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2005-02-24 - Male - 51 Years old

181564

Adverse reaction report number 181564
Latest AER version number 1
Market authorization holder AER number SUS1200500110
Initial received date 2005-02-24
Latest received date 2008-09-23
Age 51 Years
Gender Male
Weight N/A
Type of report Spontaneous
Reporter type Consumer Or Other Non Health Professional
Source of report MAH
Report outcome Not recovered/not resolved
Serious report? Yes

Reason for seriousness

Death
Disability
Cogenital anomaly
Life threateting
Hospitalization
Other medically important Yes

Product information

Product description Dosage form Health product role Route of administration Dose Frequency Therapy duration Indication(s)
ADDERALL XRCAPSULE, EXTENDED RELEASESuspectOral45 Milligram1 every 1 Day(s) Attention deficit/hyperactivity disorder
CORTONETABLETConcomitantUnknown
WELLBUTRINTABLET (EXTENDED-RELEASE)ConcomitantUnknown

Adverse reaction term information

MedDRA version: v.21.1
Adverse reaction terms Reaction duration
Blood creatine increased
Fatigue
Prescribed overdose
Renal failure
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