Sildenafil side effects: what 57,505 FDA adverse event reports show
Drug class
Phosphodiesterase-5 (pde5) inhibitor
Brand names
Sildenafil Citrate
Who reports
57,505 reports · 73% serious · 8,592 with death outcome · 56% female
Used for
Sildenafil citrate is indicated for the treatment of erectile dysfunction. Sildenafil citrate is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) ( 1 )
What it is
Sildenafil tablets, USP, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
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.
- 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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,199 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 |
|---|---|---|---|---|---|---|
| Heart sounds | 33 | 187.7 123.2–286.0ROR 187.8 · calibrated p 3e-9 ✓ | 115.4 EB05 86.0 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=33 · ♀ 100% (drug 56%) · 100% clinician | not reported in cached trials |
| Pulmonary hypertensive crisis | 90 | 186.4 144.5–240.4ROR 186.7 · calibrated p 1e-9 ✓ | 119.9 EB05 100.5 · IC025 +5.8 3/3 methods agree | Labeled (related wording) related wording | serious n=90 | NCT00666198: 5/3,304 (0.2%) on Sildenafil (serious AE) |
| Device wireless communication issue | 84 | 184.6 141.9–240.2ROR 184.9 · calibrated p 1e-9 ✓ | 118.9 EB05 99.1 · IC025 +5.8 3/3 methods agree | Reporting / coding artifact | serious n=27 · 100% consumer | not reported in cached trials |
| High risk sexual behaviour | 44 | 118.5 84.3–166.7ROR 118.6 · calibrated p 7e-8 ✓ | 86.1 EB05 66.8 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=44 · ♀ 0% (drug 56%) · 100% clinician | not reported in cached trials |
| Catheter site irritation | 76 | 113.9 88.0–147.5ROR 114.1 · calibrated p 7e-8 ✓ | 84.9 EB05 70.0 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=68 · ♀ 77% (drug 56%) | not reported in cached trials |
| Heart and lung transplant | 30 | 109.7 72.9–165.1ROR 109.7 · calibrated p 2e-7 ✓ | 80.1 EB05 58.8 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=30 · 100% clinician | not reported in cached trials |
| Catheter site pruritus | 197 | 105.8 90.3–124.0ROR 106.2 · calibrated p 8e-8 ✓ | 81.3 EB05 72.2 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=170 · ♀ 85% (drug 56%) | not reported in cached trials |
| Device maintenance issue | 122 | 100.5 82.2–122.8ROR 100.7 · calibrated p 1e-7 ✓ | 77.8 EB05 66.9 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious n=42 · 100% consumer | not reported in cached trials |
| Catheter management | 173 | 86.3 73.1–101.9ROR 86.6 · calibrated p 4e-7 ✓ | 69.3 EB05 61.0 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious n=166 · 94% clinician | not reported in cached trials |
| Transplant evaluation | 94 | 82.1 65.7–102.8ROR 82.3 · calibrated p 6e-7 ✓ | 66.2 EB05 55.7 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=94 | not reported in cached trials |
| Atrial septal defect repair | 30 | 77.3 52.1–114.7ROR 77.4 · calibrated p 2e-6 ✓ | 61.4 EB05 45.1 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=30 · 100% clinician | not reported in cached trials |
| Catheter site rash | 76 | 73.8 57.7–94.5ROR 73.9 · calibrated p 1e-6 ✓ | 60.5 EB05 49.9 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=68 · ♀ 80% (drug 56%) | not reported in cached trials |
| Ventilation perfusion mismatch | 45 | 70.7 51.4–97.3ROR 70.8 · calibrated p 2e-6 ✓ | 57.8 EB05 45.0 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=42 · 100% clinician | not reported in cached trials |
| Catheter site erythema | 328 | 67.6 60.1–76.0ROR 68.0 · calibrated p 2e-6 ✓ | 56.8 EB05 51.9 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=276 · ♀ 82% (drug 56%) | NCT00666198: 1/3,304 (0.0%) on Sildenafil (serious AE) |
| Pulmonary arterial pressure increased | 255 | 67.2 58.8–76.8ROR 67.5 · calibrated p 2e-6 ✓ | 56.5 EB05 51.0 · IC025 +5.5 3/3 methods agree | Lab value / disease marker | serious n=224 | NCT00666198: 2/3,304 (0.1%) on Sildenafil (serious AE) |
| Catheter site discharge | 168 | 65.6 55.6–77.3ROR 65.8 · calibrated p 3e-6 ✓ | 55.3 EB05 48.6 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=145 · ♀ 85% (drug 56%) | not reported in cached trials |
| Pulmonary veno-occlusive disease | 105 | 64.6 52.5–79.6ROR 64.8 · calibrated p 3e-6 ✓ | 54.4 EB05 46.2 · IC025 +5.1 3/3 methods agree | Labeled (related wording) related wording | serious n=105 · 100% clinician | NCT00666198: 3/3,304 (0.1%) on Sildenafil (serious AE) |
| Walking distance test abnormal | 57 | 63.0 47.6–83.5ROR 63.1 · calibrated p 5e-6 ✓ | 52.9 EB05 42.3 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | serious n=50 | not reported in cached trials |
| Right ventricular failure | 1,041 | 62.9 58.9–67.1ROR 64.0 · calibrated p 3e-6 ✓ | 53.6 EB05 50.9 · IC025 +5.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 42.0 | NCT00666198: 44/3,304 (1.3%) on Sildenafil (serious AE) |
| Pulmonary arterial hypertension | 2,002 | 58.0 55.3–60.7ROR 60.0 · calibrated p 4e-6 ✓ | 50.0 EB05 48.2 · IC025 +5.6 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 51.1 · serious PRR 39.5 | NCT00666198: 10/3,304 (0.3%) on Sildenafil (serious AE) |
| Oxygen consumption increased | 309 | 54.8 48.6–61.7ROR 55.1 · calibrated p 8e-6 ✓ | 47.5 EB05 43.2 · IC025 +5.3 3/3 methods agree | Lab value / disease marker | serious n=239 | not reported in cached trials |
| Infusion site discharge | 217 | 52.9 45.8–60.9ROR 53.1 · calibrated p 1e-5 ✓ | 46.0 EB05 41.1 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=62 · ♀ 77% (drug 56%) · 76% consumer | not reported in cached trials |
| Catheterisation cardiac abnormal | 34 | 52.5 36.6–75.3ROR 52.5 · calibrated p 2e-5 ✓ | 44.9 EB05 33.6 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | ♀ 100% (drug 56%) · 100% clinician | not reported in cached trials |
| Prolonged expiration | 33 | 51.9 36.0–74.7ROR 51.9 · calibrated p 2e-5 ✓ | 44.3 EB05 33.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=33 · ♀ 100% (drug 56%) · 100% clinician | not reported in cached trials |
| Right ventricular systolic pressure increased | 37 | 48.6 34.5–68.4ROR 48.6 · calibrated p 3e-5 ✓ | 42.0 EB05 31.8 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | serious n=35 · ♀ 100% (drug 56%) · 100% clinician | not reported in cached trials |
| Infusion site infection | 265 | 48.1 42.4–54.7ROR 48.4 · calibrated p 2e-5 ✓ | 42.4 EB05 38.3 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=130 · ♀ 76% (drug 56%) · 73% consumer | NCT00666198: 4/3,304 (0.1%) on Sildenafil (serious AE) |
| Pulmonary arterial pressure abnormal | 33 | 47.1 32.8–67.7ROR 47.1 · calibrated p 3e-5 ✓ | 40.8 EB05 30.4 · IC025 +4.1 3/3 methods agree | Lab value / disease marker | serious n=29 · ♀ 100% (drug 56%) · 100% clinician | NCT00666198: 2/3,304 (0.1%) on Sildenafil (serious AE) |
| Infusion site irritation | 141 | 46.5 39.0–55.4ROR 46.6 · calibrated p 2e-5 ✓ | 41.1 EB05 35.7 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=54 · 77% consumer | not reported in cached trials |
| Catheter site swelling | 101 | 44.9 36.5–55.2ROR 45.0 · calibrated p 3e-5 ✓ | 39.7 EB05 33.6 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=86 · ♀ 83% (drug 56%) | NCT00666198: 1/3,304 (0.0%) on Sildenafil (serious AE) |
| Infusion site warmth | 127 | 42.9 35.7–51.6ROR 43.0 · calibrated p 4e-5 ✓ | 38.2 EB05 33.0 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=34 · 71% consumer | not reported in cached trials |
| Right ventricular dilatation | 60 | 42.6 32.6–55.6ROR 42.6 · calibrated p 5e-5 ✓ | 37.7 EB05 30.4 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=59 · ♀ 77% (drug 56%) · 100% clinician | not reported in cached trials |
| Infusion site induration | 144 | 41.0 34.5–48.7ROR 41.1 · calibrated p 5e-5 ✓ | 36.7 EB05 32.0 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=42 · ♀ 80% (drug 56%) · 75% consumer | NCT00666198: 1/3,304 (0.0%) on Sildenafil (serious AE) |
| Vascular device occlusion | 33 | 39.5 27.6–56.6ROR 39.6 · calibrated p 9e-5 ✓ | 35.1 EB05 26.1 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=33 · ♀ 100% (drug 56%) | not reported in cached trials |
| Infusion site haemorrhage | 310 | 38.4 34.2–43.2ROR 38.6 · calibrated p 7e-5 ✓ | 34.8 EB05 31.6 · IC025 +4.9 3/3 methods agree | Labeled (related wording) related wording | serious n=99 · 80% consumer | NCT00666198: 8/3,304 (0.2%) on Sildenafil (serious AE) |
| Infusion site pain | 1,192 | 37.4 35.3–39.7ROR 38.2 · calibrated p 7e-5 ✓ | 34.0 EB05 32.4 · IC025 +5.0 3/3 methods agree | Labeled (related wording) related wording | age-adj. PRR 27.8 · serious n=428 · 74% consumer | NCT00666198: 4/3,304 (0.1%) on Sildenafil (serious AE) |
| Catheter site pain | 234 | 36.9 32.2–42.2ROR 37.0 · calibrated p 9e-5 ✓ | 33.4 EB05 30.0 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=194 · ♀ 86% (drug 56%) | not reported in cached trials |
| Infusion site vesicles | 48 | 36.7 27.3–49.5ROR 36.8 · calibrated p 1e-4 ✓ | 33.0 EB05 25.9 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | 100% consumer | not reported in cached trials |
| Infusion site inflammation | 61 | 36.1 27.8–47.0ROR 36.2 · calibrated p 1e-4 ✓ | 32.6 EB05 26.3 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | 100% consumer | NCT00666198: 2/3,304 (0.1%) on Sildenafil (serious AE) |
| Lung transplant | 318 | 35.6 31.7–39.9ROR 35.8 · calibrated p 1e-4 ✓ | 32.4 EB05 29.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=311 | NCT00666198: 1/3,304 (0.0%) on Sildenafil (serious AE) |
| Paracentesis | 55 | 35.5 26.9–46.8ROR 35.5 · calibrated p 1e-4 ✓ | 32.1 EB05 25.6 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=55 · 100% clinician | not reported in cached trials |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Heart failure | 1,997 | 4.13.9–4.3 | signal |
| Serious infection | 4,567 | 2.22.1–2.2 | signal |
| Arrhythmia / qt | 1,110 | 2.12.0–2.2 | raised |
| Gi bleeding | 924 | 1.81.7–2.0 | raised |
| Anaemia | 1,439 | 1.81.7–1.8 | raised |
| Interstitial lung disease | 418 | 1.61.4–1.7 | raised |
| Fall / fracture | 1,657 | 1.61.5–1.7 | raised |
| Kidney injury | 1,796 | 1.41.4–1.5 | raised |
| Hyponatraemia | 237 | 1.10.9–1.2 | no difference |
| Venous thromboembolism | 603 | 1.00.9–1.1 | no difference |
| Thrombocytopenia | 607 | 1.00.9–1.1 | no difference |
| Liver injury | 828 | 1.00.9–1.1 | no difference |
| Hypoglycaemia | 257 | 1.00.9–1.1 | no difference |
| Stroke | 652 | 1.00.9–1.0 | no difference |
| Myocardial infarction | 534 | 1.00.9–1.0 | no difference |
| Rhabdomyolysis / myopathy | 204 | 0.90.8–1.1 | no difference |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Sildenafil as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (14 of 40 signal terms matched).
- NCT00666198 — Special Investigation For Long-Term Use Of Sildenafil (Regulatory Post Marketing Commitment Plan) (N=3337, phase n/a; 448 AE terms posted; arms: Revatio (Sildenafil Citrate))
- NCT01122264 — A Study in Patients With Erectile Dysfunction (N=770, PHASE4; 37 AE terms posted; arms: Tadalafil On Demand; Tadalafil Once a Day; Sildenafil Citrate On Demand)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 |
|---|---|---|---|---|---|---|
| Dyspnoea (shortness of breath) | 7,986 | 5.2 5.1–5.3ROR 5.9 · calibrated p 0.158 | 5.1 EB05 5.0 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 4.8 · serious PRR 4.5 | NCT00666198: 10/3,304 (0.3%) on Sildenafil (serious AE) |
| Headache | 5,925 | 3.5 3.4–3.6ROR 3.8 · calibrated p 0.427 | 3.4 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 3.1 · serious PRR 3.4 | NCT00666198: 1/3,304 (0.0%) on Sildenafil (serious AE) |
| Diarrhoea (diarrhea) | 4,614 | 2.6 2.6–2.7ROR 2.8 · calibrated p 0.708 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | age-adj. PRR 2.3 · serious PRR 2.4 | NCT00666198: 7/3,304 (0.2%) on Sildenafil (serious AE) |
| Nausea | 4,118 | 1.9 1.8–2.0ROR 2.0 · calibrated p 0.930 | 1.9 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | age-adj. PRR 1.7 · serious PRR 2.0 | NCT00666198: 2/3,304 (0.1%) on Sildenafil (serious AE) |
| Death | 3,978 | 1.7 1.6–1.7ROR 1.7 · calibrated p 0.791 | 1.7 EB05 1.6 · IC025 +0.7 | Outcome field, not a reaction | age-adj. PRR 2.1 · serious PRR 1.3 | NCT00666198: 24/3,304 (0.7%) on Sildenafil (serious AE) |
| Fatigue (tiredness) | 3,966 | 1.9 1.8–1.9ROR 1.9 · calibrated p 0.904 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled (related wording) related wording | age-adj. PRR 1.7 · serious PRR 1.9 | not reported in cached trials |
| Dizziness | 3,428 | 2.5 2.4–2.6ROR 2.6 · calibrated p 0.766 | 2.5 EB05 2.4 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 2.2 · serious PRR 2.4 | NCT00666198: 2/3,304 (0.1%) on Sildenafil (serious AE) |
| Drug ineffective (drug did not work) | 3,177 | 0.9 0.8–0.9ROR 0.9 · calibrated p 0.225 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | age-adj. PRR 1.0 · serious PRR 0.9 · ♀ 33% (drug 56%) | not reported in cached trials |
| Cough | 3,121 | 4.1 4.0–4.2ROR 4.3 · calibrated p 0.330 | 4.1 EB05 3.9 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 3.3 · serious PRR 3.4 | NCT00666198: 1/3,304 (0.0%) on Sildenafil (serious AE) |
| Pneumonia (lung infection) | 2,717 | 3.1 3.0–3.2ROR 3.2 · calibrated p 0.570 | 3.1 EB05 3.0 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | age-adj. PRR 3.0 · serious PRR 2.5 | NCT00666198: 2/3,304 (0.1%) on Sildenafil (serious AE) |
| Vomiting | 2,461 | 1.9 1.8–2.0ROR 2.0 · calibrated p 0.920 | 1.9 EB05 1.8 · IC025 +0.9 | Labeled adverse reaction exact term | age-adj. PRR 1.7 · serious PRR 1.7 | NCT00666198: 6/3,304 (0.2%) on Sildenafil (serious AE) |
| Hypotension (low blood pressure) | 2,442 | 4.5 4.3–4.7ROR 4.6 · calibrated p 0.278 | 4.4 EB05 4.3 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 3.8 · serious PRR 3.5 | NCT00666198: 10/3,304 (0.3%) on Sildenafil (serious AE) |
| Off label use (used outside approved label) | 2,361 | 1.0 1.0–1.0ROR 1.0 · calibrated p 0.300 | 1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | age-adj. PRR 0.9 · serious PRR 1.1 | not reported in cached trials |
| Malaise (feeling unwell) | 2,226 | 1.8 1.8–1.9ROR 1.9 · calibrated p 0.878 | 1.8 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | age-adj. PRR 1.9 · serious PRR 1.8 | NCT00666198: 2/3,304 (0.1%) on Sildenafil (serious AE) |
| Pain | 2,071 | 1.2 1.2–1.3ROR 1.2 · calibrated p 0.464 | 1.2 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | age-adj. PRR 1.3 · serious PRR 1.1 | NCT00666198: 4/3,304 (0.1%) on Sildenafil (serious AE) |
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.
- Heart sounds — n=33, PRR 187.7
- High risk sexual behaviour — n=44, PRR 118.5
- Catheter site irritation — n=76, PRR 113.9
- Heart and lung transplant — n=30, PRR 109.7
- Catheter site pruritus — n=197, PRR 105.8
- Transplant evaluation — n=94, PRR 82.1
- Atrial septal defect repair — n=30, PRR 77.3
- Catheter site rash — n=76, PRR 73.8
- Ventilation perfusion mismatch — n=45, PRR 70.7
- Catheter site erythema — n=328, PRR 67.6 (also seen in trial arm)
✓ A hand-written Bradford Hill causality assessment exists for this drug: Sildenafil (PDE5 inhibitors) ↔ Non-arteritic anterior ischaemic optic neuropathy (NAION).
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 Sildenafil?
In FDA FAERS, the most frequently co-reported reaction terms for Sildenafil are dyspnoea, headache, diarrhoea, nausea, fatigue, dizziness. 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 Sildenafil have an FDA boxed warning?
No. The FDA label retrieved for Sildenafil has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Sildenafil 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 0500a861-359f-4e12-beb5-0cac8cd6ae1c, effective 20230510; matched on
openfda.generic_name.exact:"SILDENAFIL") - 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, 1,239 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 - ClinicalTrials.gov API v2 (query
SILDENAFIL, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.