Sildenafil: Side Effects, Uses & Monitoring
Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening.
- Data source
- FDA labeling via NIH DailyMed (label c152953d…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| 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 reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
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%).
Conditions associated with Sildenafil in labeling
Frequently Asked Questions
What is Sildenafil used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Sildenafil?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Sildenafil. Individual risk varies.
Does Sildenafil require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Sildenafil.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.