Testosterone Cypionate is an androgen sold in the U.S. under 2 brand and generic names, for breast neoplasms, hypogonadism and delayed puberty. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Azmiro (application NDA216318). Other testosterone cypionate products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Injectable testosterone products may have different doses, strengths, or administration instructions and they are not substitutable on a milligram-per-milligram basis. Administer AZMIRO by deep gluteal intramuscular injection only ( 2.1 ). • Prior to initiating AZMIRO, 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 concentrations are below the normal range ( 2.2 ). • Recommended dosage is 50 mg to 400 mg administered every two to four weeks as a deep intramuscular injection in the gluteal muscle. Individualize the dose and schedule based on the patient’s age, diagnosis, response to treatment, and the appearance of adverse reactions ( 2.3 ). • The prefilled syringe should be administered as an intramuscular injection by a healthcare professional only. 2.1 Important Dosage Information • Injectable testosterone products may have different doses, strengths, or administration instructions and they are not substitutable on a milligram-per-milligram basis. • Administer AZMIRO by deep gluteal intramuscular injection only. 2.2 Confirmation of Hypogonadism before Initiation of AZMIRO Prior to initiating AZMIRO, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning…
The following clinically significant adverse reactions are discussed elsewhere in the labeling: • Polycythemia [ see Warnings and Precautions ( 5.1 ) ] • Venous Thromboembolism [ see Warnings and Precautions ( 5.2 )] • Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer [ see Warnings and Precautions ( 5.3 ) ] • Blood Pressure Increases [ see Warnings and Precautions ( 5.4 ) ] • Hepatic Adverse Effects [ see Warnings and Precautions ( 5.8 ) ] • Edema [ see Warnings and Precautions ( 5.9 ) ] • Sleep Apnea [ see Warnings and Precautions ( 5.10 ) ] • Gynecomastia [ see Warnings and Precautions ( 5.11 ) ] • Lipid Changes [ see Warnings and Precautions ( 5.12 ) ] • Hypercalcemia [ see Warnings and Precautions ( 5.13 ) ] • Decreased Thyroxine-binding Globulin [ see Warnings and Precautions ( 5.14 ) ] • Increases in Prolactin [ see Warnings and Precautions ( 5.15 ) ] • Adverse Effects on Bone Maturation [ see Warnings and Precautions ( 5.16 ) ] Common adverse reactions (incidence ≥4%) are injection site erythema and injection site reaction ( 6.1 ). Other adverse reactions include: polycythemia, gynecomastia, headache, and depression ( 6.2 ). To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Injectable | — | — | View → | |
| 2 | 70/100 | Prescription | Injectable | — | — |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml mul…
Marketed Without an Approved NDA/ANDA
Advanced Pharmaceutical Technology, Inc. · May 30, 2025
Testosterone Cypionate Injection
Lack of Assurance of Sterility
Empower Clinic Services, LLC dba Empower Pharmacy · May 2, 2025
Testosterone Cypionate Injection
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Eugia US LLC · Apr 10, 2025
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
AZMIRO is contraindicated in: • Known hypersensitivity to AZMIRO or to any of its components [see Description ( 11 )]. Hypersensitivity, including skin manifestations and anaphylactoid reactions have been reported [ see Adverse Reactions ( 6.2 ) ]. • Men with carcinoma of the breast or known or suspected carcinoma of the prostate gland [ see Warnings and Precautions ( 5.3 ) ]. • Women who are pregnant. Testosterone can cause virilization of the female fetus when administered to a pregnant woman [ see Use in Specific Populations ( 8.1 ) ]. • Known hypersensitivity to AZMIRO or any of its components, skin manifestations and anaphylactoid reactions have been reported ( 4 ) • Men with carcinoma of the breast or known or suspected carcinoma of the prostate ( 4 ). • Women who are pregnant. Testosterone may cause fetal harm ( 4 ).
Insulin: In patients with diabetes, concomitant use with AZMIRO may decrease blood glucose and insulin requirements ( 7.1 ). • Oral Anticoagulants: Concomitant use with AZMIRO may cause changes in anticoagulant activity. Monitor International Normalized Ratio and prothrombin time frequently ( 7.2 ). • Corticosteroids: Concomitant use with AZMIRO may result in increased fluid retention. Use with caution, particularly in patients with cardiac, renal, or hepatic disease ( 7.3 ). 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, insulin requirements. 7.2 Oral Anticoagulants Changes in anticoagulant activity may be seen with androgens. Frequent monitoring of INR and prothrombin time may be necessary in patients taking anticoagulants, 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 should be monitored cautiously, particularly in patients with cardiac, renal or hepatic disease.
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