Cetradol

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Cetradol

Treatment option: Pain

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Cetradol

Property Description
Active ingredients Acetaminophen (Paracetamol) and Tramadol Hydrochloride
Form Fixed-Dose Combination (FDC) Oral Tablet
Pharmacological class Combination Analgesic (Narcotic Analgesic Combination)
Common use Management of moderate to moderately severe pain
Origin Synthetic

Cetradol is a fixed-dose combination (FDC) Combination Analgesic, provided as a prescription-only oral tablet. This synthetic product is distinguished by uniting two distinct pain relievers—a non-opioid and a synthetic opioid—into a single pill, a formulation widely recognized for achieving superior pain control compared to single-agent options.


What Type of Medicine is Cetradol?

Cetradol is classified as a Narcotic Analgesic Combination, grouping it with medicines that combine an opioid component with a non-opioid component. Its status as a prescription-only medicine reflects the inclusion of Tramadol Hydrochloride and its use in treating pain that is not adequately managed by less potent alternatives. Pharmacological studies support the rationale for combining these two mechanisms to enhance overall analgesic effectiveness.


What is the Composition of Cetradol?

The oral tablet contains the non-opioid analgesic Acetaminophen (Paracetamol) and the synthetic, centrally acting opioid analgesic Tramadol Hydrochloride. This fixed-dose formulation is designed to capitalize on the synergistic effect of the components. This combination strategy is a key differentiator, as it leverages the action of Acetaminophen to inhibit central pain sensitizers while Tramadol concurrently acts as a μ-opioid receptor agonist and inhibits neurotransmitter reuptake. This dual approach is clinically recognized for providing a comprehensive blockade against pain signaling.


What is the General Purpose of Combining These Ingredients?

The core purpose of combining Acetaminophen and Tramadol is to deliver an optimized level of antinociception, making it an effective choice for patients whose pain threshold requires more than a standard single-entity drug. The medicine provides this relief through a dual mechanism of action, targeting pain at multiple points in the body’s sensory pathways. The general use is to manage acute episodes of moderate to moderately severe pain, offering a robust therapeutic response that is supported by numerous clinical efficacy trials.

Regulatory References

  1. Tramadol hydrochloride and acetaminophen tablets label

What side effects are possible with Cetradol?

Possible Side Effects and Safety Information

The safety profile for this fixed-dose combination, containing Tramadol Hydrochloride and Acetaminophen, is defined by regulatory documents based on the known risks of its individual components. Adverse reactions are classified by frequency and system involvement.

Frequency-Classified Adverse Reactions

Adverse effects are categorized based on their official incidence rate in clinical use, as documented in regulatory texts:

  • Very Common (occurring in ge 1/10 patients): Nausea, Dizziness, and Somnolence (Drowsiness).
  • Common (occurring in ge 1/100 to <1/10 patients): Vomiting, Constipation, Dry mouth, Headache, and Anxiety.

These effects are largely associated with the Nervous System Disorders and Gastrointestinal Disorders categories.


Serious Adverse Reactions and Regulatory Warnings

Official labeling mandates specific warnings for several serious risks. These include the potential for life-threatening Respiratory Depression, the risk of acute Hepatotoxicity (liver damage) associated with the Acetaminophen component, and the possible development of Serotonin Syndrome. Serious warnings also address the risks of Addiction, Abuse, and Misuse, as well as the potential for Seizures.


Population-Specific Safety Considerations

The medicine is subject to defined population constraints. It is officially contraindicated for all pediatric patients under 12 years of age, and for those with severe hepatic impairment. Furthermore, the label notes an increased risk of respiratory depression for ultra-rapid metabolizers of the Tramadol component and states that prolonged use during pregnancy can result in Neonatal Opioid Withdrawal Syndrome.

Overdose and Emergency Response

The official regulatory profile for Cetradol overdose is defined by the risk of dual toxicity from its two active components, mandating an immediate emergency response for any suspected ingestion. Overdose manifestations related to the tramadol component may include life-threatening respiratory depression, severe somnolence progressing to coma, seizures, and miosis (pinpoint pupils). Signs of acetaminophen overdose may initially be limited to pallor, nausea, vomiting, or abdominal pain, but can lead to delayed, potentially fatal hepatic necrosis (acute liver failure).

Immediate medical attention is required for any suspected overdose. Patients must seek help right away, even if they feel well, due to the delayed onset of severe liver damage from the acetaminophen component. Accidental ingestion, particularly by a child, is considered an immediate medical emergency due to the risk of fatal tramadol overdose from a single dose.

Management procedures involve administering specific antidotes: Naloxone is used for opioid effects, and N-acetylcysteine (NAC) is the antidote for acetaminophen toxicity, with maximum effectiveness achieved when administered quickly. The regulatory documentation emphasizes that the risk of fatal outcomes is increased when the medication is taken concurrently with alcohol or other CNS depressants.

Therapeutic Uses of Cetradol

The combination analgesic Cetradol is commonly used for managing symptoms related to physical discomfort that may need additional management of discomfort. It is generally considered relevant in situations where patients experience pronounced discomfort.

Targeted Relief for Moderate to Moderately Severe Pain

Cetradol is commonly used to help with symptomatic relief for pain that falls in the moderate to moderately severe range of intensity. It is relevant when symptoms related to physical discomfort become more disruptive during flare-ups, contributing to easing the overall symptom load during periods of heightened symptoms.

Management of Acute Episodes and Pain Flares

“This formulation is applied during phases when symptoms intensify and supportive relief is needed.”

The medication is relevant in conditions characterized by episodic or fluctuating symptom patterns, such as acute postoperative pain or sudden, intense pain flares associated with chronic conditions like osteoarthritis. It is applied during phases when symptoms intensify and supportive relief is needed to assist with maintaining functional stability during these temporary symptomatic periods. It is also used across domains where additional symptomatic support is needed, including certain cases of chronic low back pain and established neuropathic pain.

Quick Fact: Relief for Symptoms that Interfere with Daily Functioning

The combination is applied in scenarios where additional management of discomfort is required, contributing to easing the overall symptom load.

Regulatory References

  1. DailyMed (NIH) Drug Label for Tramadol/Acetaminophen

Eligibility and Restrictions for Use

Who Can and Cannot Use Cetradol?

Cetradol (Tramadol/Acetaminophen) is a prescription medicine with specific population-based eligibility rules defined by regulatory agencies.

Absolute Contraindications

Cetradol must not be used by certain patient groups. These include:

  • Children younger than 12 years of age.
  • Children younger than 18 years of age for pain relief following tonsillectomy and/or adenoidectomy.
  • Patients with severe hepatic impairment or significant respiratory depression.
  • Individuals with a known hypersensitivity to tramadol, acetaminophen, or any opioid.
  • Patients using or who have recently used Monoamine Oxidase Inhibitors (MAOIs).

Restricted or Conditional Use

Use is limited or conditional for other populations, as stated in official labeling:

  • Pregnancy and Lactation: Use is generally not recommended during pregnancy and breastfeeding.
  • Renal Impairment: Use is not recommended for patients with severe renal insufficiency (creatinine clearance below 10 mL/min). Conditional use (dose interval adjustment) is required for moderate impairment.
  • Age and Comorbidity: Caution is required for older adults (over 75 years) and patients with conditions like a history of seizure disorder or increased intracranial pressure.

What should I know about interactions with other medicines?

Cetradol Interactions with other medicines and products

This section addresses documented interaction patterns based on official regulatory labeling.

Formal Restrictions and Contraindications

Co-administration with Monoamine Oxidase Inhibitors (MAOIs) is formally contraindicated, a restriction that extends to use within 14 days of discontinuing an MAOI. It is also prohibited to take Cetradol alongside other products containing Tramadol or Acetaminophen (Paracetamol) to prevent excessive exposure and the risk of hepatotoxicity.

Pharmacokinetic and Pharmacodynamic Effects

Use with Central Nervous System (CNS) Depressants (including alcohol) or Serotonergic Drugs (e.g., SSRIs, Triptans) enhances the risk of serious pharmacodynamic effects, such as profound sedation, respiratory depression, or serotonin syndrome, as defined in regulatory documents.

Metabolic and Exposure Alterations

The medicine interacts with the cytochrome P450 enzyme system. CYP2D6 Inhibitors (e.g., Fluoxetine) may increase tramadol plasma levels while decreasing the active M1 metabolite. CYP3A4 Inducers, notably Carbamazepine, increase tramadol metabolism, potentially leading to a significantly reduced analgesic effect. Regulatory documentation also cites reports of increased prothrombin time (INR) when Cetradol is combined with Coumarin Derivatives like Warfarin.

Other Documented Interactions

While administration with food only causes a documented delay in the time to peak plasma concentration (T max), the concurrent use of Alcohol or the herbal product St. John's Wort can lead to officially altered exposure or compounded CNS effects. Furthermore, official labeling indicates that severe renal impairment results in reduced excretion and clearance of tramadol and its M1 metabolite.

Mechanism of Action

Dual Modulatory Action

Cetradol's mechanism involves two distinct, yet complementary, actions on the central nervous system. This dual approach targets both receptor-mediated signaling and neurotransmitter availability to influence afferent signal transmission. The active metabolite of the drug weakly binds to mu-opioid receptors (mu-OR). Concurrently, the parent compound and its metabolite inhibit the reuptake of the monoamine neurotransmitters norepinephrine (NE) and serotonin (5-HT).


Modulating Signal Transmission

This mechanistic domain focuses on the descending inhibitory pathways and ascending sensory signals in the spinal cord. By blocking the reuptake of NE and 5-HT, Cetradol enhances the concentration of these messengers, which increases the inhibitory effect of descending pathways on signal propagation. Simultaneously, the mu-OR agonism reduces the release of excitatory neurotransmitters that propagate sensory signals. These combined effects result in changes to the central processing of afferent signals and an enhanced monoaminergic inhibitory tone on afferent signal flow.

Dosage and Administration Information

Cetradol is a fixed-dose combination tablet administered by the oral route. The tablets must be swallowed whole with liquid and must not be broken, crushed, or chewed, as the integrity of the tablet is required for proper administration. The medication may be taken with or without food.

Official Dosing and Frequency

The standard regimen for adult patients is typically initiated at a dose of 2 tablets every 4 to 6 hours as needed for pain relief. The frequency of use is governed by this minimum time interval between doses. Crucially, the total daily intake is limited by regulatory mandate: the absolute maximum dose must not exceed 8 tablets per 24-hour period.

Usage is designated for short-term treatment, generally limited to five days or less, for the management of acute pain. When discontinuing the medication, the official labeling specifies that cessation should involve a gradual downward taper of the dose rather than an abrupt stop.

Population-Specific Administration Rules

Dosing is adjusted for specific patient groups to comply with regulatory standards. For patients with severe renal impairment (creatinine clearance less than 30 mL/min), the maximum dose is restricted to 2 tablets every 12 hours. The minimum interval between doses for older adults (over 75 years) must be extended to not less than 6 hours. The medication is contraindicated for use in pediatric patients younger than 12 years of age. A core administration principle requires that Cetradol must not be co-administered with any other product containing tramadol or acetaminophen.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Cetradol

Evidence for use in Acute Postoperative Pain

Research explored the fixed-dose combination of Tramadol and Acetaminophen in contexts related to acute postoperative pain. This research was primarily conducted through short-term Randomized Controlled Trials (RCTs) and subsequent Systematic Reviews, which are recognized research methods for synthesizing data. These studies examined adult populations who experienced moderate to moderately severe pain after different types of surgical procedures.

The studies focused on outcomes such as pain intensity scores, overall relief ratings, and the quantity of additional pain medication used. Studies examined differences in the time to reported relief and overall relief ratings compared to a placebo. Findings described patterns related to these measured outcomes in the immediate postoperative period. However, the existing studies provide limited insight into long-term pain patterns or functional recovery outcomes beyond the initial few days after surgery.

Evidence for use in Chronic Low Back Pain

The combination analgesic was evaluated in research exploring how symptoms change over time for chronic low back pain, one of the conditions involving periods of heightened symptoms. The evidence base includes Intermediate-term RCTs that often lasted up to 12 weeks. Researchers examined outcomes related to physical discomfort, changes in pain intensity, and scales measuring physical functioning or activity level during the study period.

Trials reported patterns related to measured changes in scores for physical functioning and pain intensity. However, the outcomes reflecting daily functioning sometimes varied across studies, and evidence for this indication is limited and heterogeneous. The follow-up durations were limited to intermediate timeframes, meaning long-term effects are not fully established for use in this chronic condition.

What is Still Uncertain about Cetradol Research

The available evidence contributes to the broader evidence landscape by providing insight into short-term changes. However, several limitations are consistently noted:

  • The long-term effects are not fully established, particularly beyond the intermediate-term trial durations.
  • Data for certain groups remain insufficient, especially for pediatric populations and the oldest demographic groups.
  • Comparative evidence is lacking for a comprehensive comparison against all other available treatment options in specific chronic pain types.

Key Studies & References

  1. Tramadol/acetaminophen combination tablets for the treatment of chronic lower back pain: a multicenter, randomized, double-blind, placebo-controlled outpatient study
  2. Public Assessment Report UKPAR Tramadol hydrochloride/Paracetamol 37.5 mg/325 mg Film-coated Tablets (Regulatory Document)

Frequently Asked Questions (FAQ)

Common questions about Cetradol (FAQ)


Q: Does Cetradol stay in your system for a long time?

A: According to official pharmacokinetic data, the drug’s active components are eliminated relatively quickly in most adults. The half-lives for Tramadol and its M1 metabolite are approximately 6 to 7.5 hours, respectively. Clearance may be prolonged in patients with impaired kidney or liver function.


Q: Why does the packaging for Cetradol warn against mixing it with certain cold medicines?

A: Official warnings exist because many common cold and flu products contain either Acetaminophen or ingredients that cause drowsiness. Combining the drug with other Acetaminophen products can lead to excessive exposure and potentially cause liver damage. Combining it with CNS depressants can compound effects like drowsiness.


Q: Is Cetradol metabolized by the liver?

A: Yes. The medication is primarily metabolized, or broken down, by specialized enzyme systems in the liver. The resulting components and metabolites are then eliminated mostly by the kidneys.


Q: Can Cetradol change the results of certain lab tests?

A: Official information notes that combining this medication with Coumarin derivatives (such as Warfarin) has been associated with reports of changes in the prothrombin time (INR), which is a specific measure of blood clotting. The combination is noted to potentially require close monitoring of clotting time by a healthcare provider.


Q: What should I do if I suspect an allergic reaction to Cetradol?

A: Regulatory documents state that if symptoms of an allergic reaction occur, such as swelling of the face, lips, or throat, hives, or difficulty breathing, the medication should be stopped and emergency medical attention should be sought immediately.


Q: Why do official documents mention 'unknown risk' for Cetradol in pregnancy?

A: The medication is generally not recommended during pregnancy because prolonged use can lead to Neonatal Opioid Withdrawal Syndrome in the newborn. Regulatory documents often note that adequate data from studies in pregnant women is limited, meaning the full extent of the risk is not completely established.


Q: Can Cetradol cause sleepiness or insomnia?

A: Sleepiness or drowsiness (somnolence) is listed as a Very Common side effect in regulatory documents. Other reported side effects, such as headache and anxiety, may also affect a patient's normal sleep patterns.


Q: How is the safety profile of Cetradol determined by regulators?

A: The safety profile is established by reviewing and compiling data gathered from clinical trials and classifying adverse reactions by their reported frequency. Furthermore, regulators base the profile on the known risks of the individual active components (Tramadol and Acetaminophen), alongside ongoing post-marketing surveillance reports.


Q: How quickly does Cetradol typically start working?

A: Official data indicates that the onset of analgesic relief typically begins approximately within one hour after administration. The medication is expected to reach its peak effect within two to three hours.


Q: Can you drive or operate machinery while taking Cetradol?

A: Official warnings state that driving, operating machinery, or performing dangerous activities should be avoided until an individual knows how the medication affects their alertness and concentration, due to the risks of drowsiness and dizziness.


Q: What happens if I miss a dose of Cetradol (in general terms)?

A: Regulatory instructions indicate that if the usual dose is missed, it should be taken as soon as it is remembered. However, if it is close to the time for the next dose, the missed dose should be skipped. It is officially advised not to take a double or extra dose to compensate for the missed one.


Q: Are there any known issues with taking Cetradol before a surgery?

A: The drug carries a documented risk of serious respiratory depression. Therefore, its administration before or after surgery is subject to careful consideration and close monitoring by health professionals.


Q: What does 'contraindicated' mean in relation to Cetradol?

A: 'Contraindicated' is a mandatory regulatory term meaning that the medication must not be used in a specific situation or by a certain patient group. This is because the risk of harm in that situation significantly outweighs any potential benefit, such as in children under 12 or patients with severe liver impairment.


Q: Can Cetradol affect blood pressure?

A: Official documentation indicates that the medication may cause changes in blood pressure. This includes low blood pressure (hypotension), which can lead to dizziness or fainting, especially when changing position. Severe hypotension is listed as a potential risk.


Q: What is the half-life of Cetradol?

A: According to official data, the half-lives for the two active components, Tramadol and the M1 metabolite, are approximately 6.3 hours and 7.4 hours, respectively.


Q: Does Cetradol work differently in children versus adults?

A: Yes. The drug is officially contraindicated for use in children under 12 years of age. This restriction is based on the serious risk of respiratory depression, particularly noted in some children who are ultra-rapid metabolizers of the Tramadol component.


Q: Does Cetradol affect fertility?

A: Official studies have not fully established the effects of the medication on human fertility. Preclinical safety data may indicate risks in animal models, but the effect on human reproductive capacity is often noted as being unknown or not fully established in regulatory documents.


Q: Is Cetradol safe to take if I have diabetes?

A: Official documentation notes that the Tramadol component may cause changes in blood glucose levels, including reports of abnormally low blood sugar (hypoglycemia). Official documents indicate that the use of this medication may necessitate careful monitoring of blood glucose levels in patients with diabetes.


Q: Does Cetradol interact with birth control pills?

A: The medication interacts with the CYP3A4 enzyme system in the body. It is recommended that patients consult a pharmacist regarding their specific type of contraceptive, as certain pills may induce or inhibit these enzymes, potentially altering how the drug works.


Q: Is the maximum daily amount of Cetradol based on body weight?

A: No. The official maximum recommended dose for adults is a fixed limit of 8 tablets per 24-hour period. Adjustments to dosage and timing are made based on factors like age and the function of certain organs (e.g., kidney health), but not typically on body weight.

How should Cetradol be stored and disposed of?

How to Store and Dispose of Cetradol

Official regulatory documents define strict requirements for the storage and disposal of Cetradol (Tramadol/Paracetamol) to ensure stability and safety.


Storage Conditions

  • Temperature and Protection: The medicine must be stored below 30 C and requires protection from light and moisture. This ensures the product maintains its labeled stability.
  • Child Safety: Due to its opioid component, Cetradol must be kept out of the sight and reach of children.

Disposal Instructions

Because Cetradol contains a controlled substance, unused or expired medicine should be disposed of via an authorized drug take-back program. If a take-back option is not immediately available, the U.S. FDA advises that products containing Tramadol may be immediately flushed down the toilet to prevent accidental ingestion.

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

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