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Testosterone

Testosterone is a male hormone (androgen) used as replacement therapy for adult men whose bodies make too little or no testosterone, and it comes as injections, pellets, capsules, gels, a nasal gel and more.

Brand names JatenzoAndrodermAveedNatestoFortesta +11 more
Drug classes Androgen Receptor Agonists
Rx Schedule CIII Forms 7
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 49 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026 🚨Recall on record · 4
Other forms & routes:
Testosterone at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Testosterone is the main male hormone, used as replacement for adult men with confirmed hypogonadism (too little testosterone of their own). It is a familiar standby, on the U.S. market since about 1979 and available generically as injections, gels, patches, capsules and a nasal gel. Most men tolerate it well, usually noticing acne, mood swings or skin irritation under a gel or patch. The gels carry a boxed warning because children or women who touch unwashed skin can develop male traits, so wash your hands and keep the site covered. Expect regular checks of PSA (a prostate blood test), blood counts and blood pressure, since it can thicken the blood and raise clot risk.

Clinical pearls

  • Aveed carries a boxed warning for oil reaching the lungs and severe allergic reactions, so stay 30 minutes after each shot.
  • Testosterone can lower sperm count, possibly permanently, so raise it before starting if you still hope to father children.
  • Testosterone can lower blood sugar on insulin and alter oral blood thinners, so expect closer sugar and INR (clotting) checks.
  • Alcohol-based gels are flammable until dry, so let them dry fully before going near flames or lighting a cigarette.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Testosterone gel can transfer to children and women through skin contact, and children can develop virilization (early male traits).

Reported signs in children include enlarged penis or clitoris, pubic hair growth, more erections and libido, aggressive behavior and advanced bone age. Most cases improved when exposure stopped, but in a few, genitals stayed enlarged and bone age remained somewhat advanced.

Children should avoid contact with unwashed or unclothed application sites. Follow the instructions for use exactly. Tell a doctor if you notice these signs in a child.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asInjection, Topical cream, ointment or gel, Topical (transdermal) gel +4
Earliest FDA record1953
Companies listing it with the FDA37
FDA label last updatedJul 1, 2025
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Testosterone, written from its FDA label.

What Testosterone is used for

▾

Testosterone products are used for replacement therapy in men with low or absent natural testosterone.

  • Primary hypogonadism (testicular failure from causes such as undescended testicles, testicular torsion, infection, or testicle removal).
  • Hypogonadotropic hypogonadism (pituitary or hypothalamus problem, such as from tumors, trauma or radiation).
  • Several products (for example Aveed, AndroGel 1.62%, Testim, Vogelxo, Natesto, Jatenzo, Kyzatrex, Tlando) are labeled for adult men.
  • Testopel pellets are also mentioned for stimulating puberty in carefully selected males with clearly delayed puberty.
  • Several labels note that safety and effectiveness for age-related (late-onset) hypogonadism have not been established.

How Testosterone works

▾

Testosterone and DHT are natural androgens. They drive growth of the prostate and male sex organs, and maintain traits like body and facial hair, voice depth, and muscle and fat distribution.

In hypogonadism, the testicles (primary) or the brain's signaling (secondary) fail to produce enough testosterone. Replacement products supply the missing hormone.

Testosterone dosage

▾

The way testosterone is taken depends on the product, so follow your own label and prescriber.

  • Capsules (Jatenzo, Kyzatrex): by mouth with food, twice daily.
  • Gels (AndroGel, Testim, Vogelxo): once daily on clean, dry skin of the shoulders and/or upper arms.
  • Natesto: nasal gel, three times daily.
  • Aveed: deep intramuscular injection, given in a healthcare setting.
  • Xyosted: weekly subcutaneous injection.

Blood testosterone levels are checked after starting to guide adjustments.

Dosing details from the FDA-approved label

From the Testosterone prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • AndroGel 1.62% - hypogonadism in adult males (starting dose and dose adjustment)
    • Starting dose 40.5 mg of testosterone (2 pump actuations or a single 40.5 mg packet) applied topically once daily in the morning to clean, dry, intact skin of the shoulders and upper arms
    • Can be dose adjusted between a minimum of 20.25 mg (1 pump actuation or a single 20.25 mg packet) and a maximum of 81 mg
    • Titrate based on pre-dose morning serum testoster
    • Maximum: 81 mg of testosterone (4 pump actuations or two 40.5 mg packets)
    • Confirm hypogonadism with morning serum testosterone on at least two separate days before starting; do not apply to abdomen, genitals, chest, armpits, or knees; not substitutable with other topical testosterone products
  • Vogelxo - hypogonadism in adult males (starting dose and dose adjustment)
    • Starting dose 50 mg of testosterone (one tube, one packet, or 4 pump actuations) applied topically once daily at approximately the same time each day to clean, dry, intact skin of the shoulders and/or upper arms
    • Measure morning pre-dose serum testosterone approximately 14 days after initiation
    • If below the normal range (300 ng/dL to 1,000 ng/dL), the daily
    • Maximum: 100 mg once daily
    • Confirm hypogonadism with morning serum testosterone on at least two separate days before starting; do not apply to genitals or abdomen
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Prior to initiating AVEED, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least 2 separate days and that these serum testosterone concentrations are below the normal range. Prior to initiating Aveed, confirm the diagnosis of hypogonadism by ensuring that serum testosterone has been measured in the morning on at least two separate days and that these concentrations are below the normal range ( 2 ). For intramuscular use only ( 2.1 ). Three (3) mL (750 mg) is to be injected intramuscularly at initiation, at 4 weeks, and every 10 weeks thereafter ( 2.1 ). Following each injection of Aveed, observe patients in the healthcare setting for 30 minutes in order to provide appropriate medical treatment in the event of serious POME reactions or anaphylaxis ( 2.3 ). Inject Aveed deeply into the gluteal muscle following the usual precautions for intramuscular administration of oily solutions ( 2.3 ). 2.1 Dosage AVEED is for intramuscular use only. Dosage titration is not necessary. Inject AVEED deeply into the gluteal muscle following the usual precautions for intramuscular administration; care must be taken to avoid intravascular injection [see Dosage and Administration ( 2.3 )] . Intravascular injection of AVEED may lead to POME [see Warnings and Precautions ( 5.1 )]. The recommended dose of AVEED is 3 mL (750 mg) injected intramuscularly, followed by 3 mL (750 mg) injected after 4 weeks, then 3 mL (750 mg) injected every 10 weeks thereafter. 2.2 Preparation Instructions Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Carefully remove the gray plastic cap from the top of the vial by lifting it up from the edges with your fingers or by pushing the bottom edge of the cap upward using the top of your thumb. Remove only the gray plastic cap while leaving the aluminum metal ring and crimp seal around the gray rubber stopper in place. To facilitate the removal of medication from the vial, attach an 18-gauge needle and draw 3 mL of air into the syringe. Hold the needle at a 45° angle to the stopper with the bevel in the up orientation. Inject through the gray rubber stopper into the vial to create positive pressure within the vial chamber.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Testosterone side effects

▾

The most common effects reported in gel studies include:

Common side effects

  • Increased PSA (a prostate blood test)
  • Mood swings or emotional changes
  • High blood pressure
  • Higher red blood cell counts (hematocrit or hemoglobin)
  • Skin irritation (contact dermatitis)
  • Acne
  • Frequent urination
  • High cholesterol or other blood fats

When to get medical help

  • Call your doctor if you have leg pain, swelling, warmth or redness, which can signal a blood clot (deep vein thrombosis).
  • Get emergency help for sudden shortness of breath, which can signal a clot in the lung.
  • Seek help for signs of heart attack or stroke.
  • Tell your doctor about worsening urinary symptoms (such as trouble urinating or weak stream) from an enlarged prostate.
  • Tell your doctor if swelling, or swelling with heart failure symptoms, develops.
  • Report a prolonged erection (priapism).
  • If a child or woman around you shows signs of testosterone exposure, call a doctor and stop the gel until the cause is found.

Testosterone warnings and precautions

▾
  • Secondary exposure (boxed warning): gel can transfer to children and women and cause virilization.
  • Blood clots (DVT, pulmonary embolism) have been reported.
  • Blood pressure can rise; gel is not recommended for uncontrolled high blood pressure.
  • Red blood cell counts can rise (polycythemia), which may raise clot risk.
  • May worsen BPH; may raise the risk of prostate cancer.
  • May cause fluid retention, sleep apnea, breast enlargement and lipid changes.
  • May reduce sperm count and fertility.
  • Abuse at high doses can cause serious heart and mental health problems.
  • Alcohol-based gels are flammable until dry.

Testosterone interactions

▾

Testosterone can affect some other medicines.

  • Insulin: may lower blood sugar and reduce insulin needs.
  • Oral blood thinners: effect may change; INR and prothrombin time need closer monitoring.
  • Corticosteroids or ACTH: may increase fluid retention, especially with heart, kidney or liver disease.

Interactions listed in the FDA-approved label

From the Testosterone prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Insulin: Changes in insulin sensitivity or glycemic control may occur with androgens; in diabetic patients the metabolic effects of androgens may decrease blood glucose and therefore may decrease insulin requirements.
  • Oral anticoagulants: Changes in anticoagulant activity may be seen with androgens. More frequent monitoring of INR and prothrombin time is recommended in patients taking anticoagulants, especially at the initiation and termination of androgen therapy.
  • Corticosteroids / adrenocorticotropic hormone (ACTH): Concurrent use of testosterone with ACTH or corticosteroids may result in increased fluid retention. Requires careful monitoring, particularly in patients with cardiac, renal or hepatic disease.
Read the label’s full interactions text

7 DRUG INTERACTIONS Androgens 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 in patients taking warfarin ( 7.2 ). Use of testosterone with corticosteroids may result in increased fluid retention. Use with caution, particularly in patients with cardiac, renal, or hepatic disease ( 7.3 ). Concomitant administration of medications that are known to increase BP with XYOSTED may lead to additional increases in BP ( 7.4 ). 7.1 Insulin Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may necessitate a decrease in the dose of anti-diabetic medication. 7.2 Oral Anticoagulants Changes in anticoagulant activity may be seen with androgens, therefore more frequent monitoring of international normalized ratio (INR) and prothrombin time are recommended in patients taking warfarin, especially at the initiation and termination of androgen therapy. 7.3 Corticosteroids The concurrent use of testosterone with corticosteroids may result in increased fluid retention and requires careful monitoring, particularly in patients with cardiac, renal or hepatic disease. 7.4 Medications that May Also Increase Blood Pressure Some prescription medications and nonprescription analgesic and cold medications contain drugs known to increase blood pressure. Concomitant administration of these medications with XYOSTED may lead to additional increases in blood pressure.

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Testosterone

▾
  • Not for men with breast cancer or known or suspected prostate cancer (gel).
  • Not for pregnant women; gel can harm a fetus, and pregnant women should avoid contact.
  • Not indicated for use in women.
  • Tell your doctor about BPH, sleep apnea, high blood pressure, or heart, kidney or liver disease.
  • Safety in people under 18 has not been established for most products.
  • Older men: limited long-term safety data on heart disease and prostate cancer risk.
  • Fertility may be reduced, possibly irreversibly.

Testosterone overdose

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One report of overdose after an injectable testosterone showed very high levels linked to a stroke. For gel, treatment is stopping it, washing the site with soap and water, and supportive care.

How your body processes Testosterone

▾

Testosterone gel 1.62% delivers testosterone through the skin for 24 hours after a once-daily application, producing levels near normal. In the blood, testosterone is mostly bound to proteins, and the liver inactivates it. Active breakdown products include estradiol and DHT. Most of an injected dose leaves in urine, with some in stool. After gel is stopped, levels return to baseline within 48 to 72 hours.

How to store Testosterone

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Testosterone Enanthate Injection should be stored at 20º to 25ºC (68º to 77ºF) . at low temperatures.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

170

Supplements & herbs that interact with Testosterone

170 supplements and herbal products have documented interactions with Testosterone in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 5
  • Moderate · 129
  • Minor · 36
Every supplement checked against Testosterone — ranked by severity The full interaction hub: 5 major · 129 moderate · 36 minor · every one linked to its full report. Check Testosterone against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Testosterone: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Testosterone — the kind of thing our pharmacy team would talk through with you at the counter.

What is testosterone replacement for?

▾
It's for adult men whose bodies make too little testosterone, called hypogonadism. Your doctor should confirm this with morning blood tests on at least two different days before starting.

How do I keep my family safe if I use a gel?

▾
Testosterone gel can pass to others through skin contact. Children and women should avoid touching unwashed or unclothed application sites, and you should follow the instructions for use exactly. If a child shows signs like early pubic hair or enlarged genitals, call a doctor.

What side effects should I expect?

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Common ones include a higher PSA, mood changes, acne, higher blood pressure and skin irritation. Your doctor will check blood tests such as PSA and blood counts and monitor your blood pressure.

When should I call my doctor right away?

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Call for leg pain, swelling or redness, sudden shortness of breath, signs of heart attack or stroke, or trouble urinating. These can signal a blood clot or other serious problem.

Does it interact with my other medicines?

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It can. Tell us if you take insulin, blood thinners or corticosteroids. Insulin needs may drop, blood thinner levels may need extra INR checks, and steroids may add to fluid retention.

Will it affect fertility?

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It can lower sperm production and may reduce fertility, sometimes permanently. Talk to your doctor first if you want to have children.

Is Testosterone available over the counter?

▾
No. Testosterone is a prescription medicine: every Testosterone product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

Is Testosterone a controlled substance?

▾
Yes — Testosterone is a federally controlled substance (Schedule III) in the United States, so how it is prescribed, refilled and dispensed is regulated by the DEA.

When was Testosterone first available?

▾
The earliest FDA record we hold for Testosterone is from 1953: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Testosterone was first used.

Who makes Testosterone?

▾
37 companies currently list Testosterone products in the FDA's NDC Directory, including Bryant Ranch Prepack, Asclemed USA, Inc., Actavis Pharma, Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Testosterone on HelloPharmacist

Detailed data & references for Testosterone Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Testosterone forms and strengths (how it comes)

Testosterone is available in 7 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

By injection · Into a muscle · Under the skin
Brands Aveed Azmiro Depo-Testosterone Testopel Testosterone Cypionate Xyosted
How this form is used
What it may be used for
  • Aveed and Azmiro are used for testosterone replacement in men with hypogonadism.
  • Depo-Testosterone, Testone CIK and Testosterone Cypionate are used for replacement therapy in men with primary or hypogonadotropic hypogonadism.
  • Testopel pellets (placed under the skin) are also mentioned for stimulating puberty in carefully selected males with clearly delayed puberty.
Important instructions
  • Aveed is injected deep into the gluteal (buttock) muscle, and you are observed for 30 minutes afterward for serious reactions.
  • Azmiro is given by a healthcare professional as a deep gluteal injection; injectable testosterone products are not substitutable milligram for milligram.
Available strengths 10 strengths
Show 4 more strengths Show fewer strengths
127 FDA-listed product records ⓘ

Topical cream, ointment or gel

On the skin
Brands Vogelxo
How this form is used
What it may be used for
  • Vogelxo is used for testosterone replacement in adult men with primary or hypogonadotropic hypogonadism.
Important instructions
  • Vogelxo is applied once daily at about the same time each day to clean, dry skin of the shoulders and/or upper arms, not the genitals or abdomen.
Available strengths 6 strengths
47 FDA-listed product records ⓘ

Topical (transdermal) gel

Through the skin
Brands Testim
How this form is used
What it may be used for
  • AndroGel 1.62% and Testim are used for testosterone replacement in adult men with primary or hypogonadotropic hypogonadism.
Important instructions
  • Testim is applied once daily to clean, dry skin of the shoulders and/or upper arms, not the genitals or abdomen.
  • AndroGel 1.62% dosing differs from AndroGel 1%, so follow the label for your strength.
Available strengths 6 strengths
36 FDA-listed product records ⓘ

Capsule

By mouth
Brands Jatenzo Kyzatrex Tlando
How this form is used
What it may be used for
  • Jatenzo, Kyzatrex and Tlando are used for testosterone replacement in adult men with primary or hypogonadotropic hypogonadism.
Important instructions
  • Jatenzo and Kyzatrex are taken by mouth with food, in the morning and evening.
  • Kyzatrex is not substitutable with other oral testosterone undecanoate products.
Available strengths 7 strengths
Show 1 more strength Show fewer strengths
25 FDA-listed product records ⓘ

Topical solution

On the skin
Available strengths 1 strength
19 FDA-listed product records ⓘ

Nasal topical

In the nose
Brands Natesto
How this form is used
What it may be used for
  • Natesto is used for testosterone replacement in adult men with primary or hypogonadotropic hypogonadism.
Important instructions
  • Natesto is applied inside the nose, one pump per nostril, three times daily.
Available strengths 1 strength
5 FDA-listed product records ⓘ

Oral solution

By mouth
Available strengths 1 strength
1 FDA-listed product record ⓘ

Testosterone on the U.S. market: products, makers and brands

How Testosterone appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

37 companies list 119 Testosterone product records with the FDA, mostly as injection, topical cream, ointment or gel, topical (transdermal) gel; the earliest marketing or approval year on record is 1953. Brand names on the directory include Jatenzo, Androderm, Aveed and 13 more; the rest are generics.

7
Dose forms ⓘ
37
Labelers (makers, repackagers, distributors)
15
Brand names
119
FDA-listed product records ⓘ
1953
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (141) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack13%
Asclemed USA, Inc.7%
Actavis Pharma, Inc.6%
A-S Medication Solutions4%
Prasco Laboratories4%
Upsher-Smith Laboratories, LLC4%
Other makers62%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Testosterone is used (Medicaid data)

A general measure of how commonly Testosterone is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Testosterone is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

731,644
Medicaid prescriptions filled (Q1–Q4 2025)
$50.7M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Testosterone prescribed? Of the 1,601 medications we measure, Testosterone ranks #213 by Medicaid prescriptions — more than 87% of them.

Where Testosterone ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Testosterone product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 1 mL / 200 mg/mL injection is the most-dispensed Testosterone product — about 71% of these Medicaid prescriptions.

1 ML testosterone cypionate 200 MG/ML Injection Most dispensed

517,489 Medicaid prescriptions (Q1–Q4 2025) 71% of Testosterone prescriptions shown $19.3M gross reimbursement (before rebates) ≈ $37 per prescription (gross)

Summed across the 12 of 30 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2047882

60 ACTUAT testosterone 20.25 MG/ACTUAT Topical Gel

88,516 Medicaid prescriptions (Q1–Q4 2025) 12% of Testosterone prescriptions shown $5.3M gross reimbursement (before rebates) ≈ $60 per prescription (gross)

Summed across the 9 of 22 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1597076

testosterone cypionate 200 MG/ML Injectable Solution

41,498 Medicaid prescriptions (Q1–Q4 2025) 6% of Testosterone prescriptions shown $825,713 gross reimbursement (before rebates) ≈ $20 per prescription (gross)

Summed across the 13 of 40 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 835840

5000 MG testosterone 0.01 MG/MG Topical Gel

18,470 Medicaid prescriptions (Q1–Q4 2025) 3% of Testosterone prescriptions shown $3M gross reimbursement (before rebates) ≈ $161 per prescription (gross)

Summed across the 7 of 27 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1597129

testosterone cypionate 100 MG/ML Injectable Solution

16,530 Medicaid prescriptions (Q1–Q4 2025) 2% of Testosterone prescriptions shown $626,229 gross reimbursement (before rebates) ≈ $38 per prescription (gross)

Summed across the 7 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 835829

0.5 ML testosterone enanthate 150 MG/ML Auto-Injector

8,140 Medicaid prescriptions (Q1–Q4 2025) 1% of Testosterone prescriptions shown $5.5M gross reimbursement (before rebates) ≈ $679 per prescription (gross)

Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2099695

testosterone enanthate 200 MG/ML Injectable Solution

7,776 Medicaid prescriptions (Q1–Q4 2025) 1% of Testosterone prescriptions shown $542,741 gross reimbursement (before rebates) ≈ $70 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 835809

0.5 ML testosterone enanthate 200 MG/ML Auto-Injector

7,659 Medicaid prescriptions (Q1–Q4 2025) 1% of Testosterone prescriptions shown $5.2M gross reimbursement (before rebates) ≈ $678 per prescription (gross)

Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2099681

60 ACTUAT testosterone 12.5 MG/ACTUAT Topical Gel

6,066 Medicaid prescriptions (Q1–Q4 2025) <1% of Testosterone prescriptions shown $836,678 gross reimbursement (before rebates) ≈ $138 per prescription (gross)

Summed across the 4 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1596780

0.5 ML testosterone enanthate 100 MG/ML Auto-Injector

4,599 Medicaid prescriptions (Q1–Q4 2025) <1% of Testosterone prescriptions shown $3.2M gross reimbursement (before rebates) ≈ $689 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2099689

2500 MG testosterone 0.01 MG/MG Topical Gel

4,162 Medicaid prescriptions (Q1–Q4 2025) <1% of Testosterone prescriptions shown $681,025 gross reimbursement (before rebates) ≈ $164 per prescription (gross)

Summed across the 3 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1597123

1250 MG testosterone 0.0162 MG/MG Topical Gel

3,240 Medicaid prescriptions (Q1–Q4 2025) <1% of Testosterone prescriptions shown $875,559 gross reimbursement (before rebates) ≈ $270 per prescription (gross)

Summed across the 2 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1597120

2500 MG testosterone 0.0162 MG/MG Topical Gel

3,156 Medicaid prescriptions (Q1–Q4 2025) <1% of Testosterone prescriptions shown $845,536 gross reimbursement (before rebates) ≈ $268 per prescription (gross)

Summed across the 3 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1597126

testosterone undecanoate 237 MG Oral Capsule

1,284 Medicaid prescriptions (Q1–Q4 2025) <1% of Testosterone prescriptions shown $1.3M gross reimbursement (before rebates) ≈ $1,038 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2121770

3 ML testosterone undecanoate 250 MG/ML Injection

940 Medicaid prescriptions (Q1–Q4 2025) <1% of Testosterone prescriptions shown $1.4M gross reimbursement (before rebates) ≈ $1,463 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1490661

testosterone undecanoate 158 MG Oral Capsule

571 Medicaid prescriptions (Q1–Q4 2025) <1% of Testosterone prescriptions shown $377,258 gross reimbursement (before rebates) ≈ $661 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2121766

testosterone undecanoate 198 MG Oral Capsule

560 Medicaid prescriptions (Q1–Q4 2025) <1% of Testosterone prescriptions shown $385,745 gross reimbursement (before rebates) ≈ $689 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2121768

testosterone 75 MG Drug Implant

496 Medicaid prescriptions (Q1–Q4 2025) <1% of Testosterone prescriptions shown $370,405 gross reimbursement (before rebates) ≈ $747 per prescription (gross)

Summed across the 2 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 318240

60 ACTUAT testosterone 30 MG/ACTUAT Topical Solution

331 Medicaid prescriptions (Q1–Q4 2025) <1% of Testosterone prescriptions shown $33,682 gross reimbursement (before rebates) ≈ $102 per prescription (gross)

Summed across the 3 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1599949

testosterone undecanoate 112.5 MG Oral Capsule

49 Medicaid prescriptions (Q1–Q4 2025) <1% of Testosterone prescriptions shown $40,256 gross reimbursement (before rebates) ≈ $822 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2599054

60 ACTUAT testosterone 5.5 MG/ACTUAT Nasal Gel

12 Medicaid prescriptions (Q1–Q4 2025) <1% of Testosterone prescriptions shown $8,597 gross reimbursement (before rebates) ≈ $716 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1596784

Other Testosterone products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

100 Medicaid prescriptions (Q1–Q4 2025) <1% of Testosterone prescriptions shown $23,653 gross reimbursement (before rebates) ≈ $237 per prescription (gross)

Summed across the 1 of 429 listed NDC products with Medicaid activity.

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Testosterone, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 76 of 635 listed Testosterone NDCs with Medicaid activity.

Compare Testosterone products

A representative set of FDA-listed product records for Testosterone — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 95 of 119 products — FDA National Drug Code Directory. See every product, package size and price: browse all 119 Testosterone NDCs →

Testosterone side effects reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Testosterone — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Testosterone are fatigue, myocardial infarction, pain; about 57% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

34,757
Reports mentioning it
57%
Reported as serious
12
Distinct effects shown
Most reported effects
Fatigue
1,855
Myocardial Infarction
1,729
Pain
1,608
Cerebrovascular Accident
1,290
Deep Vein Thrombosis
1,240
Anxiety
1,199
Pulmonary Embolism
1,184
Nausea
1,173
Headache
1,162
Asthenia
1,015
Age groups
Adult · 2,560Elderly · 980Adolescent · 72Child · 8Infant · 3

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Testosterone in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Testosterone FDA approval history

How Testosterone went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Testosterone was first approved by the FDA in 1953 (Brand: DELATESTRYL · Endo Pharms); the first generic version was approved in 1972. It remains available in U.S. pharmacies today.

1953
Brand approved
Brand: DELATESTRYL · Endo Pharms
1972
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Testosterone recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 10 Testosterone recalls since July 2021, covering 12 product listings. Four of them are still ongoing or began in the last six months and are listed first. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class III Nov 7, 2025 · Teva Pharmaceuticals USA, Inc
Defective Container - A defect in the side-seal which allows leakage of product.
  • Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma,… Lots: Lot #100068692, Exp.: 04/30/2027 FDA record D-0198-2026 →
Ongoing Class II Apr 10, 2025 · Eugia US LLC
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
  • Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial, Distributed by Eugia US LLC, E. Windsor, NJ, Manufactured by: Eugia Specialties Limited, Telangana State, Ind… Lots: Lot #: 1TC24075A, Exp 11/30/2026. FDA record D-0363-2025 →
Ongoing Class II Mar 5, 2025 · Strides Pharma, Inc.
Presence of foreign substance: Presence of Benzene.
  • Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-152-02 Lots: Lot #: 5501103A, Exp Mar-25; 5501237A, 5501238A, Exp Apr-25; 5501278A, Exp May-25; 5501280A, 5501342A, Exp Jun-25; 5501372A, Exp Jul-25; 5501496A, Exp Aug-25; 5501499A, Exp Sep-25; 5501580A, Exp Oct-25; 5501582A, Exp Dec-25; 5501653A, 5501… FDA record D-0294-2025 →
  • Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-151-02 Lots: Lot #: 5501127A, 5501236A, Exp Apr-25; 5501341A, Exp Jun-25; 5501406A, Exp Jul-25; 5501408A, Exp Aug-25; 5501516A, Exp Sep-25; 5501568A, Exp Oct-25; 5501829A, Exp Mar-26; 5502000A, Exp Jul-26; 5502004A, 5502005A, Exp Aug-26; 5502092A, Exp… FDA record D-0293-2025 →
Ongoing Class II Aug 8, 2024 · Teva Pharmaceuticals USA, Inc
Superpotent Drug
  • Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USA, Inc. North Wales, PA 19454, NDC 0591-2925-30. Packet NDC # 0591-2925-32 Carton NDC # 0591-2925-30 Lots: Lot #: 100042386, Exp. Date 06/2025 FDA record D-0637-2024 →
Class III Nov 10, 2023 · Terminated · Teva Pharmaceuticals USA, Inc
OOS for viscosity
  • Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0591-2926-30 Lots: Lot #: 100029472, Exp. 2/29/2024 FDA record D-0127-2024 →
Class II Feb 15, 2023 · Terminated · Azurity Pharmaceuticals, Inc.
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
  • Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-dose vials (NDC 52536-625-10) and b) 1 mL single dose vials (NDC 52536-625-01), Rx only, Mfd for: Wilshire Pharm… Lots: Lot #23804.034A, 23803.061A, Exp 9/2024 FDA record D-0489-2023 →
Class II Jun 29, 2022 · Terminated · Teva Pharmaceuticals USA Inc
Superpotent Drug: Out of specification assay result was obtained during stability testing.
  • Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box. Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, US 84108, USA, Distribu… Lots: Lot: 1403180, EXP. 10/2022 FDA record D-1289-2022 →
Class II Jun 21, 2022 · Terminated · SUN PHARMACEUTICAL INDUSTRIES INC
cGMP - Water leakage
  • Testosterone Cypionate Injection, USP, 200mg/mL, CIII, Rx only, 1mL Single-dose vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuticals Ind… Lots: HAC4337A FDA record D-1190-2022 →
Class II Jun 10, 2022 · Terminated · SUN PHARMACEUTICAL INDUSTRIES INC
Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
  • Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutic… Lots: Lot: HAC3427A, EXP Date: 08/2023 FDA record D-1154-2022 →
Class II Jun 3, 2022 · Terminated · SUN PHARMACEUTICAL INDUSTRIES INC
CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.
  • Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose vial, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuticals Industries… Lots: Lots JKX3267A & JKX3686A Exp. Date 08/2022 Lot JKX4700A, Exp Date 10/2022 Lot JKX5727A, Exp date 11/2022 FDA record D-1176-2022 →
  • Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutic… Lots: HAC1974A, HAC1978A, Exp 06/2023 FDA record D-1153-2022 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Testosterone RxCUI 10379 12 dose forms · 38 strengths
  1. Dose form (SCDF) Buccal Film RxCUI 858105 No current FDA listing
    Clinical drug / strength (SCD) 30 MG RxCUI 858106
  2. Dose form (SCDF) Drug Implant RxCUI 378786 No current FDA listing
    Clinical drug / strength (SCD) 75 MG RxCUI 318240 100 MG RxCUI 250714 200 MG RxCUI 250244
  3. Dose form (SCDF) Injectable Suspension RxCUI 376305 In current FDA listings
    Clinical drug / strength (SCD) 50 MG/ML RxCUI 346968
  4. Dose form (SCDF) Transdermal System RxCUI 1806166 No current FDA listing
    Clinical drug / strength (SCD) 24 HR testosterone 0.0833 MG/HR RxCUI 1190953 24 HR testosterone 0.104 MG/HR RxCUI 199116 24 HR testosterone 0.167 MG/HR RxCUI 313233 24 HR testosterone 0.208 MG/HR RxCUI 313234 24 HR testosterone 0.25 MG/HR RxCUI 313235

Look up RxCUI 10379 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Testosterone costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Injection, Solution · Intramuscular 200 mg/mL $6.27–$14.14 per mL NDC details & price history
Injection, Solution · Intramuscular 100 mg/mL $6.92 per mL NDC details & price history
Injection, Solution · Intramuscular 1000 mg/10 mL $4.53 per mL NDC details & price history
Injection, Solution · Intramuscular 2000 mg/10 mL $3.58 per mL NDC details & price history
Gel · Topical 10 mg/g $0.826 per gram NDC details & price history
Gel · Topical 16.2 mg/g $0.467 per gram NDC details & price history
Gel · Topical 20.25 mg/1.25 g $3.65 per gram NDC details & price history
Gel · Topical 40.5 mg/2.5 g $1.82 per gram NDC details & price history
Gel · Topical 50 mg/5 g $3.78 per gram NDC details & price history
Gel · Transdermal 16.2 mg/g $0.467 per gram NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Testosterone brand names

Testosterone is sold under 16 brand names in the FDA directory — Jatenzo, Androderm, Aveed, Natesto and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Jatenzo Androderm Aveed Natesto Fortesta Vogelxo Androgel Testim Xyosted Tlando Kyzatrex Undecatrex Azmiro Testopel Depo-Testosterone Testosterone Cypionate

Who makes Testosterone: manufacturers and labelers

37 companies list Testosterone products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, Asclemed USA, Inc., Actavis Pharma, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bryant Ranch Prepack 15 Asclemed USA, Inc. 8 Actavis Pharma, Inc. 7 A-S Medication Solutions 5 Prasco Laboratories 5 Upsher-Smith Laboratories, LLC 5 Cipla USA Inc. 4 Eugia US LLC 4 Hikma Pharmaceuticals USA Inc. 4 Northstar Rx LLC 4 Padagis Israel Pharmaceuticals Ltd 4 Pharmacia & Upjohn Company LLC 4 Xiromed LLC 4 Antares Pharma, Inc. 3 Endo USA, Inc. 3 Marius Pharmaceuticals 3 Sun Pharmaceutical Industries, Inc. 3 TOLMAR Inc. 3 Ajenat Pharmaceuticals LLC 2 Alembic Pharmaceuticals Inc. 2 Alvogen Inc. 2 Azurity Pharmaceuticals, Inc. 2 BPI Labs LLC 2 Encube Ethicals, Inc. 2

…and 13 more on the FDA NDC directory.

Testosterone drug class (RxNorm)

Testosterone belongs to the Androgen class.

Pharmacologic class Androgen
Drug family (ATC) 3-oxoandrosten (4) derivatives, Androgens and estrogens
How it works Androgen Receptor Agonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Testosterone page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jul 1, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Testosterone.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Testosterone after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
49
Finished products in the current FDA directory
119
Companies listing them (makers, repackagers, distributors)
37
FDA labeler codes behind them ⓘ
44
Linked representative label ⓘ
Antares Pharma, Inc.
Linked label effective
Jul 1, 2025
Composite sections available
30
Linked SPL Set ID
8a3d204c-be26-49e0-8599-0ac12a272e81
Linked SPL Document ID
c8d74eb6-fa94-446a-8307-091436a536dc
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Antares Pharma, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →