- Female-to-male (FtM) treatments use anabolic-androgenic steroid (testosterone) drugs including Androgel®, Androderm®, Depo-Testosterone®, Delatestryl®, Aveed®, Axiron®, Testim®, and Testopel®.
- This page has information from the drug labels.
- These drugs are not FDA-approved for gender transition purposes.
- The FDA in 2016 required new warnings in all prescription testosterone drug labels because of the risk of adverse psychiatric and other effects.
- Testosterone drugs may be especially dangerous for females who already have polycystic ovary syndrome (POCS) or high testosterone. Click here for information.
- Additional information about specific effects such as aggression, suicide, impaired social cognition or possible dementia is here.
Female-to-male (FtM) treatments use testosterone gel, patch, injection, and pellet drugs including Androgel®, Androderm®, Depo-Testosterone®, Delatestryl®, Aveed®, Axiron®, Testim®, and Testopel®, (see Boston University 2018; Callen-Lorde 2012; Forcier 2015; Idaho 2017; Imborek 2015; Tom Waddell Health Center 2011; Unger 2016; Warner 2017).
These are anabolic-androgenic steroid drugs (see Kersey 2012 p. 572). Anabolic-androgenic steroid (AAS) drugs “are universally recognized to have psychoactive effects.” The U.S. Food and Drug Administration (FDA) has strongly discouraged the use of anabolic-androgenic drugs due to risk of adverse brain effects and other effects.
“There are no FDA-approved testosterone…therapies for women….There are also concerns about under- or overdosing as well as side effects from these treatments” (Endocrine Society 2016).
The drugs’ labels typically say that the drugs are not to be used in males under age 18.
What Research Shows
The FDA has warned against anabolic-androgenic steroid/testosterone overuse. It has also required drug companies to include information about the dangers of these drugs on the drugs’ labels.
The FDA in 2016 approved “class-wide labeling changes for all prescription testosterone products, adding a new Warning and updating the Abuse and Dependence section.” The FDA said:
“The Anabolic Steroids Control Act of 1990 placed AAS, including testosterone, in Schedule III of the Controlled Substances Act. Testosterone and other AAS are abused by adults and adolescents….Reported serious adverse outcomes include heart attack, heart failure, stroke, depression, hostility, aggression….”
The FDA (2013) said that anabolic-androgenic steroid drugs “mimic the actions of the male sex hormone testosterone” and can cause “mood swings and aggressive behavior” in girls and boys. It said that steroids and teens are a “dangerous” combination. Moreover, it said that anabolic-androgenic drugs “are known to have a range of serious adverse effects on many organ systems, and in many cases the damage is not reversible” (FDA 2013).
The National Institute on Drug Abuse (2016) said that abuse of anabolic steroids may lead to mental problems and behavioral problems such as paranoid jealousy, extreme irritability, delusions (false beliefs or ideas), extreme mood swings, ‘roid rage, and “angry feelings and behavior that may lead to violence.”
The FDA (2017) said that people should immediately stop using body building products that contain steroid ingredients:
“anabolic steroids have been associated with serious reactions such as…altered mood, irritability, increased aggression, and depression….
If you’re taking any body building products that claim to contain steroids or steroid-like substances, FDA recommends that you stop taking them immediately.”
The National Institute on Drug Abuse (2018a) noted that steroid use in the teen years might harm brain development. It said that
“steroid use in teens is of concern, especially since the hormonal systems they interact with play a critical role in brain development during these years….[Medical research] suggests that pubertal steroid exposure could produce long-lasting structural changes in certain brain regions.”
FtM treatments may be extremely dangerous, especially for patients who already have autism, psychiatric disorders, high testosterone or chronic excess testosterone conditions such as polycystic ovary syndrome (PCOS). Click here for information about the association of autism and psychiatric disorders with PCOS and high testosterone in females.
Information about specific drugs is below:
The drug label for Androgel (updated Nov. 3, 2017) says that the drug is not for women, may not be safe for patients under age 18, and has been reported to cause psychiatric problems:
“Due to the lack of controlled evaluations in women and potential virilizing effects, AndroGel 1.62% is not indicated for use in women….
6.2 Postmarketing Experience
The following adverse reactions have been identified during post approval use of AndroGel 1%….
Psychiatric Disorders: Amnesia, anxiety, depression, hostility, emotional lability, decreased libido, nervousness….
The safety and effectiveness of AndroGel 1.62% in pediatric patients less than 18 years old has not been established. Improper use may result in acceleration of bone age and premature closure of epiphyses.”
The drug label for Androderm (updated Oct. 8, 2016) says:
“5.5…consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events….
5.6 Women and children should not use ANDRODERM. Use in women and children has not been studied with ANDRODERM….
Serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids and include…serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility and aggression.”
The drug label for Aveed testosterone undecanoate injection (updated Jan. 31, 2018) says:
“Aveed is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone….
5.8 Use in Women
Due to lack of controlled evaluations in women and potential virilizing effects, Aveed is not indicated for use in women.
6.2 Postmarketing Experience
The following treatment emergent adverse events or adverse reactions have been identified during post-marketing clinical trials and during post-approval use of intramuscular testosterone undecanoate. In most cases, the dose being used was 1000 mg….
Psychiatric Disorders: aggression, anxiety, depression, insomnia, irritability, Korsakoff’s psychosis non-alcoholic, male orgasmic disorder, nervousness, restlessness, sleep disorder.”
The drug label for Axiron (updated July 18, 2018) says:
“AXIRON is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.”
The drug label for Depo-Testosterone (updated Aug. 29, 2018) says:
“DEPO-Testosterone Injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone….
The following adverse reactions in the male have occurred with some androgens:
Nervous system: Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia.”
The drug label for Testim (updated Apr. 30, 2018) says:
“Testim is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.”
The drug label for Testopel (updated Aug. 24, 2018) says:
“The following adverse reactions have been identified during post-approval use of testosterone replacement therapy, including TESTOPEL®….
Nervous System. Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia.”