Prescription medicine
Clonidine Brand names: Catapres-Tts, Qlonilik, Javadin, Nexiclon, Onyda; first approved as Catapres
Clonidine (Catapres) is a prescription medicine with an FDA approval on record since 1974. FDA's NDC Directory lists it from 43 generic labelers, and pharmacies paid $0.0241 per clonidine HCl 0.1 mg tablet in the October 7, 2026 NADAC survey; its other strengths are brand-only, $1.53 per mL (Javadin 0.02 mg/mL solution).
- Generic listed
Check it at the source: the clonidine FDA label on DailyMed (effective March 30, 2026, Unichem Pharmaceuticals (USA), Inc.); the NDA 17407 record on Drugs@FDA; every clonidine label on DailyMed.
Highlights of the record
FDA label of March 30, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageClonidine hydrochloride tablets are indicated in the treatment of hypertension.
Forms and strengths
- 0.05 mg
- 0.1 mg
- 0.17 mg
- 0.2 mg
- 0.3 mg
- 0.05 mg/ml
- 0.1 mg/ml
- 0.1 mg/24h
- 0.2 mg/24h
- 0.3 mg/24h
Tablet; patch; extended-release tablet; injection (solution); extended-release patch.
On the market
- Earliest approval on file
- September 3, 1974 Catapres, Boehringer Ingelheim; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 37 first July 1, 1986; 25 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 50 of which 43 under generic applications, 6 under brand applications, repackagers included
- Last listed patent
- August 22, 2045 Qlonilik oral solution; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0241 per tablet Clonidine HCl 0.1 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 16 since 2012 0 Class I among all firms' recalls; latest March 19, 2026; 2 more by firms not listed as its makers
- FAERS reports
- 57,116 through July 30, 2026
What is clonidine used for?
From the label: indications and usageClonidine hydrochloride tablets are indicated in the treatment of hypertension. Clonidine hydrochloride tablets may be employed alone or concomitantly with other antihypertensive agents.
Conditions named in the indications of clonidine's FDA labels, with every medicine labeled for each:
From other clonidine labelsHigh blood pressure: INDICATIONS AND USAGE Clonidine hydrochloride tablets are indicated in the treatment of hypertension.
ADHD: Clonidine hydrochloride extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see C linical Studies (14) ].
Pain: INDICATIONS AND USAGE Duraclon is indicated in combination with opiates for the treatment of severe pain in cancer patients that is not adequately relieved by opioid analgesics alone.
FDA pharmacologic class: Central alpha-2 Adrenergic Agonist.
Source: FDA drug label (clonidine hydrochloride), Unichem Pharmaceuticals (USA), Inc., effective March 30, 2026 (SPL set 21bfa28f-20df-43fd-bb80-b720d3b40696), via openFDA; the full label on DailyMed
What does the patient leaflet for clonidine 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 clonidine hydrochloride extended-release tablets?Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking clonidine hydrochloride extended-release tablets until you talk with your doctor. Clonidine hydrochloride extended-release tablets taken with alcohol or medicines that cause sleepiness or dizziness may make your sleepiness or dizziness worse. Do not drive, operate heavy machinery or do other dangerous activities until you know how clonidine hydrochloride extended-release tablets will affect you. Avoid becoming dehydrated or overheated.
From the patient leaflet: How should I store clonidine hydrochloride extended-release tablets?Store clonidine hydrochloride extended-release tablets between 68°-77°F (20°-25°C). Keep clonidine hydrochloride extended-release tablets in a tightly closed container. Keep clonidine hydrochloride extended-release tablets and all medicines out of the reach of children.
Source: FDA drug label (Clonidine hydrochloride), Ajanta Pharma USA Inc., effective October 31, 2025 (SPL set df80255e-f942-4d9f-8edd-cc95795772cb), via openFDA; the full label on DailyMed
Is there a generic for clonidine (Catapres)?
The FDA approved the first generic clonidine on July 1, 1986. 37 generic applications are approved; 25 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 clonidine from 43 labelers under a generic (ANDA) application and from 6 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Catapres tablets; a patent listed only for Qlonilik oral solution runs to August 22, 2045. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1974 earliest approval on file
- 1986 first generic approved
- 2045 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for clonidine (Catapres)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0241 per Clonidine HCl 0.1 mg tablet, down 3% from $0.0249 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.
- Clonidine HCl 0.1 mg tablet (generic)
- Javadin 0.02 mg/mL solution (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Clonidine 0.1 mg/day patch | Generic | $6.64 per patch many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +0.2% |
| Clonidine 0.2 mg/day patch | Generic | $9.05 per patch many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -3% |
| Clonidine 0.3 mg/day patch | Generic | $12.29 per patch many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +6% |
| Clonidine HCl 0.1 mg tablet | Generic | $0.0241 per tablet | $0.723 | -3% |
| Clonidine HCl 0.2 mg tablet | Generic | $0.033 per tablet | $0.990 | -3% |
| Clonidine HCl 0.3 mg tablet | Generic | $0.0408 per tablet | $1.22 | no change |
| Clonidine HCl ER 0.1 mg tablet | Generic | $0.212 per tablet | $6.35 | -26% |
| Clonidine HCl ER 0.17 mg tablet | Generic | $15.24 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $457.07 | +4% |
| Javadin 0.02 mg/mL solution | Brand | $1.53 per mL | n/a | n/a |
| Onyda XR 0.1 mg/mL suspension | Brand | $13.38 per mL | n/a | +4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has clonidine been recalled?
The FDA's Enforcement Report lists 18 recalls naming clonidine since 2012: 0 Class I (the most serious), 12 Class II, 6 Class III; 3 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of clonidine 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 19, 2026 | Class II | Teva Pharmaceuticals USA, Inc | CGMP Deviations: use of an unapproved raw material |
| September 19, 2022 | Class III | UNICHEM PHARMACEUTICALS USA INC | Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets, |
| June 9, 2022 | Class II | Mayne Pharma Inc | Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint. |
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| October 28, 2021 | Class III | Teva Pharmaceuticals USA | Failed Impurities/Degradation Specifications |
| May 26, 2020 | Class III | UNICHEM PHARMACEUTICALS USA INC | Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container. |
| January 29, 2020 | Class III | UNICHEM PHARMACEUTICALS USA INC | Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure due to potential migration of Benzophenone at very low level … |
| March 29, 2019 | Class III | X-Gen Pharmaceuticals Inc. | Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the clonidine label say about other medicines?
The clonidine label names 8 other medicines in its interaction, contraindication or warning sections. The labels of 36 other medicines name clonidine. 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 |
|---|---|---|
| Amitriptyline | drug interactions | Amitriptyline in combination with clonidine enhances the manifestation of corneal lesions in rats (see Toxicology ). |
| Atropine | warnings and precautions | There have been post-marketing reports of patients with conduction abnormalities and/or taking other sympatholytic drugs who developed severe bradycardia requiring intravenous (IV) atropine, IV isoproterenol, and temporary cardiac pacing while taking clonidine. |
| Diltiazem | drug interactions | Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concomitantly with diltiazem or verapamil. |
| Fluphenazine | drug interactions | There is one reported case of a patient with acute delirium associated with the simultaneous use of fluphenazine and oral clonidine. |
| Haloperidol | drug interactions | Based on observations in patients in a state of alcoholic delirium it has been suggested that high intravenous doses of clonidine may increase the arrhythmogenic potential (QT- prolongation, ventricular fibrillation) of high intravenous doses of haloperidol. |
| Isoproterenol | warnings and precautions | There have been post-marketing reports of patients with conduction abnormalities and/or taking other sympatholytic drugs who developed severe bradycardia requiring intravenous (IV) atropine, IV isoproterenol, and temporary cardiac pacing while taking clonidine. |
| Phentolamine | warnings | An excessive rise in blood pressure following discontinuation of clonidine hydrochloride tablets therapy can be reversed by administration of oral clonidine hydrochloride or by intravenous phentolamine. |
| Verapamil | drug interactions | Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concomitantly with diltiazem or verapamil. |
Other labels that name clonidine
- Amiodarone
- Apraclonidine
- Atenolol
- Betaxolol
- Bisoprolol
- Carvedilol
- Ceritinib
- Clomipramine
- Crizotinib
- Ephedrine
- Epinephrine
- Esmolol
- Glimepiride
- Glipizide
- Insulin aspart
- Insulin degludec
- Insulin detemir
- Insulin glargine
- Insulin glulisine
- Insulin human
- Insulin lispro
- Macimorelin
- Metoprolol
- Milnacipran
- Nateglinide
- Nebivolol
- Propranolol
- Repaglinide
- Sotalol
- Timolol
Source: FDA drug label (clonidine hydrochloride), Unichem Pharmaceuticals (USA), Inc., effective March 30, 2026 (SPL set 21bfa28f-20df-43fd-bb80-b720d3b40696), via openFDA; the full label on DailyMed
What do FAERS reports show for clonidine?
The FDA Adverse Event Reporting System holds 57,116 reports that list clonidine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6,861 are coded as a death and 19,924 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 clonidine?
73 other medicines are given the same way (oral) and in the same FDA class as clonidine or labeled mainly for the same use (high blood pressure), the same class first. High blood pressure lists all 88 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 |
|---|---|---|---|---|
| Guanfacine | High blood pressure, ADHD | 37 labelers | $0.147 per tablet 1 mg tablet | A presentation being discontinued |
| Metoprolol | High blood pressure | 64 labelers | $0.085 per tablet 100 mg tablet | A presentation being discontinued |
| Diltiazem | High blood pressure | 42 labelers | $0.144 per capsule 24h ER(cd) 120 mg capsule | A presentation being discontinued |
| Lisinopril | High blood pressure | 36 labelers | $0.0254 per tablet 20 mg tablet | No current entry |
| Propranolol | High blood pressure | 38 labelers | $0.0493 per tablet 20 mg tablet | In shortage |
| Losartan | High blood pressure | 44 labelers | $0.0327 per tablet 50 mg tablet | No current entry |
| Amlodipine | High blood pressure | 42 labelers | $0.0102 per tablet 5 mg tablet | No current entry |
| Valsartan | High blood pressure | 34 labelers | $0.0963 per tablet 40 mg tablet | A presentation being discontinued |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does clonidine compare with medicines for the same use?
19 side-by-side pages set clonidine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to clonidine
- 73 medicines for the same use
- Other central alpha-2 adrenergic agonists
- the pharmacologic class, with prices and generics
- Clonidine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other