Caudaline

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Caudaline

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Caudaline

Property Description
Active Ingredient Cilostazol
Form Oral Tablet
Pharmacological Class Phosphodiesterase III (PDE3) Inhibitor, Vasodilator
General Purpose Improvement of blood circulation
Origin Synthetic (Quinolinone Derivative)

Caudaline: Definition and Pharmaceutical Classification

Caudaline is a synthetic, prescription-only medication whose active ingredient is Cilostazol. It is classified as a selective Phosphodiesterase III (PDE3) Inhibitor. This classification means the medication works by interfering with a specific enzyme that regulates cell activity. Consequently, Caudaline falls under the broader categories of Antiplatelet Agents and Vasodilators, defining its dual function in both modulating blood components and widening blood vessels. This dual approach to circulatory support is used for addressing issues related to insufficient blood flow. The compound Cilostazol is a quinolinone derivative, which confirms its origin as a manufactured chemical entity, distinguishing it from naturally sourced agents.


Composition, Form, and General Therapeutic Purpose

Caudaline is supplied as a single-ingredient oral tablet containing Cilostazol, designed to improve overall blood circulation in adults. The medication is intended for oral administration, utilizing standard solid excipients to form its tablet base. The central therapeutic purpose of this medication is to enhance circulation through a combined physiological effect: it reduces the aggregation of platelets, making the blood less prone to clotting, while simultaneously promoting the relaxation of smooth muscles within the arteries. For instance, the general benefit is seen in situations where individuals require better blood supply to their legs. This dual, synergistic mechanism provides the general benefit of increasing blood flow and oxygen delivery through the peripheral arteries.

Regulatory References

  1. MedlinePlus

What side effects are possible with Caudaline?

Possible side effects and safety information

The safety profile of Caudaline (Cilostazol) is officially categorized by regulatory documents, distinguishing between common, expected effects and rare, serious adverse reactions.

Frequency-Classified Adverse Reactions

Adverse reactions are classified by incidence as reported in official labeling. Effects listed as Very Common (occurring in 10% or more of patients) include headache and dizziness. Reactions categorized as Common (occurring in 1% to less than 10% of patients) typically involve the gastrointestinal and cardiovascular systems, such as diarrhea, abnormal stools, palpitations (pounding heartbeat), tachycardia (increased heart rate), and peripheral edema (swelling).

System-Organ Class Involvement

Official documents group adverse effects by the body systems affected. Key System-Organ Classes involved include Nervous System Disorders (e.g., headache, dizziness), Cardiac Disorders (e.g., tachycardia, heart failure), Gastrointestinal Disorders (e.g., diarrhea, nausea), and Blood and Lymphatic System Disorders.

Serious Adverse Reactions and Safety Constraints

The official safety information highlights the potential for serious events, including a risk of hemorrhagic events, such as intracranial bleeding, and severe blood cell disorders, such as leukopenia and agranulocytosis. The label includes specific safety constraints: Caudaline is contraindicated in patients with heart failure of any severity, active pathological bleeding, severe renal or hepatic impairment, and in those receiving two or more concomitant antiplatelet or anticoagulant treatments. Furthermore, regulatory safety notes indicate that the majority of general adverse reactions are typically reported within the first month of treatment initiation.

Overdose and Emergency Response

Suspected Caudaline overdose necessitates seeking immediate medical attention due to the documented potential for severe clinical consequences. Regulatory authorities advise contacting emergency services immediately if overdose is suspected or if the individual has collapsed, experienced a seizure, has trouble breathing, or is unresponsive.

The official regulatory profile indicates that an overdose is expected to manifest as an exaggeration of the medication’s known pharmacological effects. Documented clinical signs include cardiovascular effects such as tachycardia (fast or irregular heartbeat) and hypotension (a significant fall in blood pressure). Other documented symptoms are severe headache, diarrhea, dizziness, and fainting.

The official documentation highlights the risk of serious, life-threatening events associated with excessive exposure. These severe outcomes include the potential for cardiac arrhythmias and major bleeding events, such as intracranial and gastrointestinal hemorrhage.

Management, as described in regulatory labeling, focuses exclusively on symptomatic and supportive treatment and requires careful observation of the patient's vital signs and cardiovascular status. It is officially stated that no specific antidote is known for Caudaline overdose, and due to high protein binding, the substance is unlikely to be efficiently removed by dialysis.

Therapeutic Uses of Caudaline

What Caudaline Treats: Main Uses and Benefits

Caudaline is commonly used to help with the symptomatic management of symptoms related to physical discomfort and generalized aches that interfere with daily functioning. Supportive symptom management is relevant for discomfort that arises from tissue irritation. Caudaline provides support that helps ease the overall symptom burden and contributes to improved comfort during periods of heightened symptoms.

This medication is applied in addressing symptom clusters that may become disruptive, such as minor swelling, heat, and redness, which are symptoms related to inflammatory or irritative states. It is considered relevant in conditions involving episodic or fluctuating manifestations where additional management of discomfort is required. Caudaline may assist with maintaining functional stability and supports patients during episodes of heightened discomfort.

Caudaline is often used during phases when symptoms become more noticeable, such as post-physical stress or temporary physiological imbalance. This supportive relief supports general well-being during symptomatic phases when symptoms create noticeable physiological strain, and is relevant for easing symptoms that interfere with daily comfort.


Quick Fact: Therapeutic Relevance for Episodic Manifestations

Caudaline is applied in scenarios where additional management of discomfort is required due to fluctuating or episodic symptom patterns.

Eligibility and Restrictions for Use

The eligibility for Caudaline is strictly defined by official regulatory documentation, primarily classifying use for Adults but establishing numerous populations where use is formally contraindicated or not established.

Populations for Whom Use is Prohibited (Contraindications)

Caudaline must not be used by patients with:

  • Heart Failure: Congestive heart failure (CHF) of any severity, a restriction highlighted by the U.S. FDA with a Boxed Warning.
  • Bleeding Risk: Any known predisposition to bleeding, including active pathologic bleeding (e.g., active peptic ulceration, recent hemorrhagic stroke).
  • Cardiac Status: Unstable angina pectoris, or having had a myocardial infarction or coronary intervention within the last six months.
  • Organ Impairment: Severe renal impairment (creatinine clearance le 25 ml/min) or moderate or severe hepatic impairment.
  • Hypersensitivity to the active substance or excipients.

Restricted and Non-Established Use

Category Regulatory Status
Pediatric Population Safety and efficacy have not been established in children.
Pregnancy Contraindicated per some regulatory authorities.
Lactation Not recommended; a decision to discontinue the drug or nursing is required.
Antiplatelet/Anticoagulant Use Contraindicated if taking two or more additional antiplatelet or anticoagulant agents.

What should I know about interactions with other medicines?

Caudaline (Cilostazol) has documented interaction patterns governed by its metabolic clearance and its pharmacodynamic effect on platelet function, which result in several mandatory restrictions in regulatory labeling.

Interaction Type Interacting Agents / Conditions Officially Documented Effect
Metabolic (Pharmacokinetic) Strong and Moderate CYP3A4 Inhibitors (e.g., Ketoconazole, Erythromycin, Diltiazem) Increase systemic exposure (AUC and Cmax) of Caudaline.
CYP2C19 Inhibitors (e.g., Omeprazole) Increase systemic exposure of the active metabolite, 3,4-dehydro-cilostazol.
Hemorrhagic Risk (Pharmacodynamic) Other Antiplatelet Agents (e.g., Aspirin, Clopidogrel) or Anticoagulants (e.g., Warfarin) Additive pharmacodynamic effect that increases the risk of bleeding.
Food/Absorption High-fat Meal Significantly increases Cmax (peak concentration) by approximately 90% and AUC (total exposure) by 25%.

The official interaction profile strictly limits co-administration with two or more additional antiplatelet or anticoagulant agents due to the combined risk of hemorrhage. The medication is also contraindicated in patients with heart failure of any severity, and its use is restricted in cases of moderate or severe hepatic impairment or severe renal impairment due to altered metabolism and clearance. Administration must be separated from food to prevent the documented increase in drug absorption.

Mechanism of Action

Caudaline modulates multiple intracellular signaling pathways by interacting with diverse molecular targets, including the serine/threonine protein kinase AKT1, the tumor suppressor protein TP53, and the mitogen-activated protein kinase MAPK1. This interaction profile classifies it as a modulator across several key cellular networks.

At the molecular level, Caudaline functions as a direct inhibitor or allosteric regulator of these protein targets. This modification of protein activity leads to the downstream suppression of pro-inflammatory transcription factors, such as NF-kappaB, and influences the activity of inflammatory mediators like Interleukin-6 and Tumor Necrosis Factor ( TNF-alpha). Intracellular consequences include the modulation of cellular metabolism and the promotion of endothelial cell proliferation. The resulting system-level physiological consequence involves the systemic modulation of inflammatory signaling and the regulation of cellular growth and survival pathways within targeted tissues.

Dosage and Administration Information

How Caudaline Is Used

Caudaline (Cilostazol) is administered orally as a tablet. Standard prescribing guidelines define a approach to its use, which centers on a fixed dose taken on a structured schedule relative to meals to manage absorption. The standard adult regimen requires a dose of 100 mg per administration, taken twice daily, which establishes a total daily intake of 200 mg.

Key Administration Conditions

Instruction Area Official Requirement
Dosing Frequency Twice daily (b.i.d.)
Timing & Food Must be taken on an empty stomach: 30 minutes before or 2 hours after breakfast and the evening meal.
Dose Adjustment Reduce the dose to 50 mg twice daily when coadministered with certain inhibitors of CYP3A4 or CYP2C19 enzymes.
Beverage Restriction Consumption of grapefruit juice is restricted.

These instructions define the use protocol, which includes specific rules for population subsets, such as the absence of required dose adjustment for older adults. Furthermore, the protocol establishes a defined treatment period: the effect is typically assessed after an initial course of 12 weeks (3 months), and guidance recommends discontinuation if insufficient improvement is observed after this duration.

Recent Clinical Evidence

Caudaline was studied for its use in research exploring how symptoms change over time in conditions marked by functional limitations and outcomes related to physical discomfort. This foundation consists of short-term to intermediate-term randomized controlled trials (RCTs) that compared the medication to a non-active placebo. Researchers primarily examined physical outcomes using standardized treadmill tests, such as initial and maximum walking distance, as well as patient-reported outcomes describing daily functioning. Findings describe patterns observed in the studies related to these measurements, often highlighting changes measured during the study period of 12 to 24 weeks. The size of the change observed in the studies is documented by researchers, and findings were mixed regarding the uniformity of patient response.

Caudaline was evaluated in research exploring outcomes for patients who had undergone revascularization procedures. Studies monitored vascular outcomes like the rate at which the blood vessel re-narrowed after the procedure (restenosis). The data indicate patterns related to the need for a follow-up intervention for subsequent revascularization. The evidence is limited regarding the generalizability of these findings, as a notable portion of the research was derived from specific regional cohorts.

Research examined the medication's effects over defined time intervals, with core efficacy trials being short-term. While some post-marketing studies have monitored patients for longer, extending up to approximately three years, data are still emerging for long-term safety questions. Caudaline was evaluated in subgroups of patients with common conditions like diabetes and hypertension. The research describes patterns observed within these subgroups, but subgroup findings are uncertain due to limited patient numbers in specific categories.

The available research does not determine whether an individual will respond similarly, as findings describe group patterns, not personal outcomes. Certainty remains low regarding the medication’s effect on major hard clinical endpoints, and the available research highlights that long-term effects are not fully established.

Key Studies & References

  1. Systematic review and meta-analysis of randomized clinical trials appraising the impact of cilostazol after percutaneous coronary intervention
  2. Cilostazol (Pletal) Prescribing Information (US FDA or equivalent regulatory summary)

Frequently Asked Questions (FAQ)

Common questions about Caudaline (FAQ)


Q: How quickly does Caudaline start to work after I take it?

A: Studies and official information indicate that patients may begin to notice an improvement in their symptoms as early as 2 to 4 weeks after starting treatment. However, the full therapeutic benefit of Caudaline is often assessed after about 12 weeks of continuous treatment, based on clinical trial data.


Q: Is it normal to have mild stomach upset when starting Caudaline?

A: According to the official product information, certain gastrointestinal issues, such as diarrhea and abnormal stools, are commonly reported side effects. These effects have frequently been reported during the first month after treatment initiation.


Q: Is Caudaline safe for use during pregnancy?

A: Official regulatory documents state that the safety of Caudaline has not been established in human pregnancy. For this reason, its use is classified as contraindicated (prohibited) by some authorities. Animal studies have indicated the potential for fetal harm when the drug was administered at high doses.


Q: What research is available on the long-term effects of Caudaline?

A: Post-marketing safety studies have monitored patients for extended periods, in some cases up to approximately three years. Official safety data suggests that long-term use warrants careful monitoring, especially regarding the cardiovascular system.


Q: Will Caudaline interact with my over-the-counter pain relievers?

A: Caudaline reduces the aggregation of platelets. When certain other antiplatelet agents, like aspirin (found in some over-the-counter pain relievers), are used concomitantly, this effect may lead to an increased risk of bleeding.


Q: Why do doctors often prescribe Caudaline for [common condition]?

A: The medication is officially approved to help reduce the symptoms of intermittent claudication, a condition that causes pain, aching, or cramping in the legs during exercise. It is prescribed to help reduce these symptoms and is thought to work by increasing blood flow, which may help improve the ability to walk longer distances.


Q: What are the signs that Caudaline is starting to work for me?

A: Improvement in the condition is measured primarily by an increase in the distance a person is able to walk without experiencing pain or discomfort. This is the main outcome examined in clinical trials.


Q: Is Caudaline a controlled substance?

A: Official regulatory classification confirms that Caudaline, whose active ingredient is Cilostazol, is not scheduled or classified as a controlled substance under U.S. federal law.


Q: Are severe allergic reactions to Caudaline common?

A: Severe allergic reactions, such as hypersensitivity, are known to be possible with Caudaline, and the medication is contraindicated (prohibited) in anyone with a known allergy to the active ingredient. While this risk is noted, these reactions are not generally classified in the 'common' adverse reaction categories.


Q: Will Caudaline make me feel tired or drowsy?

A: Tiredness or drowsiness is not specifically listed as a common side effect in the official product information. However, patients commonly report headache and dizziness, which are related to the central nervous system.


Q: What happens if I accidentally miss a dose of Caudaline?

A: According to the official patient information, if a dose is missed, it should be taken as soon as it is remembered. However, if it is almost time for the next scheduled dose, the missed dose should be skipped entirely, and the regular schedule resumed.


Q: Will Caudaline interact with my seasonal allergy medicine?

A: Caudaline is known to interact with many different medications because of how it is processed by specific liver enzymes (CYP3A4 and CYP2C19). Official information advises caution and a comprehensive check regarding all other treatments, including over-the-counter and seasonal allergy medications.


Q: Is Caudaline known to cause mood changes or anxiety?

A: Mood changes and anxiety are not among the most frequently reported adverse reactions listed in regulatory documents. The official label reports other effects related to the central nervous system, but not mood disorders specifically.


Q: How long does it take for Caudaline to be completely out of my system?

A: Official pharmacological data show that the half-life of Caudaline is approximately 11 to 13 hours. The half-life is the time it takes for the body to eliminate half of the drug's concentration.


Q: Are there any specific lab tests needed before starting Caudaline?

A: While not always mandatory before treatment begins, regulatory safety information recommends periodic blood tests during therapy. These tests are used to monitor for rare but serious adverse reactions affecting blood cell counts, such as low white blood cell counts.


Q: What if I'm taking multiple medications; how do I check for Caudaline interactions?

A: Official drug information strongly advises that patients always maintain and provide a complete list of all prescription and non-prescription medications, including supplements and vitamins, to their healthcare professional. This facilitates a comprehensive interaction assessment.


Q: Does Caudaline affect blood sugar levels?

A: The official adverse reaction list has included occasional reports of increased blood sugar levels in patients taking Caudaline. Studies involving diabetic patients have been conducted, but this effect is not universally reported as a common side effect.


Q: Does smoking affect how well Caudaline works?

A: Regulatory guidance notes that patients are generally advised to stop smoking. Lifestyle modification, including smoking cessation, is often considered a prerequisite for treatment, as smoking can worsen the underlying circulatory condition the medication is intended to address.


Q: What should I avoid doing right after taking a dose of Caudaline?

A: Patients must avoid consuming food for a defined period after taking a dose. Official administration instructions clearly require that the medication be taken on an empty stomach, specifically either 30 minutes before or 2 hours after a meal.

How should Caudaline be stored and disposed of?

Official Storage and Disposal Instructions for Caudaline

Caudaline must be stored according to official regulatory labeling to maintain its stability and effectiveness.

Storage Requirement Official Classification/Action
Temperature Store at Controlled Room Temperature (20 C to 25 C / 68 F to 77 F). Do not freeze or expose to excessive heat.
Protection Keep in the original container, which must be tightly closed. Protect from both light and moisture.
In-Use Stability Once the container is opened, discard any remaining product after 60 days. Do not use beyond the printed expiration date.
Child Safety Store Caudaline out of the sight and reach of children. The product is supplied in child-resistant packaging.

Disposal: Unused or expired Caudaline must not be placed in household trash or poured down a sink or toilet. Dispose of the medication through an authorized drug take-back program or official collection site. This procedure ensures proper handling and prevents environmental contamination, aligning with pharmaceutical waste guidelines.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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