pharmacopeia
GET
/api/v1/drug/clonidine
2D structure
N-(2,6-dichlorophenyl)-4,5-dihydro-1H-imidazol-2-amine
SMILES C1CN=C(N1)NC2=C(C=CC=C2Cl)Cl
InChIKey GJSURZIOUXUGAL-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Adrenergic alpha2-Agonists.

Indications

Sourced from openFDA
  • Clonidine hydrochloride tablets are indicated in the treatment of hypertension. Clonidine hydrochloride tablets may be employed alone or concomitantly with other antihypertensive agents.ICD-10: I10

Contraindications

Sourced from openFDA
  • Clonidine hydrochloride tablets should not be used in patients with known hypersensitivity to clonidine (see PRECAUTIONS ).contraindicated

Dosage & administration

Sourced from openFDA

Adults: The dose of clonidine hydrochloride tablets 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. For questions regarding this product, call Teva at 1-888-838-2872.

Warnings & precautions

Sourced from openFDA

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, 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 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. 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.

Adverse reactions

Sourced from openFDA

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, 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.

Use in specific populations

Sourced from openFDA

Pregnancy Teratogenic Effects Reproduction studies performed in rabbits at doses up to approximately 3 times the oral maximum recommended daily human dose (MRDHD) of clonidine hydrochloride tablets 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. Clonidine crosses the placental barrier (see CLINICAL PHARMACOLOGY, Pharmacokinetics ). Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Pharmacokinetics

Sourced from openFDA
Metabolism
The pharmacokinetics of clonidine is dose-proportional in the range of 100 mcg to 600 mcg. The absolute bioavailability of clonidine on oral administration is 70% to 80%.

Overdosage

Sourced from openFDA

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.

Approval history

Sourced from openFDA
  • Oct 10, 1984NDANDA018891Lavipharm
  • Dec 16, 1986ANDAANDA070976Actavis Elizabeth
  • Dec 16, 1986ANDAANDA070974Actavis Elizabeth
  • Dec 16, 1986ANDAANDA070975Actavis Elizabeth
  • Oct 2, 1996NDANDA020615Mylan Institutional
  • Dec 3, 2009NDANDA022500Rosemont
  • May 24, 2024NDANDA217645Tris Pharma Inc
  • Oct 23, 2025NDANDA220256Azurity

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
56,140 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective4,3607.8%
  2. 2Fatigue3,4696.2%
  3. 3Pain3,4586.2%
  4. 4Nausea3,3996.1%
  5. 5Headache3,3546.0%
  6. 6Off Label Use3,3305.9%
  7. 7Hypertension3,2245.7%
  8. 8Dyspnoea2,7094.8%
  9. 9Diarrhoea2,5964.6%
  10. 10Vomiting2,4144.3%
  11. 11Dizziness2,2614.0%
  12. 12Chronic Kidney Disease2,2344.0%
  13. 13Renal Failure2,0603.7%
  14. 14Blood Pressure Increased2,0393.6%
  15. 15Acute Kidney Injury1,9303.4%

Literature

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Recent PubMed references pinned to Clonidine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 331 ClinicalTrials.gov registrations naming Clonidine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Structural analogs

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Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

Frequently asked questions

How does Clonidine work?
Mechanism-of-action class: Adrenergic alpha2-Agonists.
What is Clonidine used for?
According to FDA labeling, Clonidine carries indications including: Clonidine hydrochloride tablets are indicated in the treatment of hypertension. Clonidine hydrochloride tablets may be employed alone or concomitantly with other antihypertensive agents.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Clonidine?
Clonidine is classified as Imidazoline receptor agonists, Other antimigraine preparations, Sympathomimetics in glaucoma therapy, Central alpha-2 Adrenergic Agonist, Adrenergic alpha2-Agonists, Analgesia, Decreased Blood Pressure, Hematologic Activity Alteration, Negative Chronotropy, Neurotransmitter & Neuromuscular Transmitter Activity Alteration, Renal Arterial Vasodilation, Systemic Arterial Vasodilation.
What are the brand names for Clonidine?
Clonidine is marketed under brand names including Catapres, Duraclon, Javadin, Kapvay, Nexiclon, Onyda.
What are the contraindications for Clonidine?
Clonidine labeling lists contraindications including: Clonidine hydrochloride tablets should not be used in patients with known hypersensitivity to clonidine (see PRECAUTIONS ).. Always consult the full prescribing information and a clinician.
Note. Data for clonidine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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