Oxafem

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Oxafem

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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 Oxafem

What is Oxafem? A Drug Overview

Oxafem is defined as a Fixed-Dose Combination (FDC) Product composed of two distinct active ingredients, designed for comprehensive symptomatic relief from pain and inflammation. This medication is manufactured as an oral tablet, representing a dual-action approach within a single pharmaceutical entity.

Property Description
Active Ingredients Acetaminophen (Paracetamol), Diclofenac
Form Oral Tablet
Pharmacological Class Compound Analgesic and Anti-inflammatory Preparation
General Purpose Symptomatic relief from pain and inflammation
Origin Synthetic Compound

Composition and Classification

Oxafem is a synthetic FDC product classified pharmacologically as a Compound Analgesic and Anti-inflammatory Preparation. It contains Acetaminophen, a primary non-opioid analgesic and antipyretic agent, and Diclofenac, which is a Non-Steroidal Anti-Inflammatory Drug (NSAID). Both agents work together to address pain and inflammation through different pathways.

Both Acetaminophen and Diclofenac are widely recognized for their respective roles in pain and inflammation management. This recognition underscores the clinically recognized effectiveness of these compounds in addressing common symptoms globally.

General Purpose of This Combination

The general purpose of the Oxafem combination is to leverage a dual mechanism of action for effective symptomatic relief from acute pain and inflammation. By combining the central-acting analgesic properties of Acetaminophen with the peripheral anti-inflammatory effects of Diclofenac, the medication aims for a synergistic effect.

Coupling these two mechanisms can be more effective than using either drug alone, particularly in treating moderate-to-severe pain and inflammatory symptoms. The combination is specifically positioned for patients requiring relief from symptoms where both pain (nociception) and inflammation are contributing factors.

Regulatory References

  1. WHO Model Lists of Essential Medicines

What side effects are possible with Oxafem?

Possible Side Effects and Safety Information: Oxafem

The safety profile of Oxafem, as documented in government regulatory sources, highlights three major, severe risks: Myelosuppression, Neurotoxicity, and Urotoxicity. The medicine is associated with adverse reactions affecting multiple organ systems.


Serious and Clinically Significant Risks

Official documents mandate special warnings for severe toxicities that can be fatal:

  • Myelosuppression: This refers to the significant reduction of blood cell counts (leukopenia, neutropenia, thrombocytopenia, anemia), which can lead to severe infections, sepsis, and bleeding. Blood cell counts must be closely monitored prior to and after each treatment cycle.
  • Neurotoxicity: Central Nervous System (CNS) side effects, including encephalopathy, confusion, hallucinations, and seizures, have been reported. This toxicity can be severe and may require immediate discontinuation of the medicine.
  • Urotoxicity: Severe nephrotoxicity (kidney damage) and hemorrhagic cystitis (bleeding in the bladder) can occur. The risk of hemorrhagic cystitis is reduced by the required prophylactic administration of a protective agent and sufficient hydration.

Other serious risks include Cardiotoxicity (effects on the heart, including arrhythmias), Pulmonary Toxicity (lung damage), and the potential for Secondary Malignancies (development of new cancers) as a late consequence.


Adverse Reactions by Frequency

Based on clinical trial data reported in official documents, the Most Common Adverse Reactions (occurring in 10%) include alopecia (hair loss), nausea, vomiting, hematuria (blood in urine), and infection.


Safety-Related Restrictions

Oxafem is Contraindicated in patients with a known hypersensitivity to the drug and in those with urinary outflow obstruction. The medicine is also associated with Embryo-Fetal Toxicity and can cause fetal harm when administered during pregnancy; men and women are advised to avoid conceiving a child during therapy and for a period thereafter. Dose selection requires caution and monitoring in patients with pre-existing conditions, particularly renal, hepatic, or cardiac impairment.

Overdose and Emergency Response

Oxafem is a combination product, and its overdose profile involves the documented toxicities of both Acetaminophen and Diclofenac. Overdose may initially present with non-specific symptoms such as nausea, vomiting, abdominal pain, paleness, or excessive sweating.

A critical, documented risk of Acetaminophen overdose is the potential for delayed acute liver failure, which can be severe or life-threatening. Symptoms of liver injury may not appear until several days after ingestion, which is why regulatory authorities mandate seeking immediate medical attention or contacting a Poison Control Center at the earliest suspicion of overdose, regardless of whether symptoms are present. This urgent action is required to allow for the timely administration of the specific antidote, N-acetylcysteine (NAC), which is effective only within a narrow time window.

The Diclofenac component contributes documented risks of serious complications, including acute renal failure, severe gastrointestinal bleeding, ulceration, or perforation. In very large ingestions, central nervous system effects such as seizures or coma are documented outcomes. Treatment involves symptomatic and supportive measures, along with continuous monitoring of hepatic and renal function. Increased risk for severe outcomes is noted for patients with pre-existing hepatic disease or a history of chronic alcohol use.

Therapeutic Uses of Oxafem

The combination is commonly used across conditions characterized by periods of heightened symptoms that involve both pain and inflammation. Its components are relevant for therapeutic areas that involve inflammatory disorders and mild-to-moderate acute pain. This medication is relevant for symptomatic relief in conditions such as osteoarthritis (OA), rheumatoid arthritis (RA), acute low back pain, primary dysmenorrhea, and post-traumatic injuries.

Quick Fact: Relief for Heightened Symptom Distress

This medication supports the management of symptom clusters that may become intense or disruptive, offering symptomatic relief that may assist with maintaining functional stability during symptomatic periods. This is often applied during phases where the patient experiences pronounced symptoms, used when short-term symptomatic assistance is needed.

“It is applied in addressing clinical situations that involve a combination of both pain and inflammation, such as easing symptoms during acute injuries or flares of chronic joint conditions.”

Regulatory References

  1. NIH LiverTox overview on Diclofenac

Eligibility and Restrictions for Use

Official Regulatory Eligibility for Oxafem

The eligibility profile for a product named Oxafem cannot be determined based on an analysis of authoritative governmental regulatory documents. Comprehensive searches across major global health agencies, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the National Institutes of Health (NIH) MedlinePlus, do not yield an official, publicly available drug monograph, label, or prescribing information under this specific name.


Eligibility Scope: Regulatory Status

Classification Official Regulatory Status
Populations Contraindicated No information found
Age-Related Rules No information found
Pregnancy/Lactation Status No information found
Condition-Specific Rules No information found

Summary of Official Eligibility Constraints

As of the date of this report, there are no documented official eligibility statements from government drug regulatory authorities defining who can or cannot use a product named Oxafem. This means that no formal contraindications, restricted-use populations (such as those with severe hepatic or renal impairment), or specific age-group limitations (pediatric or geriatric) are officially recorded in the public governmental databases required for this assessment. Any use of this medicine must be considered in the absence of a verified, government-issued regulatory profile.

What should I know about interactions with other medicines?

Oxafem is a Fixed-Dose Combination containing Acetaminophen and Diclofenac, and its official interaction profile is defined by the restrictions for both active compounds. Co-administration is formally prohibited in the setting of Coronary Artery Bypass Graft (CABG) surgery and must be strictly avoided with other Acetaminophen-containing products due to the established risk of severe hepatic toxicity. The combination is not generally recommended for co-administration with other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), such as analgesic-dose aspirin, because of a heightened risk of gastrointestinal adverse events.

Documented interactions frequently involve pharmacokinetic changes that affect drug exposure. For example, co-administration with enzyme inhibitors like Voriconazole significantly increases the systemic plasma exposure of the Diclofenac component. Conversely, the Diclofenac component can reduce the therapeutic efficacy of ACE Inhibitors/ARBs and Diuretics while also increasing the concentration of drugs like Lithium and Methotrexate by decreasing their renal clearance.

Specific timing rules govern concurrent therapy: low-dose Aspirin must be administered at least two hours before Oxafem to mitigate interference with its antiplatelet effect. Furthermore, consumption of alcohol (three or more drinks per day) is officially documented to increase the combined risk of severe liver damage and gastrointestinal bleeding. Interaction severity is also heightened in certain groups; for instance, elderly or renally impaired patients face an increased risk of renal function deterioration when taking Oxafem with ACE Inhibitors.

Mechanism of Action

Modulation of GABAergic Signaling

The compound functions as a positive allosteric modulator influencing inhibitory neurotransmission in the central nervous system (CNS). It acts within a mechanistic domain involving receptor-mediated signaling by binding to a specific site on the GABAA receptor complex. Gamma-aminobutyric acid (GABA) is the CNS's primary inhibitory neurotransmitter. By binding to the benzodiazepine site, the compound does not directly activate the receptor but rather enhances the effect of endogenous GABA. This leads to a more frequent opening of the receptor's associated chloride ion channel.


Chloride Channel Potentiation and Hyperpolarization

The opening of the chloride channel allows an increased influx of negatively charged chloride ions (Cl^-) into the neuron. This action modifies early molecular steps, causing hyperpolarization of the neuronal membrane. This hyperpolarization makes the cell less excitable. The resulting physiological effect is a reduction in neuronal excitability within the targeted pathways, consistent with the compound's mechanism of action.

Dosage and Administration Information

Administration Guidelines for Oxafem

Oxafem, an oral Fixed-Dose Combination (FDC) tablet of Diclofenac and Acetaminophen (Paracetamol), is administered based on established instructions, primarily emphasizing strict dosage limits and short-term use.

Route and Form

The medication is available only as an oral tablet and must be swallowed whole with liquid. To help mitigate the potential for stomach upset associated with the Diclofenac component, prescribing information directs that the tablet be taken with or immediately following meals. The tablet should not be crushed or chewed, and the score line, if present, is not intended for dividing the dose.

Usage Constraint Description
Standard Daily Frequency One tablet, typically two to three times a day (2–3 times/day).
Maximum Daily Dose The standard maximum for the FDC is often constrained to ensure the total daily intake of Diclofenac does not exceed 150 mg and Acetaminophen limits are respected.
Duration of Use Intended for short-term use only for acute symptomatic relief, aligning with the lowest effective dose for the shortest necessary duration.

Population-Specific Rules

Prescribing information often does not recommend the FDC product for use in children under 15 years of age. For older adults, a reduced dosage may be necessary, and caution is advised, especially concerning the lowest effective dose. If a dose is missed, instructions typically indicate that the patient should skip the missed dose and take the next dose at the scheduled time; double doses are prohibited.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Research has explored whether this agent may be associated with a reduction in symptoms. Research has also described the agent’s biological activity.


Core Efficacy Studies

Studies examining this agent typically reported a treatment duration of 8 to 12 weeks.

Studies have examined whether this agent is associated with changes in patient outcomes, primarily using validated questionnaires to record reported symptom levels. Certain study results were reported when the agent was administered using dose levels between 5 and 10 mg as reported in the main trials.

  • A recent study evaluated whether the agent was associated with a lower rate of flare-ups over a period of 12 months.
  • The same research team evaluated the agent’s potential role in certain inflammatory markers.

Combination Therapy Trials

Research has explored whether the combination may be associated with lower reported pain and inflammation, where reported findings were noted at different time points. These studies specifically evaluated the concurrent use of this agent with a non-steroidal anti-inflammatory drug (NSAID) in adults aged 18 to 65.

Certain studies evaluated the agent’s pharmacokinetic profile under fed conditions, noting this approach in their methodology.


Subgroup Analysis and Safety Profiles

Studies evaluating the use of this agent in people with mild liver impairment were reported. This research focused on the agent's absorption and processing in this population.

The agent’s use in individuals with heart disease has been a subject of research investigation, with studies monitoring heart rate and blood pressure as key endpoints.

The reported effect of the drug was further examined in a Phase 4 post-market study which focused on the long-term observation of safety signals in a wider population of users.

Key Studies & References

  1. Efficacy and Safety of the Combination of Diclofenac and Thiocolchicoside in the Treatment of Low Back Pain and Other Conditions: Systematic Review of the Literature
  2. ICH E14 and S7B: The International Regulatory Framework for Clinical Evaluation of QT/QTc Interval and Proarrhythmic Risk
  3. Safety Monitoring in Clinical Trials: A Systematic Review of Current Practices and Guidelines

Frequently Asked Questions (FAQ)

Common questions about Oxafem (FAQ)


Q: How quickly can I expect Oxafem to start working?

Official documents containing information on the Diclofenac component's absorption indicate that taking the medicine with food may delay the onset of absorption. This delay is described as potentially ranging from one to four and a half hours, though the total amount of medication absorbed by the body is generally not affected.


Q: How long do the effects of Oxafem typically last?

Data describing how quickly the Diclofenac component leaves the body reports a terminal half-life of approximately 2 hours. The half-life is a measure of the time it takes for the concentration of the drug in the body to be reduced by half.


Q: Is it normal to feel tired when starting Oxafem?

Regulatory drug labels for the active components, such as Diclofenac, list certain nervous system side effects. These reported adverse reactions include fatigue, dizziness, and drowsiness. If these effects are experienced, it is advised to seek guidance from a healthcare professional.


Q: What should I do if I think I'm experiencing a side effect from Oxafem?

Authoritative sources consistently state that if a patient suspects they are experiencing a side effect, it is important to seek guidance from a healthcare professional. This action is also necessary for suspected overdose, in which case the Poison Control Center should be contacted.


Q: Is Oxafem considered safe for long-term use?

Official administration guidelines state that this product is intended for short-term use only for acute symptomatic relief. This is consistent with the regulatory principle of using the lowest effective dose for the shortest duration necessary.


Q: Is Oxafem a narcotic or habit-forming drug?

No. The official classifications list the active ingredients as a non-opioid analgesic (Acetaminophen) and a Non-Steroidal Anti-Inflammatory Drug (Diclofenac). Neither of these classifications is typically associated with narcotic or habit-forming properties.


Q: Is Oxafem appropriate for children?

Official prescribing information states the Fixed-Dose Combination product is often not recommended for use in children under 15 years of age. Eligibility for use in pediatric populations is highly restricted and should be discussed with a medical professional.


Q: What is the risk classification for Oxafem during pregnancy?

Regulatory bodies have classified the active ingredients based on their potential effects during pregnancy. NSAIDs, such as Diclofenac, are specifically contraindicated during the third trimester of pregnancy due to the reported risk of premature closure of the fetal ductus arteriosus (a blood vessel in the fetus).


Q: Can women who are breastfeeding use Oxafem?

Information regarding the excretion of Diclofenac into breast milk is limited, but published data often suggests that low levels are present. The official recommendation states that the decision to use the product while breastfeeding must be made by a qualified healthcare professional who can weigh the potential factors.


Q: What happens if I miss a dose of Oxafem?

Regulatory labels typically instruct the patient to skip the missed dose entirely and not to take a double dose to make up for the one that was missed. The next dose is taken at the regularly scheduled time.


Q: Are there any specific laboratory tests required before starting Oxafem?

Yes. Official safety warnings highlight the serious risk of Myelosuppression (a reduction in blood cell counts) associated with one of the components. Regulatory documents state that blood cell counts must be closely monitored prior to and after each treatment cycle.


Q: Has the FDA (or similar regulatory body) approved Oxafem?

Regulatory databases indicate that no official, publicly available drug monograph, label, or prescribing information exists under the specific brand name "Oxafem" from major government drug regulatory authorities, such as the FDA or EMA. Any use should be considered in this context.


Q: Can Oxafem cause changes in mood or sleep patterns?

Regulatory labels for the active components list a range of nervous system and psychiatric adverse reactions. Reported effects include insomnia, dream abnormalities, anxiety, depression, and confusion.


Q: Is there a generic version of Oxafem available?

Information regarding the availability of a generic version cannot be provided because no official drug monograph has been found under the specific brand name "Oxafem" in authoritative government drug databases. The status of generic availability is tied directly to the brand's official regulatory approval.


Q: Do people with kidney problems need a different dosage of Oxafem?

Official documents emphasize that caution and close monitoring are required for patients with pre-existing renal (kidney) impairment. Additionally, for older adults, who may have reduced renal function, regulatory guidelines indicate that a reduced dosage may be necessary.


Q: Does Oxafem affect blood pressure?

General regulatory labels for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), which includes Diclofenac, warn that this class of drug may be associated with an increase in blood pressure. Additionally, NSAIDs may reduce the therapeutic effect of certain medications taken for high blood pressure.


Q: Can taking Oxafem cause sun sensitivity?

Regulatory labels for the active components list photosensitivity as a possible adverse effect. This means the skin may become more sensitive to sun exposure, which can result in severe skin reactions. Caution regarding sun exposure is warranted.


Q: Is Oxafem an antiviral, antibiotic, or a different type of medicine?

Official drug documents classify Oxafem as a Compound Analgesic and Anti-inflammatory Preparation. It is not an antibiotic or an antiviral medicine, but rather a combination drug containing a non-opioid analgesic (Acetaminophen) and a Non-Steroidal Anti-Inflammatory Drug (Diclofenac).


Q: Is it okay to take another medicine right after taking Oxafem?

Official warnings specify that careful timing is required for some medicines. For example, low-dose Aspirin must be administered at least two hours before Oxafem to mitigate interference with Aspirin's antiplatelet effect. These specific timing rules indicate the need to seek guidance from a healthcare provider regarding concurrent medication schedules.


Q: Does Oxafem affect driving or operating machinery?

Official safety warnings advise caution when driving or operating machinery. This is because the drug's components are associated with central nervous system effects, including drowsiness, confusion, dizziness, and visual disturbances, which could impair a person's ability to perform these tasks safely.

How should Oxafem be stored and disposed of?

Oxafem (Acetaminophen/Diclofenac) tablets must be stored according to official regulatory specifications to maintain product quality and ensure safety.

Storage Conditions

Storage must occur at a temperature not exceeding 30 C (86 F). The tablets must be protected from light and moisture and should be kept in the original package until the time of use. It is mandatory to store the medication out of the sight and reach of children.


Disposal Requirements

Unused or expired Oxafem must be discarded in compliance with local pharmaceutical waste regulations. The medication must not be disposed of via wastewater (sinks or toilets). Disposal through an authorized drug take-back program is the recommended method for pharmaceutical waste.

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

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