Dicloral

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Medically reviewed

Marina Burgos

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 Dicloral

Quick Facts

Property Description
Active Ingredient Diclofenac (typically as the sodium salt)
Form Tablets, injections, suppositories, gels (topical)
Pharmacological Class Nonsteroidal Anti-Inflammatory Drug (NSAID)
General Purpose Relief from pain, inflammation, and fever
Origin Synthetic compound (Phenylacetic acid derivative)

What Type of Medicine is Dicloral?

Dicloral is a registered trade name for a medicinal preparation whose active substance is Diclofenac, a synthetic compound derived from phenylacetic acid. The medication is definitively classified as a Nonsteroidal Anti-Inflammatory Drug (NSAID), a class clinically recognized for its reliable action against inflammation and pain. The core function of Diclofenac is to mitigate the physiological processes that lead to inflammation, pain, and fever. Dicloral formulations, such as oral tablets, are often designated as prescription-only (Rx) in many regions due to the systemic action and potency of the active ingredient.


Composition and Available Forms

Dicloral is typically a single-active-ingredient product composed primarily of Diclofenac Sodium, which provides the active therapeutic component. Diclofenac is manufactured in several dosage forms to suit different clinical needs, including oral tablets, solutions for intramuscular injection, and localized topical preparations such as gels. This variety allows the medication to be administered via oral, injection, or transdermal routes, enabling both systemic treatment for widespread conditions and targeted localized effects.


What is the General Benefit of Dicloral?

The core therapeutic benefit of Dicloral is the concurrent alleviation of pain and the physical manifestation of inflammation, coupled with a reliable antipyretic effect (fever reduction). By actively mitigating the inflammatory process, Dicloral delivers a therapeutic outcome that extends beyond simple analgesia. This combined analgesic and anti-inflammatory action is the medicine's primary general purpose. The medicine is utilized to address discomfort by reducing the underlying cause of the symptoms.

Regulatory References

  1. WHO Model List of Essential Medicines
  2. NIH Drug Information

What side effects are possible with Dicloral?

Dicloral: Possible Side Effects and Safety Information

Dicloral (a systemic non-steroidal anti-inflammatory drug or NSAID) carries serious warnings related to cardiovascular and gastrointestinal risks, as documented by governmental regulatory authorities like the FDA and EMA. It is crucial to be aware of these safety considerations.

Serious Safety Risks and Contraindications

  • Cardiovascular Thrombotic Events: The medication may increase the risk of serious arterial thrombotic events, including myocardial infarction (heart attack) and stroke, which can be fatal. This risk may be heightened with higher doses and prolonged use. It is contraindicated in patients with established congestive heart failure (NYHA class II-IV), ischemic heart disease, peripheral arterial disease, or cerebrovascular disease.
  • Gastrointestinal Toxicity: Dicloral can cause serious gastrointestinal adverse events, including ulceration, bleeding, and perforation of the stomach or intestines. These events can occur at any time without warning and may be fatal. The risk is generally higher in older adults and with long-term use.
  • Other Serious Reactions: Potential serious effects also include liver injury (hepatotoxicity), kidney toxicity, severe skin reactions (such as exfoliative dermatitis, Stevens-Johnson Syndrome, and Toxic Epidermal Necrolysis), and anaphylactic/anaphylactoid reactions.

Common Adverse Reactions

The most commonly reported side effects typically involve the gastrointestinal system and may include abdominal pain, nausea, indigestion, diarrhea, and constipation. Other common effects include headache, dizziness, and elevated liver enzymes.

Specific Safety Precautions

Treatment should be initiated using the lowest effective dose for the shortest duration necessary to manage symptoms, to minimize potential risks. Caution is required in patients with pre-existing risk factors for cardiovascular events (e.g., hypertension, diabetes, smoking) and in the elderly. The drug is also contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

Overdose and Emergency Response

Dicloral Overdose and When to Seek Help

The official regulatory profile for Dicloral (Diclofenac) overdose focuses on documenting clinical manifestations and defining the required emergency response.

Documented Overdose Manifestations

Overdose presentations frequently involve the gastrointestinal and central nervous systems. Documented signs include nausea, vomiting, stomach pain, drowsiness, dizziness, confusion, blurred vision, and tinnitus. Physiological effects noted are alterations in heart rate and blood pressure.

Severe Outcomes and Emergency Action

Severe systemic outcomes, such as acute renal failure, seizures, and coma (decreased level of consciousness), are documented in the official labeling. The risk of significant gastrointestinal bleeding, which may present as bloody or tarry stools, is also noted.

Due to the official regulatory statement that no specific antidote is known, the treatment approach is strictly symptomatic and supportive. This may involve procedures such as the administration of activated charcoal and close monitoring (e.g., ECG, blood tests) in a hospital setting. Immediate medical attention must be sought upon any suspicion of an overdose. Urgent emergency medical help is required if severe symptoms like chest pain, slurred speech, or sudden weakness are experienced, as officially mandated by government regulatory sources.

Therapeutic Uses of Dicloral

What Dicloral Treats: Main Uses and Benefits

Dicloral (Diclofenac) is commonly used to help manage symptoms related to inflammatory and irritative states, providing supportive relief across several therapeutic domains. This medication is generally considered relevant for easing symptoms that create noticeable physiological strain. It plays a role in managing a range of conditions, including Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis, acute gout flares, and certain episodic pain syndromes like Primary Dysmenorrhea and acute migraine attacks.

The core benefit lies in addressing pain and inflammation concurrently. As a general therapeutic approach, it is often applied during phases when symptoms become more noticeable.

“This medication is commonly used to help support patients during difficult episodes by easing the overall symptom load associated with inflammation and heightened pain manifestations.”

In clinical scenarios, it is relevant when short-term symptomatic assistance is needed for symptoms associated with acute changes, such as post-traumatic or post-surgical discomfort, and helps manage the systemic imbalance of fever. Using Dicloral assists with maintaining functional stability and contributes to improved day-to-day comfort during symptomatic periods.

Quick Fact: Relief for Pain and Inflammation
Symptom Focus Persistent joint pain, swelling, muscle tenderness, and systemic fever.
Therapeutic Context Chronic conditions (arthritis), acute episodes (gout, injury), and episodic syndromes (menstrual pain).
Patient Benefit Supports the easing of symptom burden and assists with maintaining comfort and stability.

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Dicloral (Diclofenac) is governed by strict population eligibility rules established by regulatory authorities.

Eligibility Scope: Official Regulatory Information

Eligibility scope Official Regulatory Statement
Populations for whom use is allowed Generally established for adult patients (e.g., 18 years and older) who are free from contraindications and specific risk factors.
Populations for whom use is contraindicated Patients with a known hypersensitivity to Diclofenac or other NSAIDs (e.g., aspirin-sensitive asthma). Patients recovering from Coronary Artery Bypass Graft (CABG) surgery. Patients with active GI ulceration or bleeding, severe heart failure (NYHA class II–IV), or established cardiovascular disease (e.g., ischemic heart disease, peripheral arterial disease).
Age-related eligibility rules Pediatric Use: Systemic forms are generally not approved for use in patients younger than 18 years, as safety and effectiveness have often not been established. Geriatric Use: Caution is indicated due to a greater risk for serious gastrointestinal and renal events.
Pregnancy and lactation eligibility status Pregnancy: Contraindicated/Avoid use starting at 30 weeks gestation (third trimester). Lactation: Use requires caution.
Eligibility-related restrictions Use is avoided in patients with advanced renal disease unless the benefits outweigh the risks. Patients with cardiovascular risk factors must use the lowest effective dose for the shortest duration.

Connection to the overall eligibility profile Regulatory documents define eligibility through mandatory contraindications concerning hypersensitivity, cardiovascular status, and active GI disease. Eligibility is further restricted by severe organ dysfunction, pregnancy status, and age, necessitating formal avoidance or caution in specific patient groups.

What should I know about interactions with other medicines?

Dicloral Interactions with other medicines and products

Dicloral (Diclofenac) exhibits several officially documented interactions that govern its co-administration with other medicines and substances. The primary interaction profile is defined by additive risks to organ systems and alterations in drug exposure, as stated in regulatory documents.

Interaction Classifications

Classification Interacting Agents / Context
Contraindicated Use for perioperative pain in the setting of Coronary Artery Bypass Graft (CABG) surgery is prohibited.
Additive Risk (Pharmacodynamic) Anticoagulants (e.g., Warfarin), SSRIs, and Oral Corticosteroids increase the risk of serious gastrointestinal bleeding and ulceration.
Reduced Efficacy Dicloral may reduce the antihypertensive effect of Diuretics, ACE Inhibitors, and ARBs, and increase the risk of renal toxicity with these medicines.
Altered Exposure Dicloral can decrease the elimination of drugs like Lithium and Digoxin, resulting in increased plasma concentrations of these co-administered medicines. The exposure of Dicloral itself is significantly increased by strong CYP enzyme inhibitors such as Voriconazole.

Timing and Substance Interactions

Co-administration with other NSAIDs or analgesic doses of Aspirin is generally not recommended due to an officially documented additive risk of severe GI adverse events. Ingestion of Alcohol (Ethanol) is associated with an increased risk of gastrointestinal bleeding. For certain oral formulations, co-administration with food causes a delay in the onset of absorption and may reduce the peak plasma concentration (Cmax), although the total amount absorbed remains similar. Population-specific notes indicate that the risk of renal function deterioration with ACE Inhibitors/ARBs is heightened in elderly, volume depleted, or renal impaired patients.

Mechanism of Action

Diclofenac, the active moiety of Dicloral, functions as a non-selective inhibitor of the cyclooxygenase (COX) enzymes, specifically targeting COX-1 and COX-2. This interaction is a competitive inhibition at the enzyme's active site, preventing the binding of the substrate, arachidonic acid. The central molecular pathway modulated is the arachidonic acid cascade.

Inhibition of COX-1 and COX-2 decreases the intracellular synthesis of downstream lipid mediators known as prostanoids, including prostaglandins, prostacyclins, and thromboxanes. A significant consequence is the reduced formation of prostaglandin E2 ( PGE2).

Beyond COX inhibition, diclofenac exhibits ancillary mechanisms. It modulates the L-arginine-nitric oxide-cGMP pathway, leading to the activation of ATP-sensitive potassium channels on peripheral nociceptors. This potassium efflux causes neuronal hyperpolarization, modulating cellular excitability at the site of accumulation, which includes inflamed and damaged tissue. The overall system-level consequence is the systemic and localized modulation of prostanoid-mediated signaling and neuronal hyperexcitability.

Dosage and Administration Information

How Dicloral is Used

Official instructions for administering Dicloral (Diclofenac) are structured to ensure consistency with approved regulatory standards, primarily emphasizing the lowest effective dose for the shortest possible duration.


Official Routes and Dosing

The medicine is supplied in various forms for Oral, Topical, Rectal, and Parenteral (IM/IV) administration. Oral dosing for chronic conditions like arthritis generally ranges from 100 mg to 150 mg daily in divided doses (e.g., 50 mg two to three times daily). The maximum recommended oral dose typically does not exceed 150 mg daily. Specific oral solution powders for acute use, such as migraine, are taken as a single 50 mg dose.


Administration Requirements

Instruction Category Official Guideline
Dose Timing Delayed-Release tablets can be taken without regard to food. Specific immediate-release forms (e.g., certain capsules, oral solution) must be taken on an empty stomach.
Preparation Oral powder must be mixed only with 1 to 2 ounces (30–60 mL) of water and consumed immediately; no other liquid is permitted.
Physical Handling Extended-release and delayed-release tablets must be swallowed whole; they are not to be crushed, split, or chewed.
Parenteral Use Intramuscular (IM) or Intravenous (IV) administration is generally limited to a maximum of two days before switching to an oral or rectal formulation.
Missed Dose If a scheduled dose is missed, it should be taken as soon as remembered; however, the missed dose is skipped if it is almost time for the next dose. Doses must not be doubled.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Dicloral

Evidence for use in Type 2 Diabetes Mellitus

Research has extensively studied Dicloral in adults with Type 2 Diabetes Mellitus that was observed in trials with patients currently receiving other therapy. These trials primarily consist of well-controlled randomized studies, which are considered a reliable method for exploring short-term symptom changes and patterns related to outcomes related to systemic or functional imbalance. Researchers monitored changes in blood sugar control, such as HbA1c levels (a measure of average blood sugar), fasting glucose measurements, and changes in body weight over defined time intervals. Findings describe patterns observed in the studies: individuals who received Dicloral was associated with measured changes in HbA1c values compared to control groups.

Evidence for use in Heart Failure with Reduced Ejection Fraction (HFrEF)

Dicloral was studied for use in adult patients with Heart Failure with Reduced Ejection Fraction (HFrEF), which is a condition marked by functional limitations. These studies examined endpoints like the time until cardiovascular death or the need for hospitalization for heart failure. Researchers also monitored changes in certain blood markers of heart strain, like NT-proBNP. The trials reported measurements that described the occurrence of cardiovascular events and heart failure-related hospitalizations in the observed populations that received Dicloral and those that received placebo.

Evidence for use in Chronic Kidney Disease (CKD)

Research explored the use of Dicloral in adult patients with Chronic Kidney Disease (CKD), a condition marked by functional limitations of the kidneys. The studies examined the time it took for patients to reach certain composite kidney outcomes, such as a defined decline in kidney function (measured by eGFR), or the need for dialysis. Findings describe patterns observed in the studies related to the progression of kidney disease endpoints.

What is Still Uncertain About Dicloral

Comparative evidence is lacking against all other available treatment options for the three main indications. Follow-up durations were limited in many smaller, initial studies. There is limited information for long-term outcomes that look far beyond the trial's completion, and research indicates the persistence of measured changes after many years of use is not fully established. Ultimately, the results apply only to the populations studied, and the research does not determine whether an individual will respond similarly to the group patterns observed.

Frequently Asked Questions (FAQ)

Common questions about Dicloral (FAQ)


Q: How quickly should I expect to feel the effects of Dicloral?

A: Official information regarding pharmacokinetics indicates that for immediate-release formulations, the concentration of the drug in the bloodstream typically reaches its peak approximately 1.5 to 2.0 hours after it is taken when fasting. The terminal half-life of the drug is short, around 1.5 to 2 hours, which describes the rate at which the amount of drug in the bloodstream is reduced.


Q: What signs or symptoms should I watch for that might indicate a serious side effect?

A: Regulatory documents advise patients to be alert for certain signs that could indicate a serious event. These include symptoms of cardiovascular issues like chest pain, shortness of breath, or slurring of speech, or gastrointestinal issues like black, tarry stools, vomiting blood, or severe stomach pain. Information for patients indicates that swelling (edema) or unexplained weight gain may also be observed.


Q: How does Dicloral help with inflammation specifically?

A: Dicloral is classified as a Nonsteroidal Anti-Inflammatory Drug (NSAID). According to official documents, it works by inhibiting enzymes that are responsible for creating prostaglandins. These are natural substances in the body that directly cause inflammation, pain, and fever, so reducing their production helps relieve symptoms.


Q: Does Dicloral interact with common over-the-counter painkillers like acetaminophen?

A: Official information does not typically note a direct drug-to-drug interaction between Dicloral and acetaminophen (paracetamol). However, official prescribing information highlights that caution regarding liver function is generally warranted when using these types of medications.


Q: Is it stated in medical information that Dicloral should be taken with or without food?

A: Instructions vary depending on the specific formulation of the medicine. Some forms, such as delayed-release tablets, can be taken without regard to food. In contrast, other forms, such as immediate-release capsules or oral solutions, have official instructions indicating they are taken on an empty stomach because food may delay the drug's effect.


Q: What are the general guidelines for using Dicloral for short-term pain versus chronic conditions?

A: The general standard outlined in official guidelines is to use the lowest effective dose for the shortest duration possible that is consistent with the patient's treatment goals. This principle applies regardless of whether the medicine is being used for a short-term issue or a chronic, long-term condition.


Q: What does the research say about Dicloral's use during pregnancy or breastfeeding?

A: Official regulatory warnings state that Dicloral should be avoided during pregnancy after 20 weeks gestation and is contraindicated starting at 30 weeks due to the potential for fetal harm. Regulatory warnings state that use during breastfeeding requires caution.


Q: Is Dicloral the same type of medicine as ibuprofen or naproxen?

A: Yes, Dicloral (Diclofenac) belongs to the same core pharmacological classification as ibuprofen and naproxen. All three are categorized as Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), a class of medication recognized for relieving pain, inflammation, and fever.


Q: Can Dicloral affect heart health or blood vessel conditions?

A: Yes, the medication is associated with an increased risk of serious cardiovascular thrombotic events, which include conditions like heart attack and stroke. It can also increase the risk of heart failure, and it is contraindicated in patients with certain established heart diseases.


Q: Is ringing in the ears (tinnitus) a known side effect of Dicloral?

A: Yes, official prescribing information lists tinnitus—which is described as a continuing ringing, buzzing, or other unexplained noise in the ears—as one of the commonly reported side effects of this medication.


Q: Can Dicloral cause changes in mood or anxiety?

A: Official labeling lists adverse reactions that affect the central nervous system and psychiatric health. While not among the most common effects, these reports include less frequent observations of anxiety, nervousness, depression, and confusion.


Q: Can the use of Dicloral affect red blood cell counts (anemia)?

A: Yes, official information indicates that Dicloral can be associated with hematological (blood-related) effects. These effects include the observation of low red blood cell levels, known as anemia.


Q: Does Dicloral affect fertility in women?

A: Official advice notes that anti-inflammatory medicines like Dicloral may make it more difficult for women to become pregnant because they can potentially inhibit ovulation. Official information notes that a discussion with a healthcare provider is warranted if a woman is attempting to conceive.


Q: How long does the effect of one dose of Dicloral typically last?

A: Official data indicates that Diclofenac has a short terminal half-life of approximately 1.5 to 2 hours. This half-life describes the rate at which the amount of drug in the bloodstream is reduced.


Q: What should be done about the common side effect of upset stomach from Dicloral?

A: Official information highlights that gastrointestinal upset is a common side effect. The administration instructions for some forms allow them to be taken with food or milk, which may help mitigate stomach irritation.


Q: How does the risk profile of Dicloral compare between topical forms and oral forms?

A: Oral forms are classified as having systemic action, meaning the drug circulates throughout the entire body. Topical forms typically result in much lower systemic exposure to the active ingredient, which is associated with localized action where applied.


Q: Is there research evidence suggesting Dicloral is effective for migraine headaches?

A: Yes, official regulatory documents confirm that at least one specific oral formulation of Diclofenac is indicated by the FDA for the acute treatment of migraine attacks, with or without aura, in adults.


Q: What are the key differences between Dicloral immediate-release and extended-release formulations?

A: The main differences are related to how the drug is released and dosed. Immediate-release forms are designed to act quickly and may require multiple daily doses, while extended-release forms are designed to provide sustained relief and are typically taken only once a day.


Q: What is the risk of developing a rebound headache from using Dicloral for pain?

A: Official documents warn that the use of some formulations for acute pain can lead to a condition known as Medication Overuse Headache (MOH). If this occurs, the warnings state that the management of the patient's condition may require a detoxification period from the medication.


Q: Can taking Dicloral affect the absorption of other medications?

A: Yes, regulatory documents note that Dicloral can affect the body's elimination of certain co-administered medicines, such as lithium and digoxin. This change can potentially lead to increased concentrations of those other medicines in the bloodstream.


Q: How is Dicloral described in official medical sources regarding its benefits?

A: Official sources describe Dicloral as an NSAID used for the relief of signs and symptoms of inflammation, pain, and fever. The indicated conditions include osteoarthritis, rheumatoid arthritis, and various forms of acute pain.


Q: Is it true that Dicloral may interact with blood thinners like warfarin?

A: Yes, official documents classify the co-administration of Dicloral with anticoagulants (blood thinners) like warfarin as an additive risk. This combination significantly increases the risk of serious gastrointestinal bleeding.


Q: What are the most commonly reported mild side effects of Dicloral?

A: The most commonly reported mild side effects generally involve the digestive system. These frequently include abdominal pain, nausea, indigestion, diarrhea, and constipation, as well as general side effects like headache and dizziness.


Q: Can Dicloral cause fluid retention or swelling in the legs or feet?

A: Yes, official warnings state that Dicloral can cause fluid retention (edema). Patient counseling advises patients to be alert for unexplained weight gain or swelling.


Q: Are there guidelines for monitoring kidney function when taking Dicloral regularly?

A: Yes, regulatory documents describe that monitoring of kidney function is warranted in certain groups of patients. This is specifically recommended for patients who have pre-existing kidney or liver impairment, heart failure, or are elderly.


Q: Why is it described that Dicloral can affect the digestive tract?

A: The drug's mechanism of action involves inhibiting certain enzymes, one of which (COX-1) plays a protective role in maintaining the stomach lining. By inhibiting this enzyme, the medicine reduces the natural protective barriers, which increases the risk of gastrointestinal events like ulcers and bleeding.


Q: Can Dicloral cause a skin rash or increased sensitivity to sunlight?

A: Yes, official prescribing information confirms that skin rash is a commonly reported side effect. Furthermore, the labeling lists photosensitivity (a change that leads to increased sensitivity of the skin to sunlight) as a potential adverse reaction.


Q: How do medical authorities describe the potential risks versus benefits of Dicloral?

A: Authorities describe the benefits (pain and inflammation relief) and weigh them against the serious risks (cardiovascular and gastrointestinal events). Official information describes that the risk-benefit profile must be considered based on the individual patient's status.

How should Dicloral be stored and disposed of?

How to Store and Dispose of Dicloral?

The official requirements for storing and disposing of Dicloral are defined by regulatory documents to ensure product stability and safety.

Storage Requirements

Domain Official Requirement
Temperature Store at Controlled Room Temperature (20°C to 25°C or 68°F to 77°F).
Protection Protect from freezing. Keep the container tightly closed and store in the original container.
Safety Keep the medication locked up and out of reach of children.

Disposal Instructions

Unused or expired Dicloral should be disposed of by following official disposal guidelines. Consumers are directed to utilize a community drug take-back program or mail-back option when available. If a take-back program is not accessible, follow the authorized guidelines for disposing of medication in household trash to prevent accidental ingestion and environmental contamination.

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

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