masculinisation) may occur. Testosterone can affect bone growth and in some cases reduce final height. Safety and efficacy have not been adequately determined in children and adolescents. Elderly patients (65 years or older) Limited data do not suggest the need for a dosage adjustment in elderly patients (see "Warnings and precautions"). Patients with impaired liver function
Testosterone PIL UK 011
No formal studies have been performed in patients with liver impairment. The use of Testosterone Enantate is contraindicated in men with past or present liver tumours (see "Do not use Testosterone Enantate"). Patients with impaired kidney function No formal studies have been performed in patients with kidney impairment. Other medicines and Testosterone Enantate Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, tell your doctor if you are having any of the following as they may be affected or affect Testosterone Enantate: • • • •
Medicines used to treat nervousness and sleep problems (barbiturates or other enzyme inducers) Medicines used to treat pain or inflammation (oxyphenbutazone) Anticoagulants which are used to thin the blood, e.g. warfarin Medicines for the treatment of diabetes, e.g. metformin. 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.
Pregnancy and breast-feeding Testosterone Enantate is intended for use by men only. It is not indicated in pregnant or breast-feeding women. Testosterone Enantate should not be used during pregnancy due to the possibility of virilisation (development of male sex characteristics) of the female foetus. Fertility Treatment with high doses of testosterone preparations may reversibly reduce sperm production (see "Possible side effects"). Driving and using machines Testosterone Enantate should not affect your ability to drive or use machinery. Testosterone Enantate contains benzyl benzoate Testosterone Enantate contains 342 mg benzyl benzoate per ampoule. Benzyl benzoate can be metabolised into benzyl alcohol and benzoic acid once the medicine is administered. Benzyl alcohol may cause allergic reactions. Ask your doctor or pharmacist for advice if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called "metabolic acidosis"). Testosterone Enantate must not be given to premature babies or neonates. Drug abuse and dependence Always take this medicine exactly as your doctor or pharmacist has told you. Testosterone PIL UK 011
Abuse of testosterone, especially if you take 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 may 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. (See "Side effects").
How to take it
Testosterone Enantate Testosterone Enantate may cause toxic reactions and allergic reactions in infants and children up to 3 years old. Testosterone Enantate is administered by a doctor or nurse. It is given by very slow injection into a muscle, usually every 2 to 3 weeks. The injections are continued for as long as your doctor considers necessary, depending on your individual circumstances. Men receiving long term treatment may later be given injections at 3 to 6 week intervals. Your doctor will measure your blood testosterone levels before starting treatment and occasionally during the treatment at the end of an injection interval and adjust your dose as necessary. During treatment, it is advisable for men to have a regular prostate check by a doctor. If you use more Testosterone Enantate than you should As Testosterone Enantate is administered in hospital by a healthcare professional it is most unlikely that you will be given the wrong dose. If you have any concerns about your dose or the use of this product speak to your doctor. If you forget to use Testosterone Enantate Please adhere to the timelines on the injection intervals agreed with your doctor for optimal efficacy of the treatment. If you stop using Testosterone Enantate When Testosterone Enantate is stopped, symptoms of testosterone deficiency may reoccur. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Possible side effects
Testosterone PIL UK 011
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some people may be allergic to Testosterone Enantate. If you experience an allergic reaction you should stop using Testosterone Enantate and tell your doctor straight away or contact the accident and emergency department of your nearest hospital. Signs of an allergic reaction may include: • severe rash • swallowing or breathing problems • swelling of your lips, face, throat or tongue • weakness, feeling dizzy or faint • nausea Common side effects (may affect up to 1 in 10 patients): • Increase in red blood cell count, haematocrit (percentage of red blood cells in blood) and haemoglobin (the component of red blood cells that carries oxygen); these are identified by periodic blood tests • Weight gain Rare side effects (may affect up to 1 in 1000 patients): The oily liquid (Testosterone Enantate) 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 oil microembolism. Not known (frequency cannot be estimated from the available data):
- Liver tumours have been observed which can cause serious internal bleeding. Tell your doctor if you notice any new pain in the stomach that is severe or persists
- High levels of red blood cells (polycythaemia), blood circulation problems, high levels of calcium in the blood
- Abnormal liver function test results, yellowing of the skin and eyes (jaundice), enlarged liver
- Increased blood testosterone levels
- Increase in blood estradiol
- High blood pressure
- Coughing, bronchitis, sinusitis, snoring
- Shortness of breath
- Feeling dizzy
- Acne, hair loss, skin reactions such as redness, rash, urticaria (raised red spots), itching, dryness of the skin, "pins and needles", male pattern baldness
- Various kinds of injection site reactions including pain, itching, hardening, swelling, bruising and inflammation
- Increase in a prostatic-specific antigen (increased immune response)
Testosterone PIL UK 011
•
• • • • • • • • • • • • • • • •
Increased or decreased interest in sex, abnormal overdevelopment of the breasts in a man, early onset of puberty (Testosterone Enantate is not indicated for use in children – see section 2 "Warnings and precautions") Feeling pain in the breast In high doses or over a long period of time, retention of too much water, and even swelling of the ankles may occur Men may develop reduced sperm count, and frequent or persistent painful erections (if this happens, it is important to tell your doctor as it can injure the penis) Enlarged prostate and associated problems Increased appetite, changes in blood test results (e.g. increased blood sugars or fats) Increase in creatine phosphokinase in the blood Urinary tract disorders (e.g. decreased flow of urine, urinary retention, urge to pass urine at night) Prostatic disorders (e.g. prostatic dysplasia, or hardening or inflammation of the prostate), painful testicles, painful, hardened or enlarged breasts Headache, migraine, tremor, weakness, depression, anxiety, sleeplessness, restlessness, aggression, irritability Emotional disorder Changes in bone growth (increase or premature stoppage), joint pain, pain in limbs, muscle problems (e.g. spasm, pain or stiffness) Stomach problems, feeling sick, diarrhoea Tiredness Excessive sweating Hot flush Changes in the sound or tone of the voice.
Hostility, nervousness and increased hair growth have been reported under treatment with testosterone containing preparations. Reporting of side effects: If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the internet 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.
How to store it
Testosterone Enantate Keep this medicine out of the sight and reach of children. The information in Sections 5 and 6 is primarily for healthcare professionals. Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month. Testosterone PIL UK 011
Testosterone Enantate ampoules should be stored away from light. Testosterone Enantate should be inspected visually prior to administration and only clear solution free from particles should be used. 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 Testosterone Enantate contains The active substance is Testosterone Enantate. Each 1 ml ampoule contains 250 mg testosterone enantate (the equivalent of about 180mg testosterone) in oily solution. The other ingredients are: benzyl benzoate and castor oil refined. What Testosterone Enantate looks like and contents of pack Testosterone Enantate is a clear, yellowish oily liquid.Each ampoule is clear glass and contains 1 ml of solution for injection. They are supplied in packs of 3 ampoules. Marketing Authorisation Holder Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB, UK. Manufacturer Bayer AG, Berlin, Germany. This leaflet was last revised in November 2025 Alliance and associated devices are registered trademarks of Alliance Pharmaceuticals Limited. © Alliance Pharmaceuticals Limited 2025.
Testosterone PIL UK 011
Frequently asked questions about Testosterone Enantate 250 mg/ ml Solution for Injection Ampoules
How do I take Testosterone Enantate 250 mg/ ml Solution for Injection Ampoules?
Testosterone Enantate 250 mg/ ml Solution for Injection Ampoules comes as injection containing 250mg. 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 Testosterone Enantate 250 mg/ ml Solution for Injection Ampoules?
The active substance in Testosterone Enantate 250 mg/ ml Solution for Injection Ampoules is testosterone enantate.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Testosterone Enantate 250 mg/ ml Solution for Injection Ampoules, 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 Testosterone Enantate 250 mg/ ml Solution for Injection Ampoules 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 enantate
- 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.
4.2. Posology and method of administration
Posology
To stimulate development of underdeveloped androgen-dependent organs and for initial treatment of deficiency symptoms, 250mg Testosterone Enantate intramuscularly every two to three weeks.
For maintenance treatment: 250mg Testosterone Enantate intramuscularly every three to six weeks, according to individual requirement.
Serum testosterone levels should be measured before start of treatment and occasionally during the treatment at the end of an injection interval. Serum levels below normal range would indicate the need for a shorter injection interval. In case of high serum levels an extension of the injection interval may be considered.
Special populations
Paediatric population
Testosterone Enantate is not indicated for use in children and adolescents (see 4.4 Special warnings and precautions for use).
Safety and efficacy have not been adequately determined in children and adolescents.
Elderly patients
Limited data do not suggest the need for a dosage adjustment in elderly patients (see 4.4 Special warnings and precautions for use).
Patients with hepatic impairment
No formal studies have been performed in patients with hepatic impairment. The use of Testosterone Enantate is contraindicated in men with past or present liver tumours (see 4.3 Contraindications).
Patients with renal impairment
No formal studies have been performed in patients with renal impairment.
Method of Administration
Solution for intramuscular injection.
The injection must be administered extremely slowly (see 4.4 Special warnings and precautions for use and 4.8 Undesirable effects). The oily solution is injected immediately after its drawing up into the syringe.
4.3. Contraindications
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• Androgen-dependent carcinoma of the prostate or of the male mammary gland
• Hypercalcaemia
• Past or present liver tumours
• Nephrosis
4.4. Special warnings and precautions for use
Older patients treated with androgens may be at increased risk for the development of prostatic hyperplasia. Although there are no clear indications that androgens actually generate prostatic carcinoma, these can enhance the growth of any existing prostatic carcinoma. Therefore carcinoma of the prostate has to be excluded before starting therapy with testosterone preparations.
There is limited experience on the safety and efficacy of the use of Testosterone Enantate 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.
As a precaution, regular examinations of the prostate are recommended in men.
In patients receiving long-term androgen therapy, the following laboratory parameters should also be monitored regularly: haemoglobin and haematocrit (to detect cases of polycythaemia), liver function tests and lipid profile.
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 case, treatment must be stopped immediately.
Testosterone may cause a rise in blood pressure and Testosterone Enantate should be used with caution in men with hypertension.
Testosterone Enantate should be used with caution in patients with epilepsy, migraine, diabetes mellitus or skeletal metastases.
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.
Cases of benign and malignant liver tumours, which may lead to life-threatening intra-abdominal haemorrhage, have been observed after the use of Testosterone Enantate. If severe upper abdominal complaints, liver enlargement or signs of intra-abdominal haemorrhage occur, a liver tumour should be included in the differential-diagnosis and, if necessary, the preparation should be withdrawn.
Caution should be exercised in patients predisposed to oedema, as treatment with androgens may result in increased sodium retention (see 4.8 Undesirable effects).
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.
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.
In children testosterone, besides masculinisation, can cause accelerated growth and bone maturation and premature epiphyseal closure, thereby reducing final height.
Testosterone Enantate should not be used in women since, depending on the individual sensitivity to androgenic impulses, women may develop signs of virilisation, e.g. acne, hirsutism, voice changes.
Pre-existing sleep apnoea may be potentiated.
Androgens should not be used for enhancing muscular development in healthy individuals or for increasing physical ability.
As with all oily solutions, Testosterone Enantate 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, hyperhidrosis, 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 oil microembolism. Treatment is usually supportive, e.g. by administration of supplemental oxygen.
If, in individual cases, frequent or persistent erections occur, the dose should be reduced or the treatment discontinued in order to avoid injury to the penis.
Excipients
Also contains 342 mg benzyl benzoate per ampoule. Benzyl benzoate can be hydrolysed into benzyl alcohol and benzoic acid. Benzyl alcohol may cause allergic reactions. High volumes should be used with caution and only if necessary, especially in subjects with liver or kidney impairment because of the risk of accumulation of benzyl alcohol and toxicity (metabolic acidosis).
4.5. Interaction with other medicinal products and other forms of interaction
Barbiturates and other enzyme inducers
Interactions can occur with drugs that induce microsomal enzymes which can result in increased clearance of testosterone
Oxyphenbutazone
Increased oxyphenbutazone serum levels have been reported.
Oral anticoagulants
The clotting status should be monitored particularly closely when Testosterone Enantate is administered together with coumarin derivatives.
Hypoglycaemics
The hypoglycaemic effect of antidiabetics may be enhanced, possibly requiring a reduction in dosage of the hypoglycaemic agent.
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. Monitoring of haematocrit and haemoglobin levels is recommended in patients receiving both treatments.
4.6. Fertility, pregnancy and lactation
Pregnancy
Testosterone Enantate is intended for use by men only. Testosterone Enantate is not indicated in pregnant women (see 5.3 Preclinical safety data).
Lactation
Testosterone Enantate is intended for use by men only. Testosterone Enantate is not indicated in breast feeding women (see 5.3 Preclinical safety data).
Fertility
Testosterone Enantate replacement therapy may reversibly reduce spermatogenesis (see 4.8 Undesirable effects and 5.3 Preclinical safety data).
4.7. Effects on ability to drive and use machines
Testosterone Enantate has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Undesirable effects are listed by MedDRA System Organ Classes. Assessment of undesirable effects is based on the following frequency groupings:
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
System Organ Class
Undesirable effect
Frequency
Neoplasms benign, malignant and unspecified (including cysts and polyps)
Benign tumour of liver
Malignant liver tumour
Not known
Blood and lymphatic system disorders
Polycythaemia
Not known
Immune system disorders
Hypersensitivity
Not known
Metabolism and nutrition disorders
Hypercalcaemia
Water retention
Increased appetite
Hypercholesterolaemia
Blood triglycerides increased
Blood cholesterol increased
Not known
Psychiatric disorders
Depression
Anxiety
Libido increased
Libido decreased
Insomnia
Restlessness
Aggression
Irritability
Emotional disorder
Not known
Nervous system disorders
Headache
Dizziness
Paraesthesia
Migraine
Tremor
Not known
Vascular disorders
Hot flush
Hypertension
Not known
Respiratory, thoracic and mediastinal disorders
Pulmonary oil microembolism
Rare
Cough
Dyspnoea
Dysphonia
Bronchitis
Sinusitis
Snoring
Not known
Cardiac disorders
Disorder circulatory system
Not known
Gastrointestinal disorders
Abdominal disorder
Intra-abdominal haemorrhage
Nausea
Diarrhoea
Not known
Hepatobiliary disorders
Jaundice
Liver enlargement
Not known
Renal and urinary disorders
Urine flow decreased
Urinary retention
Urinary tract disorder
Nocturia
Dysuria
Not known
Skin and subcutaneous tissue disorders
Acne
Alopecia
Rash
Urticaria
Pruritus
Male pattern baldness
Erythema
Hyperhidrosis
Dry skin
Not known
Musculoskeletal and connective tissue disorders
Premature epiphyseal closure1
Bone formation increased
Arthralgia
Pain in extremity
Myalgia
Muscle disorder2
Musculoskeletal stiffness
Not known
General disorders and administration site conditions
Various kinds of Injection site reaction3
Asthenia
Oedema
Fatigue
Not known
Investigations
Prostatic specific antigen increased
Liver function test abnormal
Aspartate aminotransferase increased
Glycosylated haemoglobin increased
Blood pressure increased
Blood testosterone
Increased
Estradiol increased
Blood creatine phosphokinase increased
Not known
Weight increased
Haematocrit increased
Red blood cell count increased
Haemoglobin increased
Common
Reproductive system and breast disorders
Gynaecomastia
Prostatic disorder
Erection increased
Spermatogenesis abnormal
Precocious puberty1
Testicular pain
Prostate examination abnormal
Benign prostatic hyperplasia
Prostatic dysplasia
Prostate induration
Prostatitis
Breast induration
Breast pain
Not known
1In pre-pubertal males
2Muscle disorder: Muscle spasms, Muscle strain
3Injection site pain, Injection site erythema, Injection site induration, Injection site swelling, Injection site inflammation, Injection site hematoma, Injection site reaction.
Description of selected adverse reactions
Pulmonary microembolism of oily solutions can in rare cases lead to signs and symptoms such as cough, dyspnoea, malaise, hyperhidrosis, chest pain, dizziness, paraesthesia, or syncope. These reactions may occur during or immediately after the injections and are reversible. Cases suspected by the company or the reporter to represent oily pulmonary microembolism have been reported from post marketing experience (see section 'Special warnings and precautions for use').
High-dosed or long-term administration of testosterone increases the tendency to water retention and oedema.
Spermatogenesis is inhibited by long-term and high-dosed treatment with Testosterone Enantate.
If, in individual cases, frequent or persistent painful erections (priapism) occur, the dose should be reduced or the treatment discontinued in order to avoid injury to the penis.
Hostility, nervousness and increased hair growth have been reported under treatment with testosterone containing preparations.
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
No special therapeutic measure apart from termination of therapy with the drug or dose reduction is necessary after overdosage.
Acute toxicity data show that Testosterone Enantate can be classified as non-toxic following a single intake. Even in the case of an inadvertent administration of a multiple of the dose required for therapy, no acute toxicity risk is expected.
🇷🇴 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 enantate. 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 enantate. 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 Testosterone Enantate 250 mg/ ml Solution for Injection Ampoules. 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.