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testosterone

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Brand names: AndroGel, Testim

Androgen Hormone Rx

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

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 →

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.

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.

How to Take It

Your doctor will insert the testosterone pellets under your skin. The number of pellets you get depends on how much testosterone you need. You will likely get them every 3 to 6 months. Make sure to follow your doctor's instructions carefully.

Pregnancy & Breastfeeding

Testosterone can harm an unborn baby. You should not use this medicine if you are pregnant or may become pregnant. Talk to your doctor if you have any questions.

Missed Dose

Since the pellets are implanted, you don't have to worry about a missed dose. Talk to your doctor if you think the pellets are not working anymore.

Storage

Store at room temperature, away from heat and moisture.

Side Effects (from patient reports)

Based on 22,199 FDA adverse event reports.

Heart attack
3,269
Medication not working
2,963
Pain
2,379
Blood clot in a deep vein
2,176
Testosterone level decreased
2,093
Stroke
2,091
Blood clot in the lungs
2,028
Tiredness
2,004
Anxiety
1,647
Using the medicine for something it's not approved for
1,549

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

Death-Related Reports

1,852

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
2 DRUG INEFFECTIVE 2,963
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
10 OFF LABEL USE 1,549
11 ASTHENIA 1,440
12 ECONOMIC PROBLEM 1,209
13 HEADACHE 1,182
14 NAUSEA 1,178
15 EMOTIONAL DISTRESS 1,034

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) 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

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.

What to do: You can take these medications together without any special monitoring or dose changes.

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.

What to do: Your doctor may need to monitor your hormone levels or adjust your dosage if you take these together.

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 most commonly reported side effects of testosterone include Acne, Male-pattern baldness, Increased or decreased sex drive, Headache, Anxiety. Based on 22,199 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does testosterone interact with other medications?
Yes, testosterone has 2 known drug interactions. Notable interactions include lovastatin, medroxyprogesterone. Always inform your doctor about all medications you are taking.
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.
Is testosterone safe during pregnancy?
Testosterone can harm an unborn baby. You should not use this medicine if you are pregnant or may become pregnant. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
Has testosterone been recalled?
There are 13 recalls associated with testosterone products. CGMP Deviations: 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.

Active Recalls

Class II October 14, 2025

CGMP Deviations: Potential presence of metal particulate matter

FARMAKEIO OUTSOURCING LLC

Class II October 14, 2025

CGMP Deviations: Potential presence of metal particulate matter

FARMAKEIO OUTSOURCING LLC

Class III June 16, 2025

Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.

Qualgen, LLC

Class II April 28, 2025

Presence of Particulate Matter: Glass particles were found in pellet vials.

BSO LLC

Class II April 10, 2025

cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.

Eugia US LLC

Class II August 8, 2024

Superpotent Drug

Teva Pharmaceuticals USA, Inc

Class II March 7, 2022

Lack of Assurance of Sterility

TMC Acquisition LLC dba Tailor Made Compounding

Class II March 7, 2022

Lack of Assurance of Sterility

TMC Acquisition LLC dba Tailor Made Compounding

Class II March 7, 2022

Lack of Assurance of Sterility

TMC Acquisition LLC dba Tailor Made Compounding

Class II November 17, 2016

Lack of Assurance of Sterility

Tri-Coast Pharmacy

Class II November 17, 2016

Lack of Assurance of Sterility

Tri-Coast Pharmacy

Class II November 17, 2016

Lack of Assurance of Sterility

Tri-Coast Pharmacy

Class II May 29, 2013

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Lowlite Investments, Inc. D/B/A Olympia Pharmacy

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What the FDA Data Shows for testosterone

The FDA label for testosterone (sold under brand names such as AndroGel, Testim) classifies it as a prescription-only medication in the Androgen Hormone class. Testosterone pellets treat low testosterone in men. Official labeling lists 8 commonly reported side effects, including Acne, Male-pattern baldness, Increased or decreased sex drive.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 22,199 voluntary reports. The database also lists 2 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $1.10 versus $3.79 for the brand — a 71% generic savings.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 13 recall records on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC). Shortage status: FDA Drug Shortages Database.

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: July 17, 2025

All federal data sources used on this page