Sildenafil Side Effects

Medically reviewed by Drugs.com. Last updated on Jun 13, 2023.

For healthcare professionals

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

General adverse events

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

• 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)

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.

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

Sildenafil side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer