Guanfacine Recall

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Questions & Answers

Side Effects & Adverse Reactions

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


Guanfacine extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications. The efficacy of guanfacine extended-release tabletswere studied for the treatment of ADHD in three controlled monotherapy clinical trials (up to 8 weeks in duration) and one controlled adjunctive trial with psychostimulants (8 weeks in duration) in children and adolescents ages 6 to 17 who met DSM-IV® criteria for ADHD [see Clinical Studies (14)]. The effectiveness of guanfacine extended-release tablets for longer-term use (more than 8 weeks) has not been systematically evaluated in controlled trials.


There is currently no drug history available for this drug.

Other Information

Guanfacine is a once-daily, extended-release formulation of guanfacine hydrochloride (HCl) in a matrix tablet formulation for oral administration only. The chemical designation is N-amidino-2-(2,6-dichlorophenyl) acetamide monohydrochloride. The molecular formula is C9H9Cl2 N3O(HCl corresponding to a molecular weight of 282.55. The chemical structure is:


Guanfacine hydrochloride, USP is a white to off-white crystalline powder, sparingly soluble in water (approximately 1 mg/mL) and alcohol and slightly soluble in acetone. The only organic solvent in which it has relatively high solubility is methanol (greater than 30 mg/mL). Each tablet contains guanfacine hydrochloride, USP equivalent to 1 mg, 2 mg, 3 mg, or 4 mg of guanfacine base. The tablets also contain colloidal silicon dioxide, crospovidone, fumaric acid, glyceryl behenate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, microcrystalline cellulose, and povidone.  In addition, the 1 mg and 2 mg tablets contain FD&C Yellow #6 Aluminum Lake and the 3 mg and 4 mg tablets contain D&C Yellow #10.

Guanfacine Manufacturers

  • Avkare, Inc.
    Guanfacine (Guanfacine) Tablet, Extended Release [Avkare, Inc.]
  • Teva Pharmaceuticals Usa Inc
    Guanfacine Tablet, Extended Release [Teva Pharmaceuticals Usa Inc]
  • Genpharm Inc.
    Guanfacine (Guanfacine) Tablet [Genpharm Inc.]
  • Physicians Total Care, Inc.
    Guanfacine (Guanfacine Hydrochloride) Tablet [Physicians Total Care, Inc.]
  • Cardinal Health
    Guanfacine (Guanfacine Hydrochloride) Tablet [Cardinal Health]
  • Cardinal Health
    Guanfacine Tablet [Cardinal Health]
  • Epic Pharma, Llc
    Guanfacine Tablet [Epic Pharma, Llc]
  • Golden State Medical Supply, Inc.
    Guanfacine Tablet [Golden State Medical Supply, Inc.]
  • Mylan Pharmaceuticals Inc.
    Guanfacine (Guanfacine Hydrochloride) Tablet [Mylan Pharmaceuticals Inc.]
  • Carilion Materials Management
    Guanfacine Tablet [Carilion Materials Management]
  • Actavis Pharma, Inc.
    Guanfacine Tablet [Actavis Pharma, Inc.]

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