Drug · FAERS side-effect profile with label screen
Silodosin side effects: what 3,954 FDA adverse event reports show
Who reports
3,954 reports · 88% serious · 499 with death outcome · 2% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Silodosin, a selective alpha‑1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) . Silodosin capsules is not indicated for the treatment of hypertension. Silodosin capsules, an alpha‑1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
FDA label, Indications and Usage
What it is
Silodosin capsules, USP is a selective antagonist of alpha‑1 adrenoreceptors.
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 40 strongest signals
Labeled adverse reaction 1Labeled (related wording) 3Likely indication confounding 1Lab value / disease marker 1Not in label — unassessed 34
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.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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.
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. 137 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 |
|---|---|---|---|---|---|---|
| Urinary retention | 121 | 19.3 16.2–23.1ROR 19.9 · χ² 2,081 / p <1e-300 | 19.2 EB05 16.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 13.7 | no trial data cached |
| Inappropriate antidiuretic hormone secretion | 36 | 18.8 13.6–26.1ROR 19.0 · χ² 587 / p 4e-130 | 18.6 EB05 14.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.3 · 97% clinician | no trial data cached |
| Erectile dysfunction | 70 | 14.4 11.4–18.2ROR 14.7 · χ² 861 / p 1e-189 | 14.3 EB05 11.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 13.3 | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 46 | 14.0 10.5–18.7ROR 14.2 · χ² 542 / p 4e-120 | 13.8 EB05 10.6 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.9 | no trial data cached |
| Sopor | 29 | 11.5 8.0–16.6ROR 11.6 · χ² 268 / p 2e-60 | 10.9 EB05 7.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 · 100% clinician | no trial data cached |
| Prostatic specific antigen increased | 28 | 10.7 7.4–15.5ROR 10.8 · χ² 237 / p 8e-54 | 10.0 EB05 7.0 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious PRR 9.0 | no trial data cached |
| Hypomagnesaemia | 25 | 9.6 6.5–14.1ROR 9.6 · χ² 183 / p 5e-42 | 8.7 EB05 6.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 · 96% clinician | no trial data cached |
| Generalised oedema | 21 | 9.1 5.9–13.9ROR 9.1 · χ² 142 / p 4e-33 | 8.0 EB05 5.4 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Pneumonia aspiration | 42 | 8.9 6.6–12.1ROR 9.0 · χ² 288 / p 6e-65 | 8.4 EB05 6.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Hypocalcaemia (low calcium) | 29 | 8.2 5.7–11.7ROR 8.2 · χ² 175 / p 3e-40 | 7.4 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · 100% clinician | no trial data cached |
| Interstitial lung disease | 74 | 8.1 6.5–10.2ROR 8.3 · χ² 456 / p 2e-101 | 7.8 EB05 6.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 · 96% clinician | no trial data cached |
| Hepatic encephalopathy | 14 | 8.0 4.7–13.4ROR 8.0 · χ² 78 / p 5e-19 | 6.6 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Dysuria (painful urination) | 55 | 7.9 6.1–10.3ROR 8.0 · χ² 326 / p 4e-73 | 7.5 EB05 6.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Haematuria (blood in urine) | 51 | 7.9 6.0–10.4ROR 8.0 · χ² 300 / p 2e-67 | 7.5 EB05 5.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Delusion | 23 | 7.9 5.2–11.9ROR 7.9 · χ² 131 / p 1e-30 | 7.0 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Cytokine release syndrome | 27 | 7.5 5.2–11.0ROR 7.6 · χ² 146 / p 6e-34 | 6.8 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 · 96% clinician | no trial data cached |
| Cerebral infarction | 34 | 7.4 5.3–10.3ROR 7.4 · χ² 181 / p 1e-41 | 6.8 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Nocturia (night-time urination) | 16 | 7.0 4.3–11.4ROR 7.0 · χ² 76 / p 1e-18 | 6.0 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Presyncope (near-fainting) | 31 | 6.8 4.8–9.7ROR 6.8 · χ² 148 / p 3e-34 | 6.2 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Dizziness postural | 12 | 6.6 3.8–11.7ROR 6.6 · χ² 52 / p 3e-13 | 5.4 EB05 3.3 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious n=8 | no trial data cached |
| Micturition urgency | 14 | 6.6 3.9–11.1ROR 6.6 · χ² 60 / p 4e-15 | 5.5 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Pulmonary congestion | 16 | 6.4 3.9–10.5ROR 6.4 · χ² 68 / p 9e-17 | 5.5 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Covid-19 pneumonia | 14 | 6.2 3.7–10.5ROR 6.3 · χ² 57 / p 3e-14 | 5.3 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Hypokalaemia (low potassium) | 54 | 6.2 4.8–8.1ROR 6.3 · χ² 233 / p 7e-53 | 5.9 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 · 94% clinician | no trial data cached |
| Hepatic cytolysis | 14 | 6.1 3.6–10.3ROR 6.1 · χ² 54 / p 8e-14 | 5.1 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Ileus | 14 | 6.0 3.6–10.2ROR 6.1 · χ² 54 / p 1e-13 | 5.1 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Rash maculo-papular | 25 | 6.0 4.0–8.8ROR 6.0 · χ² 99 / p 1e-23 | 5.4 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · 92% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 63 | 5.9 4.7–7.6ROR 6.0 · χ² 255 / p 1e-57 | 5.7 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 · 94% clinician | no trial data cached |
| Hyperbilirubinaemia | 11 | 5.7 3.1–10.2ROR 5.7 · χ² 38 / p 4e-10 | 4.7 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Oral candidiasis (oral thrush) | 13 | 5.3 3.1–9.1ROR 5.3 · χ² 41 / p 7e-11 | 4.5 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Hepatic function abnormal | 37 | 5.3 3.8–7.3ROR 5.3 · χ² 125 / p 3e-29 | 5.0 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.7 · 94% clinician | no trial data cached |
| Arrhythmia | 47 | 5.2 3.9–7.0ROR 5.3 · χ² 157 / p 2e-36 | 5.0 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Hypertensive crisis | 11 | 5.2 2.9–9.4ROR 5.2 · χ² 33 / p 4e-9 | 4.4 EB05 2.6 · IC025 +1.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 3.4 | no trial data cached |
| Bradycardia (slow heart rate) | 52 | 5.2 4.0–6.8ROR 5.2 · χ² 172 / p 1e-39 | 5.0 EB05 3.9 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 · 94% clinician | no trial data cached |
| Altered state of consciousness | 20 | 4.9 3.2–7.6ROR 4.9 · χ² 59 / p 9e-15 | 4.5 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 · 95% clinician | no trial data cached |
| Lymphopenia | 13 | 4.9 2.8–8.4ROR 4.9 · χ² 37 / p 7e-10 | 4.2 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 139 | 4.8 4.1–5.7ROR 5.0 · χ² 422 / p 4e-94 | 4.8 EB05 4.1 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.2 · 98% clinician | no trial data cached |
| Subdural haematoma | 13 | 4.8 2.8–8.3ROR 4.8 · χ² 35 / p 1e-9 | 4.2 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Hyperkalaemia (high potassium) | 31 | 4.7 3.3–6.7ROR 4.7 · χ² 87 / p 5e-21 | 4.4 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 16 | 4.6 2.8–7.5ROR 4.6 · χ² 41 / p 6e-11 | 4.1 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | 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 |
|---|---|---|---|---|---|---|
| Acute kidney injury (sudden kidney damage) | 139 | 4.8 4.1–5.7ROR 5.0 · χ² 422 / p 4e-94 | 4.8 EB05 4.1 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.2 · 98% clinician | no trial data cached |
| Anaemia (low red blood cells) | 126 | 3.5 2.9–4.2ROR 3.6 · χ² 225 / p 5e-51 | 3.5 EB05 3.0 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Hypotension (low blood pressure) | 123 | 3.3 2.7–3.9ROR 3.3 · χ² 192 / p 6e-44 | 3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 | no trial data cached |
| Urinary retention | 121 | 19.3 16.2–23.1ROR 19.9 · χ² 2,081 / p <1e-300 | 19.2 EB05 16.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 13.7 | no trial data cached |
| Drug interaction | 119 | 4.0 3.3–4.7ROR 4.1 · χ² 264 / p 1e-59 | 3.9 EB05 3.4 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 2.6 | no trial data cached |
| Syncope (fainting) | 74 | 3.9 3.1–4.9ROR 4.0 · χ² 159 / p 1e-36 | 3.8 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 | no trial data cached |
| Interstitial lung disease | 74 | 8.1 6.5–10.2ROR 8.3 · χ² 456 / p 2e-101 | 7.8 EB05 6.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 · 96% clinician | no trial data cached |
| Atrial fibrillation | 71 | 3.9 3.1–4.9ROR 3.9 · χ² 148 / p 2e-34 | 3.8 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Erectile dysfunction | 70 | 14.4 11.4–18.2ROR 14.7 · χ² 861 / p 1e-189 | 14.3 EB05 11.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 13.3 | no trial data cached |
| Hyponatraemia (low sodium) | 63 | 5.9 4.7–7.6ROR 6.0 · χ² 255 / p 1e-57 | 5.7 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 · 94% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 56 | 2.2 1.7–2.8ROR 2.2 · χ² 35 / p 1e-9 | 2.2 EB05 1.7 · IC025 +0.7 | Not in label — unassessed | serious PRR 1.5 · 98% clinician | no trial data cached |
| Dysuria (painful urination) | 55 | 7.9 6.1–10.3ROR 8.0 · χ² 326 / p 4e-73 | 7.5 EB05 6.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Hot flush (hot flashes) | 54 | 3.8 2.9–5.0ROR 3.8 · χ² 109 / p 9e-26 | 3.7 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 2.0 · 81% consumer | no trial data cached |
| Hypokalaemia (low potassium) | 54 | 6.2 4.8–8.1ROR 6.3 · χ² 233 / p 7e-53 | 5.9 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 · 94% clinician | no trial data cached |
| Bradycardia (slow heart rate) | 52 | 5.2 4.0–6.8ROR 5.2 · χ² 172 / p 1e-39 | 5.0 EB05 3.9 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 · 94% clinician | 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.
- Urinary retention — n=121, PRR 19.3
- Inappropriate antidiuretic hormone secretion — n=36, PRR 18.8
- Erectile dysfunction — n=70, PRR 14.4
- Sopor — n=29, PRR 11.5
- Hypomagnesaemia — n=25, PRR 9.6
- Generalised oedema — n=21, PRR 9.1
- Pneumonia aspiration — n=42, PRR 8.9
- Hypocalcaemia — n=29, PRR 8.2
- Interstitial lung disease — n=74, PRR 8.1
- Dysuria — n=55, PRR 7.9
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 Silodosin?
In FDA FAERS, the most frequently co-reported reaction terms for Silodosin are acute kidney injury, anaemia, hypotension, urinary retention, syncope, interstitial lung disease. 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 Silodosin have an FDA boxed warning?
No. The FDA label retrieved for Silodosin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Silodosin 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 43f83422-680f-411e-bbc3-2b092e64a017, effective 20260507; matched on
openfda.generic_name.exact:"SILODOSIN") - 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, 177 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.