What the label lists and what reports show
Testosterone side effects
Testosterone's FDA label: “The most common adverse reactions in patients who received AZMIRO were injection site erythema (26%) and injection site reaction (4%).” FAERS holds 34,691 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (1,850 reports).
- Generic listed
- DEA Schedule III
Check it at the source: the testosterone FDA label on DailyMed (effective July 25, 2025, Azurity Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of JATENZO?JATENZO may cause serious side effects including: Increase in blood pressure. JATENZO can increase your blood pressure, which can increase your risk of having a heart attack or stroke over time. Your risk may be greater if you already have heart disease or if you have had a heart attack or stroke. You may need to start new blood pressure medicines or have your medicines adjusted to control your blood pressure while on JATENZO. If your blood pressure cannot be controlled, JATENZO may need to be stopped. Your healthcare provider should check your blood pressure while you use JATENZO. Increase in red blood cell count (hematocrit) or hemoglobin. JATENZO increases red blood cell counts in some patients. High red blood cell counts increase the risk of blood clots, strokes, and heart attacks. You may need to stop JATENZO if your red blood cell count increases. […]
Source: FDA drug label (Jatenzo), TOLMAR Inc., effective September 30, 2025 (SPL set ed7b5d41-7475-4c10-99b9-b62b3434ae60), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions in patients who received AZMIRO were injection site erythema (26%) and injection site reaction (4%).
Table 2: Number (%) of Patients with Adverse Reactions ≥ 2% in a 4-Month Study with JATENZO
This table is printed in the Jatenzo label published by TOLMAR Inc. of September 30, 2025; the label quoted above does not print one.
| Preferred Term | Among the 569 patients who received JATENZO in all Phase 2 and 3 trials combined, the… Three of the 166 patients (1.8%) in the 4-month study experienced adverse reactions that… Overall (N = 166) n (%) |
|---|---|
| Headache | 8 (4.8) |
| Hematocrit increased | 8 (4.8) |
| Hypertension | 6 (3.6) |
| High-density lipoprotein decreased | 5 (3.0) |
| Nausea | 4 (2.4) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe 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 ).
Source: FDA drug label, Azurity Pharmaceuticals, Inc., effective July 25, 2025 (SPL set 235b5625-570d-3fba-e063-6394a90aa2d1), via openFDA; the full label on DailyMed
What do FAERS reports show?
34,691 reports list testosterone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,532 are coded as a death and 8,785 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Testosterone: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions