Home FDA labels 0db3ff09-e75b-4a2b-a0bf-1a9459b917a4 GUANFACINE openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
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Brand name GUANFACINE
Generic name GUANFACINE
Manufacturer A-S Medication Solutions
Product type HUMAN PRESCRIPTION DRUG
SPL set ID 0836a1d5-f1fc-4b94-9667-667278a74c93
SPL ID 0db3ff09-e75b-4a2b-a0bf-1a9459b917a4
Version 1
Effective date 2025-08-28
Source export date 2026-10-22
Source partition 11
Source file https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
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warnings and cautions 5 WARNINGS AND PRECAUTIONS • Hypotension, bradycardia, syncope: Titrate slowly and monitor vital signs frequently in patients at risk for hypotension, heart block, bradycardia, syncope, cardiovascular disease, vascular disease, cerebrovascular disease or chronic renal failure. Measure heart rate and blood pressure prior to initiation of therapy, following dose increases, and periodically while on therapy. Avoid concomitant use of drugs with additive effects unless clinically indicated. Advise patients to avoid becoming dehydrated or overheated ( 5.1 ). • Sedation and somnolence: Occur commonly with guanfacine. Consider the potential for additive sedative effects with CNS depressant drugs. Caution patients against operating heavy equipment or driving until they know how they respond to guanfacine ( 5.2 ). • Cardiac Conduction Abnormalities: May worsen sinus node dysfunction and atrioventricular (AV) block, especially in patients taking other sympatholytic drugs. Titrate slowly and monitor vital signs frequently ( 5.3 ). • Rebound Hypertension: Abrupt discontinuation of guanfacine can lead to clinically significant and persistent rebound hypertension. Subsequent hypertensive encephalopathy was also reported. To minimize the risk of rebound hypertension upon discontinuation, the total daily dose of guanfacine should be tapered in decrements of no more than 1 mg every 3 to 7 days ( 5.4 ). 5.1 Hypotension, Bradycardia, and Syncope Treatment with guanfacine can cause dose-dependent decreases in blood pressure and heart rate. Decreases were less pronounced over time of treatment. Orthostatic hypotension and syncope have been reported [see Adverse Reactions (6.1)] . Measure heart rate and blood pressure prior to initiation of therapy, following dose increases, and periodically while on therapy. Titrate guanfacine slowly in patients with a history of hypotension, and those with underlying conditions that may be worsened by hypotension and bradycardia; e.g., heart block, bradycardia, cardiovascular disease, vascular disease, cerebrovascular disease, or chronic renal failure. In patients who have a history of syncope or may have a condition that predisposes them to syncope, such as hypotension, orthostatic hypotension, bradycardia, or dehydration, advise patients to avoid becoming dehydrated or overheated. Monitor blood pressure and heart rate, and adjust dosages accordingly in patients treated concomitantly with antihypertensives or other drugs that can reduce blood pressure or heart rate or increase the risk of syncope. 5.2 Sedation and Somnolence Somnolence and sedation were commonly reported adverse reactions in clinical studies [see Adverse Reactions (6.1)] . Before using guanfacine with other centrally active depressants, consider the potential for additive sedative effects. Caution patients against operating heavy equipment or driving until they know how they respond to treatment with guanfacine. Advise patients to avoid use with alcohol. 5.3 Cardiac Conduction Abnormalities The sympatholytic action of guanfacine may worsen sinus node dysfunction and atrioventricular (AV) block, especially in patients taking other sympatholytic drugs. Titrate guanfacine slowly and monitor vital signs frequently in patients with cardiac conduction abnormalities or patients concomitantly treated with other sympatholytic drugs. 5.4 Rebound Hypertension In post marketing experience, abrupt discontinuation of guanfacine has resulted in clinically significant and persistent rebound hypertension above baseline levels and increases in heart rate. Hypertensive encephalopathy has also been reported in association with rebound hypertension with both extended release guanfacine and immediate release guanfacine [see Adverse Reactions (6.2)] . In these cases, high-dosage guanfacine was discontinued; concomitant stimulant use was also reported, which may potentially increase hypertensive response upon abrupt discontinuation of guanfacine. Children commonly have gastrointestinal illnesses that lead to vomiting, and a resulting inability to take medications, so they may be especially at risk for rebound hypertension. To minimize the risk of rebound hypertension upon discontinuation, the total daily dose of guanfacine should be tapered in decrements of no more than 1 mg every 3 to 7 days [see Dosage and Administration (2.5)] . Blood pressure and heart rate should be monitored when reducing the dose or discontinuing guanfacine. If abrupt discontinuation occurs (especially with concomitant stimulant use), patients should be closely followed for rebound hypertension.
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adverse reactions table <table cellspacing="0" cellpadding="0" border="0" width="97%"><colgroup><col width="23.84%"/><col width="18%"/><col width="23.12%"/><col width="15%"/><col width="20.04%"/></colgroup><thead><tr><th styleCode="Lrule Rrule Toprule" colspan="5" align="justify"> <content styleCode="bold">Table 6: Percentage of Patients Experiencing Most Common (≥5% and at least twice the rate for placebo) Adverse Reactions in the Monotherapy Flexible Dose Study 4</content> </th></tr><tr><th styleCode="Lrule Rrule Toprule" align="justify"> </th><th styleCode="Lrule Rrule Toprule" align="justify"> </th><th styleCode="Lrule Rrule Toprule" colspan="3" align="center"> <content styleCode="bold">Guanfacine</content> </th></tr><tr><th styleCode="Lrule Rrule Toprule" align="center"> <content styleCode="bold">Adverse Reaction Term</content> </th><th styleCode="Lrule Rrule Toprule" align="center"> <content styleCode="bold">Placebo</content> <content styleCode="bold">(N=112)</content> </th><th styleCode="Lrule Rrule Toprule" align="center"> <content styleCode="bold">AM</content> <content styleCode="bold">(N=107)</content> </th><th styleCode="Lrule Rrule Toprule" align="center"> <content styleCode="bold">PM</content> <content styleCode="bold">(N=114)</content> </th><th styleCode="Lrule Rrule Toprule" align="center"> <content styleCode="bold">All Doses of </content><content styleCode="bold">Guanfacine</content><content styleCode="bold"><sup> </sup></content> <content styleCode="bold">(N=221)</content> </th></tr></thead><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top"> Somnolence<sup>a</sup> </td><td styleCode="Rrule" align="center" valign="top"> 15% </td><td styleCode="Rrule" align="center" valign="top"> 57% </td><td styleCode="Rrule" align="center" valign="top"> 54% </td><td styleCode="Rrule" align="center" valign="top"> 56% </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top"> Abdominal Pain<sup>b </sup> </td><td styleCode="Rrule" align="center" valign="top"> 7% </td><td styleCode="Rrule" align="center" valign="top"> 8% </td><td styleCode="Rrule" align="center" valign="top"> 19% </td><td styleCode="Rrule" align="center" valign="top"> 14% </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top"> Fatigue </td><td styleCode="Rrule" align="center" valign="top"> 3% </td><td styleCode="Rrule" align="center" valign="top"> 10% </td><td styleCode="Rrule" align="center" valign="top"> 11% </td><td styleCode="Rrule" align="center" valign="top"> 11% </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top"> Irritability </td><td styleCode="Rrule" align="center" valign="top"> 3% </td><td styleCode="Rrule" align="center" valign="top"> 7% </td><td styleCode="Rrule" align="center" valign="top"> 7% </td><td styleCode="Rrule" align="center" valign="top"> 7% </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top"> Nausea </td><td styleCode="Rrule" align="center" valign="top"> 1% </td><td styleCode="Rrule" align="center" valign="top"> 6% </td><td styleCode="Rrule" align="center" valign="top"> 5% </td><td styleCode="Rrule" align="center" valign="top"> 5% </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top"> Dizziness </td><td styleCode="Rrule" align="center" valign="top"> 3% </td><td styleCode="Rrule" align="center" valign="top"> 6% </td><td styleCode="Rrule" align="center" valign="top"> 4% </td><td styleCode="Rrule" align="center" valign="top"> 5% </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top"> Vomiting </td><td styleCode="Rrule" align="center" valign="top"> 2% </td><td styleCode="Rrule" align="center" valign="top"> 7% </td><td styleCode="Rrule" align="center" valign="top"> 4% </td><td styleCode="Rrule" align="center" valign="top"> 5% </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top"> Hypotension<sup>c</sup> </td><td styleCode="Rrule" align="center" valign="top"> 0% </td><td styleCode="Rrule" align="center" valign="top"> 6% </td><td styleCode="Rrule" align="center" valign="top"> 4% </td><td styleCode="Rrule" align="center" valign="top"> 5% </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top"> Decreased Appetite </td><td styleCode="Rrule" align="center" valign="top"> 3% </td><td styleCode="Rrule" align="center" valign="top"> 6% </td><td styleCode="Rrule" align="center" valign="top"> 3% </td><td styleCode="Rrule" align="center" valign="top"> 4% </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top"> Enuresis<sup>d</sup> </td><td styleCode="Rrule" align="center" valign="top"> 1% </td><td styleCode="Rrule" align="center" valign="top"> 2% </td><td styleCode="Rrule" align="center" valign="top"> 5% </td><td styleCode="Rrule" align="center" valign="top"> 4% </td></tr><tr><td styleCode="Lrule Rrule" colspan="5" align="justify" valign="top"> a: The somnolence term includes somnolence, sedation, and hypersomnia. b: The abdominal pain term includes abdominal pain, abdominal pain lower, abdominal pain upper, and abdominal tenderness c: The hypotension term includes hypotension, diastolic hypotension, orthostatic hypotension, blood pressure decreased, blood pressure diastolic decreased, blood pressure systolic decreased). d: The enuresis term includes enuresis, nocturia, and urinary incontinence. </td></tr></tbody></table>
adverse reactions table <table cellspacing="0" cellpadding="0" border="0" width="97%"><colgroup><col width="20%"/><col width="20%"/><col width="20%"/><col width="20%"/><col width="20%"/></colgroup><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="5" align="justify" valign="top"> <content styleCode="bold">Table 7: Adverse Reactions Leading to Discontinuation (≥2% for all doses of </content><content styleCode="bold">Guanfacine and >rate than in placebo) in Monotherapy Flexible Dose Study 4</content> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top"> </td><td styleCode="Rrule" align="justify" valign="top"> </td><td styleCode="Rrule" colspan="3" align="center" valign="top"> <content styleCode="bold">Guanfacine</content> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="center" valign="top"> <content styleCode="bold">Adverse Reaction Term</content> </td><td styleCode="Rrule" align="center" valign="top"> <content styleCode="bold">Placebo</content> <content styleCode="bold">(N=112)</content> </td><td styleCode="Rrule" align="center" valign="top"> <content styleCode="bold">AM</content> <content styleCode="bold">(N=107)</content> </td><td styleCode="Rrule" align="center" valign="top"> <content styleCode="bold">PM</content> <content styleCode="bold">(N=114)</content> </td><td styleCode="Rrule" align="center" valign="top"> <content styleCode="bold">All Doses of </content><content styleCode="bold">Guanfacine<sup> </sup></content> <content styleCode="bold">(N=221)</content> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top"> </td><td styleCode="Rrule" align="center" valign="top"> n (%) </td><td styleCode="Rrule" align="center" valign="top"> n (%) </td><td styleCode="Rrule" align="center" valign="top"> n (%) </td><td styleCode="Rrule" align="center" valign="top"> n (%) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top"> Total patients </td><td styleCode="Rrule" align="center" valign="top"> 0 (0%) </td><td styleCode="Rrule" align="center" valign="top"> 8 (7%) </td><td styleCode="Rrule" align="center" valign="top"> 7 (6%) </td><td styleCode="Rrule" align="center" valign="top"> 15 (7%) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top"> Somnolence<sup>a </sup> </td><td styleCode="Rrule" align="center" valign="top"> 0 (0%) </td><td styleCode="Rrule" align="center" valign="top"> 4 (4%) </td><td styleCode="Rrule" align="center" valign="top"> 3 (3%) </td><td styleCode="Rrule" align="center" valign="top"> 7 (3%) </td></tr><tr><td styleCode="Lrule Rrule" colspan="5" align="justify" valign="top"> Adverse reactions leading to discontinuation in ≥2% in any dose group but did not meet this criteria in all doses combined: fatigue a: The somnolence term includes somnolence, sedation, and hypersomnia. </td></tr></tbody></table>
adverse reactions table <table cellspacing="0" cellpadding="0" border="0" width="97%"><colgroup><col width="18.82%"/><col width="20%"/><col width="20%"/><col width="20%"/><col width="21.2%"/></colgroup><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="5" align="justify" valign="top"> <content styleCode="bold">Table 8: Other Common Adverse Reactions (≥2% for all doses of </content><content styleCode="bold">Guanfacine and >rate than in placebo) in the Monotherapy Flexible Dose Study 4</content> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top"> </td><td styleCode="Rrule" align="justify" valign="top"> </td><td styleCode="Rrule" colspan="3" align="center" valign="top"> <content styleCode="bold">Guanfacine</content> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="center" valign="top"> <content styleCode="bold">Adverse Reaction Term </content> </td><td styleCode="Rrule" align="center" valign="top"> <content styleCode="bold">Placebo</content> <content styleCode="bold">(N=112) </content> </td><td styleCode="Rrule" align="center" valign="top"> <content styleCode="bold">AM</content> <content styleCode="bold">(N=107) </content> </td><td styleCode="Rrule" align="center" valign="top"> <content styleCode="bold">PM</content> <content styleCode="bold">(N=114) </content> </td><td styleCode="Rrule" align="center" valign="top"> <content styleCode="bold">All Doses of </content><content styleCode="bold">Guanfacine </content> <content styleCode="bold">(N=221) </content> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top"> Headache </td><td styleCode="Rrule" align="center" valign="top"> 11% </td><td styleCode="Rrule" align="center" valign="top"> 18% </td><td styleCode="Rrule" align="center" valign="top"> 16% </td><td styleCode="Rrule" align="center" valign="top"> 17% </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top"> Insomnia<sup>a</sup> </td><td styleCode="Rrule" align="center" valign="top"> 6% </td><td styleCode="Rrule" align="center" valign="top"> 8% </td><td styleCode="Rrule" align="center" valign="top"> 6% </td><td styleCode="Rrule" align="center" valign="top"> 7% </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top"> Diarrhea<sup>a</sup> </td><td styleCode="Rrule" align="center" valign="top"> 4% </td><td styleCode="Rrule" align="center" valign="top"> 4% </td><td styleCode="Rrule" align="center" valign="top"> 6% </td><td styleCode="Rrule" align="center" valign="top"> 5% </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top"> Lethargy </td><td styleCode="Rrule" align="center" valign="top"> 0% </td><td styleCode="Rrule" align="center" valign="top"> 4% </td><td styleCode="Rrule" align="center" valign="top"> 3% </td><td styleCode="Rrule" align="center" valign="top"> 3% </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top"> Constipation </td><td styleCode="Rrule" align="center" valign="top"> 2% </td><td styleCode="Rrule" align="center" valign="top"> 2% </td><td styleCode="Rrule" align="center" valign="top"> 4% </td><td styleCode="Rrule" align="center" valign="top"> 3% </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top"> Dry Mouth </td><td styleCode="Rrule" align="center" valign="top"> 1% </td><td styleCode="Rrule" align="center" valign="top"> 3% </td><td styleCode="Rrule" align="center" valign="top"> 3% </td><td styleCode="Rrule" align="center" valign="top"> 3% </td></tr><tr><td styleCode="Lrule Rrule" colspan="5" align="justify" valign="top"> Adverse reactions ≥2% for all doses of guanfacine and >rate in placebo in any dose group but did not meet this criteria in all doses combined: affect lability (affect lability, mood swings), increased weight, syncope/loss of consciousness (loss of consciousness, presyncope, syncope), dyspepsia, tachycardia (tachycardia, sinus tachycardia), and bradycardia (bradycardia, sinus bradycardia). a: The insomnia term includes insomnia, initial insomnia, middle insomnia, terminal insomnia, and sleep disorder. </td></tr></tbody></table>
adverse reactions table <table cellspacing="0" cellpadding="0" border="0" width="97%"><colgroup><col width="33.34%"/><col width="33.34%"/><col width="33.32%"/></colgroup><thead><tr><th styleCode="Lrule Rrule Toprule" colspan="3" align="justify"> <content styleCode="bold">Table 9: Percentage of Patients Experiencing Most Common (≥ 5% and at least twice the rate for placebo) Adverse Reactions in the Monotherapy Flexible Dose Study 5</content> </th></tr><tr><th styleCode="Lrule Rrule Toprule" align="center"> <content styleCode="bold">Adverse Reaction Term</content> </th><th styleCode="Lrule Rrule Toprule" align="center"> <content styleCode="bold">Placebo </content> <content styleCode="bold">(N=155)</content> </th><th styleCode="Lrule Rrule Toprule" align="center"> <content styleCode="bold">All Doses of </content><content styleCode="bold">Guanfacine </content> <content styleCode="bold">(N=157)</content> </th></tr></thead><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top"> Somnolence<sup>a </sup> </td><td styleCode="Rrule" align="center" valign="top"> 23% </td><td styleCode="Rrule" align="center" valign="top"> 54% </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top"> Insomnia<sup>b</sup> </td><td styleCode="Rrule" align="center" valign="top"> 6% </td><td styleCode="Rrule" align="center" valign="top"> 13% </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top"> Hypotension<sup>c</sup> </td><td styleCode="Rrule" align="center" valign="top"> 3% </td><td styleCode="Rrule" align="center" valign="top"> 9% </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top"> Dry Mouth </td><td styleCode="Rrule" align="center" valign="top"> 0% </td><td styleCode="Rrule" align="center" valign="top"> 8% </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top"> Postural Dizziness </td><td styleCode="Rrule" align="center" valign="top"> 2% </td><td styleCode="Rrule" align="center" valign="top"> 5% </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top"> Bradycardia<sup>d</sup> </td><td styleCode="Rrule" align="center" valign="top"> 0% </td><td styleCode="Rrule" align="center" valign="top"> 5% </td></tr><tr><td styleCode="Lrule Rrule" colspan="3" align="justify" valign="top"> a: The somnolence term includes somnolence, sedation, and hypersomnia. b: The insomnia term includes insomnia, initial insomnia, middle insomnia, terminal insomnia, and sleep disorder. c: The hypotension term includes hypotension, diastolic hypotension, orthostatic hypotension, blood pressure decreased, blood pressure diastolic decreased, blood pressure systolic decreased). d: The bradycardia term includes bradycardia and sinus bradycardia. </td></tr></tbody></table>
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