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2013-05-02 - Female

522896

Adverse reaction report number 522896
Latest AER version number 2
Market authorization holder AER number ALL1-2013-02588
Initial received date 2013-05-02
Latest received date 2013-05-28
Age N/A
Gender Female
Weight N/A
Type of report Spontaneous
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 XRSuspectOral10 Milligram1 every 1 Day(s) Anxiety
ADDERALL XRSuspectOral10 Milligram1 every 1 Day(s) Attention deficit/hyperactivity disorder
ADDERALL XRSuspectOral10 Milligram1 every 1 Day(s) Depression
ADDERALL XRSuspectOral20 MilligramAs required Anxiety
ADDERALL XRSuspectOral20 MilligramAs required Attention deficit/hyperactivity disorder
ADDERALL XRSuspectOral20 MilligramAs required Depression
ADDERALL XRCAPSULE, EXTENDED RELEASESuspectOral10 MilligramAs required Anxiety
ADDERALL XRCAPSULE, EXTENDED RELEASESuspectOral10 MilligramAs required Attention deficit/hyperactivity disorder
ADDERALL XRCAPSULE, EXTENDED RELEASESuspectOral10 MilligramAs required Depression
WELLBUTRINTABLET (EXTENDED-RELEASE)SuspectUnknown Major depression

Adverse reaction term information

MedDRA version: v.21.1
Adverse reaction terms Reaction duration
Acne
Anxiety
Drug effect decreased
Erythema
Fatigue
Feeling jittery
Headache
Increased appetite
Major depression
Musculoskeletal stiffness
Nervousness
Product prescribing error
Pruritus
Seborrhoea
Skin odour abnormal
Somnolence
Therapeutic response unexpected
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