Safety

CONTRAINDICATIONS

  • Nitrates: Administration of VIAGRA to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form either regularly and/or intermittently is contraindicated. VIAGRA was shown to potentiate the hypotensive effect of nitrates.

  • Concomitant Guanylate Cyclase (GC) Stimulators: Do not use VIAGRA in patients who are using a GC stimulator, such as riociguat. PDE5 inhibitors, including VIAGRA, may potentiate the hypotensive effects of GC stimulators.

  • Hypersensitivity Reactions: VIAGRA is contraindicated in patients with a known hypersensitivity to sildenafil, as contained in VIAGRA and REVATIO, or any component of the tablet. Hypersensitivity reactions have been reported, including rash and urticaria.

SELECTED WARNINGS & PRECAUTIONS

  • Cardiovascular: Patients should not use VIAGRA if sexual activity is inadvisable due to cardiovascular status. Physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by the vasodilatory effects of VIAGRA, especially in combination with sexual activity. There are no controlled clinical data on the safety or efficacy of VIAGRA in patients with the following characteristics: recent serious cardiovascular events, hypotension, or uncontrolled hypertension; if prescribed, this should be done with caution.

  • Prolonged Erection: Prolonged erection greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result. Use VIAGRA with caution in patients predisposed to priapism.

  • Effects on the Eye: Patients should stop VIAGRA and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION). VIAGRA should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a "crowded" optic disc may also be at an increased risk of NAION. There are no controlled clinical data on the safety or efficacy of VIAGRA in patients with retinitis pigmentosa; if prescribed, this should be done with caution.

  • Hearing Loss: Sudden decrease or loss of hearing has been reported in temporal association with the intake of PDE5 inhibitors, including VIAGRA. (It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors.) Physicians should advise patients to stop taking PDE5 inhibitors, including VIAGRA, and seek prompt medical attention in the event of sudden decrease or loss of hearing.

  • Potential Drug Interactions: VIAGRA can potentiate the hypotensive effects of nitrates, alpha-blockers, and antihypertensives. Initiate VIAGRA at 25 mg with concomitant use of alpha-blockers.

    CYP3A4 inhibitors (eg, ritonavir, ketoconazole, itraconazole, erythromycin) increase VIAGRA plasma exposure. Do not exceed 25 mg of VIAGRA in a 48-hour period with ritonavir. Consider a starting dose of 25 mg of VIAGRA with erythromycin or strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, saquinavir).

    Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures.

  • Sexually Transmitted Diseases: Use of VIAGRA offers no protection against sexually transmitted diseases, including the human immunodeficiency virus (HIV); therefore, physicians should consider counseling their patients about protective measures.

Specific Populations

  • Specific Populations: Consider a starting dose of 25 mg of VIAGRA for patients age >65, patients with hepatic impairment or severe renal impairment.

COMMON ADVERSE REACTIONS

Adverse reactions reported by ≥2% of patients treated with VIAGRA and more frequent than placebo in fixed-dose phase II/III studies

Adverse reaction VIAGRA 25 mg
(n=312)
VIAGRA 50 mg
(n=511)
VIAGRA 100 mg
(n=506)
Placebo
(n=607)
Headache 16% 21% 28% 7%
Flushing 10% 19% 18% 2%
Dyspepsia 3% 9% 17% 2%
Abnormal vision* 1% 2% 11% 1%
Nasal congestion 4% 4% 9% 2%
Back pain 3% 4% 4% 2%
Myalgia 2% 2% 4% 1%
Nausea 2% 3% 3% 1%
Dizziness 3% 4% 3% 2%
Rash 1% 2% 3% 1%

*Abnormal vision: Mild to moderate in severity and transient, predominantly color tinge to vision, but also increased sensitivity to light, or blurred vision.

Adverse reactions reported by ≥2% of patients treated with VIAGRA and more frequent than placebo in flexible-dose phase II/III studies

Adverse reaction VIAGRA
(n=734)
Placebo
(n=725)
Headache 16% 4%
Flushing 10% 1%
Dyspepsia 7% 2%
Nasal congestion 4% 2%
Abnormal vision* 3% 0%
Back pain 2% 2%
Dizziness 2% 1%
Rash 2% 1%

*Abnormal vision: Mild to transient, predominantly color tinge to vision, but also increased sensitivity to light or blurred vision. In these studies, only 1 patient discontinued due to abnormal vision.

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