testosterone
Brand names: AndroGel, Testim
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.
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
Age Distribution
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
Reactions in Hospitalization Reports
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?
Can this medicine cause liver problems?
Will this medicine affect my fertility?
Can this medicine cause mood changes?
How often will I need to get the pellets implanted?
Can this medicine cause my body to retain fluid?
Can testosterone pellets be used for age-related low testosterone?
What should I do if the implantation site gets infected?
Can this medication cause breast enlargement?
Can this medication cause changes in my skin?
What are the common side effects of testosterone?
Does testosterone interact with other medications?
What drug class is testosterone?
Is there a generic version of testosterone?
Is testosterone safe during pregnancy?
Has testosterone been recalled?
Is testosterone currently in shortage?
Active Recalls
CGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC
CGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC
Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
Qualgen, LLC
Presence of Particulate Matter: Glass particles were found in pellet vials.
BSO LLC
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Eugia US LLC
Superpotent Drug
Teva Pharmaceuticals USA, Inc
Lack of Assurance of Sterility
TMC Acquisition LLC dba Tailor Made Compounding
Lack of Assurance of Sterility
TMC Acquisition LLC dba Tailor Made Compounding
Lack of Assurance of Sterility
TMC Acquisition LLC dba Tailor Made Compounding
Lack of Assurance of Sterility
Tri-Coast Pharmacy
Lack of Assurance of Sterility
Tri-Coast Pharmacy
Lack of Assurance of Sterility
Tri-Coast Pharmacy
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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Medication Guides
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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
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages