Sildenafil Powder side effects: what 35,364 FDA adverse event reports show
Drug class
Phosphodiesterase-5 (pde-5) inhibitor
Label matched
Sildenafil Powder, (Sildenafil)
Who reports
35,364 reports · 80% serious · 6,123 with death outcome · 54% female
Used for
Adults Sildenafilfororal suspension is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [ see Clinical Studies (14 )] . Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) for oral suspension.
What it is
Sildenafil for oral suspension, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA® for erectile dysfunction.
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). 1,188 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 |
|---|---|---|---|---|---|---|
| Pulmonary hypertensive crisis | 70 | 211.8 161.1–278.3ROR 212.2 · calibrated p 5e-10 ✓ | 149.4 EB05 122.3 · IC025 +5.8 3/3 methods agree | Labeled (related wording) related wording | serious n=70 · 100% clinician | no trial data cached |
| Device wireless communication issue | 62 | 195.7 146.8–260.8ROR 196.0 · calibrated p 1e-9 ✓ | 140.5 EB05 113.5 · IC025 +5.7 3/3 methods agree | Reporting / coding artifact | serious n=18 · 100% consumer | no trial data cached |
| High risk sexual behaviour | 42 | 181.6 128.5–256.8ROR 181.9 · calibrated p 3e-9 ✓ | 130.7 EB05 100.7 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=42 · ♀ 0% (drug 54%) · 100% clinician | no trial data cached |
| Heart and lung transplant | 21 | 114.6 71.8–182.9ROR 114.7 · calibrated p 2e-7 ✓ | 88.5 EB05 61.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=21 | no trial data cached |
| Device maintenance issue | 89 | 111.0 88.5–139.2ROR 111.3 · calibrated p 7e-8 ✓ | 91.7 EB05 76.8 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious n=24 · 100% consumer | no trial data cached |
| Atrial septal defect repair | 25 | 101.4 66.3–155.0ROR 101.4 · calibrated p 3e-7 ✓ | 81.3 EB05 57.9 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=25 · 100% clinician | no trial data cached |
| Transplant evaluation | 68 | 91.1 70.5–117.5ROR 91.2 · calibrated p 3e-7 ✓ | 77.3 EB05 63.0 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=68 | no trial data cached |
| Catheter management | 110 | 82.2 67.4–100.4ROR 82.5 · calibrated p 6e-7 ✓ | 71.3 EB05 60.8 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | serious n=108 · ♀ 82% (drug 54%) · 95% clinician | no trial data cached |
| Ventilation perfusion mismatch | 31 | 74.8 51.5–108.7ROR 74.9 · calibrated p 2e-6 ✓ | 63.9 EB05 47.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=30 · ♀ 100% (drug 54%) · 100% clinician | no trial data cached |
| Right ventricular failure | 756 | 71.0 65.9–76.5ROR 72.5 · calibrated p 1e-6 ✓ | 63.3 EB05 59.6 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 45.8 | no trial data cached |
| Pulmonary arterial pressure increased | 172 | 69.6 59.5–81.5ROR 70.0 · calibrated p 2e-6 ✓ | 61.9 EB05 54.5 · IC025 +5.5 3/3 methods agree | Lab value / disease marker | serious n=160 · ♀ 76% (drug 54%) | no trial data cached |
| Pulmonary veno-occlusive disease | 73 | 69.4 54.5–88.5ROR 69.6 · calibrated p 2e-6 ✓ | 61.2 EB05 50.3 · IC025 +5.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=73 · 100% clinician | no trial data cached |
| Substance abuser | 22 | 69.1 44.4–107.4ROR 69.1 · calibrated p 5e-6 ✓ | 58.9 EB05 41.0 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=22 · 100% clinician | no trial data cached |
| Catheter site pruritus | 87 | 65.4 52.4–81.6ROR 65.5 · calibrated p 3e-6 ✓ | 58.2 EB05 48.6 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=73 · ♀ 89% (drug 54%) | no trial data cached |
| Pulmonary arterial hypertension | 1,440 | 65.0 61.6–68.6ROR 67.7 · calibrated p 2e-6 ✓ | 58.5 EB05 56.0 · IC025 +5.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 42.6 | no trial data cached |
| Right ventricular dilatation | 52 | 59.2 44.5–78.7ROR 59.3 · calibrated p 7e-6 ✓ | 52.8 EB05 41.8 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=51 · ♀ 81% (drug 54%) · 100% clinician | no trial data cached |
| Walking distance test abnormal | 35 | 59.1 41.7–83.6ROR 59.1 · calibrated p 8e-6 ✓ | 52.3 EB05 39.3 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious n=31 | no trial data cached |
| Catheter site discharge | 99 | 58.6 47.6–72.0ROR 58.7 · calibrated p 6e-6 ✓ | 52.8 EB05 44.6 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=84 · ♀ 88% (drug 54%) | no trial data cached |
| Catheter site erythema | 183 | 56.7 48.7–66.0ROR 57.0 · calibrated p 7e-6 ✓ | 51.5 EB05 45.5 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=151 · ♀ 81% (drug 54%) | no trial data cached |
| Catheter site rash | 37 | 52.9 37.8–74.1ROR 53.0 · calibrated p 2e-5 ✓ | 47.5 EB05 36.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=32 · ♀ 100% (drug 54%) | no trial data cached |
| Right ventricular dysfunction | 83 | 49.4 39.5–61.9ROR 49.6 · calibrated p 2e-5 ✓ | 45.2 EB05 37.6 · IC025 +4.8 3/3 methods agree | Labeled (related wording) related wording | serious n=82 · ♀ 77% (drug 54%) · 100% clinician | no trial data cached |
| Cardiospasm | 43 | 49.4 36.2–67.5ROR 49.5 · calibrated p 2e-5 ✓ | 44.8 EB05 34.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=43 · ♀ 100% (drug 54%) | no trial data cached |
| Infusion site discharge | 131 | 49.1 41.1–58.7ROR 49.3 · calibrated p 2e-5 ✓ | 45.1 EB05 39.0 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=36 · ♀ 82% (drug 54%) · 82% consumer | no trial data cached |
| Oxygen consumption increased | 178 | 48.3 41.5–56.2ROR 48.5 · calibrated p 2e-5 ✓ | 44.5 EB05 39.3 · IC025 +5.1 3/3 methods agree | Lab value / disease marker | serious n=148 · ♀ 75% (drug 54%) | no trial data cached |
| Catheterisation cardiac abnormal | 20 | 47.5 30.1–74.9ROR 47.5 · calibrated p 4e-5 ✓ | 42.3 EB05 28.9 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Infusion site infection | 168 | 47.4 40.5–55.5ROR 47.6 · calibrated p 2e-5 ✓ | 43.7 EB05 38.4 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=73 · ♀ 76% (drug 54%) · 72% consumer | no trial data cached |
| N-terminal prohormone brain natriuretic peptide increased | 103 | 46.9 38.4–57.4ROR 47.1 · calibrated p 2e-5 ✓ | 43.2 EB05 36.6 · IC025 +4.8 3/3 methods agree | Lab value / disease marker | serious n=101 · 92% clinician | no trial data cached |
| Infusion site induration | 100 | 44.8 36.6–54.9ROR 44.9 · calibrated p 3e-5 ✓ | 41.4 EB05 35.0 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=29 · ♀ 78% (drug 54%) · 82% consumer | no trial data cached |
| Right ventricular systolic pressure increased | 22 | 44.6 28.9–68.8ROR 44.6 · calibrated p 6e-5 ✓ | 40.2 EB05 28.0 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious n=20 · 100% clinician | no trial data cached |
| Catheter site swelling | 64 | 44.3 34.4–57.1ROR 44.4 · calibrated p 4e-5 ✓ | 40.8 EB05 33.1 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=52 · ♀ 79% (drug 54%) | no trial data cached |
| Pulmonary arterial pressure abnormal | 20 | 44.2 28.1–69.7ROR 44.3 · calibrated p 7e-5 ✓ | 39.8 EB05 27.2 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious n=19 | no trial data cached |
| Infusion site irritation | 86 | 44.0 35.4–54.8ROR 44.1 · calibrated p 4e-5 ✓ | 40.7 EB05 33.9 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=27 · 82% consumer | no trial data cached |
| Paracentesis | 42 | 43.2 31.6–59.1ROR 43.2 · calibrated p 5e-5 ✓ | 39.6 EB05 30.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=42 · ♀ 100% (drug 54%) · 100% clinician | no trial data cached |
| Immunisation | 29 | 42.4 29.1–61.9ROR 42.5 · calibrated p 7e-5 ✓ | 38.7 EB05 28.3 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=29 · ♀ 100% (drug 54%) | no trial data cached |
| Catheter site irritation | 21 | 41.7 26.8–64.9ROR 41.7 · calibrated p 9e-5 ✓ | 37.8 EB05 26.1 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Infusion site inflammation | 43 | 40.3 29.6–54.9ROR 40.3 · calibrated p 7e-5 ✓ | 37.2 EB05 28.8 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | 100% consumer | no trial data cached |
| Heart transplant | 56 | 39.3 30.0–51.6ROR 39.4 · calibrated p 8e-5 ✓ | 36.5 EB05 29.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=56 | no trial data cached |
| Lung transplant | 218 | 38.6 33.6–44.2ROR 38.8 · calibrated p 7e-5 ✓ | 36.1 EB05 32.3 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=216 | no trial data cached |
| Infusion site haemorrhage | 194 | 37.7 32.6–43.6ROR 37.9 · calibrated p 8e-5 ✓ | 35.4 EB05 31.4 · IC025 +4.8 3/3 methods agree | Labeled (related wording) related wording | serious n=52 · 87% consumer | no trial data cached |
| Palmoplantar keratoderma | 43 | 37.6 27.6–51.1ROR 37.6 · calibrated p 1e-4 ✓ | 34.9 EB05 27.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=43 · ♀ 100% (drug 54%) | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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) | 4,499 | 4.7 4.6–4.9ROR 5.3 · calibrated p 0.205 | 4.7 EB05 4.6 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Headache | 2,891 | 2.7 2.7–2.8ROR 2.9 · calibrated p 0.660 | 2.7 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | no trial data cached |
| Death | 2,686 | 1.9 1.8–1.9ROR 1.9 · calibrated p 0.900 | 1.8 EB05 1.8 · IC025 +0.8 | Outcome field, not a reaction | serious PRR 1.3 | no trial data cached |
| Diarrhoea (diarrhea) | 2,344 | 2.2 2.1–2.3ROR 2.2 · calibrated p 0.929 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Nausea | 2,198 | 1.7 1.6–1.7ROR 1.7 · calibrated p 0.767 | 1.7 EB05 1.6 · IC025 +0.7 | Not in label — unassessed | serious PRR 1.7 | no trial data cached |
| Fatigue (tiredness) | 2,141 | 1.6 1.6–1.7ROR 1.7 · calibrated p 0.754 | 1.6 EB05 1.6 · IC025 +0.6 | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| Dizziness | 1,776 | 2.1 2.0–2.2ROR 2.2 · calibrated p 0.963 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Drug ineffective (drug did not work) | 1,732 | 0.8 0.7–0.8ROR 0.8 · calibrated p 0.166 | 0.8 EB05 0.7 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.0 | no trial data cached |
| Pneumonia (lung infection) | 1,676 | 3.1 2.9–3.2ROR 3.2 · calibrated p 0.569 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 | no trial data cached |
| Pulmonary arterial hypertension | 1,440 | 65.0 61.6–68.6ROR 67.7 · calibrated p 2e-6 ✓ | 58.5 EB05 56.0 · IC025 +5.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 42.6 | no trial data cached |
| Vomiting | 1,412 | 1.8 1.7–1.9ROR 1.8 · calibrated p 0.842 | 1.8 EB05 1.7 · IC025 +0.7 | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| Off label use (used outside approved label) | 1,410 | 1.0 0.9–1.0ROR 1.0 · calibrated p 0.282 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.0 | no trial data cached |
| Condition aggravated | 1,377 | 2.7 2.6–2.9ROR 2.8 · calibrated p 0.702 | 2.7 EB05 2.6 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.7 | no trial data cached |
| Hypotension (low blood pressure) | 1,355 | 4.0 3.8–4.2ROR 4.2 · calibrated p 0.351 | 4.0 EB05 3.8 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 | no trial data cached |
| Cough | 1,254 | 2.7 2.5–2.8ROR 2.7 · calibrated p 0.723 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 | 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.
- High risk sexual behaviour — n=42, PRR 181.6
- Heart and lung transplant — n=21, PRR 114.6
- Atrial septal defect repair — n=25, PRR 101.4
- Transplant evaluation — n=68, PRR 91.1
- Ventilation perfusion mismatch — n=31, PRR 74.8
- Right ventricular failure — n=756, PRR 71.0
- Substance abuser — n=22, PRR 69.1
- Catheter site pruritus — n=87, PRR 65.4
- Right ventricular dilatation — n=52, PRR 59.2
- Catheter site discharge — n=99, PRR 58.6
✓ 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 Powder?
In FDA FAERS, the most frequently co-reported reaction terms for Sildenafil Powder 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 Powder have an FDA boxed warning?
No. The FDA label retrieved for Sildenafil Powder has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Sildenafil Powder 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 598f2b9c-cfb9-4f26-8508-83ca5055c305, effective 20240313; matched on
openfda.generic_name.exact:"SILDENAFIL POWDER,") - 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, 1,228 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 2026-10-14. 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.