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Prescribing information and adverse event reporting can be found here.
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Why Testogel?EfficacySafety Information

Safety Information

Contraindications1,2

Testogel is contraindicated in:

  • Cases of known or suspected prostatic cancer or breast carcinoma
  • Hypersensitivity to testosterone or any of the excipients

Please also see below for special warnings and precautions.

Other considerations

  • Active desire to have children, currently or possibly in the future3
  • Haematocrit >54%3
  • Severe chronic heart failure – New York Heart Association (NYHA) class IV3
     

Adverse Reactions1,2

Adverse reactions with testosterone products include: Increased haematocrit, increased red blood cell count and increased haemoglobin (common = 1/100 to < 1/10).

MedDRA system organ class

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)

Frequency not known (cannot be estimated from the available data)

Neoplasms benign, malignant and unspecified (incl. cysts and polyps)

Hepatic neoplasm

Prostate cancer

Metabolism and nutrition disorders

Weight gain, electrolyte changes (retention of sodium, chloride, potassium, calcium, inorganic phosphate and water) during high dose and/or prolonged treatment

Psychiatric disorders

Mood disorders, emotional symptoms (mood swings, affective disorder, anger, aggression, impatience, insomnia, abnormal dreams, increased libido)

Nervous system disorders

Dizziness, paraesthesia, amnesia, hyperaesthesia, headache

Vascular disorders

Hypertension

Malignant hypertension, hot flushes/flushing, phlebitis

Respiratory, thoracic and mediastinal disorders

Sleep apnoea
 

Gastrointestinal disorders

Diarrhoea

Oral pain, abdominal distension

Hepatobiliary disorders

Jaundice, liver function test abnormalities

Skin and subcutaneous disorder

Alopecia, urticaria

Acne, hirsutism, rash, dry skin, seborrhoea, skin lesions, contact dermatitis, hair colour changes, application site hypersensitivity, application site pruritus

Skin reactions†

Renal and urinary disorders

Urinary tract obstruction
 

Musculoskeletal and connective tissue disorders

Muscle cramps

Reproductive system and breast disorders

Gynaecomastia*

Nipple disorder, prostate abnormalities, testicular pain, increased frequency of erections
 

Priapism

Libido changes, therapy with high-dose of testosterone preparations commonly reversibly interrupts or reduces spermatogenesis, thereby reducing the size of the testicles

General disorders and administration site conditions

Application site reaction

Pitting oedema
 

Asthenia, malaise, oedema, hypersensitivity reactions, increases the occurrences of water retention and oedema*
 

Investigations

Changes in laboratory tests (polycythaemia, lipids), haematocrit increased, haemoglobin increased, red blood cell count increased

PSA increased

Weight gain

*May develop and persist in patients treated for hypogonadism with testosterone; †Skin reactions, because of the alcohol contained in the product, frequent applications to the skin may cause irritation and dry skin; ‡High dose or long-term administration of testosterone occasionally increases the occurrences of water retention and oedema.

Special warnings:1,2

Testogel is contraindicated in cases of known or suspected prostatic cancer or breast carcinoma.    

Testogel contains alcohol and is flammable until dry.

Transfer Risk1,2

If no precautions are taken, testosterone gel can be transferred to other people by close skin-to-skin contact at any time after dosing. Due to the risk of transfer, patients should be informed that other persons should not come into contact with the area of the body where testosterone gel has been applied. As secondary transmission via clothes cannot be excluded, additional caution should be taken whilst using this product. Before close contact with another person, the application site should be washed with soap and water once the recommended time period (1 hour) has passed and the site should be covered with clean clothing. In the event of a person coming into contact with this medicine, they should immediately wash the affected area with soap and water and contact their HCP. This product contains ethanol. In neonates, high concentrations of ethanol may cause severe local reactions and systemic toxicity due to significant absorption through immature skin.1,2

For full prescribing information, including side effects, precautions and contraindications, please consult the Summary of Product Characteristics.

Testogel 16.2 mg/g SmPC external link Testogel 40.5 mg/g, transdermal gel in sachet SmPC external link 

References

  1. 1
    Testogel 16.2 mg/g gel - Summary of Product Characteristics (SmPC) - https://www.medicines.org.uk/emc/. Available at: https://www.medicines.org.uk/emc/product/8919/smpc. Accessed November 2025
  2. 2
    Testogel 40.5 mg, transdermal gel in sachet - Summary of Product Characteristics (SmPC) Available at: https://www.medicines.org.uk/emc/product/13255/smpc. Accessed November 2025
  3. 3
    Hackett G, et al. Trends Urol Mens Health. 2023;14(3):21–25.

MAT-PROMO-TES-0140 November 2025

Adverse event reporting     
Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or   
Apple App Store. Adverse events should also be reported to Besins Healthcare (UK) Ltd Drug Safety on 0203 862 0920 or Email: drugsafety@besins-healthcare.com