Drug · FAERS side-effect profile with label screen

Testosterone Gel and 1% side effects: what 243 FDA adverse event reports show

Testosterone Gel, 1% · 13 reaction terms · 419 drug–reaction co-reports · data 2026-09-14

Drug class

Androgen

FDA label (Established Pharmacologic Class) of the closest related product

Label matched

Testosterone Gel, 1% (Testosterone Gel, 1%)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

243 reports · 7% serious · 0 with death outcome · 4% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Testosterone gel, 1% is indicated for 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 conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals.

FDA label, Indications and Usage

What it is

Testosterone gel, 1% is a clear, colorless to yellowish hydroalcoholic gel containing testosterone, USP. The active pharmacologic ingredient in testosterone gel 1% is testosterone, USP an androgen.

FDA label, Description section

Boxed warning

SECONDARY EXPOSURE TO TESTOSTERONE Virilization has been reported in children who were secondarily exposed to testosterone gel [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.2 )] . Children should av.

FDA 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 10 strongest signals

Reporting / coding artifact 9Not in label — unassessed 1

What the badges mean

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. 3 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
Device delivery system issue	101	333.4 287.0–387.3ROR 568.2 · χ² 33,053 / p <1e-300	312.4 EB05 264.6 · IC025 +6.7 3/3 methods agree	Reporting / coding artifact	79% consumer	no trial data cached
Incorrect dose administered by device	34	115.2 84.3–157.4ROR 133.7 · χ² 3,735 / p <1e-300	108.2 EB05 81.0 · IC025 +4.9 3/3 methods agree	Reporting / coding artifact	88% consumer	no trial data cached
Product packaging quantity issue	12	94.6 54.5–164.3ROR 99.4 · χ² 1,019 / p 7e-224	82.5 EB05 50.3 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
No adverse event	147	71.3 64.4–78.9ROR 177.8 · χ² 10,195 / p <1e-300	70.6 EB05 61.5 · IC025 +5.6 3/3 methods agree	Reporting / coding artifact	78% consumer	no trial data cached
Drug dose omission by device	63	70.7 57.2–87.5ROR 95.0 · χ² 4,274 / p <1e-300	69.3 EB05 56.1 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	87% consumer	no trial data cached
Product odour abnormal	5	41.4 17.4–98.6ROR 42.2 · χ² 159 / p 1e-36	35.5 EB05 15.4 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Device defective	6	31.9 14.5–70.3ROR 32.6 · χ² 150 / p 9e-35	28.5 EB05 13.1 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Product substitution issue	21	31.4 20.8–47.2ROR 34.2 · χ² 589 / p 2e-130	30.6 EB05 21.1 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	serious PRR 139.4 · 86% consumer	no trial data cached
Device malfunction	15	19.2 11.8–31.3ROR 20.4 · χ² 241 / p 1e-54	18.6 EB05 11.6 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Wrong technique in device usage process	5	9.4 3.9–22.4ROR 9.6 · χ² 30 / p 3e-8	6.0 EB05 2.6 · IC025 +0.9 3/3 methods agree	Reporting / coding artifact	–	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
No adverse event	147	71.3 64.4–78.9ROR 177.8 · χ² 10,195 / p <1e-300	70.6 EB05 61.5 · IC025 +5.6 3/3 methods agree	Reporting / coding artifact	78% consumer	no trial data cached
Device delivery system issue	101	333.4 287.0–387.3ROR 568.2 · χ² 33,053 / p <1e-300	312.4 EB05 264.6 · IC025 +6.7 3/3 methods agree	Reporting / coding artifact	79% consumer	no trial data cached
Drug dose omission by device	63	70.7 57.2–87.5ROR 95.0 · χ² 4,274 / p <1e-300	69.3 EB05 56.1 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	87% consumer	no trial data cached
Incorrect dose administered by device	34	115.2 84.3–157.4ROR 133.7 · χ² 3,735 / p <1e-300	108.2 EB05 81.0 · IC025 +4.9 3/3 methods agree	Reporting / coding artifact	88% consumer	no trial data cached
Product substitution issue	21	31.4 20.8–47.2ROR 34.2 · χ² 589 / p 2e-130	30.6 EB05 21.1 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	serious PRR 139.4 · 86% consumer	no trial data cached
Device malfunction	15	19.2 11.8–31.3ROR 20.4 · χ² 241 / p 1e-54	18.6 EB05 11.6 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Product packaging quantity issue	12	94.6 54.5–164.3ROR 99.4 · χ² 1,019 / p 7e-224	82.5 EB05 50.3 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Device defective	6	31.9 14.5–70.3ROR 32.6 · χ² 150 / p 9e-35	28.5 EB05 13.1 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Wrong technique in device usage process	5	9.4 3.9–22.4ROR 9.6 · χ² 30 / p 3e-8	6.0 EB05 2.6 · IC025 +0.9 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Product odour abnormal	5	41.4 17.4–98.6ROR 42.2 · χ² 159 / p 1e-36	35.5 EB05 15.4 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Poor quality product administered	4	33.6 12.7–88.9ROR 34.2 · χ² 96 / p 5e-23	26.9 EB05 7.7 · IC025 +1.1 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Device breakage	3	6.6 2.1–20.2ROR 6.6 · χ² 9 / p 0.001	3.8 EB05 1.5 · IC025 -0.2 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	–	no trial data cached
Libido decreased (lower sex drive)	3	20.8 6.8–64.1ROR 21.1 · χ² 39 / p 3e-10	12.0 EB05 2.8 · IC025 +0.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 108.0	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.

Drug dose omission by device — n=63, PRR 70.7

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 Gel and 1%?

In FDA FAERS, the most frequently co-reported reaction terms for Testosterone Gel and 1% are drug dose omission by device, poor quality product administered, libido decreased. 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 Gel and 1% have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: SECONDARY EXPOSURE TO TESTOSTERONE Virilization has been reported in children who were secondarily exposed to testosterone gel [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.2 )] . Children should av.

Do FAERS signals prove that Testosterone Gel and 1% 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 353de205-d642-4f26-875b-b9ea4707a755, effective 20260407; matched on openfda.generic_name.exact:"TESTOSTERONE GEL, 1%")
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, 13 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.