Deflamat

Quick links to important sections

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 Deflamat

Deflamat is a combination medication containing two active components: diclofenac and misoprostol. Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID), which works by inhibiting the production of prostaglandins—chemicals in the body responsible for inflammation, pain, and fever.

Misoprostol, the second component, is a synthetic prostaglandin E1 analog. It helps to protect the lining of the stomach and intestines from the potentially irritating effects of the diclofenac, such as ulcers or bleeding.

Use and Indications

This fixed-dose combination drug is primarily indicated for managing the signs and symptoms of rheumatoid arthritis and osteoarthritis. It is specifically prescribed to adult patients who require the anti-inflammatory and pain-relieving effects of diclofenac but are considered at a high risk of developing NSAID-induced gastric or duodenal ulcers and their associated complications.

As with all prescription medications, Deflamat should be used only under the guidance of a healthcare professional, who will weigh the benefits of treatment against the potential risks, especially concerning cardiovascular and gastrointestinal safety.

What side effects are possible with Deflamat?

Possible Side Effects and Safety Information

The safety profile for Deflamat, as documented by government regulatory bodies, centers on serious life-threatening risks and a range of common, less severe adverse reactions.

Serious Safety Risks

Official regulatory documents include a Boxed Warning that highlights two major safety concerns:

  • Cardiovascular Thrombotic Events: An increased risk of serious, potentially fatal cardiovascular events, including myocardial infarction (MI) and stroke. This risk may begin early in treatment and may increase with longer use and higher doses.
  • Gastrointestinal Risk: An increased risk of serious gastrointestinal adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal.

Population-Specific Restrictions and Contraindications

The medicine is contraindicated in certain patient populations and clinical situations:

  • It must not be used in the setting of coronary artery bypass graft (CABG) surgery.
  • It is strictly contraindicated in pregnant women due to the potential for fetal harm, including the premature closure of the fetal ductus arteriosus.

Common Adverse Reactions

The documented adverse reactions are formally classified by the body system affected (System-Organ Class) and by their frequency.

Frequency Examples of Adverse Reactions (by System-Organ Class)
Common Headache, dizziness, vertigo, abdominal pain, diarrhea, nausea, dyspepsia, elevated liver enzymes, and rash.
Rare Hypersensitivity reactions, asthma, drowsiness, and hepatic disorders (e.g., hepatitis).
Very Rare Severe skin reactions (e.g., Stevens-Johnson syndrome), acute renal failure, and blood/lymphatic system disorders (e.g., agranulocytosis).

Treatment should use the lowest effective dose for the shortest possible duration consistent with individual patient goals, in line with regulatory safety recommendations.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdosage of Deflamat, a product containing diclofenac and misoprostol, is a situation that requires immediate emergency medical attention. The official regulatory profile documents clinical manifestations linked to both active components. Symptoms commonly associated with the diclofenac component include lethargy, drowsiness, nausea, vomiting, and epigastric pain, sometimes progressing to gastrointestinal bleeding. Manifestations related to misoprostol overexposure may include sedation, tremor, convulsions, breathing difficulty (dyspnea), low blood pressure (hypotension), and slow heart rate (bradycardia).

Severe outcomes documented in regulatory labeling include acute renal failure, coma, respiratory depression, and severe gastrointestinal hemorrhage. Due to these potential life-threatening complications, any suspected overdose requires immediately contacting emergency services or a Poison Control Center.

Treatment is restricted to symptomatic and supportive therapy, as no specific antidote is known for either diclofenac or misoprostol. Regulatory text describes management procedures such as administration of activated charcoal or gastric emptying if performed soon after ingestion. Monitoring of renal function, hepatic function, and vital signs is generally required. Special consideration is noted for the elderly, who face an increased risk of severe gastrointestinal effects, and for pregnant individuals, where exposure is associated with a specific, severe fetal risk.

Therapeutic Uses of Deflamat

Quick Facts

  • May assist in the relief of: Pain associated with certain inflammatory conditions
  • Commonly used for: Management of symptoms related to rheumatoid arthritis and osteoarthritis
  • Supportive use in: Certain autoimmune conditions and inflammatory skin diseases

Deflamat (Deflazacort) is a prescription medication utilized in the management of specific conditions where reducing inflammation is a therapeutic goal. Its primary uses are centered on providing symptomatic relief for individuals with certain autoimmune and chronic inflammatory disorders.

This treatment is indicated for the management of the signs and symptoms of inflammatory conditions such as rheumatoid arthritis and osteoarthritis, which involve discomfort and swelling in the joints. The medication is also employed to help manage other inflammatory disorders, including certain types of inflammatory skin diseases and allergic diseases.

Furthermore, Deflazacort is recognized for its role in the long-term management of Duchenne muscular dystrophy in patients two years of age and older. This application supports the goal of maintaining muscle function in affected individuals. The overall benefit is focused on supporting an improved quality of life and facilitating the management of challenging chronic diseases.

Eligibility and Restrictions for Use

Deflamat (diclofenac) is a non-steroidal anti-inflammatory drug (NSAID) whose use is strictly governed by patient health status, particularly concerning cardiovascular and gastrointestinal risks.

Contraindicated Populations

Use of this medicine is formally contraindicated in several groups, most notably:

  • Patients with known hypersensitivity to diclofenac, aspirin, or other NSAIDs, especially if this has triggered asthma, acute rhinitis, or urticaria.
  • Individuals with active gastrointestinal ulceration, bleeding, or perforation, or a history of recurrent peptic ulcer/haemorrhage.
  • Patients with established cardiovascular disease, including congestive heart failure (NYHA II–IV), ischaemic heart disease, peripheral arterial disease, or cerebrovascular disease. It is also contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
  • Patients with severe hepatic or severe renal failure.
  • Women in the last trimester of pregnancy.

Restrictions and Special Consideration

Caution is required for the elderly due to a generally higher risk of severe adverse events. Use is generally not recommended in children and adolescents below 14 years of age. Treatment should only be considered after careful assessment for patients with significant cardiovascular risk factors (e.g., high blood pressure, diabetes, smoking) or those with a history of gastrointestinal disorders. The medicine may impair female fertility and should be avoided by women attempting to conceive.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for diclofenac/misoprostol details several classes of substances that present significant interaction risks.

Interaction Type Interacting Substances/Classes
Contraindicated Combinations Other NSAIDs (including analgesic aspirin), Magnesium-containing antacids, and use during CABG surgery (due to diclofenac) [1.2, 2.4, 2.6].
Increased Bleeding Risk Anticoagulants (e.g., Warfarin), Antiplatelet drugs, and SSRIs/SNRIs [2.1].
Altered Drug Exposure Lithium, Digoxin, and Methotrexate, whose plasma levels may be increased to toxic levels [2.2, 2.5].
Blood Pressure Impact ACE Inhibitors, ARBs, and Diuretics, whose blood pressure-lowering or natriuretic effects may be diminished [2.4].
Organ Toxicity Risk Cyclosporine and Tacrolimus due to increased potential for nephrotoxicity [2.4].

Co-administration with alcohol is strongly advised against due to the risk of increased gastrointestinal bleeding [2.1]. The diclofenac component is metabolized by the CYP2C9 enzyme, meaning inhibitors or inducers of this enzyme may change the drug's overall exposure [1.1]. Regulatory documents note that in elderly or renal-impaired patients, co-administration with ACE inhibitors or ARBs may cause a deterioration of renal function [2.4].

Mechanism of Action

Modulating Inflammatory Pathways via Enzyme Inhibition

The primary COX-2 inhibition mechanism involves the diclofenac component, which acts as a competitive inhibitor of the Cyclooxygenase-2 (COX-2) enzyme. By suppressing COX-2, the drug reduces the synthesis of pro-inflammatory Prostaglandin E₂ (PGE₂), a key mediator in the arachidonic acid cascade. This mechanistic action primarily reduces the sensitization of nociceptors** (pain-sensing nerves) and modulates the physiological events ( vasodilation, capillary permeability) related to fluid extravasation.


Functional Counterbalance and Mucosal Defense

The misoprostol component counteracts a consequence of diclofenac's COX-1 inhibition. Diclofenac's inhibition of Cyclooxygenase-1 (COX-1) disrupts the COX-dependent synthesis of homeostatic prostaglandins in the stomach. Misoprostol, a synthetic PGE₁ analog, intervenes by functioning as an agonist on gastric Prostaglandin E₁ Receptors (EP₃). This receptor activation initiates two concurrent actions that support mucosal integrity: stimulating the secretion of mucus and bicarbonate, and decreasing histamine-stimulated gastric acid release. This complementary mechanism supports the maintenance of gastric defense homeostasis against the COX-1 inhibition-mediated consequences of diclofenac.

Dosage and Administration Information

How to Use Deflamat: Official Administration Guidelines

Deflamat (diclofenac sodium/misoprostol) is a prescription medicine administered orally. The official instructions for use are strictly defined to ensure proper application and maximize the gastroprotective benefits of the combination drug.


Official Administration and Dosing

Instruction Detail
Route of Administration Oral (by mouth).
Dosing Schedule Principle Use the lowest effective dosage for the shortest duration consistent with treatment goals. Dosing frequency is typically two, three, or four times daily (BID, TID, or QID), depending on the indication and the specific strength used.
Administration Context Tablets must be taken with food to minimize gastrointestinal upset.
Tablet Integrity Tablets must be swallowed whole; they must not be crushed, chewed, or dissolved to preserve the delayed-release formulation.

Population-Specific Use

Population Official Instruction
Older Adults Close monitoring is recommended.
Renal Impairment Avoid use in patients with advanced renal disease.
Pediatric Patients Safety and efficacy in patients under 18 years of age have not been established.

Procedural Protocol

Official instructions establish a fixed procedural structure for administration: the delayed-release tablet must be taken orally, intact, and in conjunction with food, two to four times daily as prescribed. Patients are explicitly advised not to take this medicine with magnesium-containing antacids. This protocol is designed to achieve the intended anti-inflammatory effect while providing consistent mucosal protection against the diclofenac component.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Deflamat

The medicine known as Deflamat can refer to two different drug compositions evaluated in scientific studies for distinct conditions. Evidence, primarily from regulatory sources and peer-reviewed trials, describes how these medications were studied for their approved uses. Research provides insight into group patterns, but research does not determine whether an individual will respond similarly.

Evidence for the Diclofenac/Misoprostol Combination

This section will summarize the structure of randomized controlled trials (RCTs) and systematic reviews that was studied for the fixed-dose combination in managing symptoms of rheumatoid arthritis (RA) and osteoarthritis (OA).

Studies explored adult patients with symptomatic RA and OA, and the outcomes measured focused on changes in physical discomfort and how patients reported their experience on functional scales. Key trials monitored outcomes related to the gastrointestinal lining.

Trials reported measurements of how symptoms evolved in the observed populations, and findings were observed in studies that compared the combination to diclofenac alone. When comparing the combination to diclofenac without the misoprostol component, studies reported different measurements of ulcer incidence.

Evidence for the Deflazacort Corticosteroid

This section will detail the clinical trials, comparative studies, and observational research evaluated in this steroid for its approved indications, including Duchenne Muscular Dystrophy (DMD) and inflammatory conditions.

Studies in Duchenne Muscular Dystrophy (DMD)

The research base for this medication in DMD includes randomized, double-blind, placebo-controlled trials, in addition to extended observational studies with longer follow-up. Study endpoints focused on outcomes reflecting daily functioning or activity level, such as muscle strength measurements and the age at which independent walking was lost.

Findings describe patterns observed in the studies over short and medium time intervals. Trials reported measurements of functional status changes that differed over periods of up to one year when compared to placebo. Observational studies described patterns of functional milestones, such as the age of loss of ambulation, as monitored in patient cohorts receiving this treatment. Comparative trials also monitored outcomes related to skeletal health and growth measurements.

Studies in Rheumatoid Arthritis and Juvenile Chronic Arthritis

This research was evaluated in comparative trials against other established corticosteroids for adults with RA and children with Juvenile Chronic Arthritis. Studies monitored outcomes linked to inflammatory or irritative states and patient-reported outcomes describing perceived discomfort.

Studies reported measurements of symptom changes that appeared similar when compared against other standard steroid treatments in these conditions. Research has also explored differences in skeletal health markers between this medication and other standard therapies.

Frequently Asked Questions (FAQ)

Common questions about Deflamat (FAQ)


Q: Can I take Deflamat on an empty stomach?

Regulatory documents recommend that Deflamat tablets be taken with food to help mitigate potential gastrointestinal upset, such as diarrhea. The official context for administration states it is taken with food, which is intended to support the medicine's protective strategy.


Q: What should I do if I miss a dose of Deflamat?

Official patient information notes that if a dose is missed, it can be taken as soon as it is remembered. However, if it is almost time for the next scheduled dose, the missed dose is typically skipped, and the regular schedule is resumed. Doses should not be doubled.


Q: How long does it take for Deflamat to start working for pain?

The anti-inflammatory component, diclofenac, typically achieves its highest concentration in the bloodstream about 1 to 4 hours after administration. The misoprostol component (for gastric protection) is active in the stomach much sooner, usually within 30 minutes.


Q: What is the maximum daily dose I can take?

Official labeling specifies that the lowest effective dosage should be used for the shortest duration consistent with treatment goals. Dosages exceeding a certain threshold are not recommended for each condition, such as osteoarthritis or rheumatoid arthritis.


Q: Can I drive or operate machinery after taking this medicine?

Official product information notes that certain rare side effects can affect the central nervous system, including feeling dizzy, drowsy, or experiencing vertigo. Patients are advised to be aware of how the medicine may affect them before engaging in activities that require full attention, such as driving or operating machinery.


Q: What happens if I accidentally take too much Deflamat?

Taking more than prescribed may increase the chance of severe side effects. Official guidance indicates that if an overdose is suspected, emergency medical assistance should be contacted immediately.


Q: Is there a generic version of Deflamat available?

Yes, official regulatory sources confirm that the U.S. Food and Drug Administration (FDA) has approved generic versions of the combination tablet containing diclofenac sodium and misoprostol delayed-release.


Q: Can this drug be split or cut in half?

No, the official administration guidelines strictly state that the tablets must be swallowed whole. They should not be cut, crushed, or chewed. This practice is not recommended to preserve the delayed-release formulation.


Q: Does Deflamat cause weight gain?

Post-marketing safety data indicates that unusual weight gain and swelling (edema) in the arms or legs have been reported by some patients. Should these symptoms occur, it is recommended to consult a healthcare professional.

How should Deflamat be stored and disposed of?

How to Store and Dispose of Deflamat?

Strict adherence to official labeling is required for storing and disposing of Deflamat (diclofenac/misoprostol) to maintain stability and ensure safety.


Storage Requirements

Condition Requirement
Temperature Store at 20 C to 25 C (68 F to 77 F).
Protection Keep away from heat, moisture, and direct light. Do not freeze.
Packaging Store in the original container and keep it tightly closed.

Disposal and Safety

Deflamat must be stored out of the sight and reach of children to prevent accidental exposure.

Do not throw away unused or expired medicine via wastewater or household waste. Consult with a pharmacist regarding the official procedure for discarding medicine no longer needed, which helps protect the environment.

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

Available in countries:

Equivalent of Deflamat found in:

A-Z Index: