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The following groups of patients with cardiovascular disease were not included in clinical safety and efficacy trials for CIALIS, and therefore until further information is available, CIALIS is not recommended for the following groups of patients:

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Additional, less frequent adverse reactions ( 6%) reported in the controlled clinical trials of CIALIS for BPH or ED and BPH included: gastroesophageal reflux disease, upper abdominal pain, nausea, vomiting, arthralgia , and muscle spasm.

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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.

In Study K, the effect of CIALIS 5 mg once daily on Qmax was evaluated as a safety endpoint. Mean Qmax increased from baseline in both the treatment and placebo groups (CIALIS 5 mg: mL/sec, placebo: mL/sec) however, these changes were not significantly different between groups.

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Physicians should discuss with patients the contraindication of CIALIS with any use of a GC stimulator, such as riociguat, for pulmonary arterial hypertension. Patients should be counseled that the concomitant use of CIALIS with GC stimulators may cause blood pressure to drop to an unsafe level.

Administration of CIALIS to patients who are using any form of organic nitrate, is contraindicated. In clinical pharmacology studies, CIALIS was shown to potentiate the hypotensive effect of nitrates. In a patient who has taken CIALIS, where nitrate administration is deemed medically necessary in a life-threatening situation, at least 98 hours should elapse after the last dose of CIALIS before nitrate administration is considered. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring [see DOSAGE AND ADMINISTRATION , CONTRAINDICATIONS , and CLINICAL PHARMACOLOGY ].

CIALIS was studied in the general ED population in 7 randomized, multicenter, double-blinded, placebo-controlled, parallel-arm design, primary efficacy and safety studies of 67-weeks duration. Two of these studies were conducted in the United States and 5 were conducted in centers outside the US. Additional efficacy and safety studies were performed in ED patients with diabetes mellitus and in patients who developed ED status post bilateral nerve-sparing radical prostatectomy.

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