Sildenafil Citrate side effects: what 126,457 FDA adverse event reports show
Drug class
Phosphodiesterase-5 (pde5) inhibitor
Brand names
Sildenafil Citrate
Who reports
126,457 reports · 67% serious · 18,360 with death outcome · 45% 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 is a pyrazolo[4,3-d]pyrimidin-7-one having a methyl substituent at the 1-position, a propyl substituent at the 3-position and a 2-ethoxy-5-[(4-methylpiperazin-1-yl)sulfonyl]phenyl group at the 5-position.
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.
- 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.
- 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). 1,222 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 |
|---|---|---|---|---|---|---|
| Semen volume increased | 102 | 436.2 300.6–633.1ROR 436.5 · calibrated p 1e-12 ✓ | 116.6 EB05 98.8 · IC025 +5.9 3/3 methods agree | Lab value / disease marker | ♀ 0% (drug 45%) · 100% consumer | not reported in cached trials |
| Erection increased | 3,024 | 425.1 397.3–454.8ROR 435.5 · calibrated p 2e-13 ✓ | 118.2 EB05 114.7 · IC025 +6.8 3/3 methods agree | Labeled (related wording) related wording | serious n=1,853 · ♀ 0% (drug 45%) · 97% consumer | not reported in cached trials |
| Cyanopsia | 373 | 268.2 227.4–316.4ROR 269.0 · calibrated p 4e-11 ✓ | 101.3 EB05 93.0 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious n=138 · ♀ 0% (drug 45%) | not reported in cached trials |
| Malignant melanoma stage ii | 77 | 156.4 114.4–213.9ROR 156.5 · calibrated p 7e-9 ✓ | 78.7 EB05 65.0 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=77 · ♀ 0% (drug 45%) · 100% consumer | not reported in cached trials |
| Malignant melanoma stage iii | 77 | 100.9 75.9–134.1ROR 101.0 · calibrated p 2e-7 ✓ | 61.7 EB05 51.0 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=77 · ♀ 0% (drug 45%) · 100% consumer | not reported in cached trials |
| Pulmonary hypertensive crisis | 99 | 98.1 76.4–125.9ROR 98.2 · calibrated p 2e-7 ✓ | 60.9 EB05 51.4 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | serious n=99 · 100% clinician | NCT00666198: 5/3,304 (0.2%) on Sildenafil (serious AE) |
| Malignant melanoma stage iv | 103 | 94.0 73.8–119.8ROR 94.1 · calibrated p 3e-7 ✓ | 59.3 EB05 50.3 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=103 · ♀ 0% (drug 45%) · 100% consumer | not reported in cached trials |
| Device wireless communication issue | 89 | 91.5 70.6–118.7ROR 91.6 · calibrated p 3e-7 ✓ | 58.2 EB05 48.8 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | ♀ 100% (drug 45%) · 100% consumer | not reported in cached trials |
| Catheter site pruritus | 283 | 79.2 68.7–91.2ROR 79.3 · calibrated p 7e-7 ✓ | 53.4 EB05 48.4 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=242 · ♀ 85% (drug 45%) | not reported in cached trials |
| Malignant melanoma in situ | 391 | 74.5 66.1–84.0ROR 74.7 · calibrated p 1e-6 ✓ | 51.3 EB05 47.1 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=391 · ♀ 0% (drug 45%) · 100% consumer | not reported in cached trials |
| Catheter management | 279 | 74.1 64.3–85.3ROR 74.2 · calibrated p 1e-6 ✓ | 51.0 EB05 46.2 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious n=265 · ♀ 73% (drug 45%) · 92% clinician | not reported in cached trials |
| Malignant melanoma stage i | 83 | 72.1 55.7–93.4ROR 72.2 · calibrated p 2e-6 ✓ | 49.7 EB05 41.4 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=83 · ♀ 0% (drug 45%) · 100% consumer | not reported in cached trials |
| Ejaculation disorder | 862 | 71.4 65.9–77.3ROR 71.8 · calibrated p 1e-6 ✓ | 49.8 EB05 47.1 · IC025 +5.5 3/3 methods agree | Labeled (related wording) related wording | serious n=176 · ♀ 0% (drug 45%) · 100% consumer | not reported in cached trials |
| Catheter site irritation | 93 | 68.1 53.4–86.7ROR 68.1 · calibrated p 2e-6 ✓ | 47.8 EB05 40.2 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=83 · ♀ 100% (drug 45%) | not reported in cached trials |
| Penis disorder | 708 | 65.7 60.2–71.7ROR 66.1 · calibrated p 2e-6 ✓ | 47.0 EB05 44.2 · IC025 +5.4 3/3 methods agree | Labeled (related wording) related wording | serious n=235 · ♀ 0% (drug 45%) · 100% consumer | not reported in cached trials |
| Painful erection | 194 | 64.1 54.3–75.7ROR 64.2 · calibrated p 3e-6 ✓ | 46.0 EB05 40.9 · IC025 +5.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=112 · ♀ 0% (drug 45%) · 100% consumer | not reported in cached trials |
| Premature ejaculation | 160 | 54.3 45.4–64.9ROR 54.3 · calibrated p 9e-6 ✓ | 40.8 EB05 35.7 · IC025 +4.9 3/3 methods agree | Labeled (related wording) related wording | ♀ 0% (drug 45%) · 100% consumer | not reported in cached trials |
| Catheter site rash | 111 | 54.0 43.6–66.9ROR 54.1 · calibrated p 1e-5 ✓ | 40.5 EB05 34.6 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=98 · ♀ 100% (drug 45%) | not reported in cached trials |
| Transplant evaluation | 123 | 52.5 42.8–64.3ROR 52.5 · calibrated p 1e-5 ✓ | 39.7 EB05 34.1 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=122 · ♀ 100% (drug 45%) · 100% clinician | not reported in cached trials |
| Catheter site discharge | 265 | 52.5 45.7–60.2ROR 52.6 · calibrated p 1e-5 ✓ | 39.8 EB05 35.9 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=226 · ♀ 81% (drug 45%) | not reported in cached trials |
| Pulmonary arterial pressure increased | 388 | 51.4 45.9–57.6ROR 51.6 · calibrated p 1e-5 ✓ | 39.2 EB05 36.1 · IC025 +5.1 3/3 methods agree | Lab value / disease marker | serious n=336 · ♀ 75% (drug 45%) | NCT00666198: 2/3,304 (0.1%) on Sildenafil (serious AE) |
| Right ventricular failure | 1,675 | 51.4 48.7–54.3ROR 52.1 · calibrated p 1e-5 ✓ | 39.3 EB05 37.7 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 33.9 · ♀ 71% (drug 45%) | NCT00666198: 44/3,304 (1.3%) on Sildenafil (serious AE) |
| Catheter site erythema | 492 | 50.8 45.9–56.2ROR 51.0 · calibrated p 1e-5 ✓ | 38.9 EB05 36.1 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=410 · ♀ 82% (drug 45%) | NCT00666198: 1/3,304 (0.0%) on Sildenafil (serious AE) |
| Ventilation perfusion mismatch | 63 | 48.8 36.8–64.6ROR 48.8 · calibrated p 2e-5 ✓ | 37.3 EB05 30.2 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=60 · ♀ 100% (drug 45%) · 100% clinician | not reported in cached trials |
| Pulmonary arterial hypertension | 3,316 | 48.7 46.9–50.6ROR 50.0 · calibrated p 1e-5 ✓ | 37.7 EB05 36.6 · IC025 +5.2 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 46.7 · serious PRR 32.7 · ♀ 73% (drug 45%) | NCT00666198: 10/3,304 (0.3%) on Sildenafil (serious AE) |
| Device maintenance issue | 128 | 48.5 39.8–59.1ROR 48.5 · calibrated p 2e-5 ✓ | 37.4 EB05 32.3 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | ♀ 69% (drug 45%) · 100% consumer | not reported in cached trials |
| Walking distance test abnormal | 84 | 46.0 36.1–58.6ROR 46.0 · calibrated p 3e-5 ✓ | 35.8 EB05 29.8 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious n=70 · ♀ 100% (drug 45%) | not reported in cached trials |
| Pulmonary veno-occlusive disease | 138 | 40.8 33.9–49.2ROR 40.9 · calibrated p 5e-5 ✓ | 32.7 EB05 28.4 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious n=138 · ♀ 73% (drug 45%) · 100% clinician | NCT00666198: 3/3,304 (0.1%) on Sildenafil (serious AE) |
| Infusion site infection | 449 | 40.8 36.8–45.2ROR 40.9 · calibrated p 5e-5 ✓ | 32.8 EB05 30.3 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=242 · ♀ 77% (drug 45%) | NCT00666198: 4/3,304 (0.1%) on Sildenafil (serious AE) |
| Oxygen consumption increased | 426 | 36.4 32.7–40.4ROR 36.5 · calibrated p 9e-5 ✓ | 29.9 EB05 27.6 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious n=329 · ♀ 71% (drug 45%) | not reported in cached trials |
| Infusion site discharge | 295 | 34.4 30.4–39.0ROR 34.5 · calibrated p 1e-4 ✓ | 28.5 EB05 25.9 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=90 · ♀ 79% (drug 45%) · 77% consumer | not reported in cached trials |
| Catheter site swelling | 158 | 34.3 28.9–40.7ROR 34.3 · calibrated p 1e-4 ✓ | 28.4 EB05 24.9 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=134 · ♀ 100% (drug 45%) | NCT00666198: 1/3,304 (0.0%) on Sildenafil (serious AE) |
| Spontaneous penile erection | 104 | 33.1 26.8–40.9ROR 33.2 · calibrated p 2e-4 ✓ | 27.6 EB05 23.4 · IC025 +4.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | ♀ 0% (drug 45%) · 100% consumer | not reported in cached trials |
| Infusion site warmth | 190 | 31.0 26.5–36.2ROR 31.0 · calibrated p 2e-4 ✓ | 26.1 EB05 23.1 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=57 · ♀ 76% (drug 45%) · 72% consumer | not reported in cached trials |
| Optic ischaemic neuropathy | 551 | 30.2 27.6–33.1ROR 30.4 · calibrated p 3e-4 ✓ | 25.6 EB05 23.9 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious n=544 · ♀ 0% (drug 45%) | not reported in cached trials |
| Infusion site irritation | 189 | 29.6 25.3–34.5ROR 29.6 · calibrated p 3e-4 ✓ | 25.1 EB05 22.3 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=74 · ♀ 73% (drug 45%) · 73% consumer | not reported in cached trials |
| Infusion site oedema | 125 | 29.3 24.2–35.5ROR 29.3 · calibrated p 3e-4 ✓ | 24.9 EB05 21.4 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | ♀ 100% (drug 45%) · 100% consumer | NCT00666198: 2/3,304 (0.1%) on Sildenafil (serious AE) |
| Infusion site cellulitis | 74 | 28.3 22.1–36.2ROR 28.3 · calibrated p 4e-4 ✓ | 24.1 EB05 19.8 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=53 · ♀ 100% (drug 45%) · 100% consumer | NCT00666198: 3/3,304 (0.1%) on Sildenafil (serious AE) |
| Catheter site inflammation | 80 | 28.0 22.1–35.4ROR 28.0 · calibrated p 5e-4 ✓ | 23.9 EB05 19.8 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=67 · ♀ 100% (drug 45%) · 100% clinician | not reported in cached trials |
| Pulmonary hypertension | 3,016 | 27.8 26.8–28.9ROR 28.5 · calibrated p 3e-4 ✓ | 23.9 EB05 23.2 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | age-adj. PRR 28.4 · serious PRR 20.7 · ♀ 68% (drug 45%) | NCT00666198: 10/3,304 (0.3%) on Sildenafil (serious AE) |
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 | 3,844 | 3.63.5–3.7 | signal |
| Serious infection | 8,366 | 1.81.8–1.8 | raised |
| Arrhythmia / qt | 2,018 | 1.71.7–1.8 | raised |
| Gi bleeding | 1,636 | 1.51.4–1.6 | raised |
| Fall / fracture | 3,333 | 1.51.4–1.5 | raised |
| Anaemia | 2,621 | 1.51.4–1.5 | raised |
| Kidney injury | 3,563 | 1.31.3–1.3 | raised |
| Interstitial lung disease | 745 | 1.31.2–1.4 | raised |
| Myocardial infarction | 1,560 | 1.31.2–1.3 | raised |
| Stroke | 1,600 | 1.11.0–1.1 | raised |
| Venous thromboembolism | 1,262 | 1.00.9–1.0 | no difference |
| Depression | 1,612 | 0.90.9–1.0 | lower than other drugs |
| Hyponatraemia | 418 | 0.90.8–0.9 | lower than other drugs |
| Thrombocytopenia | 1,060 | 0.80.8–0.8 | lower than other drugs |
| Liver injury | 1,427 | 0.80.7–0.8 | lower than other drugs |
| Pancreatitis | 365 | 0.70.7–0.8 | lower than other drugs |
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 (11 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) | 13,325 | 4.0 3.9–4.0ROR 4.3 · calibrated p 0.322 | 3.9 EB05 3.8 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 4.0 · serious PRR 3.7 · ♀ 69% (drug 45%) | NCT00666198: 10/3,304 (0.3%) on Sildenafil (serious AE) |
| Drug ineffective (drug did not work) | 12,749 | 1.6 1.6–1.6ROR 1.7 · calibrated p 0.756 | 1.6 EB05 1.6 · IC025 +0.7 | Reporting / coding artifact | age-adj. PRR 1.5 · serious PRR 1.0 · ♀ 10% (drug 45%) · 76% consumer | not reported in cached trials |
| Headache | 10,218 | 2.7 2.7–2.8ROR 2.9 · calibrated p 0.665 | 2.7 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 2.6 · serious PRR 2.7 | NCT00666198: 1/3,304 (0.0%) on Sildenafil (serious AE) |
| Death | 9,126 | 1.8 1.7–1.8ROR 1.8 · calibrated p 0.844 | 1.8 EB05 1.7 · IC025 +0.8 | Outcome field, not a reaction | age-adj. PRR 2.0 · serious PRR 1.5 | NCT00666198: 24/3,304 (0.7%) on Sildenafil (serious AE) |
| Diarrhoea (diarrhea) | 7,048 | 1.8 1.8–1.9ROR 1.9 · calibrated p 0.873 | 1.8 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | age-adj. PRR 1.8 · serious PRR 1.8 · ♀ 67% (drug 45%) | NCT00666198: 7/3,304 (0.2%) on Sildenafil (serious AE) |
| Nausea | 6,488 | 1.4 1.3–1.4ROR 1.4 · calibrated p 0.565 | 1.4 EB05 1.3 · IC025 +0.4 | Labeled adverse reaction exact term | age-adj. PRR 1.4 · serious PRR 1.5 · ♀ 70% (drug 45%) | NCT00666198: 2/3,304 (0.1%) on Sildenafil (serious AE) |
| Fatigue (tiredness) | 6,388 | 1.4 1.3–1.4ROR 1.4 · calibrated p 0.565 | 1.4 EB05 1.3 · IC025 +0.4 | Labeled (related wording) related wording | age-adj. PRR 1.3 · serious PRR 1.5 | not reported in cached trials |
| Dizziness | 5,856 | 2.0 1.9–2.0ROR 2.0 · calibrated p 0.948 | 1.9 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | age-adj. PRR 1.9 · serious PRR 2.0 | NCT00666198: 2/3,304 (0.1%) on Sildenafil (serious AE) |
| Pneumonia (lung infection) | 4,978 | 2.6 2.5–2.6ROR 2.6 · calibrated p 0.755 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | age-adj. PRR 2.6 · serious PRR 2.3 · ♀ 66% (drug 45%) | NCT00666198: 2/3,304 (0.1%) on Sildenafil (serious AE) |
| Cough | 4,765 | 2.9 2.8–2.9ROR 2.9 · calibrated p 0.651 | 2.8 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 2.6 · serious PRR 2.6 · ♀ 69% (drug 45%) | NCT00666198: 1/3,304 (0.0%) on Sildenafil (serious AE) |
| Malaise (feeling unwell) | 4,486 | 1.7 1.6–1.7ROR 1.7 · calibrated p 0.784 | 1.7 EB05 1.6 · IC025 +0.7 | Not in label — unassessed | age-adj. PRR 1.9 · serious PRR 1.7 · ♀ 66% (drug 45%) | NCT00666198: 2/3,304 (0.1%) on Sildenafil (serious AE) |
| Off label use (used outside approved label) | 3,948 | 0.8 0.7–0.8ROR 0.7 · calibrated p 0.153 | 0.8 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | age-adj. PRR 0.8 · serious PRR 0.9 | not reported in cached trials |
| Vomiting | 3,797 | 1.3 1.3–1.4ROR 1.4 · calibrated p 0.545 | 1.3 EB05 1.3 · IC025 +0.4 | Labeled adverse reaction exact term | age-adj. PRR 1.4 · serious PRR 1.3 · ♀ 68% (drug 45%) | NCT00666198: 6/3,304 (0.2%) on Sildenafil (serious AE) |
| Hypotension (low blood pressure) | 3,777 | 3.2 3.1–3.3ROR 3.2 · calibrated p 0.555 | 3.1 EB05 3.0 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 3.0 · serious PRR 2.7 | NCT00666198: 10/3,304 (0.3%) on Sildenafil (serious AE) |
| Pain | 3,773 | 1.0 1.0–1.0ROR 1.0 · calibrated p 0.317 | 1.0 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | age-adj. PRR 1.2 · serious PRR 1.0 | 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.
- Cyanopsia — n=373, PRR 268.2
- Malignant melanoma stage ii — n=77, PRR 156.4
- Malignant melanoma stage iii — n=77, PRR 100.9
- Malignant melanoma stage iv — n=103, PRR 94.0
- Catheter site pruritus — n=283, PRR 79.2
- Malignant melanoma in situ — n=391, PRR 74.5
- Malignant melanoma stage i — n=83, PRR 72.1
- Catheter site irritation — n=93, PRR 68.1
- Catheter site rash — n=111, PRR 54.0
- Transplant evaluation — n=123, PRR 52.5
✓ 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" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - PubChem CID 135398744 description (ChEBI)
- 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, 1,262 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.