Sildenafil: Side Effects, Uses & Monitoring
Facts extracted from current FDA product labeling for Sildenafil. Educational only — not medical advice.
Reported adverse reactions
| Reaction | Highest frequency reported* |
|---|---|
| Headache | 46% |
| Edema* | 25% |
| Nausea | 25% |
| Pain in extremity | 17% |
| Dyspepsia | 13% |
| Flushing | 10% |
| Epistaxis | 9% |
| Diarrhea | 9% |
| Nasal congestion | 9% |
| Insomnia | 7% |
| Dyspnea exacerbated | 7% |
| Myalgia | 7% |
| Erythema | 6% |
| Pyrexia | 6% |
| Rhinitis | 4% |
| Gastritis | 3% |
| Sinusitis | 3% |
| Paresthesia | 3% |
*Highest percentage across placebo-controlled trial tables summarized in current labeling.
Labeled uses
Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when sildenafil tablets were added to background epoprostenol therapy [see Clinical Studies (14)]. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).
Medical disclaimer: Always consult a qualified healthcare professional about any medication.