Testosterone Replacement Therapy Side Effects and Safety: What the FDA Record Shows

Testosterone Replacement Therapy Side Effects are documented on the FDA prescribing label, and reported separately by patients and doctors to the FDA’s adverse event system. This page sets out what the official record actually says about Testosterone Replacement Therapy: what it is approved to treat, what the label warns about, its recall history, and what the reported side effects are — along with what those figures do and do not mean.

What Testosterone Replacement Therapy Is Prescribed For, and Where Testosterone Replacement Therapy Side Effects Come From

According to the FDA label, estosterone gel 1.62% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. […]

Two separate official sources describe testosterone replacement therapy side effects. The prescribing label records what was observed in clinical trials, where the drug was compared against a control group. The FDA’s adverse event database records what patients and clinicians have reported since approval, which is a much larger but far less controlled picture. Both appear below, and they answer different questions.

The FDA Boxed Warning on Testosterone Replacement Therapy

A boxed warning is the most serious warning the FDA requires on a prescription label. It does not mean the medicine should not be used. It means there is a specific risk serious enough that the FDA requires it to appear at the very top of the prescribing information, so that prescribers weigh it deliberately for each patient.

Prescribers see this warning every time they consult the label. If it concerns you, it is a reasonable thing to raise at your next appointment and ask how it applies to your own situation.

Warnings Beyond the Common Testosterone Replacement Therapy Side Effects

The label’s warnings and precautions section describes risks the FDA requires prescribers to weigh. For Testosterone Replacement Therapy it covers: onitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH ( 5.1 ) Avoid unintentional exposure of women or children to testosterone gel 1.62%.

Secondary exposure to testosterone can produce signs of virilization. Testosterone gel 1.62% should be discontinued until the cause of virilization is identified ( 5.2 ) Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients using testosterone products.

Evaluate patients with signs or symptoms consistent with DVT or PE. ( 5.4 ) Some postmarketing studies have shown an increased risk of myocardial infarction and stroke associated with use of testosterone replacement therapy. […]

These are the risks the FDA has judged significant enough to state formally, and they sit apart from the routine testosterone replacement therapy side effects most people ask about. They apply to different patients to very different degrees, which is why the same medicine can be routine for one person and unsuitable for another.

Testosterone Replacement Therapy Side Effects Listed on the FDA Label

The label’s adverse reactions section records what was observed in clinical trials: he most common adverse reaction (incidence ≥ 5%) is an increase in prostate specific antigen (PSA). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Prasco Laboratories at 1-866-525-0688 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Testosterone gel 1.62% was evaluated in a two-phase, 364-day, controlled clinical study. The first phase was a multi-center, randomized, double-blind, parallel-group, placebo-controlled period of 182 days, in which 234 hypogonadal men were treated with testosterone gel 1.62% and 40 received placebo. […]

Trial data is the most reliable source for how common testosterone replacement therapy side effects are, because the people taking the drug were compared against people who were not. A symptom that appeared just as often in the control group is not caused by the medicine.

Reported Testosterone Replacement Therapy Side Effects in the FDA Database

Who the Label Says Should Take Extra Care

Contraindications. The label states that Testosterone Replacement Therapy should not be used in certain situations: estosterone gel 1.62% is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )].

Testosterone gel 1.62% is contraindicated in women who are pregnant. Testosterone gel 1.62% can cause virilization of the female fetus when administered to a pregnant woman. Pregnant women need to be aware of the potential for transfer of testosterone from men treated with testosterone gel 1.62%. […]

Interactions with other medicines. ndrogens may decrease blood glucose and therefore may decrease insulin requirements in diabetic patients ( 7.1 ) Changes in anticoagulant activity may be seen with androgens. More frequent monitoring of International Normalized Ratio (INR) and prothrombin time is recommended ( 7.2 ) Use of testosterone with adrenocorticotrophic hormone (ACTH) or corticosteroids may result in increased fluid retention. […]

Older adults. 8.5 Geriatric Use There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing testosterone gel 1.62% to determine whether efficacy in those over 65 years of age differs from younger subjects. Of the 234 patients enrolled in the clinical trial utilizing testosterone gel 1.62%, 21 were over 65 years of age. […]

Your pharmacist can check your full medicine list against this in a couple of minutes, including anything bought over the counter, and that check is free.

Testosterone Replacement Therapy Recall History

The FDA enforcement database records 25 recall entries involving Testosterone Replacement Therapy products (17 Class II, 8 Class III). A recall almost always concerns specific manufactured batches rather than the medicine itself, and different manufacturers of the same generic drug have separate recall records.

The FDA classifies recalls by how serious the potential consequence is. Class I means a reasonable probability of serious harm or death; Class II means temporary or reversible harm is possible; Class III means the product breaks a regulation but is unlikely to cause harm.

If a batch you have was recalled, the pharmacy that dispensed it is the fastest way to find out and to get a replacement. Do not simply stop taking a prescribed medicine because a recall notice exists — the recall may not affect your batch, and stopping can carry its own risk.

Is Testosterone Replacement Therapy the Subject of Litigation?

As of the date on this page, we are not tracking consolidated federal litigation over Testosterone Replacement Therapy. Safety questions have been raised about this medicine, and questions being raised is not the same thing as a case being filed or proven.

We monitor federal court filings and FDA safety communications, and this page is updated when the record changes. Our active case pages list the drug and device litigation currently underway.

If You Are Worried About Testosterone Replacement Therapy Side Effects

Concern about testosterone replacement therapy side effects is a good reason to have a conversation, and not a reason to act alone. Do not stop taking a prescribed medicine, or change how you take it, because of anything you read here. Talk to the prescriber or pharmacist who knows your medical history first. Stopping some medicines abruptly carries risks of its own, and your prescriber can tell you whether that applies to yours.

Write down what you have noticed and when it started before the appointment. Not everything that happens while taking a medicine is one of its testosterone replacement therapy side effects, and a specific account — what changed, when, and how often — is what lets a clinician tell the difference.

You can also report a side effect directly to the FDA through MedWatch. Reports from patients are part of how safety signals are detected, and filing one takes a few minutes.

Frequently Asked Questions

What are the most commonly reported testosterone replacement therapy side effects?

In FDA reports, the most frequently mentioned are myocardial infarction, pain, fatigue. The label’s own adverse reactions section, drawn from clinical trials, is the better guide to how common a side effect actually is, because reports to the FDA are not collected in a way that supports rates.

Has Testosterone Replacement Therapy been recalled?

There are 25 recall records for Testosterone Replacement Therapy products, the most recent dated 2025-12-10. Recalls generally affect specific manufactured batches rather than the medicine as a whole. Your pharmacy can tell you whether a batch you have was affected.

Does Testosterone Replacement Therapy have a boxed warning?

Yes. The boxed warning is reproduced above. It is the most serious warning the FDA requires, and it exists so that prescribers weigh a specific risk for each patient rather than overlooking it.

Do the FDA report numbers tell me how common these testosterone replacement therapy side effects are?

No. Reports are unverified, anyone can file one, and the total mostly reflects how many people take the medicine and how much attention it is getting. A high count is not evidence of danger, and a low one is not evidence of safety. Clinical trial data on the label is the source that supports rates.

Where can I check testosterone replacement therapy side effects for the exact product I have?

DailyMed holds the current FDA label for every marketed product, searchable by the name on your packaging. Different manufacturers and formulations of the same medicine can have slightly different labels, so checking the one you actually have is worth the two minutes.

Official Sources

• DailyMed (National Library of Medicine) — the current FDA prescribing label for every product
• FDA Adverse Event Reporting System dashboard — the public report data summarised above
• FDA recalls and safety alerts — current recall notices
• FDA MedWatch — how to report a side effect yourself

Related Guides

• All Drug Safety Profiles
• Drug Safety Explainers
• Product Recalls
• Active Case Pages

Medical and legal disclaimer. This page summarises publicly available FDA data about Testosterone Replacement Therapy and is general information, not medical advice, and not legal advice. It is not a substitute for the judgement of a clinician who knows your medical history. Nothing here states that Testosterone Replacement Therapy caused any illness or injury in any individual.

Adverse event reports are unverified and do not establish causation. FDA labels are revised regularly; confirm current information on DailyMed or with your pharmacist. Do not stop taking a prescribed medicine, or change how you take it, because of anything you read here. Talk to the prescriber or pharmacist who knows your medical history first.