ADVERSE REACTIONS Stendra

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of an drug are not to be directly when compared to rates from the clinical trials of one other drug and could not reflect the rates seen in practice.

STENDRA was administered to 1923 men during clinical trials. In trials of STENDRA to be used PRN, an overall total of 493 patients were exposed for greater than or adequate to 6 months, and 153 patients were treated for higher than or equal to calendar year.

In three randomized, double-blind, placebo-controlled trials lasting up to 3 months in duration, the mean ages of patients was 56.4 years (vary from 23 to 88 years). 83.9 % of patients were White (83.9%), 13.8% were Black, 1.4% Asian, and < 1% Hispanic. 41.1% were current or previous smokers. 30.6% had diabetes. Page 5 of 22

The discontinuation rate as a result of adverse reactions for patients helped by STENDRA 50 mg, 100 mg, or 200 mg was 1.4%, 2.0%, and two.0%, respectively, compared to 1.7% for placebo-treated patients.

Table 1 is definitely the effects reported when STENDRA was taken as recommended (upon an as-needed basis) from all of these 3 clinical trials.

Table 1: Effects Reported by More than or Adequate to 2% of Patients Addressed with STENDRA From three Placebo-Controlled Clinical Trials Lasting a couple of months for STENDRA Use pro re nata

Side effects reported by more than or corresponding to 1%, but fewer than 2% of patients in different STENDRA dose group, and more than placebo included: upper respiratory tract infection (URI), bronchitis, influenza, sinusitis, sinus congestion, hypertension, dyspepsia, nausea, constipation, and rash.

Within an, open-label, long-term extension study of two of these randomized, double-blind, placebo-controlled trials, the whole duration of treatment was up to 52 weeks. One of the 712 patients who participated in this open-label extension study, the mean day of the populace was 56.4 years (include 23 to 88 years). The discontinuation rate on account of effects for patients given STENDRA (50 mg, 100 mg, or 200 mg) was 2.8%.

On this extension trial, all eligible patients were initially assigned to STENDRA 100 mg. At any point over the trial, patients could request to have their dose of STENDRA increased to 200 mg or decreased to 50 mg according to their individual step to treatment. As a whole, 536 (approximately 75%) patients increased their dose to 200 mg and 5 (less than 1%) patients reduced their dose to 50 mg.

Table 2 presents the adverse reactions reported when STENDRA was taken as recommended (while on an as-needed basis) in this particular open-label extension trial.

Table 2: Effects Reported by More than or Equal to 2% of Patients Helped by STENDRA within an Open-Label Extension Trial

Adverse reactions reported by over or of about 1%, but under 2% of patients in the open-label extension study included: upper respiratory infection (URI), influenza, sinusitis, bronchitis, dizziness, lower back pain, arthralgia, hypertension, and diarrhea.

Within an additional, randomized, double-blind, placebo-controlled study lasting approximately a couple of months in males who had undergone bilateral nerve-sparing radical prostatectomy for cancer of the prostate, the mean era of patients was 58.4 years (range 40 – 70). Table 3 presents the adverse reactions reported in this particular additional study.

Table 3: Effects Reported by Above or Equal to 2% of Patients Addressed with STENDRA in the Placebo-Controlled Clinical test Lasting 3 Months in Patients Who Underwent Bilateral Nerve-Sparing Radical Prostatectomy

Across all trials with any STENDRA dose, 1 patient reported a change in chromatic vision.

These events took place in fewer than 1% of patients in the three placebo-controlled 3-month clinical trials and/or even the open-label, long-term extension study lasting 1 year. A causal relationship to STENDRA is uncertain. Excluded using this list are the ones events that were minor, those with no plausible relation to drug use and reports too imprecise to be meaningful.

Body as a whole — edema peripheral, fatigue

Cardiovascular — angina, unstable angina, deep vein thrombosis, palpitations

Digestive — gastritis, gastroesophageal reflux disease, hypoglycemia, blood sugar increased, alanine aminotransferase increased, oropharyngeal pain, stomach discomfort, vomiting

Musculoskeletal — muscle spasms, musculoskeletal pain, myalgia, pain in extremity

Nervous — depression, insomnia, somnolence, vertigo

Respiratory — cough, dyspnea exertional, epistaxis, wheezing

Skin and Appendages – pruritus

Urogenitalbalanitis, erection increased, nephrolithiasis,pollakiuria, urinary tract infection