Description
Cialis Prescribing Information
CIALIS® is indicated for the treatment of erectile dysfunction (ED). CIALIS is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). CIALIS is indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH).
Full Prescribing Information
1. Indications and Usage for Cialis
1.1 Erectile Dysfunction
CIALIS® is indicated for the treatment of erectile dysfunction (ED).
1.2 Benign Prostatic Hyperplasia
CIALIS is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia
CIALIS is indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH).
Cialis Side Effects
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, cramping, or stiffness
- 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 or stuffy 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 stomach pain
- voice changes
- watering of the eyes
Serious side effects of Cialis
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, discomfort, 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
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]
References
1. (2003) “Product Information. Cialis (tadalafil).” Lilly, Eli and Company
2. Cerner Multum, Inc. “UK Summary of Product Characteristics.”
3. Cerner Multum, Inc. “Australian Product Information.”
4. (2009) “Product Information. Adcirca (tadalafil).” United Therapeutics Corporation
5. Kloner RA, Mitchell M, Emmick JT (2003) “Cardiovascular effects of tadalafil.” Am J Cardiol, 92(9 Suppl), p. 37-46
6. Kloner RA, Mitchell M, Emmick JT (2003) “Cardiovascular effects of tadalafil in patients on common antihypertensive therapies.” Am J Cardiol, 92(9A), 47M-57M
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