Medical Editor: John P. Cunha, DO, FACOEP
What Is Delatestryl?
Delatestryl (testosterone enanthate) is an androgen, a male sex hormone, used in men who do not make enough of a natural substance called testosterone. Delatestryl is available in generic form.
What Are Side Effects of Delatestryl?
Common side effects of Delatestryl include:
- nausea,
- vomiting,
- headache,
- anxiety,
- depression,
- skin color changes,
- increased or decreased sexual interest,
- breast swelling in men,
- numbness or tingly feeling,
- oily skin,
- hair loss,
- acne, and
- injection site reactions (pain, redness, or swelling).
In women, side effects of Delatestryl may also include:
- changes in menstrual periods,
- male-pattern hair growth (such as on the chin or chest),
- male pattern baldness, or
- enlarged clitoris.
Tell your doctor if you any serious side effects of Delatestryl including:
- mental/mood changes,
- trouble sleeping,
- snoring,
- signs of serious liver disease (such as persistent abdominal pain or nausea, unusual tiredness, yellowing eyes or skin, dark urine),
- hands/ankles/feet swelling,
- unusual tiredness,
- shortness of breath, or
- fast or irregular heartbeat.
Dosage for Delatestryl
Dosage and duration of therapy with Delatestryl depends on the age, sex, diagnosis, patient's response to treatment, and appearance of adverse effects.
What Drugs, Substances, or Supplements Interact with Delatestryl?
Delatestryl may interact with blood thinners, or corticosteroids. Tell your doctor all medications and supplements you use.
Delatestryl During Pregnancy and Breastfeeding
Delatestryl must not be used during pregnancy. It may harm a fetus. It is recommended that women use 2 forms of birth control (e.g., condoms and birth control pills) while using this medication; consult your doctor. It is unknown if this drug passes into breast milk. It may affect milk production and it may harm a nursing infant. Breastfeeding while using this drug is not recommended.
Additional Information
Our Delatestryl (testosterone enanthate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
QUESTION
Testosterone is a chemical found only in men. See AnswerGet emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Tell your caregivers right away if you have a tight feeling in your throat, a sudden urge to cough, or if you feel light-headed or short of breath during or shortly after receiving the injection.
You will be watched closely for at least 30 minutes to make sure you do not have a reaction to the injection.
Call your doctor at once if you have:
- chest pain or pressure, pain spreading to your jaw or shoulder;
- shortness of breath, breathing problems at night (sleep apnea);
- swelling in your ankles or feet, rapid weight gain;
- a seizure;
- unusual changes in mood or behavior;
- increased or ongoing erection of the penis, ejaculation problems, decreased amounts of semen, decrease in testicle size;
- painful or difficult urination, increased urination at night, loss of bladder control;
- high levels of calcium in the blood--stomach pain, constipation, increased thirst or urination, muscle pain or weakness, joint pain, confusion, and feeling tired or restless; or
- high potassium level--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement;
- liver problems--right-sided upper stomach pain, vomiting, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes).
- signs of a blood clot deep in the body--swelling, warmth, or redness in an arm or leg;
- signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
- signs of a stroke--sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, balance problems.
Women receiving testosterone may develop male characteristics, which could be irreversible if treatment is continued. Call your doctor at once if you notice any of these signs of excess testosterone:
- acne;
- changes in your menstrual periods (including missed periods);
- male-pattern hair growth (such as on the chin or chest);
- hoarse or deepened voice; or
- enlarged clitoris.
Your testosterone injections may be delayed or permanently discontinued if you have certain side effects.
Common side effects (in men or women) may include:
- breast swelling;
- acne, increased facial or body hair growth, male-pattern baldness;
- increased or decreased interest in sex;
- headache, anxiety, depressed mood;
- increased blood pressure;
- numbness or tingly feeling;
- abnormal liver function tests;
- high red blood cell counts (hematocrit or hemoglobin);
- increased PSA (prostate-specific antigen); or
- pain, bruising, bleeding, redness, or a hard lump where the medicine was injected.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
SLIDESHOW
Low Testosterone (Low T) Treatments See SlideshowSIDE EFFECTS
Endocrine And Urogenital, Female - The most common side effects of androgen therapy are amenorrhea and other menstrual irregularities, inhibition of gonadotropin secretion, and virilization, including deepening of the voice and clitoral enlargement. The latter usually is not reversible after androgens are discontinued. When administered to a pregnant woman, androgens cause virilization of the external genitalia of the female fetus.
Male - Gynecomastia, and excessive frequency and duration of penile erections. Oligospermia may occur at high dosages (see CLINICAL PHARMACOLOGY).
Skin and Appendages - Hirsutism, male pattern baldness, and acne.
Cardiovascular Disorders - myocardial infarction, stroke
Fluid and Electrolyte Disturbances - Retention of sodium, chloride, water, potassium, calcium (see WARNINGS), and inorganic phosphates.
Gastrointestinal - Nausea, cholestatic jaundice, alterations in liver function tests; rarely, hepatocellular neoplasms, peliosis hepatis (see WARNINGS).
Hematologic - Suppression of clotting factors II, V, VII, and X; bleeding in patients on concomitant anticoagulant therapy; polycythemia.
Nervous System - Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia.
Metabolic - Increased serum cholesterol.
Vascular Disorders - venous thromboembolism Miscellaneous - Rarely, anaphylactoid reactions; inflammation and pain at injection site.
Drug Abuse And Dependence
Controlled Substance
DELATESTRYL contains testosterone, a Schedule III controlled substance in the Controlled Substances Act.
Abuse
Drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. Abuse and misuse of testosterone are seen in male and female adults and adolescents. Testosterone, often in combination with other anabolic androgenic steroids (AAS), and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders. There have been reports of misuse of men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice.
Abuse-Related Adverse Reactions
Serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids, and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility and aggression.
The following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility.
The following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness, and menstrual irregularities.
The following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty.
Because these reactions are reported voluntarily from a population of uncertain size and may include abuse of other agents, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Dependence
Behaviors Associated With Addiction
Continued abuse of testosterone and other anabolic steroids, leading to addiction is characterized by the following behaviors:
- Taking greater dosages than prescribed
- Continued drug use despite medical and social problems due to drug use
- Spending significant time to obtain the drug when supplies of the drug are interrupted
- Giving a higher priority to drug use than other obligations
- Having difficulty in discontinuing the drug despite desires and attempts to do so
- Experiencing withdrawal symptoms upon abrupt discontinuation of use
Physical dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug. Individuals taking supratherapeutic doses of testosterone may experience withdrawal symptoms lasting for weeks or months which include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido and hypogonadotropic hypogonadism.
Drug dependence in individuals using approved doses of testosterone for approved indications has not been documented.
Read the entire FDA prescribing information for Delatestryl (Testosterone Enanthate)
© Delatestryl Patient Information is supplied by Cerner Multum, Inc. and Delatestryl Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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