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2004-10-01 - Male - 11 Years old

174933

Adverse reaction report number 174933
Latest AER version number 0
Market authorization holder AER number SUS1200400612
Initial received date 2004-10-01
Latest received date 2004-10-01
Age 11 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 RELEASESuspectUnknown10 Milligram1 every 1 Day(s)3 Day(s)
CLONIDINENOT SPECIFIEDConcomitant
DEXEDRINENOT SPECIFIEDConcomitant

Adverse reaction term information

MedDRA version: v.21.1
Adverse reaction terms Reaction duration
Dizziness
Hypotension
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