Drug · FAERS side-effect profile with label screen
Dhea (Dehydroepiandrosterone) side effects: what 1,908 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Dhea
openFDA label
Who reports
1,908 reports · 49% serious · 48 with death outcome · 75% female
openFDA FAERS counts, all years, deduplication not applied
Used for
• For the temporary relief of symptoms including: • fatigue • low energy These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.
FDA label, Indications and Usage
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 38 strongest signals
Reporting / coding artifact 6Lab value / disease marker 1No label text to screen 31
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.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- 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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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. 42 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Sleep apnoea syndrome | 27 | 15.5 10.7–22.6ROR 15.7 · χ² 353 / p 6e-79 | 15.2 EB05 10.7 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.1 | no trial data cached |
| Thyroid disorder | 15 | 10.7 6.5–17.7ROR 10.8 · χ² 122 / p 9e-29 | 9.3 EB05 5.6 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.2 | no trial data cached |
| Fibromyalgia | 21 | 9.5 6.2–14.6ROR 9.6 · χ² 152 / p 4e-35 | 8.5 EB05 5.6 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.3 | no trial data cached |
| Malignant melanoma | 11 | 9.0 5.0–16.3ROR 9.1 · χ² 71 / p 2e-17 | 7.2 EB05 4.1 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.7 | no trial data cached |
| Bursitis | 9 | 8.2 4.3–15.7ROR 8.2 · χ² 50 / p 8e-13 | 6.2 EB05 3.4 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.0 | no trial data cached |
| Ligament sprain | 7 | 7.8 3.7–16.3ROR 7.8 · χ² 35 / p 2e-9 | 5.6 EB05 2.8 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=4 | no trial data cached |
| Nocturia (night-time urination) | 8 | 7.3 3.6–14.5ROR 7.3 · χ² 37 / p 5e-10 | 5.4 EB05 2.9 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.6 | no trial data cached |
| Therapeutic response unexpected | 27 | 6.6 4.5–9.6ROR 6.7 · χ² 123 / p 8e-29 | 6.0 EB05 4.3 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 10.0 | no trial data cached |
| Adrenal insufficiency | 7 | 6.4 3.1–13.5ROR 6.4 · χ² 27 / p 1e-7 | 4.7 EB05 2.5 · IC025 +0.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.5 | no trial data cached |
| Carpal tunnel syndrome | 8 | 6.3 3.1–12.5ROR 6.3 · χ² 30 / p 2e-8 | 4.8 EB05 2.6 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.9 | no trial data cached |
| Blood thyroid stimulating hormone increased | 5 | 6.0 2.5–14.3ROR 6.0 · χ² 16 / p 3e-5 | 4.1 EB05 1.9 · IC025 +0.5 | Lab value / disease marker | serious n=2 | no trial data cached |
| Erectile dysfunction | 13 | 5.5 3.2–9.5ROR 5.6 · χ² 44 / p 2e-11 | 4.7 EB05 2.9 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.6 | no trial data cached |
| Vaginal discharge | 5 | 5.5 2.3–13.1ROR 5.5 · χ² 14 / p 9e-5 | 3.9 EB05 1.8 · IC025 +0.4 | No label text to screen label has no adverse-reaction text | serious n=3 | no trial data cached |
| Gastroenteritis viral | 9 | 5.5 2.8–10.5ROR 5.5 · χ² 29 / p 5e-8 | 4.4 EB05 2.5 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.7 | no trial data cached |
| Musculoskeletal discomfort | 8 | 5.1 2.6–10.2ROR 5.1 · χ² 23 / p 1e-6 | 4.1 EB05 2.2 · IC025 +0.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.9 | no trial data cached |
| Hunger | 6 | 4.9 2.2–10.9ROR 4.9 · χ² 15 / p 6e-5 | 3.7 EB05 1.9 · IC025 +0.5 | No label text to screen label has no adverse-reaction text | serious n=4 | no trial data cached |
| Mental impairment | 10 | 4.5 2.4–8.4ROR 4.5 · χ² 24 / p 5e-7 | 3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.3 | no trial data cached |
| Pelvic pain | 7 | 4.2 2.0–8.9ROR 4.2 · χ² 14 / p 8e-5 | 3.4 EB05 1.8 · IC025 +0.5 | No label text to screen label has no adverse-reaction text | serious PRR 4.8 | no trial data cached |
| Back disorder | 6 | 4.0 1.8–9.0ROR 4.0 · χ² 11 / p 5e-4 | 3.2 EB05 1.7 · IC025 +0.3 | No label text to screen label has no adverse-reaction text | serious PRR 5.7 | no trial data cached |
| Tooth disorder | 8 | 3.9 2.0–7.9ROR 3.9 · χ² 15 / p 6e-5 | 3.3 EB05 1.8 · IC025 +0.5 | No label text to screen label has no adverse-reaction text | serious PRR 5.0 | no trial data cached |
| Unevaluable event | 27 | 3.9 2.7–5.7ROR 4.0 · χ² 56 / p 3e-14 | 3.7 EB05 2.7 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.4 | no trial data cached |
| Metrorrhagia | 6 | 3.8 1.7–8.5ROR 3.8 · χ² 10 / p 9e-4 | 3.1 EB05 1.6 · IC025 +0.2 | No label text to screen label has no adverse-reaction text | serious n=3 | no trial data cached |
| Paranoia | 6 | 3.8 1.7–8.5ROR 3.8 · χ² 10 / p 9e-4 | 3.1 EB05 1.6 · IC025 +0.2 | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Systemic lupus erythematosus | 12 | 3.7 2.1–6.6ROR 3.7 · χ² 21 / p 2e-6 | 3.3 EB05 2.1 · IC025 +0.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.5 | no trial data cached |
| Tendonitis | 5 | 3.5 1.5–8.5ROR 3.5 · χ² 7 / p 0.005 | 2.9 EB05 1.4 · IC025 -0.0 PRR-only: not supported by EBGM or IC | No label text to screen label has no adverse-reaction text | serious PRR 5.3 | no trial data cached |
| Gastric disorder | 11 | 3.5 1.9–6.3ROR 3.5 · χ² 17 / p 2e-5 | 3.1 EB05 1.9 · IC025 +0.6 | No label text to screen label has no adverse-reaction text | serious PRR 7.1 | no trial data cached |
| Rash generalised | 8 | 3.3 1.7–6.7ROR 3.4 · χ² 11 / p 5e-4 | 2.9 EB05 1.6 · IC025 +0.3 | No label text to screen label has no adverse-reaction text | serious PRR 3.3 | no trial data cached |
| Crying | 11 | 3.3 1.8–6.0ROR 3.3 · χ² 16 / p 4e-5 | 3.0 EB05 1.8 · IC025 +0.6 | No label text to screen label has no adverse-reaction text | serious PRR 3.0 | no trial data cached |
| Local swelling | 5 | 3.1 1.3–7.5ROR 3.1 · χ² 5 / p 0.011 | 2.6 EB05 1.3 · IC025 -0.2 PRR-only: not supported by EBGM or IC | No label text to screen label has no adverse-reaction text | serious PRR 2.7 | no trial data cached |
| Application site pruritus | 6 | 2.9 1.3–6.5ROR 2.9 · χ² 6 / p 0.008 | 2.5 EB05 1.3 · IC025 -0.1 PRR-only: not supported by EBGM or IC | No label text to screen label has no adverse-reaction text | serious n=3 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 24 | 2.9 1.9–4.3ROR 2.9 · χ² 28 / p 7e-8 | 2.8 EB05 2.0 · IC025 +0.8 | No label text to screen label has no adverse-reaction text | serious PRR 3.5 | no trial data cached |
| Drug prescribing error | 5 | 2.8 1.2–6.8ROR 2.8 · χ² 4 / p 0.020 | 2.4 EB05 1.2 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | – | no trial data cached |
| Abnormal dreams | 7 | 2.8 1.3–5.8ROR 2.8 · χ² 6 / p 0.006 | 2.5 EB05 1.3 · IC025 +0.0 | No label text to screen label has no adverse-reaction text | serious PRR 3.3 | no trial data cached |
| Wrong technique in drug usage process | 9 | 2.7 1.4–5.2ROR 2.7 · χ² 8 / p 0.002 | 2.5 EB05 1.4 · IC025 +0.2 | Reporting / coding artifact | – | no trial data cached |
| Abasia | 6 | 2.6 1.2–5.8ROR 2.6 · χ² 5 / p 0.016 | 2.3 EB05 1.2 · IC025 -0.2 PRR-only: not supported by EBGM or IC | No label text to screen label has no adverse-reaction text | serious PRR 3.1 | no trial data cached |
| Drug administration error | 7 | 2.5 1.2–5.2ROR 2.5 · χ² 5 / p 0.015 | 2.3 EB05 1.2 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 3.6 | no trial data cached |
| Product substitution issue | 12 | 2.3 1.3–4.0ROR 2.3 · χ² 8 / p 0.003 | 2.2 EB05 1.4 · IC025 +0.1 | Reporting / coding artifact | serious PRR 3.8 | no trial data cached |
| Acne | 14 | 2.0 1.2–3.4ROR 2.0 · χ² 6 / p 0.006 | 2.0 EB05 1.3 · IC025 +0.1 | No label text to screen label has no adverse-reaction text | serious PRR 4.1 | 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 |
|---|---|---|---|---|---|---|
| Unevaluable event | 27 | 3.9 2.7–5.7ROR 4.0 · χ² 56 / p 3e-14 | 3.7 EB05 2.7 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.4 | no trial data cached |
| Therapeutic response unexpected | 27 | 6.6 4.5–9.6ROR 6.7 · χ² 123 / p 8e-29 | 6.0 EB05 4.3 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 10.0 | no trial data cached |
| Sleep apnoea syndrome | 27 | 15.5 10.7–22.6ROR 15.7 · χ² 353 / p 6e-79 | 15.2 EB05 10.7 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.1 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 24 | 2.9 1.9–4.3ROR 2.9 · χ² 28 / p 7e-8 | 2.8 EB05 2.0 · IC025 +0.8 | No label text to screen label has no adverse-reaction text | serious PRR 3.5 | no trial data cached |
| Fibromyalgia | 21 | 9.5 6.2–14.6ROR 9.6 · χ² 152 / p 4e-35 | 8.5 EB05 5.6 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.3 | no trial data cached |
| Thyroid disorder | 15 | 10.7 6.5–17.7ROR 10.8 · χ² 122 / p 9e-29 | 9.3 EB05 5.6 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.2 | no trial data cached |
| Acne | 14 | 2.0 1.2–3.4ROR 2.0 · χ² 6 / p 0.006 | 2.0 EB05 1.3 · IC025 +0.1 | No label text to screen label has no adverse-reaction text | serious PRR 4.1 | no trial data cached |
| Erectile dysfunction | 13 | 5.5 3.2–9.5ROR 5.6 · χ² 44 / p 2e-11 | 4.7 EB05 2.9 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.6 | no trial data cached |
| Inappropriate schedule of drug administration | 12 | 1.8 1.0–3.2ROR 1.8 · χ² 4 / p 0.027 | 1.8 EB05 1.1 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 3.7 | no trial data cached |
| Injection site reaction | 12 | 1.9 1.1–3.4ROR 1.9 · χ² 4 / p 0.018 | 1.9 EB05 1.2 · IC025 -0.1 PRR-only: not supported by EBGM or IC | No label text to screen label has no adverse-reaction text | serious PRR 3.9 | no trial data cached |
| Product substitution issue | 12 | 2.3 1.3–4.0ROR 2.3 · χ² 8 / p 0.003 | 2.2 EB05 1.4 · IC025 +0.1 | Reporting / coding artifact | serious PRR 3.8 | no trial data cached |
| Systemic lupus erythematosus | 12 | 3.7 2.1–6.6ROR 3.7 · χ² 21 / p 2e-6 | 3.3 EB05 2.1 · IC025 +0.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.5 | no trial data cached |
| Device issue | 11 | 1.4 0.8–2.5ROR 1.4 · χ² 1 / p 0.181 | 1.4 EB05 0.8 · IC025 -0.6 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 4.2 | no trial data cached |
| Crying | 11 | 3.3 1.8–6.0ROR 3.3 · χ² 16 / p 4e-5 | 3.0 EB05 1.8 · IC025 +0.6 | No label text to screen label has no adverse-reaction text | serious PRR 3.0 | no trial data cached |
| Gastric disorder | 11 | 3.5 1.9–6.3ROR 3.5 · χ² 17 / p 2e-5 | 3.1 EB05 1.9 · IC025 +0.6 | No label text to screen label has no adverse-reaction text | serious PRR 7.1 | 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 Dhea (Dehydroepiandrosterone)?
In FDA FAERS, the most frequently co-reported reaction terms for Dhea (Dehydroepiandrosterone) are sleep apnoea syndrome, suicidal ideation, fibromyalgia, thyroid disorder, acne, erectile dysfunction. 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 Dhea (Dehydroepiandrosterone) have an FDA boxed warning?
No. The FDA label retrieved for Dhea (Dehydroepiandrosterone) has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Dhea (Dehydroepiandrosterone) 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 d6edd874-495c-4eb5-bf3d-72c2ee41fc88, effective 20240923; matched on
openfda.generic_name.exact:"DHEA (DEHYDROEPIANDROSTERONE)") - 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, 80 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.