This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Intuniv (Guanfacine) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (116)
Life Threatening Events (2)
Reports by Reaction Type
Syncope (29),
Dizziness (9),
Hallucination (9),
Hypotension (8),
Off Label Use (7),
Somnolence (6),
Loss of Consciousness (6),
Fatigue (6),
Inappropriate Schedule of Drug Administration (6),
Convulsion (6),
Headache (5),
Chest Pain (5)
Below are a few examples of reports where side effects / adverse reactions may be related to Intuniv (Guanfacine). For a complete list or a specific selection of reports, please use the links above.
Possible Intuniv side effects in 7 year old female
Reported by a physician on 2012-08-24
Patient: 7 year old female, weighing 29.9 kg (65.9 pounds)
Reactions: Somnolence
Drug(s) suspected as cause:
Intuniv
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 7 year old male
Reported by a physician from United States on 2012-08-23
Patient: 7 year old male
Reactions: Hallucination
Drug(s) suspected as cause:
Intuniv
Possible Intuniv side effects in 7 year old male
Reported by a consumer/non-health professional from United States on 2012-08-13
Patient: 7 year old male
Reactions: Pancreatitis
Drug(s) suspected as cause:
Intuniv
Possible Intuniv side effects in female
Reported by a physician from United States on 2012-08-09
Patient: female, weighing 29.0 kg (63.9 pounds)
Reactions: Anaphylactic Shock
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 female
Reported by a consumer/non-health professional from United States on 2012-07-10
Patient: female, weighing 23.6 kg (51.9 pounds)
Reactions: Distractibility, Weight Increased, Product Packaging Issue, Impulsive Behaviour, Growth Accelerated
Drug(s) suspected as cause:
Concerta
Dosage: 36 mg tablet
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Intuniv
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2011-01-01
Possible Intuniv side effects in male
Reported by a individual with unspecified qualification from United States on 2012-07-09
Patient: male
Reactions: Malaise, TIC, Medication Error, Dystonia, Chest Pain, Tachycardia, Wrong Drug Administered, Drug Dispensing Error, Tremor
Drug(s) suspected as cause:
Intuniv
Invega
Possible Intuniv side effects in
Reported by a individual with unspecified qualification from United States on 2012-07-09
Patient:
Reactions: Circumstance or Information Capable of Leading To Medication Error, Medication Error
Drug(s) suspected as cause:
Intuniv
Dosage: tablet oral
Administration route: Oral
Tenex
Dosage: tablet oral
Administration route: Oral
Possible Intuniv side effects in 10 year old male
Reported by a physician from United States on 2012-07-06
Patient: 10 year old male, weighing 32.7 kg (71.8 pounds)
Reactions: Hallucinations, Mixed, Diarrhoea, Pyrexia
Drug(s) suspected as cause:
Intuniv
Possible Intuniv side effects in male
Reported by a physician from United States on 2012-06-28
Patient: male, weighing 29.5 kg (64.9 pounds)
Reactions: Benign Intracranial Hypertension, Pyrexia, Headache
Drug(s) suspected as cause:
Intuniv
Dosage: 2 mg, 1x/day:qd
Administration route: Oral
Start date: 2011-09-14
End date: 2011-09-20
Intuniv
Dosage: 3 mg, 1x/day:qd
Start date: 2011-09-21
Intuniv
Dosage: 1 mg, 1x/day:qd
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2011-09-07
End date: 2011-09-13
Intuniv
Dosage: unk, unknown
Administration route: Oral
End date: 2012-01-24
Other drugs received by patient: Adderall 5; Prozac
Possible Intuniv side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-26
Patient: male
Reactions: Affect Lability, Bipolar Disorder, Mood Altered, Aggression
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Adderall XR 10
Dosage: unk, 1x/day:qd
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Intuniv
Dosage: 2 mg, 1x/day:qd
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2012-01-01
End date: 2012-01-01
Intuniv
Dosage: 1 mg, 1x/day:qd
Administration route: Oral
Start date: 2012-01-01
End date: 2012-01-01
Possible Intuniv side effects in male
Reported by a physician from United States on 2012-06-25
Patient: male
Reactions: Cardiac Disorder, Hypersomnia
Drug(s) suspected as cause:
Intuniv
Possible Intuniv side effects in 7 year old
Reported by a physician from United States on 2012-06-22
Patient: 7 year old
Reactions: Haematoma, Loss of Consciousness
Drug(s) suspected as cause:
Intuniv
Possible Intuniv side effects in 8 year old male
Reported by a consumer/non-health professional from United States on 2012-06-18
Patient: 8 year old male
Reactions: Parkinsonian Rest Tremor
Drug(s) suspected as cause:
Intuniv
Possible Intuniv side effects in
Reported by a individual with unspecified qualification from United States on 2012-06-12
Patient:
Reactions: Circumstance or Information Capable of Leading To Medication Error, Medication Error, Wrong Drug Administered, Drug Dispensing Error
Drug(s) suspected as cause:
Intuniv
Dosage: oral
Administration route: Oral
Invega
Dosage: oral
Administration route: Oral
Possible Intuniv side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-28
Patient: male
Reactions: Suicidal Behaviour, Therapeutic Response Unexpected, Anger, Depressed Mood, Lethargy, Crying, Aggression
Drug(s) suspected as cause:
Intuniv
Dosage: 1 mg, 1x/day:qd
Administration route: Oral
Start date: 2012-03-15
Intuniv
Dosage: 1 mg, 1x/day:qd
Administration route: Oral
Start date: 2012-02-28
End date: 2012-03-06
Intuniv
Dosage: 2 mg, 1x/day:qd
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2012-03-07
End date: 2012-03-14
Possible Intuniv side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-24
Patient: female
Reactions: Heart Rate Decreased, Suicide Attempt, Blood Pressure Decreased
Drug(s) suspected as cause:
Intuniv
Possible Intuniv side effects in 8 year old male
Reported by a consumer/non-health professional from United States on 2012-05-22
Patient: 8 year old male, weighing 30.8 kg (67.9 pounds)
Reactions: Middle Insomnia, Hallucinations, Mixed, Insomnia
Drug(s) suspected as cause:
Intuniv
Possible Intuniv side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-16
Patient: male
Reactions: Malaise, Vomiting, Hallucination, Visual, Fear, Insomnia, Abnormal Behaviour, Pyrexia
Drug(s) suspected as cause:
Intuniv
Possible Intuniv side effects in 6 year old male
Reported by a consumer/non-health professional from United States on 2012-05-04
Patient: 6 year old male
Reactions: Aggression
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Adderall XR 10
Dosage: unk, 1x/day:qd
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Intuniv
Dosage: 2 mg, 1x/day:qd
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2012-01-01
End date: 2012-01-01
Intuniv
Dosage: 1 mg, 1x/day:qd
Administration route: Oral
Start date: 2012-01-01
End date: 2012-01-01
Possible Intuniv side effects in 11 year old female
Reported by a physician from United States on 2012-04-27
Patient: 11 year old female, weighing 39.0 kg (85.8 pounds)
Reactions: Confusional State, Hypotension, Bradycardia, Asthenia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Intuniv
Other drugs received by patient: Intuniv
Possible Intuniv side effects in 12 year old male
Reported by a pharmacist from United States on 2012-04-23
Patient: 12 year old male, weighing 38.1 kg (83.8 pounds)
Reactions: Headache
Drug(s) suspected as cause:
Intuniv
Other drugs received by patient: Vyvanse; Vyvanse; Vitamin B6; Isoniazid
Possible Intuniv side effects in female
Reported by a physician from United States on 2012-04-16
Patient: female, weighing 36.3 kg (79.8 pounds)
Reactions: Hallucination, Visual, Homicidal Ideation
Drug(s) suspected as cause:
Intuniv
Dosage: 1 mg, 1x/day:qd
Administration route: Oral
Start date: 2011-05-01
End date: 2011-07-01
Intuniv
Dosage: 2 mg, 1x/day:qd
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2011-07-01
End date: 2011-09-01
Other drugs received by patient: Risperdal
Possible Intuniv side effects in 9 year old male
Reported by a consumer/non-health professional from United States on 2012-04-16
Patient: 9 year old male
Reactions: Hallucination
Drug(s) suspected as cause:
Intuniv
Other drugs received by patient: Concerta
Possible Intuniv side effects in 6 year old female
Reported by a consumer/non-health professional from United States on 2012-04-13
Patient: 6 year old female
Reactions: Heart Rate Increased, Hypotension, Accidental Overdose
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Intuniv
Dosage: 1 mg, 1x/day:qd
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2012-01-24
Intuniv
Dosage: 1 mg, 1x/day:qd
Administration route: Oral
Possible Intuniv side effects in male
Reported by a physician from United States on 2012-04-13
Patient: male, weighing 29.0 kg (63.9 pounds)
Reactions: Suicidal Ideation
Drug(s) suspected as cause:
Intuniv
Indication: Autism Spectrum Disorder
Intuniv
Dosage: 1 mg, 1x/day:qd
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2011-05-01
End date: 2012-01-01
Intuniv
Indication: Oppositional Defiant Disorder
Other drugs received by patient: Risperdal; Risperdal; Melatonin; Risperdal
Possible Intuniv side effects in male
Reported by a consumer/non-health professional from United States on 2012-04-10
Patient: male, weighing 39.0 kg (85.8 pounds)
Reactions: Fatigue, Dysstasia, Affect Lability, Fall, Hallucination
Drug(s) suspected as cause:
Intuniv
Dosage: 1 mg, 1x/day:qd
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2012-01-25
End date: 2012-01-27
Vyvanse
Dosage: 30 mg, 1x/day:qd
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2011-01-01
Possible Intuniv side effects in male
Reported by a consumer/non-health professional from United States on 2012-04-09
Patient: male
Reactions: Syncope
Drug(s) suspected as cause:
Intuniv
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