Label Changes for:

Procardia (nifedipine) 10 mg Capsules

September 2011

Changes have been made to the WARNINGS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – September 2011

 

WARNINGS

Use in Essential Hypertension
  • Procardia and other immediate-release nifedipine capsules have also been used for the long-term control of essential hypertension, although Procardia capsules have not been approved for this purpose and no properly controlled studies have been conducted to define an appropriate dose or dose interval for such treatment.
  • Procardia capsules should not be used for the control of essential hypertension

ADVERSE REACTIONS

  • Acute generalized exanthematous pustulosis also has been reported
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