Tadalafil Side Effects
Some side effects of tadalafil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to tadalafil: oral tablet
Along with its needed effects, tadalafil 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
- cold sweats
- faintness or lightheadedness when getting up suddenly from a lying or sitting position
- fast or irregular heartbeat
- hearing loss
- pain or discomfort in the arms, jaw, back, or neck
- pounding in the ears
- shortness of breath
- slow or fast heartbeat
- unusual tiredness or weakness
- Painful or prolonged erection of the penis
- Abdominal or stomach pain
- blistering, peeling, or loosening of the skin
- cracks in the skin
- decrease or change in vision
- 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
- 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
- stomach discomfort, upset, or pain
- 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
- 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
- increased erection
- lack or loss of strength
- loose stools
- muscle aching or cramping
- muscle stiffness
- nasal congestion
- neck 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
- spontaneous penile erection
- stomach upset
- swelling of the eyelids
- swelling or puffiness of the eyes or face
- swollen joints
- 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
- Changes in color vision
For Healthcare Professionals
Applies to tadalafil: oral tablet
Cardiovascular side effects have included angina pectoris, chest pain, hypotension, hypertension, myocardial infarction, postural hypotension, palpitations, syncope, and tachycardia.
Dermatologic side effects have included pruritus, rash, and sweating.
Gastrointestinal side effects have included dyspepsia, diarrhea, dry mouth, dysphagia, esophagitis, gastroesophageal reflux, gastritis, loose stools, nausea, upper abdominal pain, and vomiting.
General side effects have included asthenia, face edema, facial flushing, fatigue, and pain in a limb.
Genitourinary side effects have included increased erection and spontaneous penile erection.
Hepatic side effects have included abnormal liver function tests such as an increased GGTP.
Musculoskeletal side effects have included back pain or myalgia, arthralgia, and neck pain.
Respiratory side effects have included nasal congestion, dyspnea, epistaxis, pharyngitis, nasopharyngitis, upper respiratory tract infection, and bronchitis.
Nervous system side effects have included headache, dizziness, hypesthesia, insomnia, paresthesia, somnolence, migraine and vertigo. Postmarketing experience has included seizure and seizure recurrence and transient global amnesia.
Ocular side effects have included blurred vision, changes in color vision, conjunctivitis (including conjunctival hyperemia), eye pain, increased lacrimation, and swelling of the eyelids.
Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely postmarketing in temporal association with the use of phosphodiesterase type 5 (PDE5) inhibitors, including tadalafil.
Other side effects have included cases of sudden decrease or loss of hearing reported postmarketing in temporal association with the use of PDE5 inhibitors, including tadalafil. In some 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. It is not possible to determine whether these reported events are related directly to the use of tadalafil, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors.
Hypersensitivity side effects have included Stevens-Johnson syndrome and exfoliative dermatitis.
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