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2017-10-18 - Unknown

901535339

Adverse reaction report number 901535339
Latest AER version number 0
Market authorization holder AER number CA201725910
Initial received date 2017-10-18
Latest received date 2017-10-18
Age N/A
Gender Unknown
Weight N/A
Type of report Spontaneous
Reporter type Other 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 RELEASESuspectUnknown15 Milligram Product used for unknown indication

Adverse reaction term information

MedDRA version: v.21.1
Adverse reaction terms Reaction duration
Disturbance in attention
Drug ineffective
Feeling jittery
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