Clonidine Hydrochloride
Tablet · Oral, Intravenous
Uses
Clonidine hydrochloride tablets USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets USP may be employed alone or concomitantly with other antihypertensive agents.
Dosage and administration
Adults The dose of clonidine hydrochloride tablets USP must be adjusted according to the patient’s individual blood pressure response. The following is a general guide to its administration. Initial Dose 0.1 mg tablet twice daily (morning and bedtime). Elderly patients may benefit from a lower initial dose. Maintenance Dose Further increments of 0.1 mg per day may be made at weekly intervals if necessary until the desired response is achieved. Taking the larger portion of the oral daily dose at bedtime may minimize transient adjustment effects of dry mouth and drowsiness. The therapeutic doses most commonly employed have ranged from 0.2 mg to 0.6 mg per day given in divided doses. Studies have indicated that 2.4 mg is the maximum effective daily dose, but doses as high as this have rarely been employed. Renal Impairment Patients with renal impairment may benefit from a lower initial dose. Patients should be carefully monitored. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine following dialysis.
Contraindications
Clonidine hydrochloride tablets USP should not be used in patients with known hypersensitivity to clonidine (see PRECAUTIONS ).
Warnings
Withdrawal Patients should be instructed not to discontinue therapy without consulting their physician. Sudden cessation of clonidine treatment has, in some cases, resulted in symptoms such as nervousness, agitation, headache, and tremor accompanied or followed by a rapid rise in blood pressure and elevated catecholamine concentrations in the plasma. The likelihood of such reactions to discontinuation of clonidine therapy appears to be greater after administration of higher doses or continuation of concomitant beta-blocker treatment and special caution is therefore advised in these situations. Rare instances of hypertensive encephalopathy, cerebrovascular accidents and death have been reported after clonidine withdrawal. When discontinuing therapy with clonidine hydrochloride tablets USP, the physician should reduce the dose gradually over 2 to 4 days to avoid withdrawal symptomatology. An excessive rise in blood pressure following discontinuation of clonidine hydrochloride tablets USP therapy can be reversed by administration of oral clonidine hydrochloride or by intravenous phentolamine. If therapy is to be discontinued in patients receiving a beta-blocker and clonidine concurrently, the beta-blocker should be withdrawn several days before the gradual discontinuation of clonidine hydrochloride tablets USP. Because children commonly have gastrointestinal illnesses that lead to vomiting, they may be particularly susceptible to hypertensive episodes resulting from abrupt inability to take medication.
Precautions
General In patients who have developed localized contact sensitization to clonidine-TTS, continuation of clonidine-TTS or substitution of oral clonidine hydrochloride therapy may be associated with the development of a generalized skin rash. In patients who develop an allergic reaction to clonidine-TTS, substitution of oral clonidine hydrochloride may also elicit an allergic reaction (including generalized rash, urticaria, or angioedema). The sympatholytic action of clonidine may worsen sinus node dysfunction and atrioventricular (AV) block, especially in patients taking other sympatholytic drugs. There are post-marketing reports of patients with conduction abnormalities and/or taking other sympatholytic drugs who developed severe bradycardia requiring IV atropine, IV isoproterenol and temporary cardiac pacing while taking clonidine. In hypertension caused by pheochromocytoma, no therapeutic effect of clonidine hydrochloride tablets USP can be expected. Perioperative Use Administration of clonidine hydrochloride tablets USP should be continued to within 4 hours of surgery and resumed as soon as possible thereafter. Blood pressure should be carefully monitored during surgery and additional measures to control blood pressure should be available if required. Information for Patients Patients should be cautioned against interruption of clonidine hydrochloride tablets USP therapy without their physician’s advice. Since patients may experience a possible sedative effect, dizziness, or accommodation disorder with use of clonidine, caution patients about engaging in activities such as driving a vehicle or operating appliances or machinery. Also, inform patients that this sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs. Patients who wear contact lenses should be cautioned that treatment with clonidine hydrochloride tablets USP may cause dryness of eyes. Drug Interactions Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs. If a patient receiving clonidine hydrochloride is also taking tricyclic antidepressants, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose. If a patient receiving clonidine is also taking neuroleptics, orthostatic regulation disturbances (e.g., orthostatic hypotension, dizziness, fatigue) may be induced or exacerbated. Monitor heart rate in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction, e.g., digitalis, calcium channel blockers and beta-blockers. Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concomitantly with diltiazem or verapamil. Amitriptyline in combination with clonidine enhances the manifestation of corneal lesions in rats (see Toxicology ). 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. Causal relationship and relevance for clonidine oral tablets have not been established. Toxicology In several studies with oral clonidine hydrochloride, a dose-dependent increase in the incidence and severity of spontaneous retinal degeneration was seen in albino rats treated for six months or longer. Tissue distribution studies in dogs and monkeys showed a concentration of clonidine in the choroid. In view of the retinal degeneration seen in rats, eye examinations were performed during clinical trials in 908 patients before, and periodically after, the start of clonidine therapy. In 353 of these 908 patients, the eye examinations were carried out over periods of 24 months or longer. Except for some dryness of the eyes, no drug-related abnormal ophthalmological findings were recorded and, according to specialized tests such as electroretinography and macular dazzle, retinal function was unchanged. In combination with amitriptyline, clonidine hydrochloride administration led to the development of corneal lesions in rats within 5 days. Carcinogenesis, Mutagenesis, Impairment of Fertility Chronic dietary administration of clonidine was not carcinogenic to rats (132 weeks) or mice (78 weeks) dosed, respectively, at up to 46 or 70 times the maximum recommended daily human dose as mg/kg (9 or 6 times the MRDHD on a mg/m 2 basis). There was no evidence of genotoxicity in the Ames test for mutagenicity or mouse micronucleus test for clastogenicity. Fertility of male or female rats was unaffected by clonidine doses as high as 150 mcg/kg (approximately 3 times MRDHD). In a separate experiment, fertility of female rats appeared to be affected at dose levels of 500 to 2000 mcg/kg (10 to 40 times the oral MRDHD on a mg/kg basis; 2 to 8 times the MRDHD on a mg/m 2 basis). Pregnancy Teratogenic Effects: Pregnancy Category C. Reproduction studies performed in rabbits at doses up to approximately 3 times the oral maximum recommended daily human dose (MRDHD) of clonidine hydrochloride tablets USP produced no evidence of a teratogenic or embryotoxic potential in rabbits. In rats, however, doses as low as 1/3 the oral MRDHD (1/15 the MRDHD on a mg/m 2 basis) of clonidine were associated with increased resorptions in a study in which dams were treated continuously from 2 months prior to mating. Increased resorptions were not associated with treatment at the same time or at higher dose levels (up to 3 times the oral MRDHD) when the dams were treated on gestation days 6 to 15. Increases in resorption were observed at much higher dose levels (40 times the oral MRDHD on a mg/kg basis; 4 to 8 times the MRDHD on a mg/m 2 basis) in mice and rats treated on gestation days 1 to 14 (lowest dose employed in the study was 500 mcg/kg). No adequate, well-controlled studies have been conducted in pregnant women.
Side effects
Most adverse effects are mild and tend to diminish with continued therapy. The most frequent (which appear to be dose-related) are dry mouth, occurring in about 40 of 100 patients; drowsiness, about 33 in 100; dizziness, about 16 in 100; constipation and sedation, each about 10 in 100. The following less frequent adverse experiences have also been reported in patients receiving clonidine hydrochloride tablets USP, but in many cases patients were receiving concomitant medication and a causal relationship has not been established. Body as a Whole: Fatigue, fever, headache, pallor, weakness, and withdrawal syndrome. Also reported were a weakly positive Coombs’ test and increased sensitivity to alcohol. Cardiovascular: Bradycardia, congestive heart failure, electrocardiographic abnormalities (i.e., sinus node arrest, junctional bradycardia, high degree AV block and arrhythmias), orthostatic symptoms, palpitations, Raynaud’s phenomenon, syncope, and tachycardia. Cases of sinus bradycardia and atrioventricular block have been reported, both with and without the use of concomitant digitalis. Central Nervous System: Agitation, anxiety, delirium, delusional perception, hallucinations (including visual and auditory), insomnia, mental depression, nervousness, other behavioral changes, paresthesia, restlessness, sleep disorder, and vivid dreams or nightmares. Dermatological: Alopecia, angioneurotic edema, hives, pruritus, rash, and urticaria. Gastrointestinal: Abdominal pain, anorexia, constipation, hepatitis, malaise, mild transient abnormalities in liver function tests, nausea, parotitis, pseudo-obstruction (including colonic pseudo-obstruction), salivary gland pain, and vomiting. Genitourinary: Decreased sexual activity, difficulty in micturition, erectile dysfunction, loss of libido, nocturia, and urinary retention. Hematologic: Thrombocytopenia. Metabolic: Gynecomastia, transient elevation of blood glucose or serum creatine phosphokinase, and weight gain. Musculoskeletal: Leg cramps and muscle or joint pain. Oro-otolaryngeal: Dryness of the nasal mucosa. Ophthalmological: Accommodation disorder, blurred vision, burning of the eyes, decreased lacrimation, and dryness of eyes.
Drug interactions
Drug Interactions Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs. If a patient receiving clonidine hydrochloride is also taking tricyclic antidepressants, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose. If a patient receiving clonidine is also taking neuroleptics, orthostatic regulation disturbances (e.g., orthostatic hypotension, dizziness, fatigue) may be induced or exacerbated. Monitor heart rate in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction, e.g., digitalis, calcium channel blockers and beta-blockers. Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concomitantly with diltiazem or verapamil. Amitriptyline in combination with clonidine enhances the manifestation of corneal lesions in rats (see Toxicology ). 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. Causal relationship and relevance for clonidine oral tablets have not been established.
Pregnancy
Pregnancy
Pediatric use
Pediatric Use Safety and effectiveness in pediatric patients have not been established in adequate and well-controlled trials (see WARNINGS, Withdrawal ).
Overdosage
Hypertension may develop early and may be followed by hypotension, bradycardia, respiratory depression, hypothermia, drowsiness, decreased or absent reflexes, weakness, irritability and miosis. The frequency of CNS depression may be higher in children than adults. Large overdoses may result in reversible cardiac conduction defects or dysrhythmias, apnea, coma and seizures. Signs and symptoms of overdose generally occur within 30 minutes to two hours after exposure. As little as 0.1 mg of clonidine has produced signs of toxicity in children. There is no specific antidote for clonidine overdosage. Clonidine overdosage may result in the rapid development of CNS depression; therefore, induction of vomiting with ipecac syrup is not recommended. Gastric lavage may be indicated following recent and/or large ingestions. Administration of activated charcoal and/or a cathartic may be beneficial. Supportive care may include atropine sulfate for bradycardia, intravenous fluids and/or vasopressor agents for hypotension and vasodilators for hypertension. Naloxone may be a useful adjunct for the management of clonidine-induced respiratory depression, hypotension and/or coma; blood pressure should be monitored since the administration of naloxone has occasionally resulted in paradoxical hypertension. Tolazoline administration has yielded inconsistent results and is not recommended as first-line therapy. Dialysis is not likely to significantly enhance the elimination of clonidine. The largest overdose reported to date involved a 28-year old male who ingested 100 mg of clonidine hydrochloride powder. This patient developed hypertension followed by hypotension, bradycardia, apnea, hallucinations, semicoma, and premature ventricular contractions. The patient fully recovered after intensive treatment. Plasma clonidine levels were 60 ng/ml after 1 hour, 190 ng/ml after 1.5 hours, 370 ng/ml after 2 hours, and 120 ng/ml after 5.5 and 6.5 hours. In mice and rats, the oral LD 50 of clonidine is 206 and 465 mg/kg, respectively.
Description
Clonidine hydrochloride, USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in four dosage strengths: 0.05 mg, 0.1 mg, 0.2 mg, and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. Clonidine hydrochloride tablets USP contain the following inactive ingredients: lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. The 0.1 mg also contains D&C yellow #10 aluminum lake, the 0.3 mg contains D&C yellow #10 aluminum lake and FD&C blue #1 aluminum lake, and the 0.05 mg contains D&C yellow #10 aluminum lake. Clonidine hydrochloride, USP is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula: C 9 H 9 Cl 2 N 3
• HCl Mol. Wt. 266.56 Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol. the structural formula for Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride.
How supplied
Clonidine hydrochloride tablets USP are supplied as follows: Clonidine hydrochloride tablets USP 0.05 mg, yellow, oval, debossed 05 on one side and plain on the other side. Bottles of 100 NDC 52817-183-10 Clonidine hydrochloride tablets USP 0.1 mg, yellow, round, debossed MP 657 on one side and plain on the other side. Bottles of 100 NDC 52817-180-10 Bottles of 500 NDC 52817-180-50 Bottles of 1000 NDC 52817-180-00 Clonidine hydrochloride tablets USP 0.2 mg, white, round, debossed MP 658 on one side and plain on the other side. Bottles of 100 NDC 52817-181-10 Bottles of 500 NDC 52817-181-50 Bottles of 1000 NDC 52817-181-00 Clonidine hydrochloride tablets USP 0.3 mg, green, round, debossed MP 659 on one side and plain on the other side. Bottles of 100 NDC 52817-182-10 Bottles of 500 NDC 52817-182-50 Bottles of 1000 NDC 52817-182-00 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER. Add ress medical inquiries to: 1-877-541-5504 . Manufactured by: Frontida BioPharm, Inc Philadelphia, PA 19124 Distributed by: TruPharma, LLC Tampa, FL 33609 Rev01, March 2025
Patient information
Information for Patients Patients should be cautioned against interruption of clonidine hydrochloride tablets USP therapy without their physician’s advice. Since patients may experience a possible sedative effect, dizziness, or accommodation disorder with use of clonidine, caution patients about engaging in activities such as driving a vehicle or operating appliances or machinery. Also, inform patients that this sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs. Patients who wear contact lenses should be cautioned that treatment with clonidine hydrochloride tablets USP may cause dryness of eyes.
Label text from the FDA structured product label by TruPharma, LLC (revised Apr 30, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Clonidine Hydrochloride in 141 products
Clonidine Hydrochloride NDC products (141)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-7477 | Clonidine Hydrochloride .1 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-1909 | Clonidine Hydrochloride .2 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-1910 | Clonidine Hydrochloride .3 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-5577 | Clonidine Hydrochloride .1 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6744 | Clonidine Hydrochloride .1 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6946 | Clonidine Hydrochloride .1 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7009 | Clonidine Hydrochloride .1 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7475 | Clonidine Hydrochloride .1 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 0228-4241 | Clonidine Hydrochloride .1 mg/1 Tablet, Extended Release | Actavis Pharma, Inc. | ANDA |
| 0228-2129 | Clonidine Hydrochloride .3 mg/1 Tablet | Actavis Pharma, Inc. | ANDA |
| 0228-2128 | Clonidine Hydrochloride .2 mg/1 Tablet | Actavis Pharma, Inc. | ANDA |
| 0228-2127 | Clonidine Hydrochloride .1 mg/1 Tablet | Actavis Pharma, Inc. | ANDA |
| 27241-108 | Clonidine Hydrochloride .1 mg/1 Tablet, Extended Release | Ajanta Pharma USA Inc. | ANDA |
| 62332-055 | Clonidine Hydrochloride .2 mg/1 Tablet | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-056 | Clonidine Hydrochloride .3 mg/1 Tablet | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-169 | Clonidine Hydrochloride .05 mg/1 Tablet | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-054 | Clonidine Hydrochloride .1 mg/1 Tablet | Alembic Pharmaceuticals Inc. | ANDA |
| 46708-308 | Clonidine Hydrochloride .3 mg/1 Tablet | Alembic Pharmaceuticals Limited | ANDA |
| 46708-307 | Clonidine Hydrochloride .2 mg/1 Tablet | Alembic Pharmaceuticals Limited | ANDA |
| 46708-306 | Clonidine Hydrochloride .1 mg/1 Tablet | Alembic Pharmaceuticals Limited | ANDA |
| 60687-113 | Clonidine Hydrochloride .1 mg/1 Tablet | American Health Packaging | ANDA |
| 60687-124 | Clonidine Hydrochloride .2 mg/1 Tablet | American Health Packaging | ANDA |
| 60687-462 | Clonidine Hydrochloride .1 mg/1 Tablet, Extended Release | American Health Packaging | ANDA |
| 71610-449 | Clonidine Hydrochloride .3 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 43353-316 | Clonidine Hydrochloride .3 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 87063-183 | Clonidine Hydrochloride .3 mg/1 Tablet | ASCLEMED USA INC. | ANDA |
| 87063-182 | Clonidine Hydrochloride .2 mg/1 Tablet | ASCLEMED USA INC. | ANDA |
| 87063-181 | Clonidine Hydrochloride .1 mg/1 Tablet | ASCLEMED USA INC. | ANDA |
| 76420-066 | Clonidine Hydrochloride .1 mg/1 Tablet | Asclemed USA, Inc. | ANDA |
| 76420-283 | Clonidine Hydrochloride .1 mg/1 Tablet | Asclemed USA, Inc. | ANDA |
| 76420-285 | Clonidine Hydrochloride .2 mg/1 Tablet | Asclemed USA, Inc. | ANDA |
| 76420-286 | Clonidine Hydrochloride .3 mg/1 Tablet | Asclemed USA, Inc. | ANDA |
| 59651-232 | Clonidine Hydrochloride .1 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 59651-233 | Clonidine Hydrochloride .2 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 59651-234 | Clonidine Hydrochloride .3 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 50268-192 | Clonidine Hydrochloride .1 mg/1 Tablet | AvPAK | ANDA |
| 50268-193 | Clonidine Hydrochloride .2 mg/1 Tablet | AvPAK | ANDA |
| 50268-194 | Clonidine Hydrochloride .3 mg/1 Tablet | AvPAK | ANDA |
| 68001-568 | Clonidine Hydrochloride .1 mg/1 Tablet, Extended Release | BluePoint Laboratories | ANDA |
| 68001-239 | Clonidine Hydrochloride .3 mg/1 Tablet | BluePoint Laboratories | ANDA |
| 68001-238 | Clonidine Hydrochloride .2 mg/1 Tablet | BluePoint Laboratories | ANDA |
| 68001-237 | Clonidine Hydrochloride .1 mg/1 Tablet | BluePoint Laboratories | ANDA |
| 63629-9269 | Clonidine Hydrochloride .2 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-2319 | Clonidine Hydrochloride .3 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-3028 | Clonidine Hydrochloride .2 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-2318 | Clonidine Hydrochloride .3 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-2317 | Clonidine Hydrochloride .2 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-2316 | Clonidine Hydrochloride .2 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-2315 | Clonidine Hydrochloride .1 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-2314 | Clonidine Hydrochloride .1 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-2489 | Clonidine Hydrochloride .1 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 72162-1679 | Clonidine Hydrochloride .1 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 72162-1367 | Clonidine Hydrochloride .1 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 72162-1680 | Clonidine Hydrochloride .2 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-9682 | Clonidine Hydrochloride .3 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 72162-1681 | Clonidine Hydrochloride .3 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-2889 | Clonidine Hydrochloride .3 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-2692 | Clonidine Hydrochloride .2 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 72162-2609 | Clonidine Hydrochloride .1 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-2266 | Clonidine Hydrochloride .1 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1624 | Clonidine Hydrochloride .3 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1495 | Clonidine Hydrochloride .2 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-0922 | Clonidine Hydrochloride .1 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-0915 | Clonidine Hydrochloride .3 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 72162-2610 | Clonidine Hydrochloride .2 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 72162-2611 | Clonidine Hydrochloride .3 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-0777 | Clonidine Hydrochloride .1 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 55154-2577 | Clonidine Hydrochloride .2 mg/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 55154-0189 | Clonidine Hydrochloride .1 mg/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 55154-2576 | Clonidine Hydrochloride .1 mg/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 67046-1552 | Clonidine Hydrochloride .2 mg/1 Tablet | Coupler LLC | ANDA |
| 67046-1000 | Clonidine Hydrochloride .2 mg/1 Tablet | Coupler LLC | ANDA |
| 67046-0646 | Clonidine Hydrochloride .3 mg/1 Tablet | Coupler LLC | ANDA |
| 61919-605 | Clonidine Hydrochloride .1 mg/1 Tablet | DirectRX | ANDA |
| 0143-9724 | Clonidine Hydrochloride 100 ug/mL Injection, Solution | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0143-9723 | Clonidine Hydrochloride 500 ug/mL Injection, Solution | Hikma Pharmaceuticals USA Inc. | ANDA |
| 68180-606 | Clonidine Hydrochloride .1 mg/1 Tablet, Extended Release | Lupin Pharmaceuticals, Inc. | ANDA |
| 0904-7443 | Clonidine Hydrochloride .2 mg/1 Tablet | Major Pharmaceuticals | ANDA |
| 0904-7442 | Clonidine Hydrochloride .1 mg/1 Tablet | Major Pharmaceuticals | ANDA |
| 58657-647 | Clonidine Hydrochloride .1 mg/1 Tablet | Method Pharmaceuticals, LLC | ANDA |
| 58657-649 | Clonidine Hydrochloride .3 mg/1 Tablet | Method Pharmaceuticals, LLC | ANDA |
| 58657-648 | Clonidine Hydrochloride .2 mg/1 Tablet | Method Pharmaceuticals, LLC | ANDA |
| 0615-2572 | Clonidine Hydrochloride .1 mg/1 Tablet | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 0615-2574 | Clonidine Hydrochloride .3 mg/1 Tablet | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 0615-8272 | Clonidine Hydrochloride .2 mg/1 Tablet | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 51655-353 | Clonidine Hydrochloride .1 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-962 | Clonidine Hydrochloride .2 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-451 | Clonidine Hydrochloride .3 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-445 | Clonidine Hydrochloride .1 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-339 | Clonidine Hydrochloride .3 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-362 | Clonidine Hydrochloride .2 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 66267-464 | Clonidine Hydrochloride .3 mg/1 Tablet | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-4661 | Clonidine Hydrochloride .1 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4545 | Clonidine Hydrochloride .1 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3987 | Clonidine Hydrochloride .1 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3625 | Clonidine Hydrochloride .1 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3016 | Clonidine Hydrochloride .2 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2699 | Clonidine Hydrochloride .1 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2210 | Clonidine Hydrochloride .1 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 72789-091 | Clonidine Hydrochloride .1 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-924 | Clonidine Hydrochloride .3 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-925 | Clonidine Hydrochloride .2 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 68788-7145 | Clonidine Hydrochloride .1 mg/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8494 | Clonidine Hydrochloride .1 mg/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8163 | Clonidine Hydrochloride .3 mg/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8080 | Clonidine Hydrochloride .2 mg/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 63187-202 | Clonidine Hydrochloride .1 mg/1 Tablet | Proficient Rx LP | ANDA |
| 71205-829 | Clonidine Hydrochloride .2 mg/1 Tablet | Proficient Rx LP | ANDA |
| 71205-570 | Clonidine Hydrochloride .1 mg/1 Tablet | Proficient Rx LP | ANDA |
| 71205-218 | Clonidine Hydrochloride .2 mg/1 Tablet | Proficient Rx LP | ANDA |
| 71205-588 | Clonidine Hydrochloride .1 mg/1 Tablet | Proficient Rx LP | ANDA |
| 67296-2120 | Clonidine Hydrochloride .1 mg/1 Tablet | Redpharm Drug | ANDA |
| 67296-2260 | Clonidine Hydrochloride .1 mg/1 Tablet | Redpharm Drug | ANDA |
| 70518-1035 | Clonidine Hydrochloride .1 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-1060 | Clonidine Hydrochloride .2 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-1962 | Clonidine Hydrochloride .1 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-4379 | Clonidine Hydrochloride .3 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-4357 | Clonidine Hydrochloride .2 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-4342 | Clonidine Hydrochloride .1 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-3295 | Clonidine Hydrochloride .2 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-3162 | Clonidine Hydrochloride .1 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-2203 | Clonidine Hydrochloride .3 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 43547-435 | Clonidine Hydrochloride .1 mg/1 Tablet, Extended Release | Solco Healthcare LLC | ANDA |
| 43547-566 | Clonidine Hydrochloride .2 mg/1 Tablet | Solco Healthcare LLC | ANDA |
| 43547-567 | Clonidine Hydrochloride .3 mg/1 Tablet | Solco Healthcare LLC | ANDA |
| 43547-565 | Clonidine Hydrochloride .1 mg/1 Tablet | Solco Healthcare LLC | ANDA |
| 70069-044 | Clonidine Hydrochloride .1 mg/1 Tablet, Extended Release | Somerset Therapeutics, LLC | ANDA |
| 60760-057 | Clonidine Hydrochloride .1 mg/1 Tablet | St. Mary's Medical Park Pharmacy | ANDA |
| 60760-992 | Clonidine Hydrochloride .1 mg/1 Tablet | St. Mary's Medical Park Pharmacy | ANDA |
| 52817-180 | Clonidine Hydrochloride .1 mg/1 Tablet | TruPharma, LLC | ANDA |
| 52817-181 | Clonidine Hydrochloride .2 mg/1 Tablet | TruPharma, LLC | ANDA |
| 52817-182 | Clonidine Hydrochloride .3 mg/1 Tablet | TruPharma, LLC | ANDA |
| 52817-183 | Clonidine Hydrochloride .05 mg/1 Tablet | TruPharma, LLC | ANDA |
| 29300-468 | Clonidine Hydrochloride .1 mg/1 Tablet | Unichem Pharmaceuticals (USA), Inc. | ANDA |
| 29300-137 | Clonidine Hydrochloride .3 mg/1 Tablet | Unichem Pharmaceuticals (USA), Inc. | ANDA |
| 29300-136 | Clonidine Hydrochloride .2 mg/1 Tablet | Unichem Pharmaceuticals (USA), Inc. | ANDA |
| 87441-023 | Clonidine Hydrochloride .1 mg/1 Tablet | Unit Dose Solutions, Inc. | ANDA |
| 87441-024 | Clonidine Hydrochloride .2 mg/1 Tablet | Unit Dose Solutions, Inc. | ANDA |
| 83939-0005 | Clonidine Hydrochloride .1 mg/1 Tablet | VERITYRX, LLC | ANDA |
| 83939-0006 | Clonidine Hydrochloride .1 mg/1 Tablet | VERITYRX, LLC | ANDA |
| 71034-001 | Clonidine Hydrochloride .1 mg/1 Tablet, Extended Release | Xiamen LP Pharmaceutical Co., Ltd. | ANDA |
Clonidine Hydrochloride recalls
- D-1541-2022 Sep 28, 2022 · Class III · Terminated
Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets, - D-1291-2020 Jun 17, 2020 · Class III · Terminated
Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container. - D-0829-2020 Feb 12, 2020 · Class III · Terminated
Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure due to potential migration of Benzophenone at very low level into product from container label.
Frequently asked questions
What is Clonidine Hydrochloride used for?
Clonidine hydrochloride tablets USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets USP may be employed alone or concomitantly with other antihypertensive agents.
What are the side effects of Clonidine Hydrochloride?
Most adverse effects are mild and tend to diminish with continued therapy. The most frequent (which appear to be dose-related) are dry mouth, occurring in about 40 of 100 patients; drowsiness, about 33 in 100; dizziness, about 16 in 100; constipation and sedation, each about 10 in 100. The following less frequent adverse experiences have also been reported in patients receiving clonidine… See the full label for the complete list.
Who makes Clonidine Hydrochloride?
Clonidine Hydrochloride is listed by 37 labelers in the FDA NDC directory, including A-S Medication Solutions, Actavis Pharma, Inc., Ajanta Pharma USA Inc., Alembic Pharmaceuticals Inc..
Has Clonidine Hydrochloride been recalled?
The FDA enforcement database lists 3 recalls for Clonidine Hydrochloride, most recently D-1541-2022 (class iii): Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,