Sildenafil vs Treprostinil: side effects in FDA adverse event reports
At a glance
| Sildenafil | Treprostinil | |
|---|---|---|
| Drug class | – | Prostacycline Vasodilator |
| Brand names | Sildenafil Citrate | – |
| FAERS reports | 126,457 | 124,472 |
| Serious | 67% | 57% |
| Death outcome | 18,360 | 14,973 |
| Boxed warning | No | No |
Signals both drugs share
| Reaction | Sildenafil | Treprostinil | Label screen (A / B) |
|---|---|---|---|
| Pulmonary arterial hypertension | 3,316 · PRR 48.7 | 4,475 · PRR 74.5 | Labeled adverse reaction / Likely indication confounding |
| Infusion site infection | 449 · PRR 40.8 | 1,518 · PRR 348.1 | Not in label — unassessed / Labeled adverse reaction |
| Infusion site discharge | 295 · PRR 34.4 | 915 · PRR 195.1 | Not in label — unassessed / Labeled (related wording) |
| Infusion site irritation | 189 · PRR 29.6 | 585 · PRR 150.2 | Not in label — unassessed / Labeled (related wording) |
| Infusion site warmth | 190 · PRR 31.0 | 584 · PRR 159.7 | Not in label — unassessed / Labeled (related wording) |
| Catheter site pruritus | 283 · PRR 79.2 | 298 · PRR 86.8 | Not in label — unassessed / Labeled (related wording) |
| Infusion site oedema | 125 · PRR 29.3 | 356 · PRR 127.0 | Labeled (related wording) / Labeled (related wording) |
| Infusion site cellulitis | 74 · PRR 28.3 | 236 · PRR 147.9 | Not in label — unassessed / Labeled (related wording) |
| Pulmonary hypertensive crisis | 99 · PRR 98.1 | 84 · PRR 77.4 | Labeled (related wording) / Likely indication confounding |
| Catheter site irritation | 93 · PRR 68.1 | 108 · PRR 86.0 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Sildenafil
- Erection increased — n=3,024, PRR 425.1 Labeled (related wording)
- Pulmonary hypertension — n=3,016, PRR 27.8 Labeled (related wording)
- Right ventricular failure — n=1,675, PRR 51.4 Labeled (related wording)
- Ejaculation disorder — n=862, PRR 71.4 Labeled (related wording)
- Penis disorder — n=708, PRR 65.7 Labeled (related wording)
- Optic ischaemic neuropathy — n=551, PRR 30.2 Labeled (related wording)
- Painful erection — n=194, PRR 64.1 Labeled adverse reaction
- Premature ejaculation — n=160, PRR 54.3 Labeled (related wording)
Labeled signals distinctive to Treprostinil
- Infusion site pain — n=5,691, PRR 135.7 Labeled adverse reaction
- Infusion site erythema — n=3,287, PRR 110.7 Labeled (related wording)
- Infusion site swelling — n=1,871, PRR 73.3 Labeled (related wording)
- Infusion site haemorrhage — n=1,402, PRR 128.6 Labeled (related wording)
- Infusion site induration — n=651, PRR 142.7 Labeled (related wording)
- Infusion site discomfort — n=295, PRR 68.1 Labeled (related wording)
- Infusion site discolouration — n=293, PRR 86.7 Labeled (related wording)
- Infusion site inflammation — n=277, PRR 117.4 Labeled (related wording)
Common questions
Which has more reported side effects, Sildenafil or Treprostinil?
Sildenafil has 126,457 FAERS reports and Treprostinil 124,472. More reports does not mean more dangerous: volume follows how widely and how long a drug has been used, prescription vs over-the-counter status, and publicity. The seriousness share (67% vs 57%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Sildenafil and Treprostinil share?
Both drugs carry disproportionality signals for pulmonary arterial hypertension, infusion site infection, infusion site discharge, infusion site irritation, infusion site warmth. Shared signals often reflect a shared drug class or the condition both are used for.
Is Sildenafil or Treprostinil safer?
FAERS cannot answer that: it has no denominator and no comparator. Use this page to see which risks are already on each label and which signals are unlabeled, then check the prescribing information and your clinician for your situation.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, openFDA count queries for seriousness and deaths. Pair chosen because it is a commonly searched comparison. Generated 2026-10-08.