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Note: This document contains side effect information about sildenafil. Some of the dosage forms listed on this page may not apply to the brand name Revatio.
More frequent side effects include: epistaxis, insomnia, and rhinitis. See below for a comprehensive list of adverse effects.
Applies to sildenafil: oral powder for suspension, oral tablet
Other dosage forms:
Along with its needed effects, sildenafil (the active ingredient contained in Revatio) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking sildenafil:
Incidence not known
Some side effects of sildenafil may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Applies to sildenafil: intravenous solution, oral powder for reconstitution, oral tablet
The most common adverse reactions reported in clinical trials are headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash.
Very common (10% or more): Flushing (10%)
Uncommon (0.1% to 1%): Heart rate increased, palpitations, tachycardia, hypertension, hypotension
Rare (less than 0.1%): Myocardial infarction, atrial fibrillation, sudden cardiac death, ventricular arrhythmia, unstable angina
Frequency not reported: Ventricular arrhythmia, sudden cardiac death, angina pectoris, AV block, tachycardia, palpitation, hypotension, postural hypotension, myocardial ischemia, cerebral thrombosis, cardiac arrest, heart failure, abnormal electrocardiogram, cardiomyopathy, shock
Postmarketing reports: Serious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction; sudden cardiac death; ventricular arrhythmia; cerebrovascular hemorrhage; transient ischemic attack; hypertension; subarachnoid, intracerebral, and pulmonary hemorrhage have been reported in temporal association with the use of this drug.
Very common (10% or more): Dyspepsia (up to 17%), diarrhea
Common (1% to 10%): Nausea, vomiting, dry mouth, gastritis, gastroesophageal reflux disease, hemorrhoids, abdominal distension
Rare (less than 0.1%): Oral hypoesthesia
Frequency not reported: Glossitis, colitis, dysphagia, gastroenteritis, esophagitis, stomatitis, gingivitis
Very common (10% or more): Pain in extremity
Common (1% to 10%): Back pain, myalgia
Frequency not reported: Arthritis, arthrosis, myalgia, tendon rupture, tenosynovitis, bone pain, myasthenia, synovitis
Very common (10% or more): Headache (up to 28%)
Common (1% to 10%): Dizziness, migraine, tremor, paresthesia, burning sensation
Uncommon (0.1% to 1%): Somnolence, hypoesthesia
Rare (less than 0.1%): Cerebrovascular accident, syncope
Frequency not reported: Transient ischemic attack, seizure, seizure recurrence, ataxia, hypertonia, neuralgia, neuropathy, paresthesia, somnolence, reflexes decreased
Postmarketing reports: Transient global amnesia
Very common (10% or more): Abnormal vision (up to 11%)
Common (1% to 10%): Visual color distortion, retinal hemorrhage, visual impairment, vision blurred, photophobia, chromatopsia, cyanopsia, eye irritation, ocular hyperemia
Uncommon (0.1% to 1%): Conjunctival disorders, eye disorders, eye pain, lacrimation disorders, visual acuity reduced, diplopia, abnormal sensation in eye, photopsia, visual brightness, conjunctivitis
Rare (less than 0.1%): Retinal hemorrhage, arteriosclerotic retinopathy, retinal disorder, glaucoma, visual field defect, myopia, asthenopia, vitreous floaters, iris disorder, mydriasis, halo vision, eye edema, eye swelling, eyelid edema, scleral discoloration
Frequency not reported: Non-arteritic anterior ischemic optic neuropathy (NAION), retinal vascular occlusion, visual field defect, cataract
This drug has lesser affinity for isoenzyme PDE6, an enzyme found in the retina. This lower selectivity is thought to be the basis for abnormalities related to color vision observed with higher doses or plasma levels.
Nonarteritic anterior ischemic optic neuropathy developed in one eye within minutes to hours after ingestion of sildenafil. Four of the five patients had no vascular risk factors for ischemic optic neuropathy.
-Abnormal Vision: Mild to moderate and transient, predominantly color tinge to vision, but also increased sensitivity to light, or blurred vision.
-Visual color distortions: Chloropsia, chromatopsia, cyanopsia, erythropsia and xanthopsia
-Lacrimation disorders: Dry eye, lacrimal disorder and lacrimation increased
Very common (10% or more): Pharyngitis (18%), rhinitis
Common (1% to 10%): Nasal congestion, epistaxis, cough
Uncommon (0.1% to 1%): Sinus congestion
Rare (less than 0.1%): Throat tightness, nasal edema, nasal dryness
Frequency not reported: Asthma, dyspnea, laryngitis, pharyngitis, sinusitis, bronchitis, sputum increased, cough increased
Common (1% to 10%): Rash, alopecia, erythema, night sweats
Frequency not reported: Steven-Johnson syndrome (SJS), toxic epidermal necrolysis(TEN), urticaria, herpes simplex, pruritus, sweating, skin ulcer, contact dermatitis, exfoliative dermatitis
Common (1% to 10%): Anemia
Frequency not reported: Leukopenia
Postmarketing reports: In patients with pulmonary arterial hypertension (secondary to sickle cell disease) taking Revatio (R), vaso-occlusive crises requiring hospitalization were more commonly reported. The clinical relevance of this finding in male patients treated with sildenafil (the active ingredient contained in Revatio) for erectile dysfunction is unknown.
Common (1% to 10%): Fluid retention
Frequency not reported: Thirst, edema, gout, unstable diabetes, hyperglycemia, hyperuricemia, hypoglycemic reaction, hypernatremia
Common (1% to 10%): Cellulitis, influenza, bronchitis, sinusitis, rhinitis, gastroenteritis, vertigo, pyrexia
Uncommon (0.1% to 1%): Tinnitus, chest pain, fatigue, gynecomastia
Rare (less than 0.1%): Deafness, irritability
Frequency not reported: Sudden hearing loss, edema, face edema, peripheral edema, pain, chills accidental fall, accidental injury
Common (1% to 10%): Insomnia, anxiety
Frequency not reported: Abnormal dreams, depression
Uncommon (0.1% to 1%): Penile hemorrhage, hematospermia
Frequency not reported: Priapism, prolonged erection, increased erection, cystitis, nocturia, urinary frequency, urinary incontinence, abnormal ejaculation, genital edema, anorgasmia
Uncommon (0.1% to 1%): Hematuria
Rare (less than 0.1%): Hypersensitivity reactions, including rash and urticaria
Frequency not reported: Liver function tests abnormal
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