Index of reports
> Cases with Off Label Use (7)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Intuniv (Guanfacine) where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Intuniv side effects in 5 year old male
Reported by a physician from United States on 2012-08-23
Patient: 5 year old male
Reactions: Off Label Use, Hallucination
Drug(s) suspected as cause:
Intuniv
Possible Intuniv side effects in 3 year old male
Reported by a physician from United States on 2012-08-08
Patient: 3 year old male
Reactions: Off Label Use, Ventricular Extrasystoles
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Intuniv
Possible Intuniv side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-19
Patient: female, weighing 27.2 kg (59.9 pounds)
Reactions: Off Label Use, Syncope, Palpitations, Dizziness
Drug(s) suspected as cause:
Intuniv
Dosage: 1 mg, 1x/day:qd
Administration route: Oral
Indication: Mood Altered
Start date: 2011-03-01
End date: 2012-02-27
Intuniv
Indication: Fatigue
Possible Intuniv side effects in 7 year old male
Reported by a consumer/non-health professional from United States on 2012-02-24
Patient: 7 year old male
Reactions: Off Label Use, Personality Change, Fatigue, Incorrect Dose Administered, Anger, Tension, Suicidal Ideation
Drug(s) suspected as cause:
Intuniv
Dosage: 1 mg, 1x/day:qd
Administration route: Oral
Start date: 2010-05-01
End date: 2011-01-01
Intuniv
Dosage: 2 mg, 1x/day:qd
Administration route: Oral
Indication: Impulsive Behaviour
Start date: 2011-01-01
End date: 2011-01-01
Intuniv
Dosage: 1 mg, 1x/day:qd
Administration route: Oral
Start date: 2011-01-01
Other drugs received by patient: Metadate CD
Possible Intuniv side effects in 4 year old male
Reported by a physician from United States on 2011-10-28
Patient: 4 year old male
Reactions: Off Label Use, Hypotension, Sinus Bradycardia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Intuniv
Dosage: 2 mg 1x/day: qd oral; 1 mg 1x/day: qd oral
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2011-01-01
End date: 2011-01-01
Intuniv
Dosage: 2 mg 1x/day: qd oral; 1 mg 1x/day: qd oral
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2011-01-01
End date: 2011-04-01
Possible Intuniv side effects in 3 year old
Reported by a consumer/non-health professional from United States on 2011-10-26
Patient: 3 year old
Reactions: Off Label Use, Adverse Event, Bradycardia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Intuniv
Possible Intuniv side effects in male
Reported by a consumer/non-health professional from United States on 2011-10-13
Patient: male
Reactions: Inappropriate Schedule of Drug Administration, Head Injury, Fall, Abdominal Pain Upper, Periorbital Haematoma, Off Label Use, Syncope, DRY Mouth, Dizziness
Drug(s) suspected as cause:
Intuniv
Other drugs received by patient: Tramadol HCL
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