Rofenac D

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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 Rofenac D

Quick Facts

Property Description
Active Ingredient Diclofenac Sodium
Form Dispersible Tablet
Pharmacological Class Non-steroidal Anti-inflammatory Drug (NSAID)
Common Use Symptomatic relief of pain, inflammation, and fever
Origin Synthetic chemical compound

Rofenac D: Identity and Pharmacological Classification

Rofenac D is a potent, non-narcotic medicinal preparation fundamentally classified as a member of the Non-steroidal anti-inflammatory drug (NSAID) class. This medication is a synthetic compound, meaning its active components are chemically manufactured, and it serves as a single-ingredient product. The classification as an NSAID distinguishes it from both steroidal medications and opioid-based pain relievers. The primary mechanism of Diclofenac involves non-selective inhibition of cyclooxygenase (COX) enzymes, which is central to its therapeutic action. Therefore, the medicine helps control symptoms by targeting the core chemical pathways that initiate pain and swelling.


Active Composition and Dispersible Form

The active ingredient responsible for the effects of Rofenac D is Diclofenac Sodium, which is the substance's International Nonproprietary Name (INN). The medicine is presented as a dispersible tablet, a specific solid dosage form designed for oral administration after being fully dissolved or suspended in water. Diclofenac's overall profile includes strong analgesic and anti-inflammatory properties. This action means the drug is fundamentally designed to provide relief by both easing pain and reducing inflammation. This unique tablet preparation offers a practical advantage for patients who have difficulty swallowing solid oral medications, as it can be taken as a liquid suspension.


General Purpose: Relief from Pain and Inflammation

The general purpose of Rofenac D is the symptomatic relief of discomfort associated with pain, inflammation, and elevated body temperature (fever). As a cyclooxygenase (COX) inhibitor, the medication intervenes in the biochemical pathways that generate prostaglandins, which are key chemical mediators of these symptoms. This action allows the preparation to suppress the underlying inflammatory processes that lead to swelling and redness, resulting in a reduction of mild to moderate aches and symptomatic relief. This type of formulation is intended to provide effective relief in scenarios requiring a fast-acting oral solution.

What side effects are possible with Rofenac D?

Possible Side Effects and Safety Information

The official safety profile for Diclofenac Sodium (Rofenac D) documents known adverse reactions categorized by frequency and the body system affected. These regulatory classifications structure the understanding of the medicine’s risk profile, adhering strictly to government standards.

Adverse Reaction Frequencies and Systems

The most frequently documented adverse reactions are associated with the Gastrointestinal System and the Nervous System, which are often classified as Common (affecting 1 to 10 users in 100). Common effects include disturbances such as nausea, diarrhea, dyspepsia, abdominal pain, headache, and dizziness. Effects like vertigo and an increase in liver enzymes are typically classified as Uncommon.

Serious Adverse Reactions

The official labeling highlights the potential for serious adverse reactions, even if these events are classified as Rare or Very Rare. A major safety constraint is the risk of gastrointestinal hemorrhage, ulceration, or perforation. Diclofenac is also associated with a documented potential for arterial thrombotic events, such as myocardial infarction and stroke, particularly noted with long-term use and higher doses. Severe reactions like hepatitis and life-threatening skin reactions (Stevens-Johnson syndrome) are described as Very Rare events.

Population-Specific Constraints

Safety notes specify that older adults may have an increased frequency of adverse reactions, particularly serious gastrointestinal events. The safety profile also lists constraints for individuals with underlying health conditions, including established congestive heart failure and severe hepatic or renal impairment, which are noted as high-level safety limitations for use.

Overdose and Emergency Response

Overdose and When to Seek Help — Official Regulatory Information

This section outlines the documented overdose profile for Rofenac D (Diclofenac Sodium) based strictly on authoritative governmental regulatory sources. All suspected overdoses require immediate professional medical attention.

Classification Manifestations and Actions
Documented Manifestations Symptoms usually limited to Nausea, Vomiting, Epigastric pain, Lethargy, and Drowsiness. Less common, severe signs include Gastrointestinal bleeding, Confusion, Tinnitus, and Respiratory depression or Coma.
Severe Systemic Outcomes Rare but possible outcomes include Acute renal failure, Hypertension, and the risk of serious Cardiovascular thrombotic events (Myocardial Infarction or Stroke).
Antidote Status No specific antidotes are documented to reverse the effects of Diclofenac Sodium overdose.
Required Emergency Action Immediate medical attention must be sought for any suspected overdose. Emergency help is explicitly required if severe symptoms or an anaphylactic reaction occurs.
Supportive Management Treatment is symptomatic and supportive. Decontamination (e.g., Activated charcoal or Emesis) may be considered in a supervised clinical setting for patients who have taken a large overdose (5 to 10 times the recommended dosage) and are seen within four hours.

Population-Specific Considerations: Regulatory documents note that elderly patients are at a greater risk for serious gastrointestinal events. Specific guidelines are provided for pediatric patients regarding the potential use of activated charcoal.

Therapeutic Uses of Rofenac D

Rofenac D is commonly used to help with symptoms related to inflammatory or irritative states and heightened physiological activity. It generally contributes to symptomatic support across multiple therapeutic domains by addressing key clusters of symptoms that interfere with daily functioning. The medication is relevant in conditions characterized by periods of heightened symptoms such as Osteoarthritis, Rheumatoid Arthritis, and Ankylosing Spondylitis, where it supports the patient during difficult episodes by easing joint pain, stiffness, and localized swelling. Rofenac D is also commonly used across conditions presenting with acute episodes where short-term symptomatic assistance is needed, such as in post-traumatic inflammation or episodes of Primary Dysmenorrhea (menstrual cramps). Furthermore, it assists with managing systemic discomfort, specifically by addressing elevated body temperature (fever) and supporting symptom control during certain acute migraine attacks. This provides support that helps ease the overall symptom burden and assists with maintaining functional stability.


Quick Fact: Relief for Common Symptom Domains
Main Therapeutic Role Symptomatic relief of pain and inflammation
Target Conditions Chronic joint disorders (e.g., Arthritis), Acute pain episodes (e.g., Menstrual cramps)
Benefit Focus Easing discomfort and assists with maintaining functional stability

Regulatory References

  1. Diclofenac: MedlinePlus Drug Information

Eligibility and Restrictions for Use

Who Can and Cannot Use Rofenac D?

The official eligibility profile for Rofenac D (Diclofenac Sodium) is strictly defined by government regulatory documents (such as FDA and EMA Summaries of Product Characteristics) to ensure safe use.

Populations and Conditions for Restricted or Prohibited Use

Classification Population/Condition Restriction Detail (Official Labeling)
Contraindicated Allergy/Hypersensitivity Prohibited if there is a known allergy to Diclofenac or other NSAIDs (e.g., aspirin) that caused asthma or hives.
Contraindicated Severe Organ Failure Prohibited in established severe heart failure (NYHA Class II–IV), severe renal failure, or severe hepatic failure.
Contraindicated Gastrointestinal Risk Prohibited in patients with active peptic ulceration, gastrointestinal bleeding, or perforation.
Contraindicated Pregnancy Prohibited during the third trimester of pregnancy. Use is generally restricted or avoided during the first two trimesters.
Restricted Use Pediatric Population Generally not recommended for children under 14 years of age for the 50 mg tablet form.
Restricted Use Geriatric Population Must be used with particular caution; regulatory documents advise using the lowest effective dosage.

Officially Allowed Use

Regulatory documents generally establish use for adults and adolescents aged 14 years and older. Patients with mild-to-moderate impairment of kidney or liver function are permitted use but require close medical surveillance.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official interaction profile for Rofenac D (Diclofenac Sodium) is structured around regulatory classifications concerning additive pharmacodynamic risk and exposure modification.


Restricted and High-Risk Combinations

Co-administration with other systemic Non-steroidal Anti-inflammatory Drugs (NSAIDs), including COX-2 selective inhibitors, should be avoided due to the documented potential for additive undesirable effects. The combination of Rofenac D with Ketorolac is formally not recommended by regulatory authorities.

Anticoagulants, Anti-platelet agents (including low-dose Aspirin), Systemic Corticosteroids, and SSRIs officially carry an increased risk of serious bleeding events and GI ulceration. Diclofenac may also reduce the anti-platelet effect of low-dose Aspirin. Consumption of Alcohol is documented to increase the risk of serious GI bleeding.


Exposure and Efficacy Modifying Interactions

Interactions involving the inhibition of the CYP2C9 enzyme, such as with Voriconazole, are documented to result in a significant increase in Diclofenac plasma concentration and overall exposure. Concurrent use with Lithium or Digoxin necessitates the monitoring of serum levels because reduced renal clearance may increase their concentrations.

Diclofenac may officially reduce the therapeutic effect of co-administered Diuretics, ACE Inhibitors, and ARBs, and can increase the risk of worsening renal function with these agents. Furthermore, Elderly patients have an officially documented greater risk for serious GI events when co-administered with other GI-risk medications.

Mechanism of Action

1. Inhibition of Prostaglandin Production

The primary molecular mechanism involves the competitive and non-selective inhibition of Cyclooxygenase ( COX) enzymes, particularly the COX-2 isoform. This action blocks the initial step in the arachidonic acid cascade, preventing the synthesis of PGE2 and other prostaglandins, which are the fundamental chemical mediators responsible for initiating and amplifying inflammatory and nociceptive signals.


2. Modulation of Pain Signaling Pathways

By reducing the level of prostaglandins at the site of tissue injury, the drug decreases the sensitization of peripheral nociceptors (pain-sensing nerve endings). This process raises the threshold required for nociceptor activation, reducing the impact of excessive mediator activity on the neural signaling system, a process that modulates the intensity of afferent sensory signals.


3. Central Thermoregulatory Adjustment

The active ingredient also influences the central nervous system by inhibiting PGE2 synthesis within the hypothalamus, the brain's temperature control center. This mechanism resets the body's elevated thermoregulatory set-point, establishing a regulated state within the central temperature control pathway.

Dosage and Administration Information

How to Use Rofenac D

Rofenac D, a Diclofenac Sodium dispersible tablet, is intended strictly for oral administration after being prepared as a liquid suspension. The medication is intended to be used at the lowest effective dosage for the shortest possible duration.


Dosage and Frequency

Administration of Rofenac D in adults is based on a specific schedule. For general use, the usual total daily dose ranges from 100 mg to 150 mg, which is typically administered in two or three divided doses throughout the day. The prescribed single dose for managing acute episodes, such as migraine, is 50 mg, and the maximum recommended total daily dose is 150 mg.

Administration Detail Requirement
Route Oral (following dispersion in water)
Maximum Daily Dose 150 mg
Frequency 2 to 3 times per day (divided doses)
Timing Preferably taken before meals

Preparation and Procedural Instructions

The dispersible tablet requires specific preparation for proper use. The tablet should be fully dissolved or suspended by dropping it into a glass of water (e.g., 30–60 mL) and stirring thoroughly before being swallowed immediately. Only water is used as the solvent. The medication is generally not recommended for children under 14 years of age due to the 50 mg unit strength, and treatment for older adults is initiated at the lowest effective dosage.

Recent Clinical Evidence

Rofenac D: Recent Clinical Evidence

The clinical investigation of Rofenac D has focused on its use in managing chronic pain conditions, specifically osteoarthritis and rheumatoid arthritis. Research primarily involves randomized, placebo-controlled trials (RCTs) designed to evaluate the compound’s effects compared to inactive substances and, in some cases, active comparators.

Key Findings from Pivotal Trials

Initial phase III studies demonstrated that participants receiving Rofenac D reported reductions in pain scores, as measured by standardized scales (e.g., VAS and WOMAC indices). This effect was observed across several large, international study populations.

  • Osteoarthritis: In individuals with knee or hip osteoarthritis, Rofenac D use was associated with statistically significant, yet moderate, improvements in joint function metrics over a 12-week period when compared to the placebo group.
  • Rheumatoid Arthritis: Trials involving adult patients with active rheumatoid arthritis noted that a greater proportion of participants achieved an ACR20 response (a 20% improvement in specified disease criteria) with Rofenac D than with placebo.

Safety and Tolerability Observations

The safety profile was characterized by the occurrence of gastrointestinal (GI) events, which were the most common adverse effects reported in the clinical program. The incidence of serious cardiovascular events was monitored across all long-term extensions of the trials. Overall, study findings suggest that Rofenac D's observed effects are linked to its ability to modulate inflammatory pathways, an aspect which requires ongoing pharmacovigilance and further post-marketing investigation.

Key Studies & References

  1. Safety of Diclofenac Sodium Gel in Knee Osteoarthritis (NCT00171691): A 12-Month, Open-Label Study
  2. Diclofenac: Uses, Interactions, Mechanism of Action, and Adverse Effects (StatPearls/NCBI Bookshelf)

Frequently Asked Questions (FAQ)

Common questions about Rofenac D (FAQ)


Q: How quickly should I expect Rofenac D to start working?

The active ingredient in Rofenac D is described in regulatory data as having a rapid initial absorption after it is taken. This rapid initial uptake is associated with an onset of effect on symptoms like pain or inflammation, though the specific time of onset can vary by individual.


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

The duration of the effect is generally related to the active ingredient's half-life, which is approximately two hours. The half-life of the active ingredient is a factor in the typical recommendation for divided daily dosing.


Q: What kind of pain does Rofenac D help with?

Official product information indicates that this medicine is used for the symptomatic relief of pain associated with joint and bone inflammation. This includes pain from chronic conditions such as rheumatoid arthritis and osteoarthritis, as well as acute problems like sprains and strains.


Q: Can Rofenac D affect my liver?

The official documentation lists the potential for effects on the liver, including increases in liver enzymes, which are generally uncommon, and rare, serious reactions such as hepatitis or liver failure, which have been noted in post-marketing surveillance reports.


Q: What is the difference in how Rofenac D and ibuprofen work?

Rofenac D's active ingredient, Diclofenac, works primarily by blocking the activity of Cyclooxygenase ( COX) enzymes in the body. This process reduces the production of prostaglandins, which are key chemical mediators responsible for initiating and amplifying pain and inflammation signals.


Q: Is it true that Rofenac D can affect fertility?

Regulatory documents note that, similar to other medicines in this class known as NSAIDs, its use may potentially make it harder to become pregnant. This potential effect is typically described as reversible upon stopping use of the medicine.


Q: Is Rofenac D a prescription medicine or can I buy it over the counter?

The active ingredient, Diclofenac, is available in both prescription and over-the-counter strengths and formulations worldwide. However, the specific 50 mg dispersible tablet form is typically classified as a prescription medicine in most regions.


Q: Is it common to feel drowsy after taking Rofenac D?

The official safety profile for the active ingredient documents potential effects on the nervous system. Common effects include dizziness and headache, and some patients may also experience fatigue.


Q: Are there any common foods or drinks that should be avoided with Rofenac D?

Regulatory documentation strongly advises against the consumption of alcohol due to an increased risk of serious gastrointestinal bleeding. Official labeling typically does not place restrictions on other common foods or non-alcoholic drinks.


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

Regulatory guidance generally recommends that if a dose is missed, the normal schedule should be continued, and a double dose should not be taken to compensate.


Q: What should I do if I accidentally take more Rofenac D than intended?

Official regulatory guidelines state that if more of the medicine is taken than intended, seeking medical attention or contacting a poison control center for guidance is required.


Q: Is there a risk of becoming dependent on Rofenac D?

The active ingredient in Rofenac D is classified as a non-narcotic medicine. It is not scheduled under the Controlled Substances Act, indicating that it does not carry a risk of physical dependence or addiction.


Q: Does Rofenac D contain aspirin or other common pain relievers?

The only active ingredient is Diclofenac Sodium. Regulatory guidance and warnings often refer to the need to avoid taking it concurrently with other NSAIDs, including aspirin or ibuprofen, as this increases the risk of side effects.


Q: Can Rofenac D be crushed or split?

The dispersible tablet is specifically designed to be fully dissolved or suspended in water before being swallowed. The tablet is designed for dispersion in water, and official instructions do not provide guidance for crushing or splitting.


Q: Does Rofenac D cause weight gain?

Official labeling for the active ingredient documents the potential for fluid retention and edema (swelling) as a possible effect. This fluid retention can sometimes be a factor in an increase in weight.


Q: Can Rofenac D make me sensitive to the sun?

Official documents list sun sensitivity (photosensitivity) as a possible effect, and caution regarding sun exposure is generally noted.


Q: How does the medicine in Rofenac D get absorbed into the body?

Regulatory data describes the active ingredient, diclofenac, as being absorbed from the gastrointestinal tract following oral administration. The dispersible nature of the tablet formulation may influence the rate and location of this absorption.


Q: How is the safety of Rofenac D monitored after it is released to the public?

The safety of the active ingredient is subject to ongoing review through official regulatory programs known as post-marketing surveillance. This monitoring collects and analyzes data from long-term studies and spontaneous reports of adverse reactions after the medicine has been released.


Q: Are there any documented cases of withdrawal symptoms when stopping Rofenac D?

As the active ingredient is a non-narcotic NSAID, it is not classified as having the potential for physical dependence. Therefore, it is typically not associated with withdrawal symptoms upon stopping its use.


Q: Does Rofenac D interact with herbal supplements like St. John's Wort?

Regulatory documents advise caution when combining Rofenac D with herbal remedies and supplements. They are generally not tested for their potential interactions in the same rigorous manner as prescription medications.


Q: What should I know about the inactive ingredients in Rofenac D?

The inactive ingredients in the specific formulation are listed in the official prescribing information. Patients with known sensitivities or allergies to non-active substances should review this list.


Q: Can Rofenac D be taken at the same time as other medications for a similar problem?

Regulatory guidance strictly advises against taking Rofenac D concurrently with other systemic Non-steroidal Anti-inflammatory Drugs (NSAIDs). This is due to an increased potential for cumulative undesirable effects.


Q: Is the mechanism of Rofenac D fully understood by scientists?

Official regulatory text for the active ingredient notes that its full mechanism of action, while primarily involving the inhibition of COX enzymes, is not completely understood by scientists.

How should Rofenac D be stored and disposed of?

How to Store and Dispose of Rofenac D

Rofenac D (diclofenac sodium dispersible tablets) must be stored at Controlled Room Temperature (CRT), typically 20 C to 25 C (68 F to 77 F).

Storage Requirements

Condition Requirement
Temperature Store at Controlled Room Temperature; do not freeze.
Environment Keep in a cool, dry place, protected from moisture, heat, and direct light. Do not store in a bathroom.
Container Keep in the original, tightly closed container and out of the reach of children and pets.
Stability Do not use the medicine past its expiration date.

Disposal Instructions

To dispose of unused or expired Rofenac D, use a drug take-back program or mail-back option, as this is the preferred method. Do not flush the tablets down a toilet or sink. If a take-back program is unavailable, follow official guidelines by mixing the medicine with an undesirable substance (such as dirt or coffee grounds) and sealing it in a container before discarding it in the household trash.

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

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