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2006-09-18 - Male - 17 Years old

207626

Adverse reaction report number 207626
Latest AER version number 0
Market authorization holder AER number SPV1200600685
Initial received date 2006-09-18
Latest received date 2006-10-11
Age 17 Years
Gender Male
Weight N/A
Type of report Spontaneous
Reporter type Physician
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 RELEASESuspectOral20 Milligram every 1 Day(s)7 Month(s)
ACE INHIBITORNOT SPECIFIEDDrug used to treat AE
LANOXINNOT SPECIFIEDDrug used to treat AE
MONOCORTABLETDrug used to treat AE

Adverse reaction term information

MedDRA version: v.21.1
Adverse reaction terms Reaction duration
Cardiomyopathy
Dizziness
Fatigue
Hypoaesthesia
Palpitations
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