Oxalgin-DP

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Oxalgin-DP

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Oxalgin-DP

Quick Facts

Property Description
Active Ingredients Diclofenac, Acetaminophen (Paracetamol)
Form Oral Tablet
Pharmacological Class Nonsteroidal Anti-inflammatory Drug (NSAID) and Analgesic Combination
General Purpose Relief of pain, inflammation, and fever
Origin Synthetic

Oxalgin-DP is defined as a Fixed-Dose Combination (FDC) medicinal product, meaning it contains two distinct synthetic active pharmaceutical ingredients combined within a single dosage form. Its high-level pharmacological classification is that of an NSAID and Analgesic combination. The product is supplied as an oral tablet for systemic administration. This structure is fundamentally designed to provide dual therapeutic action in one medication, addressing both pain perception and underlying inflammation.

1. What Type of Medicine is Oxalgin-DP?

The core composition includes the NSAID Diclofenac and the analgesic agent Acetaminophen, also widely known as Paracetamol. Diclofenac's action involves inhibiting the production of pain and inflammation mediators, known as prostaglandins, through the cyclooxygenase (COX) pathway, a mechanism that is clinically recognized for its effectiveness in inflammatory pain management. Oxalgin-DP is commonly encountered as a prescription-only medicine in many markets, a key regulatory factor distinguishing it from over-the-counter Acetaminophen products.

2. What is the General Benefit of the Dual Action?

The general purpose of this dual action is to provide comprehensive relief by utilizing complementary mechanisms. Acetaminophen primarily contributes a central effect that increases the pain threshold, while Diclofenac offers strong peripheral anti-inflammatory and analgesic action. The strategy of combining an NSAID with Acetaminophen is a well-established method in multi-modal pain relief; the use of FDCs can enhance analgesic efficacy compared to single-agent therapy alone. This approach supports the product's design to simultaneously address both the perception of pain and the physical symptoms of inflammation and fever, for example, to help manage discomfort associated with musculoskeletal issues.

What side effects are possible with Oxalgin-DP?

Possible side effects and safety information

The officially documented adverse reactions for this fixed-dose combination, which contains an NSAID (Diclofenac) and Acetaminophen, are classified by system and frequency according to regulatory standards.

Adverse effects span multiple System-Organ Classes (SOC), including Gastrointestinal disorders, Hepatobiliary disorders, and Nervous system disorders. Common adverse reactions listed in official documents include gastrointestinal complaints such as nausea, dyspepsia, abdominal pain, and diarrhea, as well as headache and dizziness.

Serious adverse reactions are explicitly documented in regulatory warnings. These include the risk of serious cardiovascular thrombotic events (such as myocardial infarction and stroke) and severe gastrointestinal events (bleeding, ulceration, and perforation), which can occur at any time during treatment. Serious risks also include hepatotoxicity (liver damage), particularly acute liver failure associated with the acetaminophen component, and rare but severe skin reactions like Stevens-Johnson Syndrome.

Safety-related restrictions define high-risk situations where the medicine should not be used. It is contraindicated for treating pain following coronary artery bypass graft (CABG) surgery and in patients with active peptic ulcer disease or severe hepatic or renal impairment. Older adults are identified in regulatory documents as a population with an increased risk for serious gastrointestinal adverse events. Furthermore, the risk of thrombotic events may increase with the duration of use and dose, a pattern noted in official labeling.

Overdose and Emergency Response

The official regulatory documents define the overdose profile of Oxalgin-DP, a combination of Diclofenac and Acetaminophen, by the risk of dual-organ system toxicity. Documented initial manifestations may include general symptoms such as nausea, vomiting, abdominal pain, dizziness, drowsiness, confusion, and headache. In severe cases, patients may exhibit jaundice, little or no urine output (oliguria), or more profound signs such as coma or seizures.

The primary severe outcomes are acute liver failure from the Acetaminophen component and serious gastrointestinal bleeding or perforation, alongside acute renal injury, from the Diclofenac component. These life-threatening events require immediate clinical intervention.

Immediate medical attention is required upon suspected overdose, regardless of whether symptoms are currently present. Regulatory guidance mandates contacting a Poison Help center or local emergency services right away. The management approach is symptomatic and supportive. Critically, the specific antidote N-acetylcysteine (NAC) is indicated for the Acetaminophen component and must be administered promptly to protect against severe hepatic damage. Monitoring of serum acetaminophen concentration and hepatic/renal function is required as part of the official procedural steps. The risk of severe outcomes is elevated in patients with underlying liver or kidney impairment.

Therapeutic Uses of Oxalgin-DP

What Oxalgin-DP Treats: Main Uses and Benefits

The primary role of this fixed-dose combination medication may be part of symptomatic management in conditions marked by simultaneous symptoms related to physical discomfort, inflammatory or irritative states, and often systemic imbalance (fever). It is relevant in clinical settings where symptoms that interfere with daily functioning and short-term assistance may be appropriate to help moderate distressing manifestations. The combination may be part of symptomatic management to help relieve symptoms related to physical discomfort, swelling, and stiffness associated with various arthritic conditions.

The medication may be applied in conditions presenting with acute episodes such as discomfort from osteoarthritis and rheumatoid arthritis flares, headache, intense backache, toothache, and menstrual pain (dysmenorrhea). In clinical scenarios like managing pain and swelling following physical sprains and strains, or during post-operative recovery, it offers symptomatic assistance that may help maintain functional stability. It is considered relevant in situations where symptoms related to physical discomfort are linked to systemic imbalance, such as fever. “It contributes to support that helps ease the overall symptom burden during periods of heightened physiological strain.”


Quick Fact: Relief for Pain, Inflammation, and Fever

Category Typical Symptom Domains
Pain Moderate, acute, and episodic discomfort
Inflammation Swelling, tenderness, and joint stiffness
Context Musculoskeletal injury, post-operative, or acute flare-ups

Regulatory References

  1. NIH MedlinePlus overview of Diclofenac

Eligibility and Restrictions for Use

Oxalgin-DP is a combination medication containing Diclofenac (a non-steroidal anti-inflammatory drug or NSAID) and Paracetamol (Acetaminophen). It is typically prescribed to relieve pain, inflammation, and fever in adults and, in some cases, children over 10 years of age, following a doctor's recommendation.


Contraindications (Who Cannot Use)

Oxalgin-DP is generally not recommended for individuals with the following conditions due to the risk of serious adverse effects:

  • Hypersensitivity: Known allergy to Diclofenac, Paracetamol, Aspirin, or any other NSAID.
  • Gastrointestinal Issues: Active or recurring stomach or intestinal ulcers, gastrointestinal bleeding, or inflammatory bowel diseases like Crohn’s disease or ulcerative colitis.
  • Cardiovascular Conditions: Severe or uncontrolled heart failure, recent heart surgery (Coronary Artery Bypass Graft, or CABG), or a history of heart attack or stroke.
  • Severe Organ Impairment: Severe liver disease or severe kidney failure.
  • Pregnancy and Breastfeeding: Use is generally contraindicated, especially during the third trimester of pregnancy, as it may harm the fetus.

Precautions (Use with Caution)

Consult your healthcare provider before taking Oxalgin-DP if you have a history of asthma, high blood pressure (hypertension), mild-to-moderate liver or kidney disease, blood clotting disorders, or are elderly (over 65 years), as these factors may increase the risk of side effects.

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

The interaction profile of Oxalgin-DP, a combination of Diclofenac (NSAID) and Acetaminophen (Paracetamol), is governed by documented risks of additive toxicity and altered drug exposure, as stated in regulatory prescribing information.


Official Regulatory Restrictions

Restriction Category Interacting Agents or Conditions
Prohibited Combinations Other medicines containing Acetaminophen (risk of severe liver damage).
Not Recommended/Avoid Other Nonsteroidal Anti-inflammatory Drugs (NSAIDs); Alcohol (increased GI bleeding/liver risk).

Documented Pharmacological Interactions

Combining Oxalgin-DP with specific agents may result in clinically significant interactions:

  • Anticoagulants (e.g., Warfarin) and Oral Corticosteroids increase the formal risk of serious bleeding events due to the Diclofenac component.
  • Lithium and Methotrexate exposure may be increased, as Diclofenac can reduce their clearance, necessitating careful consideration.
  • Diuretics and ACE Inhibitors/ARBs may have their therapeutic effect diminished, and the co-administration may increase the risk of deterioration in kidney function, especially in the elderly.
  • Voriconazole is documented to increase the plasma exposure of Diclofenac.

Regulatory documentation also includes population-specific cautions, noting that interactions with drugs affecting the kidneys are more pronounced in older adults or those with existing renal impairment.

Mechanism of Action

How Oxalgin-DP Works


Peripheral Enzyme Inhibition and Anti-Inflammatory Action

This domain covers the action of Diclofenac, which functions primarily by inhibiting the Cyclooxygenase-2 (COX-2) enzyme in peripheral tissues. This molecular interaction suppresses the synthesis of Prostaglandins (PGE2), molecules that mediate inflammation and nociceptive signaling. The physiological outcome of this inhibition is a decreased local Prostaglandin activity, impacting the chemical excitation of peripheral nociceptors.


Central Modulation of Pain and Temperature Pathways

The second component, Acetaminophen, operates exclusively within the Central Nervous System (CNS), focusing on pathways that modulate nociceptive signal transmission and core body temperature. Its complex mechanism involves reducing central PGE2 in the hypothalamus related to the regulation of thermostasis and facilitating inhibitory signals within the spinal cord via targets like the TRPV1 receptor to increase the central nociceptive threshold.


Multi-Modal Mechanistic Synergy

The combination leverages two distinct biological domains—a peripheral anti-inflammatory effect and a central analgesic/antipyretic effect. This multi-modal action influences non-overlapping systems, where Diclofenac addresses the chemical cause of the stimulus (peripheral Prostanoid activity) and Acetaminophen modulates the central nervous system's response (nociceptive transmission). The synergy facilitates a multi-domain physiological modulation by simultaneously influencing peripheral Prostanoid activity and modulating central nociceptive transmission.

Dosage and Administration Information

How to Use Oxalgin-DP

The fixed-dose combination of Diclofenac and Acetaminophen (Paracetamol) is designed for oral administration as a tablet for systemic use. The medication is intended for use at the lowest effective dose for the shortest possible duration necessary to manage acute symptoms, requiring periodic re-evaluation of the need for continued treatment.


General Dosing Principles

The standard adult regimen involves taking one tablet, typically containing 50 mg of Diclofenac Sodium and 325 mg to 500 mg of Paracetamol, two to three times daily (bid or tid). The total daily intake is strictly limited; for example, the regimen must not exceed three tablets per day for the 50 mg/500 mg strength combination.

Administration Rule Instruction
Route and Handling Must be swallowed whole with a liquid; tablets must not be crushed, chewed, or broken.
Timing Relative to Meals Generally taken with or immediately after food to help mitigate gastrointestinal effects.

Population and Safety Constraints

Specific dosage modifications are required for certain populations. A reduced dose and close monitoring is necessary for older adults. For patients with impaired liver or severe renal function, the maximum daily dose of Paracetamol must not exceed 2 g. A critical constraint on proper use is the absolute prohibition against taking this medicine simultaneously with any other product that contains Paracetamol (Acetaminophen) to avoid dose stacking. The fixed combination tablet form is not indicated for use in children.

Recent Clinical Evidence

Research evidence / Overview of studies for Oxalgin-DP

This overview describes the types of clinical studies that have been conducted for the fixed-dose combination (FDC) of Diclofenac and Acetaminophen, focusing on what researchers have explored and what remains to be fully characterized in the evidence landscape.


Evidence for Use in Acute Pain and Post-operative Relief

Research has explored the combination for use in clinical situations involving acute pain, such as post-operative pain and conditions like sprains and acute backache. Research designs, including Randomized Controlled Trials (RCTs), have examined short-term symptom changes and typically involved comparisons against a placebo or a single-agent treatment.

In these research scenarios, studies monitored the intensity of pain using patient-reported outcomes describing perceived discomfort. Research also examined the patient's need for other rescue analgesic medication over very short time intervals, often just the first 4 to 24 hours. Research describes the acute use of the individual components. However, research is ongoing to fully characterize the fixed combination compared to the individual components for all acute musculoskeletal conditions.


Evidence for Chronic Joint and Inflammatory Conditions

The combination was studied in research for conditions characterized by functional limitations and periods of heightened symptoms, such as osteoarthritis and rheumatoid arthritis. Research relevant to this use consists of Systematic Reviews and Meta-Analyses, which summarize the findings from multiple trials, alongside individual studies that were evaluated in this patient group.

These studies explored outcomes reflecting daily functioning or activity level, including measures of joint stiffness. The evidence provides context on outcomes related to physical discomfort that studies monitored where symptoms may vary in intensity. Evidence is limited regarding the long-term use of this specific FDC, as much of the existing research in this area focuses on the Diclofenac component alone.


Long-term Studies and Durability of Response

Clinical trials specifically designed to assess the long-term effects and durability of symptom patterns for this fixed combination are generally limited. Follow-up durations were typically short to intermediate, meaning the research focused on immediate symptom changes or changes over a period of up to a few months. The studies have a short scope, exploring primary acute and intermediate symptom management.


Key Research Gaps and Uncertainties

One key gap is the need for more trials directly addressing whether the FDC is different in effect from the two components being administered separately for all approved uses. Findings were mixed across studies attempting this comparison in some acute musculoskeletal settings. Furthermore, evidence highlights what is known—and what is still uncertain—about the long-term effects and how the treatment performs over defined time intervals.

Frequently Asked Questions (FAQ)

Common questions about Oxalgin-DP (FAQ)


Q: What kinds of pain is Oxalgin-DP primarily used to treat according to official labeling?

A: Official product information states that this medicine is primarily indicated to reduce pain from conditions like headache, toothache, backache, and menstrual pain. It is also used to relieve pain, stiffness, and swelling associated with osteoarthritis and rheumatoid arthritis.

Q: Is Oxalgin-DP ever used to treat fever or is its purpose only pain relief?

A: The Acetaminophen component of Oxalgin-DP influences the part of the central nervous system that regulates body temperature. Therefore, it is commonly described in official contexts as providing relief from fever in addition to its use for pain.

Q: Why is taking Oxalgin-DP with food often recommended in usage information?

A: Regulatory information often recommends taking the medicine with food or immediately after eating. This practice is generally advised to help lessen the potential for stomach irritation and reduce the risk of gastrointestinal side effects.

Q: Can people with a history of liver disease use Oxalgin-DP?

A: Because the medicine is processed in the liver, its use is not recommended for use in individuals with pre-existing severe liver problems, as there is a risk of further damage. Official guidelines advise that caution and close monitoring are necessary when liver impairment is present.

Q: Can people with a history of kidney disease use Oxalgin-DP?

A: Official documents note that the medicine should be used with caution in people with kidney troubles. Regulatory warnings indicate that the Diclofenac component may lead to the deterioration of kidney function over time, and close monitoring is generally advised for such patients.

Q: Are there special precautions or considerations for elderly patients taking Oxalgin-DP?

A: Official documentation specifies that reduced doses and close monitoring are necessary for older adults. Interactions and serious side effects, particularly gastrointestinal events, are noted to occur more frequently in this population.

Q: Is Oxalgin-DP considered a short-term or a long-term treatment for pain?

A: Official guidance emphasizes using the medicine at the lowest effective dose for the shortest possible duration. This principle is established to manage acute symptoms while minimizing the potential risk for adverse cardiovascular and gastrointestinal events.

Q: How quickly should a person expect to feel the pain relief effect of Oxalgin-DP?

A: The onset of action for the Diclofenac component is often noted in official documents to begin within 30 minutes after ingestion. For chronic conditions like arthritis, the full therapeutic effect may take longer to develop.

Q: What is the typical duration of pain relief from one tablet of Oxalgin-DP?

A: The duration of the pain-relieving effects from the active components is noted in some regulatory summaries to last for up to approximately eight hours.

Q: Is stomach upset or nausea a commonly reported side effect?

A: Regulatory documentation lists side effects such as nausea, vomiting, heartburn, stomach pain, and diarrhea as commonly reported.

Q: What are the official warnings regarding potential liver issues with Oxalgin-DP?

A: Official warnings exist regarding the potential for liver damage (hepatotoxicity) when taking this medicine. The maximum daily intake of the Acetaminophen component is strictly limited for people with impaired liver function.

Q: Is there any risk of kidney function changes associated with long-term use of Oxalgin-DP?

A: The Diclofenac component carries a risk of leading to kidney damage or the deterioration of existing kidney function over time, especially with prolonged use. Patients with pre-existing kidney conditions are identified as being at greater risk.

Q: What information is available about signs of a possible allergic reaction to the medicine?

A: Signs of serious allergic reactions noted in official labeling include rashes, hives, swelling of the face, lips, or throat, or difficulty breathing. Users are advised to be alert for these symptoms.

Q: Can Oxalgin-DP cause dizziness or drowsiness that would affect daily activities?

A: Yes, regulatory documents indicate that side effects such as dizziness, drowsiness, or blurred vision may occur in some people. Official warnings advise caution regarding engaging in activities that require alertness, such as driving or operating machines.

Q: What are the warnings concerning heart health and taking Oxalgin-DP?

A: Warnings exist regarding an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (heart attack) and stroke. This risk is noted to potentially increase with higher doses or longer duration of use.

Q: What is the risk profile of gastrointestinal bleeding while taking Oxalgin-DP?

A: The NSAID component is associated with a risk of serious gastrointestinal adverse events, including bleeding, ulceration, and perforation of the stomach or intestines. Official warnings note this risk can occur at any time, with or without prior warning symptoms.

Q: Is Oxalgin-DP suitable for people with a pre-existing history of asthma?

A: The Diclofenac component is typically contraindicated (not recommended for use) in patients with a history of asthma, urticaria, or allergic reactions after taking aspirin or other NSAIDs. This is due to the potential risk of a severe respiratory reaction.

Q: What is the information available about taking Oxalgin-DP during the different trimesters of pregnancy?

A: Diclofenac is not usually recommended during pregnancy, particularly in the later stages. Official information states that it may potentially affect the unborn baby's blood circulation or reduce the amount of surrounding fluid.

Q: Are there warnings or contraindications related to using Oxalgin-DP while breastfeeding?

A: Trace amounts of the Diclofenac component are noted to pass into breast milk. While official information generally considers it acceptable, alternative pain relievers with more established safety data may sometimes be preferred.

Q: Is Oxalgin-DP generally not recommended for use in children under a certain age?

A: The fixed-dose combination tablet form is generally not indicated for use in children. The use of this specific combination in those younger than 12 years of age typically requires specific medical determination.

Q: Is Oxalgin-DP considered an addictive medication or does it have habit-forming potential?

A: As a combination of a nonsteroidal anti-inflammatory drug (NSAID) and Acetaminophen, the medicine is not classified as a narcotic. It is not associated with the potential for physical dependence or habit-forming behavior.

Q: What information is available on using Oxalgin-DP for treating tension headaches or migraines?

A: The drug is officially indicated for relieving pain due to various causes, which includes headache. Certain formulations of the Diclofenac component have also been noted in official documents for use in treating migraine headaches.

Q: What should be done if a person forgets to take an Oxalgin-DP tablet at the scheduled time? (Non-dosing)

A: General guidance is to take the missed dose as soon as possible. However, if it is almost time for the next scheduled dose, the missed dose should typically be skipped to avoid exceeding the recommended intake.

Q: Is it common for people to experience a rash or itchy skin while taking Oxalgin-DP?

A: Official labeling lists skin rash and hives as possible side effects. A rash is also noted as a sign of a more serious allergic reaction, which would require immediate medical attention.

Q: Does Oxalgin-DP have documented interactions with any anti-seizure or mood-stabilizing medicines?

A: The Diclofenac component has documented interactions with certain agents, including Lithium and some antidepressants (SSRIs). These interactions may increase the risk of side effects, including bleeding.

Q: What does available research suggest about the effectiveness of Oxalgin-DP for treating joint stiffness?

A: Official indications confirm that the medicine is used to provide relief from stiffness associated with chronic inflammatory joint conditions. This includes conditions such as osteoarthritis and rheumatoid arthritis.

Q: Does official documentation specify a maximum duration for the continuous use of Oxalgin-DP?

A: Regulatory documentation strongly advises that the medicine should be used for the shortest duration possible. While a specific number of days is not universally fixed, prolonged use may increase the risk of adverse cardiovascular and gastrointestinal events.

How should Oxalgin-DP be stored and disposed of?

Official Storage and Disposal Requirements

The storage and disposal of Oxalgin-DP Tablet must strictly follow the conditions specified in the medicine's official regulatory labeling to ensure product integrity and safety.

Regulatory Requirement Description
Storage Temperature Store at room temperature, typically below 30 C
Environmental Protection Keep in a cool and dry place, protected from light and moisture
Container Rule Keep the medicine in the container or pack it came in, tightly closed
Child Safety Store out of the sight and reach of children and pets at all times
Disposal Instruction Dispose of unused medicine according to instructions on the label; do not dispose of via household waste or wastewater
Stability Do not use after the expiry date has passed

These official statements mandate the precise environment and handling procedures for the medicine, and they outline the required method for discarding expired or unused tablets.

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

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