Adcirca

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

Common side effects of Adcirca include: back pain, dyspepsia, headache, limb pain, myalgia, nausea, and flushing. Other side effects include: nasal congestion. See below for a comprehensive list of adverse effects.

Applies to tadalafil: oral tablet

Along with its needed effects, tadalafil (the active ingredient contained in Adcirca) 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 tadalafil:

Less common

• Arm, back, or jaw pain
• blurred vision
• chest pain or discomfort
• chest tightness or heaviness
• chills
• cold sweats
• confusion
• dizziness
• fainting
• faintness or lightheadedness when getting up suddenly from a lying or sitting position
• fast or irregular heartbeat
• headache
• hearing loss
• nausea
• nervousness
• pain or discomfort in the arms, jaw, back, or neck
• pounding in the ears
• shortness of breath
• slow or fast heartbeat
• sweating
• unusual tiredness or weakness
• vomiting

Rare

• Painful or prolonged erection of the penis

Incidence not known

• Abdominal or stomach pain
• blindness
• blistering, peeling, or loosening of the skin
• cough
• cracks in the skin
• decrease or change in vision
• diarrhea
• difficulty with speaking
• double vision
• fast, irregular, pounding, or racing heartbeat or pulse
• headache, severe and throbbing
• hives or welts
• inability to move the arms, legs, or facial muscles
• inability to speak
• itching
• joint or muscle pain
• loss of heat from the body
• numbness or tingling of the face, hands, or feet
• red irritated eyes
• red skin lesions, often with a purple center
• red, swollen skin
• redness of the skin
• redness or soreness of the eyes
• scaly skin
• skin rash
• slow speech
• sores, ulcers, or white spots in the mouth or on the lips
• sudden cardiac death
• swelling of the feet or lower legs

Some side effects of tadalafil 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

• Acid or sour stomach
• belching
• heartburn
• indigestion
• stomach discomfort, upset, or pain

Less common

• Bloody nose
• body aches or pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• burning, dry, or itching eyes
• burning feeling in the chest or stomach
• congestion
• difficulty with moving
• difficulty with swallowing
• dry mouth
• dryness or soreness of the throat
• excessive eye discharge
• eye pain
• feeling of constant movement of self or surroundings
• feeling of warmth, redness of the face, neck, arms and occasionally, upper chest
• fever
• hoarseness
• increased erection
• lack or loss of strength
• loose stools
• muscle aching or cramping
• muscle stiffness
• nasal congestion
• neck pain
• pain
• pain in the arms or legs
• pain or burning in the throat
• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
• reduced sensitivity to touch
• runny nose
• sensation of spinning
• sleepiness or unusual drowsiness
• sleeplessness
• spontaneous penile erection
• stomach upset
• swelling of the eyelids
• swelling or puffiness of the eyes or face
• swollen joints
• tearing
• tender, swollen glands in the neck
• tenderness in the stomach area
• trouble with sleeping
• unable to sleep
• upper abdominal or stomach pain
• voice changes
• watering of the eyes

Rare

• Changes in color vision

Applies to tadalafil: oral tablet

The most commonly reported adverse reactions were headache, nausea, dyspepsia, back pain, myalgia, flushing, nasopharyngitis, and pain in the extremity. These adverse reactions were dose dependent, transient, and generally mild or moderate.

Most patients that experienced side effects such as myocardial infarction, sudden cardiac death, stroke, palpitations, and tachycardia had preexisting cardiovascular risk factors. Many of these events were reported to occur during or shortly after sexual activity.

Very common (10% or more): Flushing (up to 14%)

Common (1% to 10%): Hypertension, hot flush

Uncommon (0.1% to 1%): Hypotension

Frequency not reported: Unstable angina pectoris, postural hypotension, ventricular arrhythmia

Postmarketing reports: Myocardial infarction, sudden cardiac death, stroke, chest pain, palpitations, and tachycardia, have been reported in temporal association with the use of this drug.

Very common (10% or more): Dyspepsia (up to 13%), nausea (up to 11%)

Common (1% to 10%): Diarrhea, gastroesophageal reflux disease, abdominal pain, gastroenteritis, constipation

Uncommon (0.1% to 1%): Vomiting

Frequency not reported: Dry mouth, dysphagia, esophagitis, gastritis, loose stools, nausea, upper abdominal pain, hemorrhoidal hemorrhage, rectal hemorrhage

Very common (10% or more): Myalgia (up to 14%), back pain (up to 12%), pain in extremity (up to 11%)

Common (1% to 10%): Pain in limb, musculoskeletal stiffness

Uncommon (0.1% to 1%): Arthralgia, muscle spasm

Frequency not reported: Neck pain

Very common (10% or more): Headache (up to 42%)

Common (1% to 10%): Dizziness (1%)

Rare (less than 0.1%): Transient global amnesia, transient ischemic attacks

Frequency not reported: Hypesthesia, somnolence, syncope, paraesthesia

Postmarketing reports: Migraine, seizure and seizure recurrence

Very common (10% or more): Nasopharyngitis (up to 13%), upper and lower respiratory tract infection (up to 13%)

Common (1% to 10%): Nasal congestion (including sinus congestion), cough, influenza, pulmonary hypertension, rhinitis

Uncommon (0.1% to 1%): Dyspnea, epistaxis

Frequency not reported: Pharyngitis

Common (1% to 10%): Urinary tract infection, menorrhagia (including uterine bleeding)

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

Rare (less than 0.1%): Prolonged erections

Frequency not reported: Erection increased, spontaneous penile erection

Postmarketing reports: Priapism

In some of the cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. In many cases, medical follow-up information was limited.

Common (1% to 10%): Peripheral edema, fatigue, edema

Uncommon (0.1% to 1%): Tinnitus

Rare (less than 0.1%): Facial edema

Frequency not reported: Vertigo, asthenia, pain

Postmarketing reports: Cases of sudden decrease or loss of hearing have been reported in temporal association with the use of this drug.

Uncommon (0.1% to 1%): Rash, urticaria, hyperhidrosis (sweating)

Rare (less than 0.1%): Angioedema

Frequency not reported: Pruritus

Postmarketing reports: Stevens-Johnson syndrome, exfoliative dermatitis

Most of the patients with NAION, but not all, had underlying anatomic or vascular risk factors, including but not necessarily limited to: Low cup to disc ratio ("crowded disc"), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia, and smoking.

Uncommon (0.1% to 1%): Ocular hyperemia, eye pain, eyelid edema

Rare (less than 0.1%): Changes in color vision

Frequency not reported: Blurred vision, conjunctivitis (including conjunctival hyperemia), eye pain, lacrimation increased

Postmarketing reports: Visual field defect, retinal vein occlusion, and retinal artery occlusion. Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported in temporal association with the use of this drug.

Uncommon (0.1% to 1%): Hematuria

Frequency not reported: Renal impairment

Frequency not reported: Abnormal liver function tests, GGTP increased