Revatio Side Effects

Generic name: sildenafil

Medically reviewed by Drugs.com. Last updated on Aug 22, 2023.

Note: This document contains side effect information about sildenafil. Some dosage forms listed on this page may not apply to the brand name Revatio.

Applies to sildenafil: oral powder for suspension, oral suspension, oral tablet. Other dosage forms:

• intravenous solution

Serious side effects of Revatio

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:

Less common

• Bladder pain
• burning feeling in the chest or stomach
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• cloudy or bloody urine
• dizziness
• increased frequency of urination
• indigestion
• pain on urination
• stomach upset
• tenderness in the stomach area

Rare

• Abnormal vision
• anxiety
• behavior change similar to drunkenness
• bleeding of the eye
• blurred vision
• bone pain
• breast enlargement
• chest pain
• chills
• cold sweats
• confusion
• cool and pale skin
• deafness or hearing loss
• decrease in amount of urine or the frequency of urination
• decreased vision
• difficulty in concentrating
• dizziness or lightheadedness, especially when getting up suddenly from a lying or sitting position
• double vision
• drowsiness
• dry eyes
• dry mouth
• dryness, redness, scaling, or peeling of the skin
• excessive hunger
• eye pain
• fainting or faintness
• fast, irregular, or pounding heartbeat
• feeling of something in the eye
• fever or chills
• headache (severe or continuing)
• increase in the size of the pupil
• increased sweating
• increased thirst
• lower back or side pain
• migraine headache
• nausea (severe or continuing)
• nervousness
• nightmares
• numbness of the hands
• painful, swollen joints
• prolonged, painful erection of penis
• redness, burning, or swelling of the eyes
• redness, itching, or tearing of the eyes
• restless sleep
• seeing shades of colors differently than before
• seizures
• sensitivity to light
• shakiness
• skin lesions with swelling
• skin paleness
• skin rash, hives, or itching
• skin ulcers
• slurred speech
• sore throat
• sudden weakness
• swelling of the face, hands, feet, or lower legs
• trouble breathing
• twitching of the muscles
• unusual feeling of burning or stinging of the skin
• unusual tiredness or weakness
• vision changes
• vision loss, temporary

Incidence not known

• Blindness

Other side effects of Revatio

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:

More common

• Aches or pains in the muscles
• bloody nose
• diarrhea
• difficult or labored breathing
• flushing
• headache
• pain or tenderness around the eyes and cheekbones
• redness of the skin
• sneezing
• stomach discomfort following meals
• stuffy or runny nose
• trouble sleeping
• unusually warm skin

Rare

• Abdominal or stomach pain
• abnormal dreams
• anxiety
• clumsiness or unsteadiness
• cough
• diarrhea or stomach cramps (severe or continuing)
• difficulty in swallowing
• ear pain
• increased amount of saliva
• increased skin sensitivity
• lack of coordination
• loss of bladder control
• mental depression
• nausea
• numbness or tingling of the hands, legs, or feet
• rectal bleeding
• redness or irritation of the tongue
• redness, soreness, swelling, or bleeding of the gums
• ringing or buzzing in the ears
• sensation of motion, usually whirling, either of one's self or of one's surroundings
• sexual problems in men (continuing), including failure to experience a sexual orgasm
• sleepiness
• sores in the mouth and on the lips
• tense muscles
• trembling and shaking
• vomiting
• waking to urinate at night
• worsening of asthma

For Healthcare Professionals

Applies to sildenafil: intravenous solution, oral powder for reconstitution, oral tablet.

General

The most common adverse reactions occurring in patients with erectile dysfunction (ED) and pulmonary arterial hypertension (PAH) included headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, rash, visual disturbance, cyanopsia, blurred vision, limb pain, priapism, upper respiratory infection, vomiting, bronchitis, pharyngitis, pyrexia, diarrhea, influenza, epistaxis.^[Ref]

Cardiovascular

Very common (10% or more): Flushing (up to 19%)

Rare (0.01% to 0.1%): Myocardial infarction, atrial fibrillation, unstable angina, tachycardia, palpitations

Frequency not reported: Shock, angina pectoris, AV block, migraine, syncope, hypotension, postural hypotension, myocardial ischemia, cerebral thrombosis, cardiac arrest, heart failure, abnormal electrocardiogram, cardiomyopathy, vasodilation, abnormal electrocardiogram, increased heart rate

Postmarketing reports: Myocardial infarction, sudden cardiac death, cardiac arrest, ventricular arrhythmia, hypertension, hypotensive events after the use with alpha-blockers, tachycardia, hypotension, syncope

Gastrointestinal

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

Musculoskeletal

Very common (10% or more): Pain in limb (up to 15%), myalgia (up to 14%), back pain (up to 13%)

Frequency not reported: Arthritis, arthrosis, myalgia, tendon rupture, tenosynovitis, bone pain, myasthenia, synovitis

Postmarketing reports: Pain in extremity, pain in jaw, arthralgia

Nervous system

Very common (10% or more): Headache (up to 28% in ED; up to 49% in PAH)

Common (1% to 10%): Dizziness, vertigo, paresthesia, tremor, burning sensation, migraine, hypoesthesia

Uncommon (0.1% to 1%): Somnolence

Rare (0.01% to 0.1%): Cerebrovascular accident, transient ischemic attack, syncope

Frequency not reported: Ataxia, hypertonia, neuralgia, neuropathy, vertigo, depression, decreased reflexes/hyporeflexia, cerebral thrombosis, convulsion

Postmarketing reports: Cerebrovascular hemorrhage, transient ischemic attack, subarachnoid hemorrhage, intracerebral hemorrhage, seizure, seizure recurrence, transient global amnesia

Ocular

Abnormal vision included a severity that was mild to moderate and transient, characterized predominantly by color tinge to vision, but also increased sensitivity to light, or blurred vision.

Lacrimation disorders included dry eye, lacrimal disorder, and lacrimation increased.

Visual color distortions included chloropsia, chromatopsia, cyanopsia, erythropsia, and xanthopsia.

Very common (10% or more): Abnormal vision (up to 11%)

Common (1% to 10%): Abnormal sensation in eye, chromatopsia, cyanopsia, diplopia, eye irritation, photophobia, retinal hemorrhage, visual acuity reduced, visual color distortion

Uncommon (0.1% to 1%): Dry eye, lacrimal disorder, photopsia, ocular hyperemia, visual brightness, conjunctivitis, eye pain

Rare (0.01% to 0.1%): Arteriosclerotic retinopathy, retinal disorder, glaucoma, visual field defect, myopia, asthenopia, vitreous floaters, iris disorder, mydriasis, halo vision, eye edema, eye swelling, eye disorder, conjunctival hyperemia, eyelid edema, scleral discoloration

Frequency not reported: Eye hemorrhage, cataract, visual disturbance, xanthopsia, erythropsia

Postmarketing reports: Diplopia, temporary vision loss/decreased vision, ocular redness or bloodshot appearance, ocular burning, ocular swelling/pressure, increased intraocular pressure, retinal edema, retinal vascular disease or bleeding, vitreous traction/detachment, non-arteritic anterior ischemic optic neuropathy (NAION)

Respiratory

Very common (10% or more): Upper respiratory tract infection (up to 31%), bronchitis (up to 20%), pharyngitis (up to 18%)

Common (1% to 10%): Nasal congestion, cough, epistaxis, dyspnea, sinusitis, rhinitis, bronchitis, pneumonia, rhinorrhea

Uncommon (0.1% to 1%): Sinus congestion

Frequency not reported: Asthma, laryngitis, increased sputum, increased cough, respiratory tract infection, throat tightness, nasal dryness, nasal edema, bronchopneumonia, hypoxia, stridor, pulmonary hypertension

Postmarketing reports: Epistaxis, pulmonary hemorrhage

Dermatologic

Common (1% to 10%): Rash, erythema, alopecia

Frequency not reported: Face edema, photosensitivity reaction, urticaria, pruritus, sweating, skin ulcer, contact dermatitis, exfoliative dermatitis

Postmarketing reports: Stevens-Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN)

Hematologic

Common (1% to 10%): Anemia

Frequency not reported: Leukopenia

Postmarketing reports: Vaso-occlusive crisis (in patients with PAH secondary to sickle cell disease)

Metabolic

Common (1% to 10%): Increased weight, fluid retention

Frequency not reported: Edema, gout, unstable diabetes, hyperglycemia, peripheral edema, hyperuricemia, hypoglycemic reaction, hypernatremia

Other

Very common (10% or more): Pyrexia (up to 17%), influenza (up to 12%)

Common (1% to 10%): Cellulitis, gynecomastia, breast enlargement, night sweats

Uncommon (0.1% to 1%): Tinnitus, chest pain, feeling hot, fatigue

Rare (0.01% to 0.1%): Deafness, irritability

Frequency not reported: Asthenia, pain, chills, accidental fall, accidental injury, thirst, sudden decrease or loss of hearing, ear pain, flu syndrome, infection, herpes simplex

Postmarketing reports: Sudden decrease or loss of hearing

Psychiatric

Common (1% to 10%): Insomnia, anxiety

Frequency not reported: Depression, abnormal dreams

Postmarketing reports: Anxiety

Genitourinary

Common (1% to 10%): Increased erection, urinary tract infection

Uncommon (0.1% to 1%): Penile hemorrhage, hematospermia

Frequency not reported: Cystitis, nocturia, urinary frequency, urinary incontinence, abnormal ejaculation, genital edema, anorgasmia, prostatic disorder

Postmarketing reports: Prolonged erection, priapism

Renal

Uncommon (0.1% to 1%): Hematuria

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity

Frequency not reported: Allergic reaction

Postmarketing reports: Hypersensitivity reaction

Hepatic

Frequency not reported: Abnormal liver tests

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer