Testosterone Undecanoate side effects: what 1,921 FDA adverse event reports show
Drug class
Androgen
Brand names
Aveed
Who reports
1,921 reports · 54% serious · 52 with death outcome · 6% female
Used for
AVEED is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals.
What it is
AVEED (testosterone undecanoate) injection contains testosterone undecanoate (17β-undecanoyloxy-4-androsten-3-one) which is an ester of the androgen, testosterone. Testosterone is formed by cleavage of the ester side chain of testosterone undecanoate.
Boxed warning
SERIOUS PULMONARY OIL MICROEMBOLISM (POME) REACTIONS AND ANAPHYLAXIS Serious POME reactions, involving urge to cough, dyspnea, throat tightening, chest pain, dizziness, and syncope; and episodes of anaphylaxis, inclu.
Causality screen of the 21 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 16 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Libido decreased (lower sex drive) | 13 | 11.5 6.7–19.7ROR 11.5 · χ² 114 / p 7e-27 | 9.9 EB05 5.6 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.0 | no trial data cached |
| Product availability issue | 20 | 9.7 6.3–15.1ROR 9.8 · χ² 148 / p 2e-34 | 8.7 EB05 5.7 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 3.2 · ♀ 50% (drug 6%) | no trial data cached |
| Erectile dysfunction | 19 | 8.1 5.1–12.6ROR 8.1 · χ² 110 / p 4e-26 | 7.0 EB05 4.6 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.1 | no trial data cached |
| Prostatic specific antigen increased | 9 | 7.1 3.7–13.6ROR 7.1 · χ² 41 / p 7e-11 | 5.4 EB05 3.0 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.7 | no trial data cached |
| Paraesthesia oral | 8 | 6.1 3.0–12.1ROR 6.1 · χ² 29 / p 4e-8 | 4.7 EB05 2.5 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.2 | no trial data cached |
| Cough | 153 | 6.0 5.1–6.9ROR 6.4 · χ² 636 / p 1e-140 | 5.9 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 10.0 | no trial data cached |
| Drug effect decreased | 28 | 5.6 3.9–8.1ROR 5.7 · χ² 101 / p 4e-24 | 5.1 EB05 3.7 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 1.5 | no trial data cached |
| Cold sweat | 9 | 5.6 2.9–10.7ROR 5.6 · χ² 29 / p 3e-8 | 4.4 EB05 2.5 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 | no trial data cached |
| Inappropriate schedule of drug administration | 36 | 5.4 3.9–7.5ROR 5.5 · χ² 127 / p 1e-29 | 5.1 EB05 3.9 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 4.0 | no trial data cached |
| Insurance issue | 7 | 5.1 2.5–10.8ROR 5.2 · χ² 19 / p 5e-6 | 4.0 EB05 2.1 · IC025 +0.7 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Faeces discoloured | 10 | 5.0 2.7–9.3ROR 5.1 · χ² 28 / p 5e-8 | 4.2 EB05 2.5 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Product physical issue | 9 | 4.9 2.6–9.5ROR 4.9 · χ² 24 / p 4e-7 | 4.0 EB05 2.3 · IC025 +0.9 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Blood test abnormal | 6 | 4.7 2.1–10.4ROR 4.7 · χ² 14 / p 1e-4 | 3.6 EB05 1.8 · IC025 +0.4 | Reporting / coding artifact | serious PRR 1.3 | no trial data cached |
| Product administration error | 8 | 4.4 2.2–8.7ROR 4.4 · χ² 18 / p 1e-5 | 3.6 EB05 2.0 · IC025 +0.7 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 | no trial data cached |
| Mood swings | 12 | 4.1 2.3–7.2ROR 4.1 · χ² 25 / p 3e-7 | 3.6 EB05 2.2 · IC025 +0.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 0.6 | no trial data cached |
| Drug effect less than expected | 5 | 3.9 1.6–9.3ROR 3.9 · χ² 8 / p 0.002 | 3.0 EB05 1.5 · IC025 +0.1 | Reporting / coding artifact | – | no trial data cached |
| Drug abuse | 29 | 3.8 2.6–5.4ROR 3.8 · χ² 57 / p 2e-14 | 3.6 EB05 2.6 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.1 | no trial data cached |
| Therapy interrupted | 23 | 3.6 2.4–5.5ROR 3.7 · χ² 42 / p 6e-11 | 3.4 EB05 2.4 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 0.8 · ♀ 45% (drug 6%) | no trial data cached |
| Anaphylactic shock | 8 | 3.4 1.7–6.8ROR 3.4 · χ² 11 / p 4e-4 | 3.0 EB05 1.7 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 3.7 | no trial data cached |
| Acne | 21 | 3.0 2.0–4.6ROR 3.0 · χ² 26 / p 1e-7 | 2.9 EB05 2.0 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 11.3 | no trial data cached |
| Gynaecomastia (male breast enlargement) | 7 | 2.4 1.2–5.1ROR 2.4 · χ² 5 / p 0.016 | 2.2 EB05 1.2 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 8.4 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Cough | 153 | 6.0 5.1–6.9ROR 6.4 · χ² 636 / p 1e-140 | 5.9 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 10.0 | no trial data cached |
| Injection site pain (pain where injected) | 54 | 1.9 1.5–2.5ROR 2.0 · χ² 24 / p 5e-7 | 1.9 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 6.4 | no trial data cached |
| Inappropriate schedule of drug administration | 36 | 5.4 3.9–7.5ROR 5.5 · χ² 127 / p 1e-29 | 5.1 EB05 3.9 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 4.0 | no trial data cached |
| Drug abuse | 29 | 3.8 2.6–5.4ROR 3.8 · χ² 57 / p 2e-14 | 3.6 EB05 2.6 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.1 | no trial data cached |
| Drug effect decreased | 28 | 5.6 3.9–8.1ROR 5.7 · χ² 101 / p 4e-24 | 5.1 EB05 3.7 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 1.5 | no trial data cached |
| Therapy interrupted | 23 | 3.6 2.4–5.5ROR 3.7 · χ² 42 / p 6e-11 | 3.4 EB05 2.4 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 0.8 · ♀ 45% (drug 6%) | no trial data cached |
| Acne | 21 | 3.0 2.0–4.6ROR 3.0 · χ² 26 / p 1e-7 | 2.9 EB05 2.0 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 11.3 | no trial data cached |
| Product availability issue | 20 | 9.7 6.3–15.1ROR 9.8 · χ² 148 / p 2e-34 | 8.7 EB05 5.7 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 3.2 · ♀ 50% (drug 6%) | no trial data cached |
| Erectile dysfunction | 19 | 8.1 5.1–12.6ROR 8.1 · χ² 110 / p 4e-26 | 7.0 EB05 4.6 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.1 | no trial data cached |
| Libido decreased (lower sex drive) | 13 | 11.5 6.7–19.7ROR 11.5 · χ² 114 / p 7e-27 | 9.9 EB05 5.6 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.0 | no trial data cached |
| Mood swings | 12 | 4.1 2.3–7.2ROR 4.1 · χ² 25 / p 3e-7 | 3.6 EB05 2.2 · IC025 +0.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 0.6 | no trial data cached |
| Prostate cancer | 11 | 1.5 0.8–2.7ROR 1.5 · χ² 1 / p 0.131 | 1.5 EB05 0.9 · IC025 -0.5 PRR-only: not supported by EBGM or IC | Labeled — boxed warning exact term | serious PRR 1.6 | no trial data cached |
| Faeces discoloured | 10 | 5.0 2.7–9.3ROR 5.1 · χ² 28 / p 5e-8 | 4.2 EB05 2.5 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Injection site swelling | 9 | 1.3 0.7–2.5ROR 1.3 · χ² 0 / p 0.277 | 1.3 EB05 0.7 · IC025 -0.8 PRR-only: not supported by EBGM or IC | Labeled (related wording) related wording | serious PRR 5.0 | no trial data cached |
| Product physical issue | 9 | 4.9 2.6–9.5ROR 4.9 · χ² 24 / p 4e-7 | 4.0 EB05 2.3 · IC025 +0.9 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Testosterone Undecanoate?
In FDA FAERS, the most frequently co-reported reaction terms for Testosterone Undecanoate are cough, injection site pain, acne, erectile dysfunction, libido decreased, mood swings. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Testosterone Undecanoate have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: SERIOUS PULMONARY OIL MICROEMBOLISM (POME) REACTIONS AND ANAPHYLAXIS Serious POME reactions, involving urge to cough, dyspnea, throat tightening, chest pain, dizziness, and syncope; and episodes of anaphylaxis, inclu.
Do FAERS signals prove that Testosterone Undecanoate causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID f80f025b-17d8-40af-8739-20ce07902045, effective 20250715; matched on
openfda.generic_name.exact:"TESTOSTERONE UNDECANOATE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 37 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.