Tadalafil Side Effects

It is possible that some side effects of tadalafil may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to tadalafil: oral tablet

As well as its needed effects, tadalafil may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking tadalafil, check with your doctor immediately:

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 tadalafil side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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

For Healthcare Professionals

Applies to tadalafil: 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.

Cardiovascular

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.

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

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

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

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

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

Other

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.

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

Ocular

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.

Renal

Uncommon (0.1% to 1%): Hematuria
Frequency not reported: Renal impairment

Hepatic

Frequency not reported: Abnormal liver function tests, GGTP increased

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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