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Intuniv (Guanfacine) - Side Effect Reports to FDA

 
 



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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