Summary

Commonly reported side effects of tadalafil include: back pain, dyspepsia, headache, limb pain, myalgia, nausea, and flushing. Other side effects include: upper respiratory tract infection, cough, and nasal congestion. Continue reading for a comprehensive list of adverse effects.

Applies to tadalafil: oral tablets.

Side effects include:

ED and/or BPH: Headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, limb pain.

PAH: Headache, myalgia, nasopharyngitis, flushing, upper/lower respiratory tract infection, pain in extremity, nausea, back pain, dyspepsia, nasal/sinus congestion.

For Healthcare Professionals

Applies to tadalafil: oral suspension, oral tablet.

General

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.^[Ref]

Cardiovascular

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.^[Ref]

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.^[Ref]

Gastrointestinal

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^[Ref]

Musculoskeletal

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^[Ref]

Nervous system

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^[Ref]

Respiratory

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^[Ref]

Genitourinary

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^[Ref]

Other

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.^[Ref]

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.^[Ref]

Dermatologic

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^[Ref]

Ocular

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.^[Ref]

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.^[Ref]

Renal

Uncommon (0.1% to 1%): Hematuria

Frequency not reported: Renal impairment^[Ref]

Hepatic

Frequency not reported: Abnormal liver function tests, GGTP increased^[Ref]