SILDENAFIL CITRATE (Page 3 of 10)

5.9 Counseling Patients About Sexually Transmitted Diseases

The use of sildenafil citrate offers no protection against sexually transmitted diseases. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), may be considered.

6 ADVERSE REACTIONS

The following are discussed in more detail in other sections of the labeling:

The most common adverse reactions reported in clinical trials (≥ 2%) are headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash.

6.1 Clinical Trials 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 clinical practice.

Sildenafil citrate was administered to over 3700 patients (aged 19 to 87 years) during pre-marketing clinical trials worldwide. Over 550 patients were treated for longer than one year.

In placebo-controlled clinical studies, the discontinuation rate due to adverse reactions for sildenafil citrate (2.5%) was not significantly different from placebo (2.3%).

In fixed-dose studies, the incidence of some adverse reactions increased with dose. The type of adverse reactions in flexible-dose studies, which reflect the recommended dosage regimen, was similar to that for fixed-dose studies. At doses above the recommended dose range, adverse reactions were similar to those detailed in Table 1 below but generally were reported more frequently.

Table 1: Adverse Reactions Reported by ≥2% of Patients Treated with Sildenafil Citrate and More Frequent than Placebo in Fixed-Dose Phase II/III Studies
Adverse Reaction 25 mg
(n=312)
50 mg
(n=511)
100 mg
(n=506)
Placebo
(n=607)
Headache 16% 21% 28% 7%
Flushing 10% 19% 18% 2%
Dyspepsia 3% 9% 17% 2%
Abnormal vision 1% 2% 11% 1%
Nasal congestion 4% 4% 9% 2%
Back pain 3% 4% 4% 2%
Myalgia 2% 2% 4% 1%
Nausea 2% 3% 3% 1%
Dizziness 3% 4% 3% 2%
Rash 1% 2% 3% 1%

Abnormal Vision: Mild to moderate in severity and transient, predominantly color tinge to vision, but also increased sensitivity to light, or blurred vision.

When sildenafil citrate was taken as recommended (on an as-needed basis) in flexible-dose, placebo-controlled clinical trials of two to twenty-six weeks duration, patients took sildenafil citrate at least once weekly, and the following adverse reactions were reported:

Table 2. Adverse Reactions Reported by ≥2% of Patients Treated with Sildenafil Citrate and More Frequent than Placebo in Flexible-Dose Phase II/III Studies
Adverse Reaction SILDENAFIL CITRATE PLACEBO
N=734 N=725
Headache 16% 4%
Flushing 10% 1%
Dyspepsia 7% 2%
Nasal Congestion 4% 2%
Abnormal vision 3% 0%
Back pain 2% 2%
Dizziness 2% 1%
Rash 2% 1%

Abnormal Vision: Mild and transient, predominantly color tinge to vision, but also increased sensitivity to light, or blurred vision. In these studies, only one patient discontinued due to abnormal vision.

The following events occurred in <2% of patients in controlled clinical trials; a causal relationship to sildenafil citrate is uncertain. Reported events include those with a plausible relation to drug use; omitted are minor events and reports too imprecise to be meaningful:

Body as a Whole: face edema, photosensitivity reaction, shock, asthenia, pain, chills, accidental fall, abdominal pain, allergic reaction, chest pain, accidental injury.

Cardiovascular: angina pectoris, AV block, migraine, syncope, tachycardia, palpitation, hypotension, postural hypotension, myocardial ischemia, cerebral thrombosis, cardiac arrest, heart failure, abnormal electrocardiogram, cardiomyopathy.

Digestive: vomiting, glossitis, colitis, dysphagia, gastritis, gastroenteritis, esophagitis, stomatitis, dry mouth, liver function tests abnormal, rectal hemorrhage, gingivitis.

Hemic and Lymphatic: anemia and leukopenia.

Metabolic and Nutritional: thirst, edema, gout, unstable diabetes, hyperglycemia, peripheral edema, hyperuricemia, hypoglycemic reaction, hypernatremia.

Musculoskeletal: arthritis, arthrosis, myalgia, tendon rupture, tenosynovitis, bone pain, myasthenia, synovitis.

Nervous: ataxia, hypertonia, neuralgia, neuropathy, paresthesia, tremor, vertigo, depression, insomnia, somnolence, abnormal dreams, reflexes decreased, hypesthesia.

Respiratory: asthma, dyspnea, laryngitis, pharyngitis, sinusitis, bronchitis, sputum increased, cough increased.

Skin and Appendages: urticaria, herpes simplex, pruritus, sweating, skin ulcer, contact dermatitis, exfoliative dermatitis.

Special Senses: sudden decrease or loss of hearing, mydriasis, conjunctivitis, photophobia, tinnitus, eye pain, ear pain, eye hemorrhage, cataract, dry eyes.

Urogenital: cystitis, nocturia, urinary frequency, breast enlargement, urinary incontinence, abnormal ejaculation, genital edema and anorgasmia.

Analysis of the safety database from controlled clinical trials showed no apparent difference in adverse reactions in patients taking sildenafil citrate with and without anti-hypertensive medication. This analysis was performed retrospectively, and was not powered to detect any pre-specified difference in adverse reactions.

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