Prescription medicine
Guanfacine Brand names: Intuniv; first approved as Tenex
Guanfacine (Intuniv) is a prescription medicine with an FDA approval on record since 1986. FDA's NDC Directory lists it from 36 generic labelers, and pharmacies paid $0.147 per guanfacine 1 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- A presentation discontinued
Check it at the source: the guanfacine FDA label on DailyMed (effective June 23, 2025, Takeda Pharmaceuticals America, Inc.); the NDA 19032 record on Drugs@FDA; every guanfacine label on DailyMed.
Highlights of the record
FDA label of June 23, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageINTUNIV ® is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see Clinical Studies (14) ].
Forms and strengths
- 1 mg
- 2 mg
- 3 mg
- 4 mg
Extended-release tablet; tablet.
On the market
- Earliest approval on file
- October 27, 1986 Tenex, Promius Pharma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 25 first October 17, 1995; 21 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 37 of which 36 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.147 per tablet Guanfacine 1 mg tablet
- Shortage (FDA)
- None current 4 past records
- Recalls by its makers (FDA)
- 1 since 2013 0 Class I among all firms' recalls; latest March 31, 2021; 2 more by firms not listed as its makers
- FAERS reports
- 7,825 through July 30, 2026
What is guanfacine used for?
From the label: indications and usageINTUNIV ® is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see Clinical Studies (14) ]. INTUNIV is a central alpha 2A -adrenergic receptor agonist indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications ( 1 , 14 ).
Conditions named in the indications of guanfacine's FDA labels, with every medicine labeled for each:
From other guanfacine labelsHigh blood pressure: INDICATIONS AND USAGE Guanfacine tablets, USP are indicated in the management of hypertension.
FDA pharmacologic class: Central alpha-2 Adrenergic Agonist.
Source: FDA drug label (Intuniv), Takeda Pharmaceuticals America, Inc., effective June 23, 2025 (SPL set b972af81-3a37-40be-9fe1-3ddf59852528), via openFDA; the full label on DailyMed
What does the patient leaflet for guanfacine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking INTUNIV ?Do not drive, operate heavy machinery, or do other dangerous activities until you know how INTUNIV affects you. INTUNIV can slow your thinking and motor skills. Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking INTUNIV until you talk with your doctor. INTUNIV taken with alcohol or medicines that cause sleepiness or dizziness may make your sleepiness or dizziness worse. Do not become dehydrated or overheated. This may increase your chance of having low blood pressure or fainting while taking INTUNIV. Do not suddenly stop INTUNIV. Tell your healthcare provider if you have been vomiting and cannot take INTUNIV, you may be at risk for rebound hypertension.
From the patient leaflet: How should I store INTUNIV ?Store INTUNIV between 68°F to 77°F (20°C to 25°C) Keep INTUNIV and all medicines out of the reach of children. General Information about the safe and effective use INTUNIV Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use INTUNIV for a condition for which it was not prescribed. Do not give INTUNIV to other people, even if they have the same symptoms that you have. It may harm them. This leaflet summarizes the most important information about INTUNIV. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about INTUNIV that is written for health professionals. For more information, go to www.INTUNIV.com or call 1-877-825-3327.
Source: FDA drug label (Intuniv), Takeda Pharmaceuticals America, Inc., effective June 23, 2025 (SPL set b972af81-3a37-40be-9fe1-3ddf59852528), via openFDA; the full label on DailyMed
Is there a generic for guanfacine (Intuniv)?
The FDA approved the first generic guanfacine on October 17, 1995. 25 generic applications are approved; 21 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists guanfacine from 36 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1986 earliest approval on file
- 1995 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for guanfacine (Intuniv)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.147 per Guanfacine 1 mg tablet, down 5% from $0.154 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Guanfacine 1 mg tablet (generic)
- Intuniv ER 2 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Guanfacine 1 mg tablet | Generic | $0.147 per tablet | $4.40 | -5% |
| Guanfacine 2 mg tablet | Generic | $0.267 per tablet | $8.02 | -12% |
| Guanfacine HCl ER 1 mg tablet | Generic | $0.133 per tablet | $3.98 | -22% |
| Guanfacine HCl ER 2 mg tablet | Generic | $0.148 per tablet | $4.43 | -25% |
| Guanfacine HCl ER 3 mg tablet | Generic | $0.166 per tablet | $4.98 | -8% |
| Guanfacine HCl ER 4 mg tablet | Generic | $0.176 per tablet | $5.29 | -17% |
| Intuniv ER 1 mg tablet | Brand | $9.39 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $281.59 | +0.8% |
| Intuniv ER 2 mg tablet | Brand | $9.26 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $277.86 | -0.4% |
| Intuniv ER 3 mg tablet | Brand | $9.29 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $278.77 | -0.8% |
| Intuniv ER 4 mg tablet | Brand | $9.27 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $278.10 | -0.4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is guanfacine in shortage?
No guanfacine presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 4 records are all marked to be discontinued, the latest updated November 13, 2025. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Guanfacine Hydrochloride, Tablet, Extended Release, 1 mg (NDC 0228-2850-11) | Actavis Pharma, Inc. | To Be Discontinued | November 13, 2025 |
| Guanfacine Hydrochloride, Tablet, Extended Release, 2 mg (NDC 0228-2851-11) | Actavis Pharma, Inc. | To Be Discontinued | November 13, 2025 |
| Guanfacine Hydrochloride, Tablet, Extended Release, 3 mg (NDC 0228-2853-11) | Actavis Pharma, Inc. | To Be Discontinued | November 13, 2025 |
| Guanfacine Hydrochloride, Tablet, Extended Release, 4 mg (NDC 0228-2855-11) | Actavis Pharma, Inc. | To Be Discontinued | November 13, 2025 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has guanfacine been recalled?
The FDA's Enforcement Report lists 3 recalls naming guanfacine since 2013: 0 Class I (the most serious), 3 Class II, 0 Class III; 1 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of guanfacine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 31, 2021 | Class II | Apotex Corp. | Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling:Label Mixup; guanFACINE HCl Tablet, 2 mg may be potentially mislabeled as buPROPion HCl ER, Tablet, 200 mg, NDC 47335073886, Pedigree: AD21790_4, EXP … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: guanFACINE HCl, Tablet, 1 mg may have potentially been mislabeled as one of the following drugs: buPROPion HCl ER, Tablet, 200 mg, NDC … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the guanfacine label say about other medicines?
The guanfacine label names 4 other medicines in its interaction, contraindication or warning sections. The labels of 5 other medicines name guanfacine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Efavirenz | drug interactions | Concomitant Drug Name or Drug Class: Strong and moderate CYP3A4 inducers, e.g., rifampin, efavirenz; Clinical Rationale and Magnitude of Drug Interaction: Guanfacine is primarily metabolized by CYP3A4 and its plasma concentrations can be significantly affected resulting in a decrease in exposure; … |
| Fluconazole | drug interactions | Concomitant Drug Name or Drug Class: Strong and moderate CYP3A4 inhibitors, e.g., ketoconazole, fluconazole; Clinical Rationale and Magnitude of Drug Interaction: Guanfacine is primarily metabolized by CYP3A4 and its plasma concentrations can be significantly affected resulting in an increase in exposure; … |
| Ketoconazole | drug interactions | Concomitant Drug Name or Drug Class: Strong and moderate CYP3A4 inhibitors, e.g., ketoconazole, fluconazole; Clinical Rationale and Magnitude of Drug Interaction: Guanfacine is primarily metabolized by CYP3A4 and its plasma concentrations can be significantly affected resulting in an increase in exposure; … |
| Rifampin | drug interactions | Concomitant Drug Name or Drug Class: Strong and moderate CYP3A4 inducers, e.g., rifampin, efavirenz; Clinical Rationale and Magnitude of Drug Interaction: Guanfacine is primarily metabolized by CYP3A4 and its plasma concentrations can be significantly affected resulting in a decrease in exposure; … |
Other labels that name guanfacine
Source: FDA drug label (Intuniv), Takeda Pharmaceuticals America, Inc., effective June 23, 2025 (SPL set b972af81-3a37-40be-9fe1-3ddf59852528), via openFDA; the full label on DailyMed
What do FAERS reports show for guanfacine?
The FDA Adverse Event Reporting System holds 7,825 reports that list guanfacine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 245 are coded as a death and 1,909 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as guanfacine?
11 other medicines are given the same way (oral) and in the same FDA class as guanfacine or labeled mainly for the same use (ADHD), the same class first. ADHD lists all 12 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Clonidine | High blood pressure, ADHD | 37 labelers | $0.0241 per tablet 0.1 mg tablet | No current entry |
| Methylphenidate | ADHD | 31 labelers | $0.158 per tablet 10 mg tablet | In shortage |
| Amphetamine and dextroamphetamine | ADHD | 25 labelers | $0.233 per tablet 10 mg tablet | In shortage |
| Lisdexamfetamine | ADHD | 19 labelers | $2.44 per capsule 20 mg capsule | In shortage |
| Atomoxetine | ADHD | 20 labelers | $0.442 per capsule 40 mg capsule | No current entry |
| Dexmethylphenidate | ADHD | 13 labelers | $1.45 per capsule 10 mg capsule | No current entry |
| Amphetamine | ADHD | 13 labelers | $0.449 per tablet 10 mg tablet | No current entry |
| Dextroamphetamine | ADHD | 14 labelers | $0.373 per tablet 10 mg tablet | No current entry |
Every medicine labeled for the same conditions as guanfacine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does guanfacine compare with medicines for the same use?
9 side-by-side pages set guanfacine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to guanfacine
- 11 medicines for the same use
- Other central alpha-2 adrenergic agonists
- the pharmacologic class, with prices and generics
- Guanfacine side effects
- the label's list beside FAERS reports
- Guanfacine shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other