Trt Side Effects

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Answer the side-effect intent for trt without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is trt?

Testosterone replacement therapy — one product is registered for this in South Africa, and this page is built from its approved leaflet.

The product and its leaflet:

• testosterone — TESTOGEL, Medi Challenge (Pty) Ltd (Transdermal gel.)

Common side effects of trt

Each medicine in this group has its own approved leaflet, and the effects below are the ones that leaflet lists. They are shown separately rather than combined, because the leaflets do not agree on what to list or how to word it.

Testosterone (TESTOGEL)

• mood disorders
• loss of memory
• headache
• dizziness
• tingling in hands and feet
• excessive physical skin sensitivity (hyperaesthesia)
• high blood pressure
• diarrhoea
• redness of your skin, acne, dry skin, skin irritation
• hair loss (temporary)
• prostatic disorders
• enlargement of male breasts or pain in the breasts

The leaflet lists 15 more. Read the full leaflet.

Serious side effects and warning signs

None of the leaflets reviewed set out a separate serious-effects list.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

Cautions from each medicine’s approved leaflet.

Testosterone (TESTOGEL)

Do not use it at all if:

• If you are hypersensitive (allergic) to testosterone or any of the other ingredients of TESTOGEL (listed in section 6)
• If you have or suspect you have prostate cancer
• If you have or suspect you have breast cancer

Use with care, and tell your doctor, if:

• TESTOGEL is only approved for men who have low levels of testosterone related to certain medical conditions. Examples of these conditions include genetic problems, and chemotherapy or infections that have damaged the testicles
• TESTOGEL is not indicated for use in men who have low testosterone levels due to their age. Testosterone levels can decrease naturally as men age, and sometimes these levels can become lower than the normal range seen in young, healthy men. Ageing men can also experience signs and symptoms such as decreases in energy level and problems with sexual function, but it is uncertain whether these are caused by the lowered testosterone levels or due to normal ageing. Therefore, the need to replace testosterone in these ageing men is unclear
• Heart attacks and strokes have been reported with testosterone treatment. Seek medical attention immediately if you have symptoms of a heart attack or stroke, such as: o chest pain o shortness of breath or trouble breathing o weakness in one part or one side of the body o slurred speech. Talk to your doctor if you have questions or concerns about TESTOGEL treatment. Before starting any treatment with TESTOGEL, your testosterone deficiency must be clearly demonstrated by clinical signs (regression of masculine characteristics, reduced lean body mass, weakness or fatigue, reduced sexual desire/drive, inability to have/maintain an erection, etc.) and confirmed by 2 separate laboratory tests carried out in the same laboratory. TESTOGEL is not recommended for:
• The treatment of male sterility or impotence
• Children, as no clinical information is available for boys under 18 years
• Women, due to the possibility of developing male characteristics. Androgens may increase the risk of an enlarged prostate gland (benign prostatic hypertrophy) or prostate cancer. Regular examinations of the prostate gland before the beginning and during therapy should be performed according to your doctor’s recommendations. If you are suffering from a severe heart, liver or kidney disease or ischaemic heart disease (a condition that affects the supply of blood to the heart), treatment with TESTOGEL may cause severe complications in the form of water retention in your body, sometimes accompanied by (congestive) heart failure. In this case, TESTOGEL treatment must be stopped immediately and diuretic therapy may be required. The following blood checks should be carried out by your doctor before and during the treatment: testosterone blood level, full blood count. 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. TESTOGEL should be used with caution if you have or ever had a blood clotting problem called thrombophilia (when blood clots form too easily) or have the following factors that increase your risk for blood clots in a vein: o previous blood clots in a vein o smoking o obesity o cancer o immobility o if one of your immediate family has had a blood clot in the leg, lung or other organ at a young age, 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. Worsening of breathing problems during sleep have been reported during treatment with testosterone in some people, particularly those who are very overweight or are already suffering from breathing difficulties. If you have cancer that affects your bones, you may develop increased levels of calcium in your blood or urine. TESTOGEL may further affect these calcium levels. Your doctor may wish to check these calcium levels using blood tests during your treatment with TESTOGEL. If you receive TESTOGEL over long periods of time you may develop an abnormal increase in the number of red blood cells in your blood (polycythaemia). You will need regular blood tests to check that this is not happening. TESTOGEL may also affect your blood fat profile and your liver function. There is limited experience on the use of TESTOGEL if you are over 65 years of age. Currently, there is no consensus about age-specific testosterone reference values. However, it should be considered that physiologically testosterone serum levels are lower with increasing age. TESTOGEL must be used with caution if you are suffering from epilepsy and/or from migraine, as these conditions may be made worse. In case of severe skin reactions, treatment should be reviewed and stopped if necessary. The following may indicate you are using too much TESTOGEL: irritability, nervousness, weight gain, frequent or prolonged erections. Report any of these to your doctor, who will adjust the daily dose of TESTOGEL. Before starting treatment, your doctor will perform a full examination. He/she will need to take blood samples on 2 visits to measure your levels of testosterone before you are given TESTOGEL. You will have regular check-ups (at least once a year and twice a year if you are elderly or an at-risk patient) during treatment. For diabetic patients: TESTOGEL may affect blood sugar levels and may require a decrease in the dose of antidiabetic medicine. Your doctor may monitor your glucose and haemoglobin levels if you are being treated with TESTOGEL. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, consult your doctor. For sportsmen and women: The attention of sportsmen and women is drawn to the fact that TESTOGEL contains an active substance (testosterone) which may produce a positive reaction in anti-doping tests. Possible transfer of testosterone: During periods of close skin contact testosterone may be transferred to another person, including children, unless you cover the treated area. This could cause your partner to show the signs of increased testosterone, such as more hair on the face and body and a deepened voice. It may cause changes in the menstrual cycle of women. Wearing clothes covering the application area or showering before contact protects against such transfer. The following precautions are recommended:

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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