Pacofen

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Medically reviewed

Rosario Oropesa

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 Pacofen

Quick Facts Overview

Property Description
Active ingredients Paracetamol, Codeine, and Caffeine
Form Tablet
Pharmacological class Compound Analgesic and CNS Stimulant combination
General purpose Relief from discomfort
Origin Mixed (Synthetic and Naturally Derived)

What is Pacofen?

Pacofen is a medication classified as a Compound Analgesic product, meaning it combines three different active ingredients to provide more comprehensive relief from discomfort than a single-ingredient medication. It is typically supplied in the form of a solid tablet designed for oral intake.

What Kind of Medicine is Pacofen?

Pacofen is a combination product that brings together a pain reliever, a strong analgesic, and a mild stimulant. The three key active ingredients are Paracetamol (Acetaminophen), Codeine, and Caffeine. The inclusion of Codeine means this product belongs to a class intended for managing pain where non-opioid options alone may be insufficient. The inclusion of caffeine can often enhance the pain-relieving effects of paracetamol, allowing the three ingredients to work together to provide more effective relief.

Composition and Origin of Pacofen

Pacofen's active components are sourced from a blend of synthetic and naturally derived substances. The Paracetamol and Caffeine are primarily synthetic compounds used widely in medicine. The Codeine component, however, is a naturally derived opioid agent, originally obtained from the opium poppy plant. Codeine is recognized as a medicine used primarily for its analgesic properties and has an established role in pain management worldwide.

General Purpose of Pacofen

Pacofen is designed for use in situations requiring more substantial pain control, such as managing the discomfort associated with severe headaches or minor injuries. Its general purpose is to offer enhanced symptomatic relief by utilizing the strengths of each ingredient working in synergy. This formulation is clinically recognized for balancing effective pain relief with reduced sedation compared to opioid-only alternatives.

What side effects are possible with Pacofen?

Possible side effects and safety information

Pacofen's safety profile, documented across official regulatory labeling, is classified by frequency and the body system affected. These regulatory classifications are intended to provide a clear understanding of the medication's adverse reactions and the specific populations where use is constrained.

The most common adverse reactions reported in official documents, often affecting the Central Nervous System and Gastrointestinal System, include drowsiness, lightheadedness, dizziness, constipation, nausea, and vomiting. Reactions such as drug dependence, acute pancreatitis, and unusual bleeding or bruising are documented with a frequency that is less common or not known according to regulatory standards.

Serious Adverse Reactions

The prescribing information highlights the potential for serious adverse reactions. These include life-threatening respiratory depression, a risk associated with the Codeine component, which is greatest during initiation of therapy or following a dose increase. Additionally, the Paracetamol component carries the risk of acute liver failure, particularly when the maximum daily dosage of 4000 mg is exceeded. Severe skin reactions, such as Stevens-Johnson syndrome, are also listed as documented potential risks.

Population-Specific Safety Constraints

Official labeling imposes explicit constraints for specific patient groups. The medication is contraindicated in children under 12 years of age and in adolescents aged 12 to 18 years following tonsillectomy or adenoidectomy. It is also contraindicated in patients with severe hepatic insufficiency and those identified as CYP2D6 ultra-rapid metabolizers. The risk of physical and psychological dependence is noted as an exposure-related safety pattern associated with prolonged use.

Overdose and Emergency Response

Overdose and when to seek help

The overdose profile for this compound analgesic is defined by the severe toxicities of its components. Symptoms of overdose may include profound sedation, vomiting, acute abdominal pain, and later, Jaundice (yellowing of skin/eyes). The primary life-threatening risks are acute liver failure from the Paracetamol component and life-threatening respiratory depression from the Codeine component, which can progress to coma or circulatory shock.

Overdose Response and Monitoring

Domain Official Regulatory Statement
Documented Manifestations Profound sedation, acute abdominal pain, Jaundice, respiratory depression.
Population-Specific Risk Accidental ingestion of a single dose of the opioid component can result in a fatal overdose in children.
Antidotes Acetylcysteine is the specific antidote for Paracetamol toxicity, and an opioid antagonist (e.g., Naloxone) is described for reversing Codeine-induced effects.

Seek immediate medical attention or contact emergency services (e.g., Poison Help hotline) upon any suspected overdose. Immediate medical management is officially required regardless of whether initial symptoms are apparent. Mandated management includes hospital observation with monitoring of vital signs and hepatic/renal function, and assessment requires specific determination of the plasma acetaminophen concentration for risk stratification.

Official regulatory documents define the overdose profile by outlining the combined, severe toxicities—the delayed risk of acute liver failure and the immediate risk of respiratory depression. This combined, potentially fatal profile dictates that immediate medical attention is mandated upon suspicion, facilitating the prompt administration of necessary antidotes and intensive hospital monitoring.

Therapeutic Uses of Pacofen

What Pacofen Treats: Main Uses and Benefits

Pacofen is commonly used for managing acute moderate pain in situations where relief from single-ingredient non-opioid options may be insufficient. The therapeutic uses for this compound are generally intended for adults and adolescents aged 12 and above. It is relevant for symptoms related to specific conditions including headache, migraine, dental pain, muscle pain, and period pain (painful menstruation). Applying this combination product assists with maintaining functional stability by providing supportive pain control, which is the key benefit sought when symptoms become noticeable and challenging to tolerate.

The medication is helpful for managing symptoms that interfere with daily comfort, especially in conditions characterized by acute or episodic symptom patterns. This includes relevant contexts such as discomfort following minor accidents or minor operations, as well as helping manage systemic symptoms associated with cold and flu in adults. The product is relevant for easing symptoms that become temporarily overwhelming and supporting the patient during difficult episodes.

“The combination is relevant for easing symptoms that become temporarily overwhelming, supporting the patient during difficult episodes.”

The combination is also commonly used to help with the reduction of fever (antipyresis), which often coexists with painful conditions. This combination supports general well-being during symptomatic phases and contributes to easing the overall symptom load.


Therapeutic Focus
Target Symptoms Moderate pain, fever, and general systemic discomfort
Therapeutic Context Short-term management of acute or episodic manifestations
Patient Benefit Supportive symptomatic relief and functional stability

Eligibility and Restrictions for Use

Official Eligibility for Pacofen Use

Pacofen is authorized for use in adults and adolescents aged 12 years and older for acute moderate pain management. Eligibility is strictly defined by regulatory bodies and is highly dependent on age, organ function, and specific metabolic status due to its Codeine and Paracetamol components.

Absolute Contraindications (Must Not Use)

The medicine is contraindicated in several population groups. This includes all children younger than 12 years of age for pain relief, and also adolescents (12–18 years) receiving it after tonsillectomy or adenoidectomy.

Use is also prohibited for women who are breastfeeding (lactation), and in patients with diagnosed severe hepatic (liver) impairment. Furthermore, individuals known to be CYP2D6 ultra-rapid metabolizers must not use this medicine due to the risk of toxicity. Pacofen is also contraindicated in those with acute respiratory depression or known paralytic ileus.

Conditional and Restricted Use

Use requires caution and is often restricted in patients with severe renal (kidney) impairment and those in the geriatric population. The medicine is not generally recommended for use during pregnancy, especially in the third trimester.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Pacofen, a combination product containing Paracetamol, Codeine, and Caffeine, has formally documented interactions governed by its active ingredients, as described in regulatory documents.

Contraindicated Combinations and Patient Status

Interaction restrictions apply to specific populations and conditions. The medicine is formally contraindicated in children under 12 years of age and in adolescents under 18 years following tonsillectomy or adenoidectomy. Furthermore, it is prohibited in patients known to be CYP2D6 Ultra-Rapid Metabolizers due to the heightened risk of respiratory depression from rapid Codeine conversion to Morphine. Co-administration with any other product containing Acetaminophen is restricted to prevent exceeding the maximum daily dose and risking hepatotoxicity.

Clinically Significant Interactions

Co-administration with Central Nervous System (CNS) Depressants, including alcohol, is officially documented to pose a risk of profound sedation, respiratory depression, coma, and death due to additive pharmacodynamic effects.

Interacting Substance/Class Official Interaction Outcome
CYP2D6 Inhibitors (e.g., Paroxetine) Reduced formation of the active metabolite, potentially lowering efficacy.
Serotonergic Drugs (e.g., SSRIs) Potential for Serotonin Syndrome.
Warfarin and Coumarin Derivatives Increased risk of bleeding due to enhanced anticoagulant effect.
Hepatic Enzyme Inducers Increased risk of Paracetamol-related hepatotoxicity.

Use with CNS depressants should be reserved for scenarios where alternative treatments are inadequate, a constraint noted in official product labeling.

Mechanism of Action

The mechanism of action for Pacofen, a combination of Paracetamol and Codeine, involves dual and complementary actions on key regulatory systems to modulate signaling sequences associated with nociception and thermoregulation.

Central Pain Modulation via Opioid Receptors

Codeine acts as a prodrug, metabolized to Morphine, which exerts its primary action by binding as an agonist to mu-opioid receptors (MOR) within the central nervous system. This interaction modifies the G-protein signaling cascade, dampening the activity patterns of key nociceptive pathways and resulting in decreased transmission of nociceptive impulses.

Targeted Inhibition of Prostaglandin Synthesis

Paracetamol selectively acts within the central nervous system to inhibit certain cyclooxygenase (COX) enzymes. This enzymatic inhibition limits the biosynthesis of prostaglandins, which are key lipid mediators involved in sensitizing pain receptors and driving the body's febrile response. This mechanism restricts the signaling consequence of elevated mediator levels, contributing to effects on nociceptive signal processing and central thermoregulation.

Synergistic Pathway Influence

The components engage distinct but reinforcing mechanistic domains—one acting via receptor-mediated signaling and the other via enzyme-mediated signaling—which together modify early molecular steps that shape the systemic physiological outcomes. This dual-pathway approach modulates the activity patterns within targeted regulatory pathways.

Dosage and Administration Information

How to Use Pacofen

Pacofen is used by the oral route, typically supplied in the form of a tablet or capsule. The administration is intended for short-term management of acute symptoms. For adults, the standard labeled regimen involves taking 1 to 2 unit doses every 4 to 6 hours, with a minimum interval of 4 hours between doses. The total intake must not exceed 8 tablets within a 24-hour period.


Administration Conditions and Duration

The usage constraint is the maximum duration of treatment, which must not exceed 3 consecutive days for acute pain management. Pacofen can be taken either with or without food. If the dosage form is a soluble tablet, the unit dose must be completely dissolved in water before ingestion.


Population-Specific Dosing

Dosing requires modification for specific populations. For adolescents aged 12 to 15 years, the labeled dose is 1 tablet every 6 hours, limited to 4 tablets in 24 hours. The use of Pacofen is not approved for children under 12 years of age. For patients with renal impairment, the interval between doses must be extended to at least 6 hours to allow for proper drug clearance, and dose reduction may be necessary for older adults.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Pacofen

Evidence for Use in Acute Moderate Pain (General)

Research into this type of combination analgesic focuses on acute, temporary pain. The evidence primarily consists of Randomized Controlled Trials (RCTs) and comprehensive Meta-Analyses. These studies were designed to measure changes in physical discomfort over specific time intervals.

Researchers studied outcomes related to physical discomfort by tracking scores such as Total Pain Relief (TOTPAR) scores and the change in a patient’s reported Pain Intensity Difference (PID) scores over several hours. Studies monitored these outcomes in populations of Adults and Adolescents (age 12 and above). The findings describe patterns observed when comparing the combination to a placebo or to paracetamol alone, contributing to the broader evidence landscape related to short-term symptom patterns.

Evidence for Use in Headaches (Tension-type and Migraine)

The evidence base for using this combination in conditions characterized by episodic or acute manifestations has been explored in Randomized Controlled Trials and Systematic Reviews. Research examined outcomes related to the percentage of participants who reported reaching a measured pain-free state at specific check-points and the measured changes in pain severity. The detailed research in this area often examines the dual combination of Paracetamol and Caffeine, rather than the three-ingredient Pacofen formulation.

Evidence for Use in Dental and Post-operative Pain

The use of this combination for outcomes related to physical discomfort following minor procedures has been evaluated in RCTs and Meta-Analyses. Research examined outcomes such as Total Pain Relief (TOTPAR) scores and the measured need for rescue analgesic medication following the procedure. Some studies have noted that combinations containing Codeine was associated with higher occurrences of specific self-reported effects, like drowsiness or nausea, when observed in some studies.

What is Still Uncertain About Pacofen Research

The research highlights what is known, but also where gaps exist. A major limitation is that the follow-up durations were limited across most trials, meaning long-term outcomes are not fully established. Evidence quality varies across studies, and comparative evidence for the specific three-ingredient combination against all other treatment options is limited. Research does not determine whether an individual will respond similarly; study results should be viewed as reflecting the specific conditions under which they were conducted.

Key Studies & References

  1. Analgesic efficacy of paracetamol and its combination with codeine and caffeine in surgical pain: a meta-analysis (Dental/Post-Op Pain)

Frequently Asked Questions (FAQ)

Common questions about Pacofen (FAQ)


Q: How long do the effects of one dose of Pacofen last?

The duration of the therapeutic effect can vary. However, regulatory documents describing the pharmacokinetics of the Codeine component indicate a half-life of approximately 2.9 hours. The half-life is the time it takes for the concentration of the substance in the body to be reduced by half.


Q: Does Pacofen interact with common supplements like vitamin D or magnesium?

Official drug interaction information focuses primarily on other prescription medications, such as specific enzyme inhibitors or anticoagulants like warfarin. The available regulatory warnings do not contain explicit information or specific warnings regarding interactions with common supplements, such as vitamin D or magnesium.


Q: Is the 'mechanism of action' of Pacofen fully understood and described?

Official labeling provides a description of the drug's dual action, detailing that Codeine acts as an opioid agonist on the mu-opioid receptor. The Paracetamol component is described as inhibiting COX enzymes to limit the biosynthesis of prostaglandins. Regulatory documents focus on providing the current established mechanism.


Q: How is the storage of Pacofen pills officially described?

Official documents state that Pacofen must be kept at Controlled Room Temperature, which is 20 C to 25 C (68 F to 77 F). Due to the risks of accidental ingestion, it is critical that the medication always be stored securely in its original container, out of the sight and reach of children and pets.


Q: Is Pacofen the same as other pain relievers I can buy?

No, Pacofen is classified as a Compound Analgesic product. This means it combines multiple ingredients, including Codeine, which is classified as an opioid agent. This composition is what distinguishes it from single-ingredient, non-opioid pain relievers commonly available over the counter.


Q: Can I use Pacofen for everyday minor aches?

Regulatory instructions indicate the medicine is intended for short-term management of acute symptoms, with a maximum authorized duration of three consecutive days. Its use is defined by official regulatory bodies for specific short-term needs.


Q: Why is Pacofen only available by prescription?

The primary reason is the inclusion of Codeine, which is classified by regulatory bodies as a narcotic analgesic. Due to the potential for dependence or misuse associated with opioid components, products containing this ingredient are typically subject to specific controlled substance regulations that require a prescription.


Q: What ingredients are in the Pacofen pill?

The tablet contains the three active ingredients: Paracetamol, Codeine, and Caffeine. Official labeling also documents the presence of inactive ingredients, which may include components like magnesium stearate, microcrystalline cellulose, and various starches and binders.


Q: Can Pacofen be crushed or split in half?

Official regulatory guidance for dosage forms such as tablets often advises that they should not be divided, crushed, or chewed. Unless specific preparation is required (like dissolving a soluble tablet), the medication is intended to be used as dispensed.


Q: Can Pacofen affect sleep quality?

Official regulatory documents list side effects that may potentially impact rest. The most commonly reported side effects include Central Nervous System effects such as drowsiness and lightheadedness.


Q: Are there any specific lifestyle changes recommended when taking Pacofen?

Regulatory information describes the serious risk of profound sedation and respiratory depression when alcohol is used concurrently with the medication. This combination is strongly cautioned against in official labeling.


Q: Does smoking affect how Pacofen works?

Official regulatory literature indicates that substances that affect CYP450 1A2 enzymes can be impacted by smoking or smoking cessation. This activity may influence the drug's plasma concentrations.


Q: Does Pacofen require any special monitoring or blood tests?

Because the Paracetamol component carries the risk of acute liver failure, healthcare professionals monitor patients for risk factors. The Codeine component has also been associated with potentially increased levels of serum amylase, which may be tracked in certain clinical settings.


Q: What do official sources say about stopping Pacofen suddenly?

Official documentation notes that following prolonged use of analgesics, symptoms such as headaches, fatigue, muscle pain, and nervousness may be observed upon abrupt discontinuation. This pattern is associated with dependency potential noted in regulatory information.


Q: Can Pacofen affect the results of a drug test?

Yes, official labeling states that the Codeine component may lead to increased serum amylase levels in laboratory tests. Additionally, the Paracetamol component may produce false positive test results for a chemical marker known as urinary 5-hydroxyindoleacetic acid.


Q: Is Pacofen appropriate for teenagers?

Official documents contain specific eligibility criteria. Use is authorized for adolescents 12 years and older for acute moderate pain relief. However, the product is strictly contraindicated in adolescents (12–18 years) who have recently received a tonsillectomy or adenoidectomy.


Q: Is Pacofen used to treat conditions other than what is listed on the label?

Regulatory documents define the official purpose of Pacofen as relief from discomfort associated with acute moderate pain. The use of the drug is authorized only for the conditions explicitly listed on the official product label.


Q: What is Pacofen's half-life?

The half-life of one of the active ingredients, Codeine, is specifically described in regulatory pharmacokinetics documents as approximately 2.9 hours. The half-life is the time it takes for the concentration of the substance in the body to decrease by half.

How should Pacofen be stored and disposed of?

How to Store and Dispose of Pacofen

Pacofen (containing Codeine) is classified as an opioid-containing product, which mandates strict security and temperature control for storage.

Storage Requirements

Pacofen must be kept at Controlled Room Temperature, which is 20 C to 25 C (68 F to 77 F). The product must be stored in its original, tightly closed container and protected from moisture to maintain stability. Due to the risk of fatal overdose from accidental ingestion, the medication must be stored securely out of the sight and reach of children and pets and inaccessible to others.

Disposal Instructions

Unused or expired Pacofen should be disposed of promptly. Regulatory guidance recommends using an official drug take-back program or mail-back envelope. If no take-back option is readily available, the tablets must be mixed with an undesirable substance, such as dirt or used coffee grounds, and sealed in a container before being discarded in the household trash.

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

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