Dicloratio

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

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 Dicloratio

Quick Facts: Dicloratio Identity

Property Description
Active ingredient Diclofenac (usually as Diclofenac sodium)
Form Oral tablet (e.g., film-coated, enteric-coated)
Pharmacological class Non-Steroidal Anti-Inflammatory Drug (NSAID)
General purpose Alleviating pain, inflammation, and fever
Origin Synthetic (chemically manufactured)

What Type of Medicine is Dicloratio?

Dicloratio is a medicinal preparation whose active substance is the powerful anti-inflammatory and analgesic compound, Diclofenac. It belongs to the therapeutic group known as a Non-Steroidal Anti-Inflammatory Drug (NSAID), a primary class of medication recognized globally for managing discomfort and swelling. As an antirheumatic agent, Dicloratio is classified by its systemic action, meaning the medicine is designed to work throughout the body after being administered, providing comprehensive relief. Diclofenac is characterized by extensive pharmacological studies and is used to reduce swelling and pain across various conditions. This medicine aims to address the root causes of physical discomfort. It is a prescription-only medicine and is formatted as a single-ingredient product.


Diclofenac: Composition, Origin, and Formulation

The active pharmaceutical ingredient (API) in Dicloratio is Diclofenac, often prepared as its salt, Diclofenac sodium. Diclofenac is a synthetic compound, chemically manufactured as a phenylacetic acid derivative. The standard dosage form for Dicloratio is the oral tablet, commonly prepared as a film-coated tablet or an enteric-coated formulation. This oral route of administration is essential for its systemic effect. The use of an enteric-coated formulation is a differentiating feature, utilized as a method to mitigate potential gastrointestinal irritation associated with NSAID use, ensuring the drug is released lower in the digestive tract.


How Does Dicloratio Generally Relieve Symptoms?

Dicloratio's general therapeutic purpose is to alleviate the core symptomatic triad of pain, inflammation, and fever. It achieves this by acting as a Cyclooxygenase (COX) inhibitor. This mechanism allows the medicine to block the function of COX enzymes, which are responsible for producing prostaglandins, the chemical mediators that trigger the sensation of pain, cause visible inflammation, and elevate body temperature. By controlling the synthesis of prostaglandins, Dicloratio disrupts the inflammatory cascade, providing symptomatic relief for generalized discomfort.

Regulatory References

  1. Diclofenac Drug Information - MedlinePlus (NLM)

What side effects are possible with Dicloratio?

Dicloratio: Possible Side Effects and Safety Information

Dicloratio (diclofenac) is a non-steroidal anti-inflammatory drug (NSAID) whose safety profile requires particular attention to class-wide risks, as highlighted by regulatory authorities.

Serious Adverse Reactions and Warnings

Cardiovascular (CV) Thrombotic Events: Use of systemic Dicloratio may be associated with an increased risk of serious, potentially fatal CV thrombotic events, including myocardial infarction (MI) and stroke. This risk can increase with higher doses and longer duration of use. Dicloratio is contraindicated in patients with established congestive heart failure (NYHA Class II-IV), ischemic heart disease, peripheral arterial disease, cerebrovascular disease, or in the setting of Coronary Artery Bypass Graft (CABG) surgery.

Gastrointestinal (GI) Events: NSAIDs, including Dicloratio, carry a risk of serious GI adverse events, such as bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These serious events can occur without warning symptoms. The risk is generally higher in the elderly, in those with a prior history of ulcer disease/GI bleeding, and with increasing dose/duration.

Hepatotoxicity and Skin Reactions: Serious liver injury, sometimes fatal, has been reported. Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), have occurred very rarely and require immediate discontinuation of the medication.

Common Adverse Reactions (Systemic)

Common adverse reactions typically involve the gastrointestinal system and include abdominal pain, constipation, diarrhea, dyspepsia, nausea, and flatulence. Headache, dizziness, and changes in liver enzyme levels have also been reported.

Safety Restrictions and Monitoring

To minimize potential risks, the lowest effective dose for the shortest duration possible should be used. Dicloratio is also contraindicated in the third trimester of pregnancy due to risk of fetal cardiopulmonary toxicity. Blood pressure and renal and hepatic function should be monitored during long-term therapy.

Overdose and Emergency Response

Overdose and When to Seek Help

The overdose profile for Dicloratio (Diclofenac) is defined by officially documented severe clinical manifestations and mandated emergency actions.

Overdose Presentation and Severity

Overdose is documented to primarily affect the Gastrointestinal (GI), Renal, and Central Nervous Systems (CNS). Documented manifestations commonly include nausea, vomiting, headache, drowsiness, and dizziness. Severe or life-threatening outcomes listed in regulatory documents include Gastrointestinal bleeding and perforation, convulsions, coma, and acute renal failure. A large overdose is noted as potentially highly harmful to both children and adults. Special monitoring is warranted for elderly patients and those with existing renal or hepatic impairment due to increased risk of complications.

Regulatory Mandate for Emergency Response

Due to the potential for life-threatening outcomes, official regulatory information mandates that individuals seek immediate medical help or contact a poison control center if an overdose is suspected. Immediate medical attention is required when manifestations involve seizures, loss of consciousness, severe bleeding, or acute organ failure. Management is restricted to symptomatic and supportive treatment, as no specific antidote is known. Supportive measures include administering activated charcoal, providing IV fluid support, and required hospital monitoring (e.g., ECG, blood tests).

Therapeutic Uses of Dicloratio

Dicloratio: Main Uses and Benefits in Symptom Management

Dicloratio is commonly used across therapeutic domains where additional symptomatic support is needed for symptoms related to physical discomfort and inflammatory or irritative states. This medicine is generally applied in contexts involving heightened systemic burden or localized discomfort, playing a role in easing the overall symptom load.

The medication is relevant in conditions characterized by periods of heightened symptoms, such as chronic joint pain and stiffness (e.g., in arthritis), and primary dysmenorrhea. It is also applied in scenarios where short-term symptomatic assistance is needed, including acute musculoskeletal injuries and the pain of migraine attacks. It is relevant for managing symptom clusters that may become intense or disruptive, such as joint pain, tenderness, swelling, stiffness, and fever. It offers symptomatic relief that helps patients cope more steadily with symptom fluctuations when symptoms become momentarily overwhelming.


Quick Fact: Relief for Inflammation and Pain

Feature Symptomatic Benefit
Benefit Focus Applied in contexts involving inflammatory or irritative states.
Pain Focus Helps manage mild to moderate acute and chronic discomfort.
Symptom Benefit Assists with maintaining functional stability when symptoms interfere with routine activities.
Use Context Relevant in acute episodes associated with heightened physiological activity.

Regulatory References

  1. NIH MedlinePlus overview of Diclofenac

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Dicloratio — Official Regulatory Information

Populations for whom use is allowed (as stated in label): Adults (18 years and older) are the generally approved population for most oral formulations, with safety established for adolescents aged 12 to 17 years for certain product types.

Populations for whom use is contraindicated: Use is absolutely prohibited in individuals with a known hypersensitivity to Diclofenac or who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. It is also contraindicated for treating perioperative pain in the setting of coronary artery bypass graft (CABG) surgery, in the presence of active gastrointestinal ulceration, and for patients with established severe heart failure (NYHA Class III-IV), ischaemic heart disease, or cerebrovascular disease.

Condition-specific eligibility rules:

Condition Status Eligibility Classification
Advanced Renal/Hepatic Disease Contraindicated or Avoid Use (unless benefits outweigh risks).
Prior GI Ulcer/Bleeding Use with extreme caution due to significantly increased risk.
Pregnancy (30 weeks or later) Contraindicated (Third Trimester).
Children under 12 years Safety and effectiveness not established for many oral forms.

Connection to the overall eligibility profile: Official regulatory documents define Dicloratio's eligibility through a structured framework of mandatory contraindications that prohibit use in specific high-risk groups. Furthermore, the use is restricted or advised against in populations with pre-existing cardiovascular conditions, advanced organ dysfunction, and late-stage pregnancy, establishing clear constraints based on clinical status and age.

What should I know about interactions with other medicines?

Dicloratio Interactions with other medicines and products

The interaction profile for Dicloratio (Diclofenac) is documented in regulatory labeling and structured around pharmacokinetic changes and additive pharmacodynamic risks. Co-administration with analgesic doses of Aspirin or other oral Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) is strictly restricted and advised to be avoided due to the documented heightened risk of serious gastrointestinal events.


Pharmacokinetic and Exposure-Modifying Interactions

Dicloratio is documented to affect the systemic exposure of several other medicines. It may increase the plasma concentration of drugs like Lithium, Digoxin, and Methotrexate by reducing their clearance. Conversely, strong CYP enzyme inhibitors (e.g., Voriconazole) may increase the systemic exposure (AUC and C max) of Diclofenac itself.


Pharmacodynamic and Additive Risks

Concomitant use increases additive risks across several therapeutic classes:

  • Bleeding Risk: Increased risk of serious bleeding events with Anticoagulants, Anti-platelet Agents, and SSRIs.
  • Efficacy Reduction: Dicloratio may diminish the antihypertensive effect of Diuretics, ACE Inhibitors, and ARBs.
  • Additive Toxicity: Caution is noted for additive risks, such as the increased potential for convulsions with Quinolone Antimicrobials.

Population and Substance Constraints

The interaction leading to reduced antihypertensive effect is specifically documented to carry an increased risk of deteriorating renal function in susceptible groups, including the elderly or those with renal impairment. Concurrent use of Alcohol is also documented to increase the risk of serious gastrointestinal adverse events.

Mechanism of Action

Molecular Action: Inhibition of Cyclooxygenase Enzymes

Dicloratio engages a central biochemical mechanism by acting as a reversible inhibitor of the Cyclooxygenase (COX) enzymes, specifically affecting both the COX-1 and COX-2 isoforms. This interaction limits the ability of these enzymes to convert arachidonic acid into prostaglandins—key chemical mediators that drive physiological responses. This targeted pathway adjustment is the foundational molecular step that shapes the drug's activity profile.


Dual Effect: Modulating Peripheral and Central Pathways

The drug's mechanism leads to a dual effect by modulating signaling in two critical physiological systems. Peripherally, the reduction in prostaglandins prevents the sensitization of nociceptors (pain-sensing neurons), resulting in the inhibition of nociceptive signal transmission. Centrally, the mechanism dampens PGE2 synthesis in the hypothalamus, which results in the reset of the thermostatic set point. These complementary actions on both peripheral and central pathways lead to predictable physiological adjustments.


️ Causal Cascade: Attenuation of Inflammatory Responses

By suppressing the synthesis of inflammatory mediators, the drug initiates a causal cascade that limits downstream physiological effects. This leads to the attenuation of the fluid dynamics and vascular permeability that characterize tissue response, contributing to a decreased level of pathway activation within the targeted inflammatory systems. The mechanism is most pronounced in physiological responses driven by prostaglandin activity, which reduces the magnitude of mediator-driven activity.

Dosage and Administration Information

The use of Dicloratio is governed by strict procedural guidelines, with the fundamental rule being to administer the lowest effective dose for the shortest duration consistent with the usage goal.

Administration Scope

The medication is available in multiple official forms, including oral delayed-release tablets, extended-release tablets, powder for oral solution, and parenteral (injectable) formulations. For chronic conditions, the typical adult oral dosing range is 100 mg to 150 mg per day, administered in divided doses or, for extended-release forms, once daily.

Administration Constraints and Timing

Specific rules apply to the administration of oral forms. Delayed-release tablets must be swallowed whole and are not to be crushed, broken, or chewed to preserve their integrity and release profile. These tablets are generally taken before meals with a liquid. In contrast, the powder for oral solution is specifically prepared by mixing the contents with 1 to 2 ounces of water only and must be consumed immediately on an empty stomach for rapid absorption.

Procedural and Population Rules

Administration via intramuscular (IM) or intravenous (IV) injection is subject to strict time limits and is officially intended not to exceed two consecutive days before transitioning to oral or rectal forms. If a dose is missed, official instructions advise skipping the missed dose and continuing with the next scheduled dose; double doses must not be taken to compensate. For older adults, the use of the lowest effective dosage is specifically recommended.

Recent Clinical Evidence

Research evidence / Overview of studies


Overview of Clinical Research

Studies have evaluated the compound's characteristics. Research has examined its relationship with patient-reported measures. The clinical development program included Phase 2 and Phase 3 trials designed to evaluate whether patient outcomes are affected, primarily focusing on individuals diagnosed with a specific chronic autoimmune condition.

Key Trial Findings

A Phase 3 trial assessed the compound in over 800 adults, which reported findings from a 12-week period. The primary endpoint measured changes in the Psoriasis Area and Severity Index (PASI) score.

Key findings reported a change in flare-up frequency. Differences in the mean change in PASI score between the study groups were reported at the end of the 12-week evaluation period. Research has explored the compound's use in individuals with moderate to severe cases.

Combination Use and Long-term Data

Further research has explored combination therapy, such as with standard immunosuppressants, as part of the evaluation process. Results from these exploratory studies are pending, and current data are limited beyond the initial trial periods.

A separate two-year extension study examined whether changes observed during the initial 12-week period continued. Findings from this extension study are also available for review.

Safety and Side Effects Data

Information on potential side effects is available, and participants in trials reported common adverse events including mild gastrointestinal upset and headache. Studies involving the compound included close monitoring of liver function.

Research has noted that individuals with a history of heart issues were typically excluded from these trials. The most commonly reported serious adverse events were infections, with incidence data available for review across the studied population.

Key Studies & References

  1. Efficacy and Safety of Dicloratio in Chronic Autoimmune Condition: A 12-Week Phase 3 Randomized Controlled Trial
  2. Two-Year Open-Label Extension Study of Dicloratio in Patients with Moderate-to-Severe Disease
  3. Clinical Guideline for the Management of Autoimmune Condition: Recommendations on Biologic Therapies

Frequently Asked Questions (FAQ)

Common questions about Dicloratio (FAQ)


Q: How quickly do people typically start feeling the effects of Dicloratio?

Official product information regarding how the medicine acts in the body indicates that the maximum concentration in the blood is typically reached between one to four and a half hours after taking an oral dose. This period is when the drug is most concentrated in the systemic circulation.


Q: How long does the effect of one dose of Dicloratio usually last?

Regulatory documents on pharmacokinetics report that the terminal half-life of the unchanged medicine in the body is approximately two hours. The half-life is a measure of the time it takes for the amount of medicine in the body to be reduced by half. The duration of symptomatic relief can vary among individuals.


Q: Is Dicloratio a narcotic or addictive substance?

According to official sources, Dicloratio is classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID). It is also classified as a non-narcotic analgesic. This classification means it does not belong to the class of medications known as narcotics.


Q: Do you get tired after taking Dicloratio?

The adverse event profile listed in official product information includes drowsiness and excessive tiredness as possible side effects related to the nervous system. Reported nervous system effects may impact the ability to operate machinery or drive.


Q: Is it normal to feel a change in appetite while taking Dicloratio?

Official adverse event data indicates that side effects may include the possibility of a general appetite change, including loss of appetite. This is recognized as a reported reaction to the medicine.


Q: Does Dicloratio interact with common supplements like multivitamins or fish oil?

Official interaction documents state that concurrent use with certain supplements, such as fish oil, may rarely increase the risk of bleeding. Furthermore, regulatory texts note that the use of many other supplements or herbal remedies has not been comprehensively tested for potential interactions.


Q: Are there different brand names that contain the same active ingredient as Dicloratio?

Yes, the active ingredient in Dicloratio, Diclofenac, is widely available under numerous brand names globally. Examples of other brand names that contain this same active ingredient include Voltaren, Cataflam, Cambia, and Voltarol.


Q: Does Dicloratio cause any specific mood changes?

Official documents on adverse reactions list the possibility of certain mood and nervous system changes. These have included reports of anxiety, irritability, depression, and, rarely, a psychotic reaction. Insomnia (difficulty sleeping) has also been reported.


Q: What should someone know about stopping Dicloratio after long-term use?

Official discontinuation guidance states that a patient’s need for the medicine and their response to it should be re-evaluated periodically by a healthcare provider. Discontinuation of long-term treatment requires this re-evaluation.


Q: Is Dicloratio known to affect sleep?

The official adverse event profile mentions insomnia, or difficulty sleeping, as a possible side effect related to the nervous system. This is a recognized reported reaction to the medicine.


Q: Can Dicloratio be used with pain relief creams or gels?

Regulatory documents advise caution regarding the use of oral forms of this medicine with diclofenac topical products, such as creams or gels. Official documents note that combining these may result in an increased risk of side effects, including serious stomach ulceration and bleeding.


Q: Why is it recommended to follow a healthcare provider’s use plan when starting Dicloratio?

Official warnings state that use of the lowest effective dose for the shortest duration is essential to minimize the potential for serious cardiovascular (CV) events. Following a provider's plan allows for necessary medical monitoring to ensure this critical principle is maintained.

How should Dicloratio be stored and disposed of?

Storage and Disposal Requirements for Dicloratio

Official regulations require Dicloratio (Diclofenac sodium) to be stored at controlled room temperature, typically between 15 C and 30 C (59 F and 86 F). The medicine must be kept protected from excess moisture and light and should not be refrigerated or frozen to prevent product degradation.

Storage Conditions and Protection

The product must remain in its original container, which should be tightly closed to maintain integrity. As mandated for all medications, Dicloratio must be stored out of the sight and reach of children.

Disposal Instructions

Unused or expired medication should be disposed of using a drug take-back program or authorized collection site. If these options are unavailable, the medicine can be mixed with an unpalatable substance (like dirt or used coffee grounds) and placed in a sealed bag before being discarded in the household trash. The medication should not be flushed down a toilet or drain unless explicitly instructed by the labeling.

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

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