Prescription medication · Androgen Hormone

testosterone

Name: testosterone - FDA Drug Safety & Adverse Event Data
Creator: PlainMeds
License: https://creativecommons.org/publicdomain/zero/1.0/

Also sold as AndroGel, Testim. Testosterone pellets treat low testosterone in men.

Compiled by PlainMeds, Drug Information Editorial Process

Data updated 2026-05-15

40,954
FDA reportsOften reported: 2
InteractionsFew interactions: 71% less
Generic vs brandBig savings: In shortage
FDA status

What the data shows

testosterone (AndroGel) is a prescription Androgen Hormone, reported at a middle-of-the-pack volume (40,954 FDA reports), whose generic runs roughly half the brand price or less (71% less).

Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.

testosterone (AndroGel) is a prescription Androgen Hormone. Testosterone pellets treat low testosterone in men.

Testosterone pellets (Testopel) are a hormone replacement therapy. They help men who don't produce enough testosterone on their own.

Verify with FDA → · CMS NADAC pricing →

Drug Shortage Alert

testosterone is currently listed as to be discontinued by the FDA. Affected manufacturer: Actavis Pharma, Inc..

View all drug shortages →

Drug Pricing (NADAC)

Brand Price

$3.79/unit

Generic Price

$1.10/unit

Generic Savings

71%

Generic Available

Yes (30 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

NADAC price trail: TESTOSTERONE 1% (25 MG/2.5 G) PK

Same CMS presentation as the headline generic unit price above (2 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: +7.3% vs prior release.

Effective	NADAC / unit	vs prior	NDCs
April 17, 2024	$1.02/GM	-	1
December 18, 2024	$1.10/GM	+7.3%	2

Compare with Another Drug → Full Side Effects Report →

What it does

Testosterone pellets treat low testosterone in men.

Common side effects

Acne, Male-pattern baldness, Increased or decreased sex drive

Key warnings

Testosterone pellets can cause blood clots in your veins.

The sections below are summarized in plain English from testosterone's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.

How It Works

Testosterone is a male sex hormone. These pellets are implanted under the skin and slowly release testosterone into your body. This helps to restore normal testosterone levels.

Side Effects (from patient reports)

Based on 40,954 FDA adverse event reports.

Myocardial Infarction

3,269
Pain

2,379
Deep Vein Thrombosis

2,176
Blood Testosterone Decreased

2,093
Cerebrovascular Accident

2,091
Pulmonary Embolism

2,028
Fatigue

2,004
Anxiety

1,647
Asthenia

1,440
Economic Problem

1,209

What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.

Reports over time

Adverse-event reports filed for testosterone each year to the FDA Adverse Event Reporting System (FAERS).

Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.

Where testosterone sits

testosterone has more FDA adverse-event reports than 70% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.

fewest reports most reports

Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is testosterone; the line is the median (50th percentile).

FDA Adverse Event Report Analysis

Detailed analysis of 40,954 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.

Total Reports

40,954

Reports Mentioning Death

1,852

4.5% of reports — not proof of cause

Hospitalization Reports

9,033

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 3,659 (10%)

Male 34,487 (90%)

Age Distribution

0–17 555

18–44 3,952

45–64 10,318

65–74 3,762

75+ 1,584

Most Reported Adverse Reactions (FAERS)

#	Reaction	Reports
1	MYOCARDIAL INFARCTION	3,269
3	PAIN	2,379
4	DEEP VEIN THROMBOSIS	2,176
5	BLOOD TESTOSTERONE DECREASED	2,093
6	CEREBROVASCULAR ACCIDENT	2,091
7	PULMONARY EMBOLISM	2,028
8	FATIGUE	2,004
9	ANXIETY	1,647
11	ASTHENIA	1,440
12	ECONOMIC PROBLEM	1,209
13	HEADACHE	1,182
14	NAUSEA	1,178
15	EMOTIONAL DISTRESS	1,034
16	INJURY	1,023
17	THROMBOSIS	976

Reactions in Death Reports

DEATH 617

MYOCARDIAL INFARCTION 366

CARDIAC ARREST 139

PULMONARY EMBOLISM 138

PAIN 127

CEREBROVASCULAR ACCIDENT 115

INJURY 80

DEEP VEIN THROMBOSIS 76

ANXIETY 75

PNEUMONIA 74

Reactions in Hospitalization Reports

MYOCARDIAL INFARCTION 1,149

PAIN 1,011

PULMONARY EMBOLISM 1,002

DEEP VEIN THROMBOSIS 922

CEREBROVASCULAR ACCIDENT 899

ANXIETY 716

ECONOMIC PROBLEM 530

ACUTE MYOCARDIAL INFARCTION 495

THROMBOSIS 451

INJURY 414

Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Testosterone pellets can cause blood clots in your veins. This includes clots in your legs (deep vein thrombosis) and lungs (pulmonary embolism). Tell your doctor right away if you have pain, swelling, warmth, or redness in your leg, or if you have trouble breathing or chest pain.

Known Drug Interactions

minor lovastatin

However, clinical studies have shown that lovastatin does not reduce basal plasma cortisol concentration or impair adrenal reserve, and does not reduce basal plasma testosterone concentration. Another HMG-CoA reductase inhibitor has been shown to reduce the plasma testosterone response to HCG. In the same study, the mean testosterone response to HCG was slightly but not significantly reduced after treatment with lovastatin 40 mg daily for 16 weeks in 21 men.

Mechanism: Lovastatin does not significantly lower the amount of testosterone in your blood or stop your body from making it.

minor medroxyprogesterone

The following laboratory tests may be affected by progestins including medroxyprogesterone acetate injectable suspension: (a) Plasma and urinary steroid levels are decreased (e.g., progesterone, estradiol, pregnanediol, testosterone, cortisol).

Mechanism: Medroxyprogesterone can lower the amount of testosterone found in your blood and urine.

This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.

Common Questions

What if I experience prolonged erections?

Tell your doctor if you have erections that happen too often or last too long.

Can this medicine cause liver problems?

Yes, this medicine can sometimes cause liver problems. Your doctor will monitor your liver function.

Will this medicine affect my fertility?

High doses of testosterone can lower your sperm count.

Can this medicine cause mood changes?

Yes, some people experience anxiety or depression while taking this medicine.

How often will I need to get the pellets implanted?

You will likely need to get the pellets implanted every 3 to 6 months.

Can this medicine cause my body to retain fluid?

Yes, this medicine can cause your body to retain fluid, including sodium, chloride, water, potassium, calcium and inorganic phosphates.

Can testosterone pellets be used for age-related low testosterone?

No, the safety and effectiveness of testosterone pellets for age-related low testosterone have not been established.

What should I do if the implantation site gets infected?

Contact your doctor immediately if you notice any signs of infection at the implantation site, such as redness, swelling, or pus.

Can this medication cause breast enlargement?

Yes, this medication can cause breast enlargement in men (gynecomastia).

Can this medication cause changes in my skin?

Yes, this medication can cause acne, oily skin, and increased hair growth.

What are the common side effects of testosterone?

The registry lists Acne, Male-pattern baldness, Increased or decreased sex drive, Headache, Anxiety among the most-reported FAERS reaction terms for testosterone. The compiled record contains 40,954 FDA adverse-event reports. These counts are not an individual symptom assessment.

Does testosterone interact with other medications?

The registry has 2 documented interaction rows for testosterone. Notable source-record pairings include lovastatin, medroxyprogesterone. These rows are not a complete medication review.

What drug class is testosterone?

testosterone belongs to the Androgen Hormone drug class. It requires a prescription (Rx). Testosterone pellets treat low testosterone in men.

Is there a generic version of testosterone?

Yes, generic testosterone is available from 30 manufacturers. The generic costs $1.10 per unit compared to $3.79 for the brand version, saving approximately 71%. Pricing is based on NADAC (National Average Drug Acquisition Cost) data from CMS.

What pregnancy or breastfeeding source fields are listed for testosterone?

The FDA label for testosterone contains product-specific pregnancy or breastfeeding language. PlainMeds does not apply that source text to an individual.

Has testosterone been recalled?

There are 28 recalls associated with testosterone products. Presence of Foreign substance - potential presence of metal particulate matter. Check the recalls section below for full details and affected products.

Is testosterone currently in shortage?

Yes, testosterone is currently listed as to be discontinued by the FDA. Affected manufacturer: Actavis Pharma, Inc.. Visit the FDA Drug Shortages database for the latest updates.