testosterone cypionate
Pharmaranks rates Testosterone Cypionate 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Testosterone Cypionate is an androgen used to treat Breast Neoplasms, Hypogonadism, Delayed Puberty.
Androgen · by Watson Labs
Generic of Azmiro
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Testosterone Cypionate
- Drug class
- Androgen
- Form
- Injectable
- Strength
- Testosterone Cypionate 100MG/ML
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- breast neoplasms, hypogonadism, delayed puberty
- Manufacturer
- Watson Labs
- Half-life
- about 10 to 100 minutes (how long it stays in your system)
- FDA application
- ANDA086029
- Availability
- Discontinued (per FDA)
What is Testosterone Cypionate?
From the FDA label:Testosterone cypionate, 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)-, (17ß)-. 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 in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate. Each mL of the 100 mg/mL solution contains: Testosterone cypionate............................................................................................100 mg Benzyl benzoate ......................................................................................................0.1 mL Cottonseed oil .........................................................................................................736 mg Benzyl alcohol (as preservative) .............................................................................9.45 mg Each mL of the 200 mg/mL solution contains: Testosterone cypionate…
How to use
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 - 400 mg should be administered every two to four weeks. Parenteral drug products should be inspected visually for particulate matter and…
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.
Warnings
Important safety information
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 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.
Who should not take Testosterone Cypionate
Known hypersensitivity to the drug Males with carcinoma of the breast Males with known or suspected carcinoma of the prostate gland Women who are pregnant (see PRECAUTIONS, Pregnancy) Patients with serious cardiac, hepatic or renal disease (see WARNINGS)
Overdose — what happens if you take too much
There have been no reports of acute overdosage with the androgens.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
How long does Testosterone Cypionate stay in your body?
The elimination half-life of testosterone cypionate is about 10 to 100 minutes — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the half-life of the natural testosterone hormone itself. The FDA label notes "considerable variation... ranging from 10 to 100 minutes," reflecting how quickly free testosterone is cleared. Two caveats matter for "how long it stays in your system": (1) Formulation dominates. Injectable esters are slow-release depots that far outlast the hormone's own half-life — testosterone cypionate ~8 days, enanthate ~4.5 days, undecanoate weeks — and oral testosterone undecanoate (Jatenzo, Kyzatrex) is a prodrug cleaved to testosterone. The 10-100 minute figure is the hormone's intrinsic clearance, not the duration of a shot. (2) Testosterone converts to active metabolites — dihydrotestosterone (DHT) and estradiol — that circulate on their own timelines. Inactivation occurs primarily in the liver, so hepatic impairment can slow clearance; ~90% is excreted in urine as conjugates. Half-life is not the drug-test detection window: anti-doping tests use the testosterone/epitestosterone ratio and isotope analysis and can flag use for far longer than clearance of the hormone.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: AndroGel (testosterone gel) FDA label, DailyMed — Clinical Pharmacology.
Drug class
How this class works, per Physiology, Testosterone - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Testosterone Cypionate ranks — best-rated androgen for:
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Testosterone Cypionate treat?
- Testosterone Cypionate (Testosterone Cypionate) may be used to treat breast neoplasms, hypogonadism, delayed puberty, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Testosterone Cypionate work?
- Testosterone Cypionate is a androgen. Androgens such as testosterone are male sex hormones that enter cells and bind the androgen receptor, switching on genes that drive male traits, muscle and bone growth, and reproductive function. Some testosterone is also converted in tissues to the more potent DHT.
- How is Testosterone Cypionate rated?
- pharmaranks gives Testosterone Cypionate a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Testosterone Cypionate?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Testosterone Cypionate. To pay less, Testosterone Cypionate is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Testosterone Cypionate?
- Testosterone Cypionate is marketed by Watson Labs. You can see Watson Labs's full profile, rating, and other products on pharmaranks.
- Is Testosterone Cypionate a brand-name or generic drug?
- Testosterone Cypionate is a generic medication; its active ingredient is Testosterone Cypionate. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Testosterone Cypionate available over the counter?
- No. Testosterone Cypionate is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Testosterone Cypionate come in?
- Testosterone Cypionate is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Testosterone Cypionate?
- Testosterone Cypionate is classified as androgen, per the FDA's Established Pharmacologic Class.
- Is Testosterone Cypionate FDA-registered?
- Testosterone Cypionate is on record with the U.S. FDA under application number ANDA086029. You can verify this on its official FDA label.
- Has Testosterone Cypionate been recalled by the FDA?
- Testosterone Cypionate has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Testosterone Cypionate safe?
- There's no single safe-or-not verdict. pharmaranks gives Testosterone Cypionate a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Testosterone Cypionate?
- Testosterone Cypionate's side effects are taken directly from its FDA label. From the label: 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.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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testosterone cypionate
70/100