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2005-05-04 - Female - 36 Years old

171024

Adverse reaction report number 171024
Latest AER version number 0
Market authorization holder AER number SUS1200500341
Initial received date 2005-05-04
Latest received date 2005-05-04
Age 36 Years
Gender Female
Weight N/A
Type of report Spontaneous
Reporter type Consumer Or Other Non Health Professional
Source of report Community
Report outcome Recovered/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 RELEASESuspect140 Milligram every 1 Day(s)1 Year(s)
TRAZODONETABLETConcomitant
BENADRYLNOT SPECIFIEDDrug used to treat AE

Adverse reaction term information

MedDRA version: v.21.1
Adverse reaction terms Reaction duration
Accidental overdose
Anxiety
Exophthalmos
Rash
Swollen tongue
Throat tightness
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