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Control Side Effects summary

Total Control reports: 2.
Control FDA safety alerts: 2001 2002 2003 2004 2005 2006 2007 2008 .
   Reported hospitalizations: 1.
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Control Side Effects: screaming, psychotic disorder, insomnia, disorientation, aggression,
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Control Side Effects reported to FDA

Control Side Effects Report #5383792-7
Consumer or non-health professional from UNITED STATES reported CONTROL problem on June 25, 2007. Male patient, 62 years of age, was treated with CONTROL. After drug was administered, patient experienced the following problems/side effects: aggression, disorientation, insomnia, psychotic disorder, screaming. CONTROL dosage: unknown. During the same period patient was treated with CELLCEPT, PROGRAF, AMBIEN, PLAVIX, PAXIL, AVANDIA, PREDNISONE. Patient recovered.



Control Side Effects Report #5383792-7
CONTROL problem was reported by a Consumer or non-health professional from UNITED STATES on June 25, 2007. Male patient, 62 years of age, was treated with CONTROL. After drug was administered, patient experienced the following problems/side effects: aggression, disorientation, insomnia, psychotic disorder, screaming. CONTROL dosage: unknown. During the same period patient was treated with CELLCEPT, PROGRAF, AMBIEN, PLAVIX, PAXIL, AVANDIA, PREDNISONE. Patient recovered.




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