Summary

Commonly reported side effects of avanafil include: headache and flushing. Other side effects include: nasopharyngitis. Continue reading for a comprehensive list of adverse effects.

Applies to avanafil: oral tablet.

Serious side effects of Avanafil

Along with its needed effects, avanafil 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 avanafil:

Less common

• Blurred vision
• dizziness
• headache
• nervousness
• pounding in the ears
• slow or fast heartbeat

Rare

• Arm, back, or jaw pain
• bladder pain
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody or cloudy urine
• chest pain, discomfort, or tightness
• chest tightness or heaviness
• difficult or labored breathing
• difficult, burning, or painful urination
• fast, irregular, pounding, or racing heartbeat or pulse
• frequent urge to urinate
• increased erection
• lower back or side pain
• nausea and vomiting
• pain in the groin or genitals
• pain, redness, or swelling in the arm or leg
• rapid weight gain
• sharp back pain just below the ribs
• sweating
• tingling of the hands or feet
• unusual tiredness or weakness
• unusual weight gain or loss

Incidence not known

• Pain or discomfort in the arms, jaw, back, or neck
• seeing flashes or sparks of light
• seeing floating spots before the eyes, veil, or curtain appearing across part of vision
• sudden decrease or loss of hearing

Other side effects of Avanafil

Some side effects of avanafil 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

• Feeling of warmth
• fever
• muscle aches
• redness of the face, neck, arms, and occasionally, upper chest
• sore throat
• stuffy or runny nose

Less common

• Acid or sour stomach
• belching
• body aches or pain
• change in color vision
• chills
• cough
• cough producing mucus
• diarrhea
• difficulty having a bowel movement (stool)
• difficulty with moving
• ear congestion
• heartburn
• indigestion
• joint pain
• loss of appetite
• loss of voice
• muscle pain or stiffness
• pain or tenderness around the eyes and cheekbones
• rash
• shivering
• sneezing
• sweating
• trouble sleeping

Rare

• Anxiety
• bloody nose
• bone pain
• burning feeling in the chest or stomach
• confusion
• cool, pale skin
• depression
• feeling of constant movement of self or surroundings
• increased hunger
• itching skin
• muscle aching or cramping
• muscle spasms
• nightmares
• seizures
• sensation of spinning
• shakiness
• sleepiness or unusual drowsiness
• slurred speech
• swollen joints
• tenderness in the stomach area

For Healthcare Professionals

Applies to avanafil: oral tablet.

General

The most common side effects reported were headache, flushing, nasal and sinus congestion and back pain.^[Ref]

Cardiovascular

Very common (10% or more): Flushing (up to 10.1%)

Common (1% to 10%): Hypertension, abnormal electrocardiogram

Uncommon (0.1% to 1%): Peripheral edema, angina, unstable angina, deep vein thrombosis, palpitations, hot flush, increased heart rate

Rare (less than 0.1%): Tachycardia, chest pain, increased blood pressure, cardiac murmur

Postmarketing reports: Hypotension^[Ref]

Genitourinary

Uncommon (0.1% to 1%): Balanitis, increased erection

Rare (less than 0.1%): Penis disorder, spontaneous penile erection, genital pruritus, increased prostate specific antigen

Postmarketing reports: Priapism, hematuria, hematospermia, penile hemorrhage^[Ref]

Dermatologic

Common (1% to 10%): Rash

Uncommon (0.1% to 1%): Pruritus^[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, dyspepsia, nausea, constipation

Uncommon (0.1% to 1%): Gastritis, gastroesophageal reflux disease, stomach discomfort, vomiting, dyspepsia, nausea

Rare (less than 0.1%): Dry mouth, lower abdominal pain^[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, arthralgia

Uncommon (0.1% to 1%): Muscle spasms, musculoskeletal pain, myalgia, pain in extremity, muscle tightness

Rare (less than 0.1%): Flank pain^[Ref]

Nervous system

Very common (10% or more): Headache (up to 12.1%)

Common (1% to 10%): Dizziness

Uncommon (0.1% to 1%): Somnolence, vertigo, sinus headache

Rare (less than 0.1%): Psychomotor hyperactivity^[Ref]

Psychiatric

Uncommon (0.1% to 1%): Depression, insomnia

Rare (less than 0.1%): Premature ejaculation, inappropriate affect^[Ref]

Renal

Uncommon (0.1% to 1%): Hematuria, nephrolithiasis, pollakiuria, urinary tract infection

Rare (less than 0.1%): Blood urine present^[Ref]

Respiratory

Common (1% to 10%): Nasal congestion, nasopharyngitis, upper respiratory infection (URI), bronchitis, sinusitis, sinus congestion

Uncommon (0.1% to 1%): Oropharyngeal pain, cough, exertional dyspnea, wheezing

Rare (less than 0.1%): Rhinorrhea, upper respiratory tract congestion^[Ref]

Hematologic

Uncommon (0.1% to 1%): Epistaxis^[Ref]

Hepatic

Uncommon (0.1% to 1%): Increased alanine aminotransferase

Rare (less than 0.1%): Increased blood bilirubin^[Ref]

Immunologic

Common (1% to 10%): Influenza

Rare (less than 0.1%): Seasonal allergy^[Ref]

Metabolic

Uncommon (0.1% to 1%): Hypoglycemia, increased blood glucose

Rare (less than 0.1%): Gout, Increased weight^[Ref]

Ocular

Uncommon (0.1% to 1%): Blurred vision, vision loss

Postmarketing reports: Non-arteritic anterior ischemic optic neuropathy (NAION)^[Ref]

Other

Uncommon (0.1% to 1%): Fatigue, tinnitus

Rare (less than 0.1%): Asthenia, influenza-like illness, increased body temperature

Postmarketing reports: Loss of hearing^[Ref]