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CIALIS (TADALAFIL): ADVERSE REACTIONS, SIDE EFFECTS

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Tadalafil was administered to over 6550 men during clinical trials worldwide. In trials of Cialis (Tadalafil) tablets for once daily use, a total of 716, 389, and 115 were treated for at least 6 months, 1 year, and 2 years, respectively. For Tadalafil (Cialis) for use as needed, over 1300 and 1000 subjects were treated for at least 6 months and 1 year, respectively.

Cialis (Tadalafil) for Use as Needed

In eight primary placebo-controlled Phase 3 studies of 12 weeks duration, mean age was 59 years (range 22 to 88) and the discontinuation rate due to adverse events in patients treated with tadalafil 10 or 20 mg was 3.1%, compared to 1.4% in placebo treated patients.

When taken as recommended in the placebo-controlled clinical trials, the following adverse events were reported for Tadalafil (Cialis) tablets for use as needed: dyspepsia, headache, back pain, nasal congestion, myalgia, flushinga, pain in limb.

Cialis for Once Daily Use

In three placebo-controlled Phase 3 clinical trials of 12 or 24 weeks duration, mean age was 58 years (range 21 to 82) and the discontinuation rate due to adverse events in patients treated with tadalafil was 4.1%, compared to 2.8% in placebo-treated patients.

The following adverse events were reported in clinical trials of 12 weeks duration: headache, nasopharyngitis, dyspepsia, back pain, flushing, upper respiratory tract infection, influenza, cough, myalgia, diarrhea, pain in extremity, nasal congestion, bronchitis, gastroesophageal reflux, urinary tract infection, abdominal pain.

The following adverse events were reported over 24 weeks treatment duration in one placebo-controlled Phase 3 clinical study: gastroenteritis viral, nasopharyngitis, influenza, upper respiratory tract infection, back pain, dyspepsia, myalgia, gastroesophageal reflux disease, hypertension, nasal congestion.

Back pain or myalgia was reported at incidence rates described above. In Tadalafil (Cialis) clinical pharmacology trials, back pain or myalgia generally occurred 12 to 24 hours after dosing and typically resolved within 48 hours. The back pain/myalgia associated with tadalafil treatment was characterized by diffuse bilateral lower lumbar, gluteal, thigh, or thoracolumbar muscular discomfort and was exacerbated by recumbancy. In general, pain was reported as mild or moderate in severity and resolved without medical treatment, but severe back pain was reported with a low frequency ( < 5% of all reports). When medical treatment was necessary, acetaminophen or non-steroidal anti-inflammatory drugs were generally effective; however, in a small percentage of subjects who required treatment, a mild narcotic (e.g., codeine) was used. Overall, approximately 0.5% of all subjects treated with Cialis for on demand use discontinued treatment as a consequence of back pain/myalgia. In the 1-year open label extension study, back pain and myalgia were reported in 5.5% and 1.3% of patients, respectively. Diagnostic testing, including measures for inflammation, muscle injury, or renal damage revealed no evidence of medically significant underlying pathology. Incidence rates for Cialis tablets for once daily use are described above. In studies of Cialis (Tadalafil) tablets for once daily use, events of back pain and myalgia were generally mild or moderate with a discontinuation rate of 0.3%.

Across all studies with any Tadalafil (Cialis) dose, reports of changes in color vision were rare ( < 0.1% of patients).

The following section identifies additional, less frequent events ( < 2%) reported in controlled clinical trials of Cialis (Tadalafil) for once daily use or use as needed. A causal relationship of these events to Tadalafil (Cialis) tablets is uncertain. Excluded from this list are those events that were minor, those with no plausible relation to drug use, and reports too imprecise to be meaningful:

Body as a whole: face edema, asthenia, fatigue, pain

Cardiovascular: chest pain, angina pectoris, hypotension, postural hypotension, myocardial infarction, palpitations, tachycardia, syncope

Digestive: dry mouth, abnormal liver function tests, dysphagia, gastritis, esophagitis, GGTP increased, nausea, loose stools, upper abdominal pain, vomiting

Musculoskeletal: neck pain, arthralgia

Nervous: hypesthesia, dizziness, insomnia, somnolence, paresthesia, vertigo

Respiratory: epistaxis, dyspnea, pharyngitis

Skin and Appendages: rash, pruritus, sweating

Ophthalmologic: changes in color vision, blurred vision, conjunctivitis (including conjunctival hyperemia), lacrimation increase, eye pain, swelling of eyelids

Otologic: sudden decrease or loss of hearing, tinnitus

Urogenital: spontaneous penile erection, erection increased

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Cialis. These events have been chosen for inclusion either due to their seriousness, reporting frequency, lack of clear alternative causation, or a combination of these factors. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The list does not include adverse events that are reported from clinical trials and that are listed elsewhere in this section.

Cardiovascular and cerebrovascular: Serious cardiovascular events, including myocardial infarction, sudden cardiac death, stroke, chest pain, palpitations, and tachycardia, have been reported postmarketing in temporal association with the use of tadalafil. Most, but not all, of these patients had preexisting cardiovascular risk factors. Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of Cialis tablets without sexual activity. Others were reported to have occurred hours to days after the use of Cialis (Tadalafil) tablets and sexual activity. It is not possible to determine whether these events are related directly to Tadalafil (Cialis), to sexual activity, to the patient's underlying cardiovascular disease, to a combination of these factors, or to other factors.

Body as a whole: hypersensitivity reactions including urticaria, Stevens-Johnson syndrome, and exfoliative dermatitis

Nervous: seizure and seizure recurrence, migraine, transient global amnesia

Ophthalmologic: retinal vein occlusion, visual field defect, retinal artery occlusion. 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 Cialis (Tadalafil). Most, but not all, of these patients had underlying anatomic or vascular risk factors for development of NAION, including but not necessarily limited to: low cup to disc ratio ("crowded disc"), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia, and smoking. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors, to the patient's underlying vascular risk factors or anatomical defects, to a combination of these factors, or to other factors.

Otologic: Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including Tadalafil (Cialis) tablets. 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. It is not possible to determine whether these reported events are related directly to the use of Cialis, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors.

Urogenital: priapism.

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