Short answer: Azmiro's own study was small: 27 men given a single 200 mg injection or a comparator and followed for 31 days. The most common reactions on Azmiro were injection-site redness (26%) and injection-site reaction (4%), all mild. The label lists other testosterone side effects including high red blood cell counts, enlarged breasts, headache and depression. Azmiro has no boxed warning.
What Azmiro is approved for: Azmiro is approved as testosterone replacement therapy in males with low or absent natural testosterone due to primary hypogonadism (testicular failure) or hypogonadotropic hypogonadism (a pituitary or hypothalamus cause). The label says safety and efficacy have not been established in men with "age-related hypogonadism" or in children under 12 (section 1).
Source
AZMIRO (testosterone cypionate) injection, for intramuscular use, CIII, prescribing information and Medication Guide. Azurity Pharmaceuticals. DailyMed, version published July 28, 2025. DailyMed setid 235b5625-570d-3fba-e063-6394a90aa2d1
No. The current Azmiro label has no boxed warning.
These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Azmiro.
| Adverse reaction | Azmiro 200 mg, single dose |
|---|---|
| Injection site erythema | 26% |
| Injection site reaction | 4% |
Randomized, single-dose, open-label study in 27 adult men with hypogonadism, aged 18 to 65, given one 200 mg Azmiro injection or a comparator testosterone injection and watched for 31 days. There was no placebo group. All cases were rated mild (slight or barely noticeable).
Other reactions linked to testosterone in studies or after approval: injection-site pain and inflammation; allergic reactions; heart attack and stroke; gynecomastia; salt and water retention; nausea, jaundice and liver test changes; polycythemia; changes in libido, headache, anxiety and depression; frequent or prolonged erections, low sperm count and priapism; blood clots in veins; male pattern baldness, oily skin and acne; and rare central serous chorioretinopathy (an eye condition).
After a single 200 mg injection in 26 men, peak testosterone (baseline-corrected) averaged 758.0 ng/dL, reached at a median of 71.7 hours. The half-life of Azmiro injected into muscle is about eight days.
In TRAVERSE, a heart-outcomes study of a testosterone gel (not Azmiro), major heart events were 7.0% vs 7.3% on placebo, and blood clots in veins were 1.7% vs 1.2% (section 5.2).
One overdose report with an injectable testosterone product described testosterone levels up to 11,400 ng/dL with a stroke.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Polycythemia (high red blood cells). Hematocrit is checked before starting and periodically during treatment. If it is high, Azmiro is stopped until it comes down; if it rises again after restarting, Azmiro is stopped for good.
Blood clots. Deep vein thrombosis and pulmonary embolism have been reported with testosterone products. In TRAVERSE, clots occurred in 1.7% on a testosterone gel vs 1.2% on placebo. If a clot is suspected, Azmiro is stopped.
Enlarged prostate and prostate cancer. BPH symptoms may worsen, and androgens may raise prostate cancer risk. Prostate cancer is checked for, including PSA, before and during treatment.
Blood pressure increases. Testosterone can raise blood pressure, which can raise heart risk over time. Blood pressure is checked periodically, and Azmiro is not recommended with uncontrolled high blood pressure.
Abuse. Testosterone has been abused at high doses, often with other anabolic steroids, which can cause serious heart and mental health problems. If abuse is suspected, serum testosterone is checked. Azmiro is a Schedule III controlled substance (section 9.1).
Not for use in women. Azmiro is not indicated for women and must not be used in pregnancy (section 4).
Sperm production. Large doses of testosterone can suppress sperm production and lower sperm count. The label adds that the impact on fertility may be irreversible (section 8.3).
Liver effects. Serious liver problems have been linked to high-dose oral 17-alpha-alkyl androgens. Azmiro is not one of these and is not known to cause them, but if signs like jaundice appear, it is stopped while the cause is checked.
Edema. Androgens can cause salt and water retention, which can be serious in people with heart, kidney or liver disease.
Sleep apnea. Testosterone may worsen sleep apnea, especially with obesity or chronic lung disease.
Gynecomastia. Breast enlargement may develop and occasionally persists.
Lipid changes. Blood fats can change, which may require a change in cholesterol medicine or stopping testosterone. Lipids are checked periodically.
High calcium. In cancer patients at risk of high calcium, calcium is checked periodically.
Thyroid lab values. Androgens can lower thyroxine-binding globulin and total T4 on tests, without a change in free thyroid hormone or signs of thyroid disease.
Prolactin increases. Prolactin is checked before starting and 3 to 4 months after. If it stays high, Azmiro is stopped.
Bone growth in children. Testosterone can speed bone maturation and close growth plates early, which may reduce adult height. Bone age of the wrist and hand is checked every 6 months in children.
From the Medication Guide that comes with Azmiro:
Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.