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2012-11-16 - Female - 16 Years old

481720

Adverse reaction report number 481720
Latest AER version number 0
Market authorization holder AER number ALL1201205541
Initial received date 2012-11-16
Latest received date 2012-11-16
Age 16 Years
Gender Female
Weight N/A
Type of report Study
Reporter type Consumer Or Other Non Health Professional
Source of report MAH
Report outcome Unknown
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 RELEASESuspectOral10 Milligram1 every 1 Day(s) Product used for unknown indication

Adverse reaction term information

MedDRA version: v.21.1
Adverse reaction terms Reaction duration
Anxiety
Fatigue
Flat affect
Headache
Heart rate increased
Palpitations
Peripheral coldness
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