WHAT IS THE SIDE EFFECT WHEN TAKING CIALIS?
In Summary
Common side effects of Cialis include: dyspepsia and headache. Other side effects include: upper respiratory tract infection, back pain, myalgia, cough, and nasal congestion. See below for a comprehensive list of adverse effects.
For the Consumer
Applies to tadalafil: oral tablet
Side effects requiring immediate medical attention
Along with its needed effects, tadalafil (the active ingredient contained in Cialis) 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
- increased erection
- nausea
- nervousness
- pain or discomfort in the arms, jaw, back, or neck
- pounding in the ears
- slow or fast heartbeat
- spontaneous penile erection
- sweating
- unusual tiredness or weakness
- vomiting
Rare
- Painful or prolonged erection of the penis
Incidence not known
- 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, itching, skin rash
- 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 skin lesions, often with a purple center
- red, irritated eyes
- red, swollen skin
- redness of the skin
- redness or soreness of the eyes
- scaly skin
- slow speech
- sores, ulcers, or white spots in the mouth or on the lips
- stomach pain
- sudden cardiac death
- swelling of the feet or lower legs
Side effects not requiring immediate medical attention
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
- 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
- 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
- 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
- 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.[Ref]
Cardiovascular
Very common (10% or more): Flushing (up to 14%)
Common (1% to 10%): Hypertension, hot flush
Uncommon (0.1% to 1%): Hypotension
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
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
Genitourinary
Uncommon (0.1% to 1%): Penile hemorrhage, hematospermia
Rare (less than 0.1%): Prolonged erections
Frequency not reported: Erection increased, spontaneous penile erection
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
Rare (less than 0.1%): Angioedema
Frequency not reported: Pruritus
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
References
1. Cerner Multum, Inc. "Australian Product Information." O 0
2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
3. "Product Information. Cialis (tadalafil)." Lilly, Eli and Company, Indianapolis, IN.
4. "Product Information. Adcirca (tadalafil)." United Therapeutics Corporation, Silver Spring, MD.
5. Kloner RA, Mitchell M, Emmick JT "Cardiovascular effects of tadalafil." Am J Cardiol 92(9 Suppl) (2003): 37-46
6. Kloner RA, Mitchell M, Emmick JT "Cardiovascular effects of tadalafil in patients on common antihypertensive therapies." Am J Cardiol 92(9A) (2003): 47M-57M
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