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Because clinical trials are conducted under widely varying conditionsadverse 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.

Janssen PharmaceuticalsIncTitusvilleNew Jersey 08560RevisedJuly 2013.

Skin and Subcutaneous Tissue Disordersacute generalized exanthematous pustulosisphotosensitivity.

Pre-treatment with and concomitant administration of ketoconazole resulted in a 24-fold and 11-fold increase in mean AUC and Cmax of nisoldipinerespectivelycompared with treatment with nisoldipine 5 mg aloneConcomitant administration of ketoconazole with nisoldipine is contraindicatedSee CONTRAINDICATIONS section

Hepatobiliary Disordersserious hepatotoxicity including hepatitis cholestaticbiopsy-confirmed hepatic necrosiscirrhosishepatic failure including cases resulting in transplantation or death.

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