Sildenafil vs Macitentan: side effects in FDA adverse event reports
At a glance
| Sildenafil | Macitentan | |
|---|---|---|
| Drug class | – | Endothelin Receptor Antagonist |
| Brand names | Sildenafil Citrate | – |
| FAERS reports | 126,457 | 68,750 |
| Serious | 67% | 71% |
| Death outcome | 18,360 | 12,527 |
| Boxed warning | No | Yes EMBRYO-FETAL TOXICITY Macitentan tablets are contraindicated for use during pregnancy because it may cause fetal harm based on animal data [see Contraindication |
Signals both drugs share
| Reaction | Sildenafil | Macitentan | Label screen (A / B) |
|---|---|---|---|
| Pulmonary arterial hypertension | 3,316 · PRR 48.7 | 3,291 · PRR 89.0 | Labeled adverse reaction / Likely indication confounding |
| Right ventricular failure | 1,675 · PRR 51.4 | 1,292 · PRR 68.1 | Labeled (related wording) / Labeled (related wording) |
| Infusion site infection | 449 · PRR 40.8 | 396 · PRR 64.4 | Not in label — unassessed / Labeled (related wording) |
| Pulmonary veno-occlusive disease | 138 · PRR 40.8 | 125 · PRR 66.6 | Labeled (related wording) / Labeled — boxed warning |
| Catheter site erythema | 492 · PRR 50.8 | 417 · PRR 75.7 | Not in label — unassessed / Not in label — unassessed |
| Infusion site discharge | 295 · PRR 34.4 | 271 · PRR 57.3 | Not in label — unassessed / Not in label — unassessed |
| Catheter site pruritus | 283 · PRR 79.2 | 276 · PRR 140.6 | Not in label — unassessed / Not in label — unassessed |
| Catheter site discharge | 265 · PRR 52.5 | 214 · PRR 73.5 | Not in label — unassessed / Not in label — unassessed |
| Infusion site irritation | 189 · PRR 29.6 | 175 · PRR 49.8 | Not in label — unassessed / Not in label — unassessed |
| Infusion site warmth | 190 · PRR 31.0 | 170 · PRR 50.1 | Not in label — unassessed / Not in label — unassessed |
| Catheter site swelling | 158 · PRR 34.3 | 145 · PRR 57.0 | Not in label — unassessed / Not in label — unassessed |
| Transplant evaluation | 123 · PRR 52.5 | 149 · PRR 125.7 | Not in label — unassessed / Not in label — unassessed |
| Catheter site rash | 111 · PRR 54.0 | 143 · PRR 141.9 | Not in label — unassessed / Not in label — unassessed |
| Catheter site irritation | 93 · PRR 68.1 | 101 · PRR 141.4 | Not in label — unassessed / Not in label — unassessed |
| Ventilation perfusion mismatch | 63 · PRR 48.8 | 39 · PRR 49.9 | 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)
- 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)
- Infusion site oedema — n=125, PRR 29.3 Labeled (related wording)
Labeled signals distinctive to Macitentan
- Cardiac failure high output — n=56, PRR 93.7 Labeled (related wording)
Common questions
Which has more reported side effects, Sildenafil or Macitentan?
Sildenafil has 126,457 FAERS reports and Macitentan 68,750. 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 71%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Sildenafil and Macitentan share?
Both drugs carry disproportionality signals for pulmonary arterial hypertension, right ventricular failure, infusion site infection, pulmonary veno-occlusive disease, catheter site erythema. Shared signals often reflect a shared drug class or the condition both are used for.
Is Sildenafil or Macitentan 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.