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2010-02-03 - Female

337470

Adverse reaction report number 337470
Latest AER version number 0
Market authorization holder AER number N/A
Initial received date 2010-02-03
Latest received date 2010-02-03
Age N/A
Gender Female
Weight 130 Pounds
Type of report Spontaneous
Reporter type Physician
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 XR 30MGCAPSULE, EXTENDED RELEASESuspectUnknown60 Milligram1 every 1 Day(s)895 Day(s)Attention deficit/hyperactivity disorder
IMOVANE 7.5 - TAB 7.5MGTABLETSuspectUnknown2 Dosage formsAs required21 Day(s)Insomnia
AMITRIPTYLINE 10TABTABLETConcomitantUnknown
CYMBALTACAPSULE, DELAYED RELEASEConcomitantUnknown

Adverse reaction term information

MedDRA version: v.21.1
Adverse reaction terms Reaction duration
Hypertension
Serotonin syndrome
Somnambulism
Tachycardia
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