Short answer: In the 84-week Aveed study of 153 men, the most common reactions were acne (5.2%), injection-site pain (4.6%), PSA increased (4.6%), estradiol increased (2.6%) and hypogonadism (2.6%). The study had no placebo group. Aveed has a boxed warning: serious pulmonary oil microembolism (POME) reactions and anaphylaxis can happen during or right after any injection, so each shot is followed by 30 minutes of observation.
What Aveed is approved for: Aveed is approved as testosterone replacement therapy in adult males with low or absent natural testosterone due to primary hypogonadism or hypogonadotropic hypogonadism, and only where the benefits outweigh the serious risks of pulmonary oil microembolism and anaphylaxis. The label says safety and efficacy have not been established in men with "age-related hypogonadism" or in males under 18 (section 1).
Source
AVEED (testosterone undecanoate) injection, for intramuscular use, CIII, prescribing information and Medication Guide. Endo. DailyMed, version published March 18, 2026. DailyMed setid f80f025b-17d8-40af-8739-20ce07902045
WARNING: SERIOUS PULMONARY OIL MICROEMBOLISM (POME) REACTIONS AND ANAPHYLAXIS
Serious POME reactions, with an urge to cough, shortness of breath, throat tightening, chest pain, dizziness and fainting, and episodes of anaphylaxis, including life-threatening ones, have been reported during or immediately after testosterone undecanoate injections. They can happen after any injection, including the first. After each Aveed injection, patients are observed in the healthcare setting for 30 minutes so treatment can be given if needed. Because of these risks, Aveed is available only through a restricted program, the Aveed REMS Program.
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 Aveed.
| MedDRA Preferred Term | AVEED 750 mg (N=153) Number of Patients (%) |
|---|---|
| Acne | 8 (5.2%) |
| Injection site pain | 7 (4.6%) |
| Prostatic specific antigen increased (*) | 7 (4.6%) |
| Estradiol increased | 4 (2.6%) |
| Hypogonadism | 4 (2.6%) |
| Fatigue | 3 (2%) |
| Irritability | 3 (2%) |
| Hemoglobin increased | 3 (2%) |
| Insomnia | 3 (2%) |
| Mood swings | 3 (2%) |
| Aggression | 2 (1.3%) |
| Ejaculation disorder | 2 (1.3%) |
| Injection site erythema | 2 (1.3%) |
| Hematocrit increased | 2 (1.3%) |
| Hyperhidrosis | 2 (1.3%) |
| Prostate Cancer | 2 (1.3%) |
| Prostate induration | 2 (1.3%) |
| Weight increased | 2 (1.3%) |
84-week study of 153 men with hypogonadism given 750 mg at the start, at 4 weeks and every 10 weeks after. There was no placebo group. (*) PSA increased means a serum PSA above 4 ng/mL. 7 men (4.6%) stopped because of side effects.
POME and anaphylaxis across 18 trials: on review, 9 POME events in 8 men and 2 anaphylaxis events were judged to have occurred among 3,556 men given intramuscular testosterone undecanoate. In the 84-week Aveed study, 1 man had a mild 10-minute coughing fit after his third injection.
PSA: average PSA rose from 1.0 to 1.5 ng/mL over 84 weeks. 14 men (10.9%) whose starting PSA was under 4 ng/mL went above 4 ng/mL.
Blood pressure: in a 16-week 24-hour monitoring study (139 men), average systolic rose 3.1 mm Hg and diastolic 2.0 mm Hg. 3.6% of 222 men had hypertension or increased blood pressure reported as a side effect.
In 7 controlled trials of 725 men at 750 mg to 1000 mg, other events reported in at least 3% included sinusitis, prostatitis, joint pain, nasopharyngitis, upper respiratory infection, bronchitis, back pain, hypertension, diarrhea and headache.
In TRAVERSE, a heart-outcomes study of a testosterone gel (not Aveed), major heart events were 7.0% vs 7.3% on placebo; arrhythmias needing treatment (5.2% vs 3.3%), atrial fibrillation (3.5% vs 2.4%), acute kidney injury (2.3% vs 1.5%) and fractures (3.5% vs 2.5%) were higher on the gel.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
POME reactions and anaphylaxis. The boxed warning risk. Most POME episodes lasted a few minutes, but some lasted hours and needed emergency or hospital care. Aveed is injected deep into the buttock muscle to avoid a blood vessel, and anyone with a suspected allergic reaction to it is not treated with it again.
Aveed REMS Program. Prescribers and healthcare settings must be certified, and settings must have on-site equipment and trained staff to manage POME and anaphylaxis.
Polycythemia (high red blood cells). Hematocrit is checked before starting, again 3 to 6 months later, then yearly. If it is high, treatment is stopped until it comes down.
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, Aveed is stopped.
Enlarged prostate and prostate cancer. BPH symptoms may worsen, and androgens may raise prostate cancer risk. The label says to check for prostate cancer before and during treatment.
Blood pressure increases. Aveed raised average blood pressure by 3.1/2.0 mm Hg after 16 weeks. Blood pressure is checked periodically, and Aveed 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. Aveed is a Schedule III controlled substance (section 9.1).
Not for use in women. Aveed is not indicated for women and must not be used in pregnancy.
Sperm production. Large doses of testosterone may suppress sperm production and lower sperm count.
Liver effects. Serious liver problems have been linked to high-dose oral 17-alpha-alkyl androgens, and liver adenomas to long-term testosterone enanthate injections. Aveed 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.
Gynecomastia. Breast enlargement occasionally develops and occasionally persists.
Sleep apnea. Testosterone may worsen sleep apnea, especially with obesity or chronic lung disease.
Lipid changes. Blood fats can change; lipids are checked periodically, particularly after starting.
High calcium. In cancer patients at risk of high calcium, calcium is checked regularly.
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.
From the Medication Guide that comes with Aveed:
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.