Drug
Testosterone Undecanoate
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Libido Decreased | 13 | 11.5 | 11.5 | signal |
| 2 | Product Availability Issue | 20 | 9.7 | 9.8 | signal |
| 3 | Erectile Dysfunction | 19 | 8.1 | 8.1 | signal |
| 4 | Prostatic Specific Antigen Increased | 9 | 7.1 | 7.1 | signal |
| 5 | Paraesthesia Oral | 8 | 6.1 | 6.1 | signal |
| 6 | Cough | 153 | 6.0 | 6.4 | signal |
| 7 | Drug Effect Decreased | 28 | 5.6 | 5.7 | signal |
| 8 | Cold Sweat | 9 | 5.6 | 5.6 | signal |
| 9 | Inappropriate Schedule Of Drug Administration | 36 | 5.4 | 5.5 | signal |
| 10 | Insurance Issue | 7 | 5.1 | 5.2 | signal |
| 11 | Faeces Discoloured | 10 | 5.0 | 5.1 | signal |
| 12 | Product Physical Issue | 9 | 4.9 | 4.9 | signal |
| 13 | Blood Test Abnormal | 6 | 4.7 | 4.7 | signal |
| 14 | Product Administration Error | 8 | 4.4 | 4.4 | signal |
| 15 | Sluggishness | 4 | 4.3 | 4.3 | signal |
| 16 | Mood Swings | 12 | 4.1 | 4.1 | signal |
| 17 | Drug Effect Less Than Expected | 5 | 3.9 | 3.9 | signal |
| 18 | Drug Abuse | 29 | 3.8 | 3.8 | signal |
| 19 | Therapy Interrupted | 23 | 3.6 | 3.7 | signal |
| 20 | Anaphylactic Shock | 8 | 3.4 | 3.4 | signal |
| 21 | Injection Site Discomfort | 3 | 3.2 | 3.2 | no signal |
| 22 | Product Odour Abnormal | 3 | 3.2 | 3.2 | no signal |
| 23 | Acne | 21 | 3.0 | 3.0 | signal |
| 24 | Injection Site Haematoma | 4 | 3.0 | 3.0 | no signal |
| 25 | Sexual Dysfunction | 3 | 2.8 | 2.8 | no signal |
| 26 | Incorrect Product Administration Duration | 5 | 2.7 | 2.7 | no signal |
| 27 | Injection Site Irritation | 3 | 2.6 | 2.6 | no signal |
| 28 | Injection Site Induration | 3 | 2.5 | 2.5 | no signal |
| 29 | Gynaecomastia | 7 | 2.4 | 2.4 | signal |
| 30 | Product Taste Abnormal | 3 | 2.4 | 2.4 | no signal |
| 31 | Injection Site Pain | 54 | 1.9 | 2.0 | no signal |
| 32 | Incorrect Route Of Drug Administration | 6 | 1.8 | 1.8 | no signal |
| 33 | Product Administered At Inappropriate Site | 3 | 1.8 | 1.8 | no signal |
| 34 | Injection Site Warmth | 3 | 1.6 | 1.6 | no signal |
| 35 | Prostate Cancer | 11 | 1.5 | 1.5 | no signal |
| 36 | Injection Site Swelling | 9 | 1.3 | 1.3 | no signal |
| 37 | Gastric Cancer | 3 | 1.3 | 1.3 | no signal |