Testosterone Cypionate
Injection, Solution · Intramuscular
Uses
Testosterone cypionate injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. 1. Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. 2. Hypogonadotropic hypogonadism (congenital or acquired)-gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Safety and efficacy of testosterone cypionate injection in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.
Dosage and administration
Prior to initiating testosterone cypionate injection, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range. Testosterone cypionate injection is for intramuscular use only. It should not be given intravenously. Intramuscular injections should be given deep in the gluteal muscle. The suggested dosage for testosterone cypionate injection varies depending on the age, sex, and diagnosis of the individual patient. Dosage is adjusted according to the patient's response and the appearance of adverse reactions. Various dosage regimens have been used to induce pubertal changes in hypogonadal males; some experts have advocated lower dosages initially, gradually increasing the dose as puberty progresses, with or without a decrease to maintenance levels. Other experts emphasize that higher dosages are needed to induce pubertal changes and lower dosages can be used for maintenance after puberty. The chronological and skeletal ages must be taken into consideration, both in determining the initial dose and in adjusting the dose. For replacement in the hypogonadal male, 50 to 400 mg should be administered every two to four weeks. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Warming and shaking the vial should redissolve any crystals that may have formed during storage at temperatures lower than recommended.
Contraindications
1. Known hypersensitivity to the drug 2. Males with carcinoma of the breast 3. Males with known or suspected carcinoma of the prostate gland 4. Women who are pregnant (see PRECAUTIONS , Pregnancy ) 5. Patients with serious cardiac, hepatic or renal disease (see WARNINGS )
Warnings
Hypercalcemia may occur in immobilized patients. If this occurs, the drug should be discontinued. Prolonged use of high doses of androgens (principally the 17-α alkyl-androgens) has been associated with development of hepatic adenomas, hepatocellular carcinoma, and peliosis hepatis —all potentially life-threatening complications. Geriatric patients treated with androgens may be at an increased risk of developing prostatic hypertrophy and prostatic carcinoma although conclusive evidence to support this concept is lacking. There have been postmarketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone products, such as testosterone cypionate. Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue treatment with testosterone cypionate and initiate appropriate workup and management. Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (MACE), such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of testosterone compared to non-use. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. Patients should be informed of this possible risk when deciding whether to use or to continue to use testosterone cypionate injection. Testosterone can increase blood pressure which can increase cardiovascular (CV) risk over time. Monitor blood pressure periodically in men using testosterone products, especially in men with hypertension. Testosterone products are not recommended for use in patients with uncontrolled hypertension. Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions (see DRUG ABUSE AND DEPENDENCE ). If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events. Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal or hepatic disease. Gynecomastia may develop and occasionally persists in patients being treated for hypogonadism. The preservative benzyl alcohol has been associated with serious adverse events, including the “gasping syndrome”, and death in pediatric patients. Although normal therapeutic doses of this product ordinarily deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the “gasping syndrome”, the minimum amount of benzyl alcohol at which toxicity may occur is not known. The risk of benzyl alcohol toxicity depends on the quantity administered and the liver and kidneys' capacity to detoxify the chemical. Premature and low-birth weight infants may be more likely to develop toxicity. Androgen therapy should be used cautiously in healthy males with delayed puberty. The effect on bone maturation should be monitored by assessing bone age of the wrist and hand every 6 months. In children, androgen treatment may accelerate bone maturation without producing compensatory gain in linear growth. This adverse effect may result in compromised adult stature. The younger the child the greater the risk of compromising final mature height. This drug has not been shown to be safe and effective for the enhancement of athletic performance. Because of the potential risk of serious adverse health effects, this drug should not be used for such purpose.
Precautions
General Patients with benign prostatic hypertrophy may develop acute urethral obstruction. Priapism or excessive sexual stimulation may develop. Oligospermia may occur after prolonged administration or excessive dosage. If any of these effects appear, the androgen should be stopped and if restarted, a lower dosage should be utilized. Testosterone cypionate should not be used interchangeably with testosterone propionate because of differences in duration of action. Testosterone cypionate is not for intravenous use. Information for Patients Patients should be instructed to report any of the following: nausea, vomiting, changes in skin color, ankle swelling, too frequent or persistent erections of the penis. Laboratory Tests Hemoglobin and hematocrit levels (to detect polycythemia) should be checked periodically in patients receiving long-term androgen administration. Serum cholesterol may increase during androgen therapy. Drug Interactions Androgens may increase sensitivity to oral anticoagulants. Dosage of the anticoagulant may require reduction in order to maintain satisfactory therapeutic hypoprothrombinemia. Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements. Drug/Laboratory Test Interferences Androgens may decrease levels of thyroxine-binding globulin, resulting in decreased total T 4 serum levels and increased resin uptake of T 3 and T 4 . Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction. Carcinogenesis Animal data Testosterone has been tested by subcutaneous injection and implantation in mice and rats. The implant induced cervical-uterine tumors in mice, which metastasized in some cases. There is suggestive evidence that injection of testosterone into some strains of female mice increases their susceptibility to hepatoma. Testosterone is also known to increase the number of tumors and decrease the degree of differentiation of chemically induced carcinomas of the liver in rats. Human data There are rare reports of hepatocellular carcinoma in patients receiving long-term therapy with androgens in high doses. Withdrawal of the drugs did not lead to regression of the tumors in all cases. Geriatric patients treated with androgens may be at an increased risk of developing prostatic hypertrophy and prostatic carcinoma although conclusive evidence to support this concept is lacking. Pregnancy Teratogenic Effects The use of testosterone in women who are pregnant is contraindicated. Testosterone is teratogenic and may cause fetal harm. Testosterone is known to cause virilization of the female fetus when administrated to pregnant women. Benzyl alcohol can cross the placenta. See WARNINGS . Nursing Mothers Testosterone cypionate injection is not recommended for use in nursing mothers. Pediatric Use Safety and effectiveness in pediatric patients below the age of 12 years have not been established.
Side effects
The following adverse reactions in the male have occurred with some androgens: Endocrine and urogenital: Gynecomastia and excessive frequency and duration of penile erections. Oligospermia may occur at high dosages. Skin and appendages: Hirsutism, male pattern of baldness, seborrhea, and acne. Cardiovascular disorders: Myocardial infarction, stroke. Fluid and electrolyte disturbances: Retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates. Gastrointestinal: Nausea, cholestatic jaundice, alterations in liver function tests, rarely hepatocellular neoplasms and peliosis hepatis (see WARNINGS ). Hematologic: Suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, and polycythemia. Nervous system: Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia. Allergic: Hypersensitivity, including skin manifestations and anaphylactoid reactions. Vascular disorders: Venous thromboembolism. Special senses: Rare cases of central serous chorioretinopathy (CSCR). Miscellaneous: Inflammation and pain at the site of intramuscular injection. To report SUSPECTED ADVERSE REACTIONS, contact Alvogen, Inc. at 1-866-770-3024 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug interactions
Drug Interactions Androgens may increase sensitivity to oral anticoagulants. Dosage of the anticoagulant may require reduction in order to maintain satisfactory therapeutic hypoprothrombinemia. Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements.
Pregnancy
Pregnancy Teratogenic Effects The use of testosterone in women who are pregnant is contraindicated. Testosterone is teratogenic and may cause fetal harm. Testosterone is known to cause virilization of the female fetus when administrated to pregnant women. Benzyl alcohol can cross the placenta. See WARNINGS .
Pediatric use
Pediatric Use Safety and effectiveness in pediatric patients below the age of 12 years have not been established.
Overdosage
There have been no reports of acute overdosage with the androgens.
Description
Testosterone Cypionate Injection, USP, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)- cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one,17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C 27 H 40 O 3 , and the molecular weight 412.61. The structural formula is represented below: Testosterone Cypionate Injection, USP is available as 200 mg/mL testosterone cypionate. Each mL of the solution contains Testosterone Cypionate, 200 mg; Benzyl Benzoate, 0.2 mL; Cottonseed Oil, 560 mg; Benzyl Alcohol (as preservative), 9.45 mg.
How supplied
Testosterone Cypionate Injection, USP, 200 mg/mL is available as follows: 1 mL Vial NDC 47781-911-93 Carton of 1 Vial 10 mL Vial NDC 47781-910-91 Carton of 10 Vials Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from light.
Patient information
Information for Patients Patients should be instructed to report any of the following: nausea, vomiting, changes in skin color, ankle swelling, too frequent or persistent erections of the penis.
Label text from the FDA structured product label by Alvogen Inc. (revised Aug 19, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Testosterone Cypionate in 53 products
Testosterone Cypionate NDC products (53)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-7585 | Testosterone Cypionate 200 mg/mL Injection, Solution | A-S Medication Solutions | ANDA · DEA CIII |
| 50090-7584 | Testosterone Cypionate 200 mg/mL Injection, Solution | A-S Medication Solutions | ANDA · DEA CIII |
| 50090-7435 | Testosterone Cypionate 200 mg/mL Injection | A-S Medication Solutions | ANDA · DEA CIII |
| 50090-4920 | Testosterone Cypionate 200 mg/mL Injection, Solution | A-S Medication Solutions | ANDA · DEA CIII |
| 50090-4147 | Testosterone Cypionate 200 mg/mL Injection, Solution | A-S Medication Solutions | ANDA · DEA CIII |
| 82983-425 | Testosterone Cypionate 200 mg/mL Injection, Solution | Ajenat Pharmaceuticals LLC | ANDA · DEA CIII |
| 82983-424 | Testosterone Cypionate 200 mg/mL Injection, Solution | Ajenat Pharmaceuticals LLC | ANDA · DEA CIII |
| 47781-910 | Testosterone Cypionate 200 mg/mL Injection, Solution | Alvogen Inc. | ANDA · DEA CIII |
| 47781-911 | Testosterone Cypionate 200 mg/mL Injection, Solution | Alvogen Inc. | ANDA · DEA CIII |
| 87063-272 | Testosterone Cypionate 200 mg/mL Injection, Solution | ASCLEMED USA INC. | ANDA · DEA CIII |
| 76420-746 | Testosterone Cypionate 200 mg/mL Injection, Solution | Asclemed USA, Inc. | ANDA · DEA CIII |
| 76420-747 | Testosterone Cypionate 200 mg/mL Injection, Solution | Asclemed USA, Inc. | ANDA · DEA CIII |
| 76420-752 | Testosterone Cypionate 200 mg/mL Injection, Solution | Asclemed USA, Inc. | ANDA · DEA CIII |
| 76420-741 | Testosterone Cypionate 200 mg/mL Injection, Solution | Asclemed USA, Inc. | ANDA · DEA CIII |
| 76420-065 | Testosterone Cypionate 200 mg/mL Injection | Asclemed USA, Inc. | ANDA · DEA CIII |
| 76420-645 | Testosterone Cypionate 200 mg/mL Injection, Solution | Asclemed USA, Inc. | ANDA · DEA CIII |
| 54288-156 | Testosterone Cypionate 200 mg/mL Injection, Solution | BPI Labs LLC | ANDA · DEA CIII |
| 54288-150 | Testosterone Cypionate 200 mg/mL Injection, Solution | BPI Labs LLC | ANDA · DEA CIII |
| 72162-2375 | Testosterone Cypionate 200 mg/mL Injection, Solution | Bryant Ranch Prepack | ANDA · DEA CIII |
| 72162-2348 | Testosterone Cypionate 200 mg/mL Injection | Bryant Ranch Prepack | ANDA · DEA CIII |
| 63629-8705 | Testosterone Cypionate 200 mg/mL Injection, Solution | Bryant Ranch Prepack | ANDA · DEA CIII |
| 63629-8706 | Testosterone Cypionate 200 mg/mL Injection, Solution | Bryant Ranch Prepack | ANDA · DEA CIII |
| 72162-1119 | Testosterone Cypionate 200 mg/mL Injection, Solution | Bryant Ranch Prepack | ANDA · DEA CIII |
| 71335-2838 | Testosterone Cypionate 200 mg/mL Injection, Solution | Bryant Ranch Prepack | ANDA · DEA CIII |
| 71335-2473 | Testosterone Cypionate 200 mg/mL Injection, Solution | Bryant Ranch Prepack | ANDA · DEA CIII |
| 71335-2470 | Testosterone Cypionate 200 mg/mL Injection, Solution | Bryant Ranch Prepack | ANDA · DEA CIII |
| 69097-536 | Testosterone Cypionate 100 mg/mL Injection | Cipla USA Inc. | ANDA · DEA CIII |
| 69097-537 | Testosterone Cypionate 200 mg/mL Injection | Cipla USA Inc. | ANDA · DEA CIII |
| 69097-802 | Testosterone Cypionate 200 mg/mL Injection, Solution | Cipla USA Inc. | ANDA · DEA CIII |
| 55150-276 | Testosterone Cypionate 1000 mg/10mL Injection, Solution | Eugia US LLC | ANDA · DEA CIII |
| 55150-277 | Testosterone Cypionate 200 mg/mL Injection, Solution | Eugia US LLC | ANDA · DEA CIII |
| 55150-278 | Testosterone Cypionate 2000 mg/10mL Injection, Solution | Eugia US LLC | ANDA · DEA CIII |
| 0143-9659 | Testosterone Cypionate 200 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA · DEA CIII |
| 0143-9005 | Testosterone Cypionate 200 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA · DEA CIII |
| 0143-9726 | Testosterone Cypionate 200 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA · DEA CIII |
| 0409-6557 | Testosterone Cypionate 100 mg/mL Injection, Solution | Hospira, Inc. | ANDA · DEA CIII |
| 0409-6562 | Testosterone Cypionate 200 mg/mL Injection, Solution | Hospira, Inc. | ANDA · DEA CIII |
| 72603-286 | Testosterone Cypionate 200 mg/mL Injection, Solution | NorthStar Rx LLC | ANDA · DEA CIII |
| 68071-3809 | Testosterone Cypionate 200 mg/mL Injection | NuCare pgarmaceuticals,Inc. | ANDA · DEA CIII |
| 68071-3840 | Testosterone Cypionate 200 mg/mL Injection, Solution | NuCare Pharmaceuticals, Inc. | ANDA · DEA CIII |
| 68071-3835 | Testosterone Cypionate 200 mg/mL Injection, Solution | NuCare Pharmaceuticals,Inc. | ANDA · DEA CIII |
| 0574-0827 | Testosterone Cypionate 200 mg/mL Injection, Solution | Padagis US LLC | ANDA · DEA CIII |
| 0574-0820 | Testosterone Cypionate 200 mg/mL Injection, Solution | Padagis US LLC | ANDA · DEA CIII |
| 63187-647 | Testosterone Cypionate 200 mg/mL Injection | Proficient Rx LP | ANDA · DEA CIII |
| 71205-289 | Testosterone Cypionate 200 mg/mL Injection | Proficient Rx LP | ANDA · DEA CIII |
| 70518-4538 | Testosterone Cypionate 200 mg/mL Injection | REMEDYREPACK INC. | ANDA · DEA CIII |
| 62756-017 | Testosterone Cypionate 100 mg/mL Injection, Solution | Sun Pharmaceutical Industries, Inc. | ANDA · DEA CIII |
| 62756-016 | Testosterone Cypionate 200 mg/mL Injection, Solution | Sun Pharmaceutical Industries, Inc. | ANDA · DEA CIII |
| 62756-015 | Testosterone Cypionate 200 mg/mL Injection, Solution | Sun Pharmaceutical Industries, Inc. | ANDA · DEA CIII |
| 52536-625 | Testosterone Cypionate 200 mg/mL Injection | Wilshire Pharmaceuticals | ANDA · DEA CIII |
| 70700-288 | Testosterone Cypionate 100 mg/mL Injection, Solution | Xiromed LLC | ANDA · DEA CIII |
| 70700-290 | Testosterone Cypionate 200 mg/mL Injection, Solution | Xiromed LLC | ANDA · DEA CIII |
| 70700-289 | Testosterone Cypionate 200 mg/mL Injection, Solution | Xiromed LLC | ANDA · DEA CIII |
Testosterone Cypionate recalls
- D-0363-2025 Apr 23, 2025 · Class II · Ongoing
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials. - D-0489-2023 Apr 12, 2023 · Class II · Terminated
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials. - D-1190-2022 Jul 20, 2022 · Class II · Terminated
cGMP - Water leakage - D-1176-2022 Jul 13, 2022 · Class II · Terminated
CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery. - D-1153-2022 Jun 29, 2022 · Class II · Terminated
CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities. - D-1154-2022 Jun 29, 2022 · Class II · Terminated
Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion - D-0242-2021 Feb 3, 2021 · Class III · Terminated
Incorrect Labeling: Incorrect lot number on secondary packaging - D-0787-2020 Jan 22, 2020 · Class II · Terminated
cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot. - D-0788-2020 Jan 22, 2020 · Class II · Terminated
cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot. - D-0167-2020 Nov 6, 2019 · Class III · Terminated
Labeling:Label Mix-up: Shipper Carton labelled Testosterone Cypionate Injection, USP, 200mg/mL, 1 ml single-dose vials, found to contain shelf cartons labelled as Testosterone Cypionate Injection USP, 200mg/mL, 10 ml … - D-1123-2019 Apr 24, 2019 · Class II · Terminated
Presence of Particulate Matter. - D-1124-2019 Apr 24, 2019 · Class II · Terminated
Presence of Particulate Matter. - D-1125-2019 Apr 24, 2019 · Class II · Terminated
Presence of Particulate Matter. - D-0977-2018 Aug 1, 2018 · Class II · Terminated
Presence of Particulate Matter: organic and inorganic compounds detected in vials of product. - D-0611-2017 Mar 29, 2017 · Class II · Terminated
Presence of Particulate Matter
Frequently asked questions
What is Testosterone Cypionate used for?
Testosterone cypionate injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. 1. Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. 2. Hypogonadotropic hypogonadism (congenital or…
What are the side effects of Testosterone Cypionate?
The following adverse reactions in the male have occurred with some androgens: Endocrine and urogenital: Gynecomastia and excessive frequency and duration of penile erections. Oligospermia may occur at high dosages. Skin and appendages: Hirsutism, male pattern of baldness, seborrhea, and acne. Cardiovascular disorders: Myocardial infarction, stroke. Fluid and electrolyte disturbances: Retention… See the full label for the complete list.
Who makes Testosterone Cypionate?
Testosterone Cypionate is listed by 21 labelers in the FDA NDC directory, including A-S Medication Solutions, Ajenat Pharmaceuticals LLC, Alvogen Inc., ASCLEMED USA INC..
Has Testosterone Cypionate been recalled?
The FDA enforcement database lists 15 recalls for Testosterone Cypionate, most recently D-0363-2025 (class ii): cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.