Testosterone Enanthate side effects: what 1,557 FDA adverse event reports show

Testosterone Enanthate · Xyosted · 42 reaction terms · 1,275 drug–reaction co-reports · data 2026-09-14

Drug class

Androgen

FDA label, Indications wording

Brand names

Xyosted

openFDA label

Who reports

1,557 reports · 30% serious · 27 with death outcome · 4% female

openFDA FAERS counts, all years, deduplication not applied

Used for

XYOSTED (testosterone enanthate) injection is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired): te.

FDA label, Indications and Usage

What it is

XYOSTED (testosterone enanthate) injection contains testosterone enanthate, an ester derivative of an endogenous androgen, testosterone. Testosterone enanthate is a white to creamy white crystalline powder described by the chemical name (17β)-17-[(1-Oxoheptyl) oxy]-androst-4-en-3-one.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 21 strongest signals

Labeled adverse reaction 3Labeled (related wording) 5Reporting / coding artifact 10Not in label — unassessed 3

What the badges mean

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. 21 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Injection site haemorrhage	133	22.2 18.8–26.1ROR 24.1 · χ² 2,671 / p <1e-300	22.1 EB05 19.1 · IC025 +4.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.9 · 86% consumer	no trial data cached
Injection site mass	59	21.2 16.5–27.2ROR 21.9 · χ² 1,113 / p 3e-244	21.0 EB05 16.9 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 3.8 · 78% consumer	no trial data cached
Injury associated with device	29	19.0 13.3–27.3ROR 19.4 · χ² 478 / p 3e-106	18.8 EB05 13.6 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	93% consumer	no trial data cached
Product dose omission issue	343	15.9 14.5–17.5ROR 20.0 · χ² 4,840 / p <1e-300	15.9 EB05 14.5 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious PRR 3.8 · 79% consumer	no trial data cached
Product administered at inappropriate site	21	15.3 10.0–23.4ROR 15.5 · χ² 266 / p 4e-60	14.8 EB05 9.8 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	95% consumer	no trial data cached
Oral candidiasis (oral thrush)	13	13.2 7.7–22.7ROR 13.3 · χ² 135 / p 2e-31	11.8 EB05 6.6 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 36.7	no trial data cached
Injection site nodule	10	12.0 6.5–22.3ROR 12.1 · χ² 90 / p 1e-21	10.0 EB05 5.1 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Incorrect dose administered by device	22	11.4 7.6–17.3ROR 11.6 · χ² 199 / p 1e-45	10.6 EB05 7.0 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious n=1 · 73% consumer	no trial data cached
Product administration error	16	10.6 6.5–17.2ROR 10.7 · χ² 129 / p 3e-30	9.3 EB05 5.7 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Product dose omission	52	10.4 7.9–13.5ROR 10.7 · χ² 432 / p 3e-96	10.0 EB05 7.8 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious PRR 3.2	no trial data cached
Unresponsive to stimuli	20	10.3 6.6–15.9ROR 10.4 · χ² 158 / p 1e-36	9.2 EB05 6.0 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 20.8	no trial data cached
Injection site bruising	56	9.4 7.2–12.1ROR 9.7 · χ² 412 / p 7e-92	9.0 EB05 7.1 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	80% consumer	no trial data cached
Accidental exposure to product	52	6.9 5.3–9.0ROR 7.1 · χ² 256 / p 6e-58	6.5 EB05 5.1 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 3.0	no trial data cached
Injection site pain (pain where injected)	153	6.7 5.7–7.7ROR 7.3 · χ² 740 / p 3e-163	6.5 EB05 5.7 · IC025 +2.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.5 · 86% consumer	no trial data cached
Device dislocation	18	5.5 3.5–8.7ROR 5.5 · χ² 62 / p 2e-15	4.8 EB05 3.2 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 14.2	no trial data cached
Device malfunction	27	5.3 3.6–7.7ROR 5.4 · χ² 90 / p 1e-21	4.9 EB05 3.5 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 37.3	no trial data cached
Drug abuse	31	4.9 3.5–6.9ROR 5.0 · χ² 92 / p 3e-22	4.6 EB05 3.4 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 9.5 · 90% clinician	no trial data cached
Intentional dose omission	10	4.8 2.6–9.0ROR 4.9 · χ² 27 / p 1e-7	4.0 EB05 2.4 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 13.8	no trial data cached
Injection site erythema (redness where injected)	40	4.3 3.1–5.8ROR 4.4 · χ² 98 / p 2e-23	4.1 EB05 3.1 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 1.3	no trial data cached
Injection site swelling	23	4.0 2.7–6.0ROR 4.1 · χ² 49 / p 1e-12	3.7 EB05 2.6 · IC025 +1.2 3/3 methods agree	Labeled (related wording) related wording	87% consumer	no trial data cached
Injection site pruritus	19	3.8 2.4–5.9ROR 3.8 · χ² 36 / p 1e-9	3.5 EB05 2.4 · IC025 +1.0 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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
Product dose omission issue	343	15.9 14.5–17.5ROR 20.0 · χ² 4,840 / p <1e-300	15.9 EB05 14.5 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious PRR 3.8 · 79% consumer	no trial data cached
Injection site pain (pain where injected)	153	6.7 5.7–7.7ROR 7.3 · χ² 740 / p 3e-163	6.5 EB05 5.7 · IC025 +2.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.5 · 86% consumer	no trial data cached
Injection site haemorrhage	133	22.2 18.8–26.1ROR 24.1 · χ² 2,671 / p <1e-300	22.1 EB05 19.1 · IC025 +4.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.9 · 86% consumer	no trial data cached
Injection site mass	59	21.2 16.5–27.2ROR 21.9 · χ² 1,113 / p 3e-244	21.0 EB05 16.9 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 3.8 · 78% consumer	no trial data cached
Injection site bruising	56	9.4 7.2–12.1ROR 9.7 · χ² 412 / p 7e-92	9.0 EB05 7.1 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	80% consumer	no trial data cached
Accidental exposure to product	52	6.9 5.3–9.0ROR 7.1 · χ² 256 / p 6e-58	6.5 EB05 5.1 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 3.0	no trial data cached
Product dose omission	52	10.4 7.9–13.5ROR 10.7 · χ² 432 / p 3e-96	10.0 EB05 7.8 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious PRR 3.2	no trial data cached
Injection site erythema (redness where injected)	40	4.3 3.1–5.8ROR 4.4 · χ² 98 / p 2e-23	4.1 EB05 3.1 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 1.3	no trial data cached
Drug abuse	31	4.9 3.5–6.9ROR 5.0 · χ² 92 / p 3e-22	4.6 EB05 3.4 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 9.5 · 90% clinician	no trial data cached
Injury associated with device	29	19.0 13.3–27.3ROR 19.4 · χ² 478 / p 3e-106	18.8 EB05 13.6 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	93% consumer	no trial data cached
Device malfunction	27	5.3 3.6–7.7ROR 5.4 · χ² 90 / p 1e-21	4.9 EB05 3.5 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 37.3	no trial data cached
Injection site swelling	23	4.0 2.7–6.0ROR 4.1 · χ² 49 / p 1e-12	3.7 EB05 2.6 · IC025 +1.2 3/3 methods agree	Labeled (related wording) related wording	87% consumer	no trial data cached
Incorrect dose administered by device	22	11.4 7.6–17.3ROR 11.6 · χ² 199 / p 1e-45	10.6 EB05 7.0 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious n=1 · 73% consumer	no trial data cached
Product administered at inappropriate site	21	15.3 10.0–23.4ROR 15.5 · χ² 266 / p 4e-60	14.8 EB05 9.8 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	95% consumer	no trial data cached
Unresponsive to stimuli	20	10.3 6.6–15.9ROR 10.4 · χ² 158 / p 1e-36	9.2 EB05 6.0 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 20.8	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Injury associated with device — n=29, PRR 19.0
Unresponsive to stimuli — n=20, PRR 10.3

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 Enanthate?

In FDA FAERS, the most frequently co-reported reaction terms for Testosterone Enanthate are injection site pain, injection site haemorrhage, injection site mass, injection site bruising, injection site erythema, injury associated with device. 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 Enanthate have an FDA boxed warning?

No. The FDA label retrieved for Testosterone Enanthate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Testosterone Enanthate 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 8a3d204c-be26-49e0-8599-0ac12a272e81, effective 20250701; matched on openfda.generic_name.exact:"TESTOSTERONE ENANTHATE")
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, field patient.drug.openfda.generic_name.exact, 42 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.