Misofenac

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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 Misofenac

Quick Facts

Property Description
Active Ingredients Diclofenac and Misoprostol
Form Oral Modified-Release Tablet
Pharmacological Class NSAID and Synthetic Prostaglandin Analog Combination
Common Use Symptomatic relief of arthritis with ulcer prevention
Origin Synthetic compounds

What Type of Medicine is Misofenac?

Misofenac is defined as a fixed-dose combination product, a single oral tablet that incorporates two distinct synthetic active ingredients. It is classified pharmacologically as a combination of a Nonsteroidal Anti-inflammatory Drug (NSAID) and a Synthetic Prostaglandin Analog. This medication is specifically engineered to provide the anti-inflammatory and analgesic properties necessary for managing conditions like chronic arthritis while proactively mitigating a significant gastrointestinal risk. Its status as a combination agent is clinically recognized for offering a streamlined approach to managing inflammation in vulnerable patient populations.

Composition and Physical Form

The core components are Diclofenac sodium and Misoprostol. Diclofenac is responsible for the principal anti-inflammatory action, while Misoprostol, a synthetic Prostaglandin E1 analog, functions as the protective agent. Diclofenac is recognized as a phenylacetic acid derivative within the NSAID group. The medication is prepared as a specialized oral modified-release tablet, often featuring an enteric-coated core designed to delay the release of the Diclofenac component until it bypasses the stomach.

The Combined Purpose of Diclofenac and Misoprostol

The general therapeutic purpose of Misofenac is to provide effective, long-term symptomatic relief of arthritis while ensuring proactive protection for the upper gastrointestinal tract. This strategy is primarily intended for patients at high risk of developing NSAID-induced gastroduodenal ulceration who require continuous anti-inflammatory therapy. Misoprostol reduces the risk of serious NSAID-induced upper gastrointestinal ulcers. This combination ensures that the necessary anti-inflammatory action is supported by mucosal protective properties, mitigating a substantial clinical risk with a single entity.

What side effects are possible with Misofenac?

Possible Side Effects and Safety Information

This information describes the adverse reactions and safety constraints for Misofenac as documented in authoritative government regulatory labels (e.g., FDA, EMA). It does not include advice, dosing instructions, or therapeutic uses.

Frequency-Classified Adverse Reactions

The possible side effects of Misofenac are categorized by how often they were reported in clinical trials and post-marketing surveillance:

  • Very Common (Affects 1 in 10 or more people): Often includes common gastrointestinal disturbances and non-severe headache.
  • Common (Affects 1 in 100 to less than 1 in 10 people): Reported events frequently involve specific Nervous System disorders and mild skin reactions.
  • Uncommon / Rare / Very Rare: These categories include less frequently reported adverse events, often involving specific immunological or cardiovascular effects.

System-Organ-Class Groupings

Adverse reactions are formally organized according to the body system affected (System-Organ-Class or SOC). Documented SOCs include Gastrointestinal disorders, Hepato-biliary disorders, Renal and urinary disorders, and Blood and lymphatic system disorders. This structure provides a comprehensive map of the drug's effects across various organ systems.

Serious Adverse Reactions

The regulatory label highlights rare but clinically significant adverse events. These may include severe gastrointestinal bleeding, ulceration, or perforation; severe cutaneous adverse reactions (like Stevens-Johnson syndrome); and serious systemic hypersensitivity reactions.

Safety Constraints and Considerations

Safety data contains specific constraints, such as the requirement to use the lowest effective dose for the shortest possible duration to mitigate certain risks. Furthermore, the label includes population-specific statements, noting increased risk or specific monitoring requirements for defined groups, such as older adults and patients with severe pre-existing renal or hepatic impairment.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose with Misofenac, a combination of Diclofenac (NSAID) and Misoprostol (prostaglandin analog), is officially documented by regulatory authorities to involve a range of clinical manifestations. These may include signs of central nervous system (CNS) toxicity such as drowsiness, lethargy, blurred vision, and tinnitus. Gastrointestinal distress, including epigastric pain and vomiting, is commonly listed, alongside cardiovascular effects like hypotension and tachycardia.

Severe Manifestations and Immediate Actions

The official prescribing information states that overdose carries a risk of severe or life-threatening outcomes. These documented complications include seizures, acute renal failure, hepatic dysfunction, cardiovascular collapse, and coma. Gastrointestinal bleeding is also listed as a potential severe manifestation. Due to the risk of these serious events, the official guidance mandates that an individual must seek immediate medical attention following any suspected overdose. Hospital monitoring is required for continuous observation and to manage complications.

Management and Specific Risks

Regulators state that no specific antidote is known for this combination. Management is officially restricted to symptomatic and supportive treatment, which may involve procedures like the administration of activated charcoal or gastric lavage, and the correction of electrolyte disturbances. Population-specific considerations are noted: increased severity is documented in the elderly, and there is a specific risk of uterine contractions in pregnant patients due to the Misoprostol component.

Therapeutic Uses of Misofenac

What Misofenac Treats: Main Uses and Benefits

Misofenac is commonly used to help with the symptoms related to physical discomfort and inflammatory states associated with chronic joint conditions, specifically Rheumatoid Arthritis and Osteoarthritis. It is relevant for managing symptoms that interfere with daily comfort, such as persistent joint pain, swelling, and stiffness. This medication may be part of symptomatic management for signs and symptoms of these conditions in a specific patient group. By easing these symptoms that interfere with daily functioning, the medication contributes to improved comfort and assists with maintaining functional stability for the patient.

Proactive Protection Against NSAID-Induced Ulcers

This medication is applied across domains where additional symptomatic support is needed because it contains an added component for managing the risk of gastrointestinal stress. It is relevant when long-term Nonsteroidal Anti-inflammatory Drug (NSAID) therapy is required, but the patient is at high risk of developing gastric and duodenal ulcers and their complications. This dual-action approach provides supportive relief during episodes of heightened discomfort while proactively addressing the risk of symptoms linked to inflammatory or irritative states in the digestive tract, and contributes to easing the overall symptom load.

“This combined approach helps maintain a sense of stability when symptoms are more noticeable, while safeguarding the patient's digestive health during required long-term treatment.”


Quick Fact

Supports the management of symptoms related to physical discomfort and associated gastrointestinal protection.

Eligibility and Restrictions for Use

Eligibility Profile for Misofenac

Misofenac (Diclofenac/Misoprostol) is intended only for adult patients (18 years and older) requiring chronic NSAID therapy who are documented to be at high risk for developing NSAID-induced gastroduodenal ulcers. Eligibility is strictly defined by regulatory documents based on absolute contraindications and population-specific restrictions.


Contraindications and Non-Eligibility

Use of Misofenac is absolutely prohibited (contraindicated) for several groups:

  • Pregnant women at any stage, due to the high risk of fetal harm from the misoprostol component.
  • Patients with a history of NSAID or Aspirin allergy, particularly those with aspirin-sensitive asthma.
  • Patients with active gastrointestinal bleeding, severe heart failure, or severe renal or hepatic failure.
  • Treatment for pain after Coronary Artery Bypass Graft (CABG) surgery.

Restricted and Conditional Use

  • Women of childbearing potential may use the medicine only if they meet specific conditions, including mandatory effective contraception and a negative pregnancy test.
  • Children and adolescents under 18 years old are not recommended to use the medicine as safety and efficacy are not established.
  • Older adults (65 years and older) may use the medicine but require close monitoring due to heightened risk of gastrointestinal and renal events.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Misofenac is defined by the officially documented effects of its Diclofenac component, which require regulatory classification and restrictions. Concomitant use with other systemic nonsteroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors and analgesic doses of aspirin, is not generally recommended due to an additive risk of serious gastrointestinal events. Misofenac is formally contraindicated for the treatment of peri-operative pain in the setting of Coronary Artery Bypass Graft (CABG) surgery.

Pharmacokinetic and Pharmacodynamic Effects

Misofenac has documented exposure-altering interactions with several medicines. Co-administration of the Diclofenac component with the CYP2C9 inhibitor Voriconazole significantly increases the maximum plasma concentration and total exposure of Diclofenac. Conversely, Diclofenac can increase the serum concentrations of Lithium and Digoxin, and it may increase the toxicity risk of Methotrexate and Cyclosporine.

Pharmacodynamic interactions lead to an increased risk of bleeding when Misofenac is combined with anticoagulants (e.g., Warfarin), antiplatelet agents, or SSRIs/SNRIs. Diclofenac also reduces the efficacy of Diuretics and ACE Inhibitors/ARBs, an effect that requires particular caution in renally impaired or elderly patients.

Administration and Substance Constraints

Specific timing rules apply for certain combinations: the product should not be used for 8–12 days following Mifepristone administration, and co-administration with Pemetrexed requires avoidance two days before and after the dose in patients with specific renal impairment. The use of Magnesium-containing Antacids is not recommended as they may exacerbate a known digestive side effect.

Mechanism of Action

Dual Mechanistic Action on Systemic and Local Physiology

Misofenac engages two primary mechanistic domains to modulate distinct physiological systems. The first component is an inhibitor that targets Cyclooxygenase (COX) enzymes ( COX-1 and COX-2) throughout the body. Blocking these enzymes prevents the conversion of arachidonic acid and thereby limits the systemic formation of specific prostanoids and other chemical mediators in the prostaglandin synthesis pathway. This mechanistic cascade results in the physiological consequence of decreased local inflammatory signaling.

The second component is a synthetic agonist that acts on specific prostaglandin receptors (e.g., EP3) in the gastric mucosal system. Activating these receptors initiates cellular signaling that modulates the function of parietal and epithelial cells. This results in reduced hydrochloric acid secretion and increased production of mucus and bicarbonate, influencing cellular processes that regulate gastric barrier function.

Dosage and Administration Information

How Misofenac is Used: Official Administration Guidelines

Misofenac is administered exclusively via the oral route as a specialized modified-release tablet, incorporating Diclofenac and Misoprostol. The design of this medication requires that the tablet must be swallowed whole and not be crushed, chewed, or broken. This procedural instruction is critical to ensure the proper release of the Diclofenac component, which is protected by an enteric coating.

Standard Dosing Regimens

The treatment protocol is intended for long-term or chronic use, requiring continuous, regular dosing to maintain both anti-inflammatory action and consistent gastrointestinal protection. The medication is explicitly intended to be taken with meals or food to mitigate potential local irritation.

Strength (Diclofenac/Misoprostol) Standard Frequency Maximum Daily Dose (Diclofenac)
50 mg / 200 mcg Two or three times a day (TID) 150 mg or 200 mg
75 mg / 200 mcg Two times a day (BID) 150 mg or 200 mg

These regimens ensure a consistent delivery of Misoprostol, which is essential for ongoing mucosal protection. If a dose is missed, standard practice is the continuation of the next scheduled dose at the usual time; patients should not take a double dose to compensate. No specific dose adjustment is generally required for older adults, but close monitoring is advised.

Recent Clinical Evidence

Research Evidence Overview for Misofenac

Evidence Structure for Rheumatoid Arthritis Symptom Management and Ulcer Protection

Research in this area has utilized short- to intermediate-term Randomized Controlled Trials (RCTs) and meta-analyses to examine outcomes. These trials were evaluated in the context of monitoring the symptoms of Rheumatoid Arthritis in patients who are also at high risk of developing gastrointestinal issues from Nonsteroidal Anti-inflammatory Drugs (NSAIDs). Studies have examined outcomes related to outcomes related to physical discomfort and outcomes reflecting daily functioning or activity level, as well as tracking specific digestive issues.

Studies have observed how symptoms such as joint pain, stiffness, and swelling evolved in the observed populations over defined time intervals. Research has also monitored the incidence of endoscopically confirmed ulcers in the stomach and upper intestine. Findings describe patterns where arthritis symptoms monitored for the combination product were monitored alongside measurements of the diclofenac component taken alone. Additionally, studies report patterns related to the frequency of ulcers in the observed populations.

Evidence Structure for Osteoarthritis Symptom Management and Ulcer Protection

Misofenac was studied for its use in monitoring the symptoms of Osteoarthritis, particularly in the hip and knee, specifically for patients who require ongoing NSAID therapy and are at high risk of digestive tract complications. Research in this area has utilized short-term Randomized Controlled Trials (RCTs), typically lasting from 4 to 12 weeks. These studies were evaluated in populations with Osteoarthritis, where research examined patient-reported outcomes describing perceived discomfort and how well patients maintained their daily functioning or activity level.

Findings describe patterns where the short-term symptom changes measured in studies were monitored alongside changes measured when the diclofenac component was taken by itself. Studies also data show patterns related to the incidence of endoscopically confirmed ulcers in this population, with results in some studies differing from measurements in groups taking only diclofenac.

What Research Limitations and Uncertainties Exist

While research contributes to the broader evidence landscape, there are several areas where certainty remains low or where more research is needed. A primary limitation is that many of the core studies focusing on ulcer prevention track the measured incidence of endoscopically confirmed ulcers, but provide limited information for long-term outcomes or measured frequencies regarding the much rarer, yet serious, ulcer complications (such as bleeding or perforation). Furthermore, the follow-up durations are often short-term in many studies, meaning that the full insight into symptom patterns and the outcomes related to systemic or functional imbalance beyond the short-term is not fully established.

Frequently Asked Questions (FAQ)

Common questions about Misofenac (FAQ)

Q: What kind of pain does Misofenac help with?

According to official product information, Misofenac is specifically indicated for the signs and symptoms of osteoarthritis and rheumatoid arthritis. It is generally studied and indicated for the long-term management of these chronic conditions in patients who are also at high risk of developing ulcers caused by traditional NSAIDs.


Q: How quickly does Misofenac start working?

The protective component of Misofenac, misoprostol, begins to show activity that is apparent around 30 minutes after taking the tablet and persists for several hours. The timing for the anti-inflammatory component (Diclofenac) to provide noticeable pain relief may vary based on clinical observation.


Q: How long does the effect of Misofenac last?

The protective effect of the misoprostol component persists for at least 3 hours after each dose. The consistent dosing schedule is intended to help maintain therapeutic levels of both active ingredients for the long-term management of chronic conditions.


Q: Are there any common side effects people notice when starting Misofenac?

Yes, regulatory documents list several common side effects. The most frequently reported issues are gastrointestinal, which may include abdominal pain, diarrhea, nausea, and flatulence. Some individuals also commonly report a headache or dizziness.


Q: Does Misofenac cause drowsiness or affect driving?

Misofenac may cause certain side effects, such as dizziness or drowsiness. Official warnings indicate these side effects may impair the ability to drive or operate machinery, so caution is advised until you know how the medication affects you.


Q: Is it normal to feel a little dizzy after taking Misofenac?

Dizziness is listed in the official safety information as a common adverse reaction that was reported in clinical studies. If dizziness becomes severe or concerning, regulatory guidance suggests consulting a healthcare provider.


Q: Are there any dietary restrictions when taking Misofenac?

Official guidance states the medication should be taken with food or meals to help mitigate potential irritation. Additionally, the use of magnesium-containing antacids is generally not recommended because they may worsen diarrhea, a known side effect.


Q: What are the signs of an allergic reaction to Misofenac?

Official warnings note that signs of a serious allergic reaction may include swelling of the face, lips, throat, or tongue, hives, or difficulty breathing. Any suspicion of a severe allergic reaction requires immediate medical attention.


Q: Does alcohol change how Misofenac works in the body?

Regulatory warnings state that consuming alcohol while taking the diclofenac component of this drug may increase the risk of gastrointestinal bleeding. Patients should be aware that the use of alcohol is associated with this increased risk.


Q: If I miss a dose of Misofenac, what is the usual recommendation?

If a dose is missed, official dosing guidance instructs that treatment should continue with the next scheduled dose at the usual time. Official guidance states that a double dose should not be taken to compensate for a missed dose.


Q: Can Misofenac cause acid reflux or heartburn?

While the drug contains a protective component, common adverse reactions still include gastrointestinal issues such as dyspepsia, which is a term often associated with indigestion or heartburn. Other reported symptoms include belching and feeling full.


Q: Does taking Misofenac with food help reduce stomach issues?

Yes, the medication is explicitly intended to be taken with food or meals. The administration requirement to take it with food is intended to mitigate potential local irritation in the stomach.


Q: What happens in the body when Misofenac is broken down?

The diclofenac component is primarily metabolized (broken down) by a specific liver enzyme called CYP2C9. The resulting substances are then eliminated from the body through urine and bile, as described in regulatory pharmacokinetic information.


Q: Can Misofenac affect the liver?

Official warnings state that Misofenac can cause liver problems (hepatotoxicity), and elevations of liver enzymes have been observed. Close monitoring of liver function is advised, especially for patients with pre-existing hepatic impairment.


Q: Are there long-term side effects associated with Misofenac use?

Official warnings for NSAIDs, including this one, note that the risk of serious adverse events such as gastrointestinal bleeding and perforation, as well as cardiovascular thrombotic events (like heart attack or stroke), is generally increased with longer duration of use.


Q: Can Misofenac affect my sleep pattern?

The official list of adverse reactions includes nervous system disorders. While not consistently listed as a 'very common' side effect, this category can sometimes involve changes to sleep, such as insomnia or drowsiness.


Q: Is it okay to take Misofenac with my blood pressure medicine?

Official information indicates that the diclofenac component can reduce the effectiveness of certain blood pressure medications, specifically Diuretics and ACE Inhibitors/ARBs. Official warnings state that blood pressure should be closely monitored by a healthcare professional.

How should Misofenac be stored and disposed of?

How to Store and Dispose of Misofenac (Diclofenac)

Regulatory documents define the following requirements for the storage and disposal of Misofenac.

Official Storage Requirements

Condition Requirement
Temperature Store at room temperature, away from heat.
Protection Keep from freezing and protect from moisture and direct light.
Child Safety Must be stored out of the reach of children.
Container Keep the medicine in its original, closed container.

Official Disposal Rules

Official disposal procedures mandate preventing environmental contamination. Expired or unused Misofenac should not be poured down the drain or disposed of in the toilet. The recommended method is to return the medicine to a drug take-back location or follow instructions for preparation before placing it in the household trash, which typically involves mixing the product with an undesirable substance such as used coffee grounds or cat litter.

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

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