Analtram

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Analtram

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 Analtram

Property Description
Active Ingredients Acetaminophen and Tramadol Hydrochloride
Form Tablets (Oral dosage form)
Pharmacological Class Combination Analgesic, CNS Active Agent
General Purpose Symptomatic treatment of moderate to severe pain
Origin Synthetic Pharmacotherapy

Definition and Pharmaceutical Identity

Analtram is a fixed-dose combination analgesic, a specialized prescription-only medicine for oral consumption. It is primarily administered as tablets or film-coated tablets, defining its essential oral dosage form. This structural design ensures the synchronous delivery of two distinct compounds, simplifying administration compared to taking two separate medications. This formulation has achieved widespread recognition for its use in patients whose pain is not adequately relieved by other analgesics.


Composition and Pharmacological Class

The medication is constituted by two core active ingredients: the non-opioid agent Acetaminophen (Paracetamol) and the synthetic opioid derivative, Tramadol Hydrochloride. This pairing places Analtram within the pharmacological class of combination analgesics, a Central nervous system (CNS) active agent. Tramadol possesses analgesic properties due to its opioid receptor binding.


General Purpose and Synergistic Action

The general purpose of this specific synthetic pharmacotherapy is the symptomatic treatment of moderate to severe pain in adults. Its clinical advantage lies in the synergistic effect of the two drugs; their combined analgesic action is purposefully designed to exceed the efficacy of either Tramadol monotherapy or Acetaminophen monotherapy administered alone. The rationale for combining these agents resides in the fact that fixed combinations may offer improved efficacy and simplified administration.

Regulatory References

  1. National Library of Medicine, U.S. National Institutes of Health

What side effects are possible with Analtram?

Possible Side Effects and Safety Information

This section outlines the officially documented adverse effects and safety constraints of Analtram (Acetaminophen and Tramadol Hydrochloride) as classified by governmental regulatory authorities.

Frequency-Classified Adverse Reactions

The most frequently reported effects are classified by the likelihood of occurrence based on clinical data. These effects primarily involve the Central Nervous System and Gastrointestinal systems.

Frequency Category Examples of Adverse Reactions (by SOC)
Very Common (≥ 1/10) Dizziness, Somnolence, Nausea, Constipation
Common (≥ 1/100) Headache, Vomiting, Dry Mouth, Diarrhea, Sweating, Fatigue
Rare (< 1/1,000) Seizures, Anaphylaxis, Severe Allergic Reactions

Serious Adverse Reactions and Safety Constraints

Official labeling mandates specific warnings for serious or life-threatening adverse reactions and outlines critical restrictions on use:

  • Serious Adverse Reactions: The medication carries risks of life-threatening Respiratory Depression, fatal Hepatotoxicity (associated with Acetaminophen), Seizures, and Serotonin Syndrome.
  • Abuse and Misuse: The drug exposes users to the risks of dependence, abuse, and misuse due to its opioid component, which can lead to overdose.
  • Time-Related Pattern: The risk of respiratory depression is highest during treatment initiation or following a dose increase.
  • Population Constraints: Use is restricted or not recommended in patients with severe hepatic or renal impairment. The drug is generally contraindicated in children under 12 years and is associated with the risk of Neonatal Opioid Withdrawal Syndrome with prolonged use in pregnancy.

This information is based strictly on regulatory safety data and does not constitute medical advice or instructions for use.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose with this medication involves a dual toxicity profile derived from the Acetaminophen and Tramadol components, requiring immediate medical attention as a potentially life-threatening emergency.

Documented Manifestations and Severe Outcomes

An overdose may present with signs of Central Nervous System (CNS) toxicity, including respiratory depression, miosis (pinpoint pupils), somnolence, and seizures. The most severe documented outcomes of the Tramadol component include fatal respiratory depression and circulatory collapse or cardiac arrest. Separately, the Acetaminophen component carries the risk of fatal hepatic necrosis and hepatic failure, often preceded by early, nonspecific symptoms like nausea and vomiting.

Required Emergency Actions

Government regulatory documents explicitly state that any suspected or known overdose requires the user to seek immediate medical attention. Contacting emergency services immediately is mandated due to the critical risks of both profound CNS depression and delayed hepatic damage. Management protocols documented in official labeling include symptomatic and supportive treatment, continuous cardiorespiratory monitoring, and the administration of two specific documented agents: N-acetylcysteine for Acetaminophen toxicity, and Naloxone for opioid-related respiratory effects. Individuals with pre-existing hepatic impairment face an increased risk of severe toxicity.

Therapeutic Uses of Analtram

What Analtram Treats: Main Uses and Benefits

Analtram is commonly used across conditions presenting with acute episodes to manage moderate to severe pain signals, and may be relevant when supportive symptom management is appropriate. It is applied across domains where additional symptomatic support is needed, primarily to help ease the burden of symptoms related to physical discomfort.

Symptom Management and Clinical Contexts

The medication is utilized in clinical settings that involve acute or unstable symptom patterns, such as managing discomfort following significant injury, trauma, or surgical procedures (postoperative pain). It helps address symptom clusters that may become intense or disruptive and can interfere with daily comfort. It is used for pain severe enough to require an opioid analgesic and for pain that requires additional symptomatic support.

“The goal of using this medication is to provide supportive relief during difficult episodes, which may help patients cope more steadily with their symptoms.”

This approach contributes to improved day-to-day comfort during symptomatic periods, supporting the patient by easing distress and assisting with maintaining functional stability when symptoms escalate temporarily.


Quick Fact: Relief for Pronounced Pain Symptoms

Eligibility and Restrictions for Use

This section outlines the official population eligibility and non-eligibility rules for Analtram (Acetaminophen/Tramadol HCl) as defined by regulatory authorities.

Populations Contraindicated (Absolute Non-Eligibility)

The medicine is absolutely prohibited for use in:

  • Children younger than 12 years of age.
  • Patients younger than 18 years of age following tonsillectomy and/or adenoidectomy.
  • Individuals with known hypersensitivity to the active ingredients or any component.
  • Patients with acute intoxication by alcohol, hypnotics, opioids, or psychotropic medicines.
  • Individuals with significant respiratory depression or acute, severe bronchial asthma.
  • Patients concurrently using Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of use.

Age-Related Eligibility Rules

Age Group Eligibility Status
Children (<12) Contraindicated (Must Not Use).
Adolescents (12–18) Contraindicated post-surgery (tonsil/adenoid).
Older Adults Use requires greater caution due to increased risk of reduced organ function.

Condition-Specific Restrictions

  • Severe Renal or Hepatic Impairment: Use is not recommended due to the risk of accumulation of the active ingredients and their metabolites.
  • Seizure Risk: Use requires caution in patients with a history of seizures, epilepsy, or conditions that increase seizure risk.
  • Pregnancy and Lactation: Use is not recommended; prolonged use in pregnancy carries the risk of Neonatal Opioid Withdrawal Syndrome (NOWS), and the medicine is excreted in breast milk.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation classifies several substances and medicinal product categories that have documented interactions with Analtram (Acetaminophen/Tramadol).

Contraindicated Combinations

Co-administration with Monoamine Oxidase Inhibitors (MAOIs) is strictly prohibited and requires a mandatory 14-day separation period. Use with other Acetaminophen-containing products is also contraindicated to prevent exceeding safe daily limits. The co-ingestion of Alcohol or other Central Nervous System (CNS) depressants carries an increased risk of profound sedation, respiratory depression, and death due to additive pharmacodynamic effects.

Pharmacokinetic and Pharmacodynamic Interactions

Interaction Type Interacting Substance Examples Regulatory Concern
Metabolic (CYP-Mediated) CYP3A4 Inhibitors, CYP2D6 Inhibitors, Carbamazepine May alter the plasma concentration and exposure of Tramadol or its active M1 metabolite.
Serotonergic SSRIs, SNRIs, Triptans, St. John’s Wort Increased risk of Serotonin Syndrome due to additive effects.
Coagulation Coumarin Derivatives (e.g., Warfarin) Reports of altered coagulation parameters, specifically increased International Normalized Ratio (INR).

These documented interactions establish mandatory restrictions and cautions, particularly in individuals with severe hepatic impairment where reduced metabolism may lead to drug accumulation.

Mechanism of Action

How Analtram Works

Dual Mechanism: mu-Opioid Receptor Agonism

The drug operates via a dual pharmacodynamic mechanism. The active metabolite, O-desmethyltramadol, functions as an agonist at the central nervous system's mu-opioid receptors (mu-ORs). Simultaneously, the parent drug, Tramadol, acts as a reuptake inhibitor of the monoamine neurotransmitters Serotonin and Norepinephrine by blocking their respective transporters (SERT and NET).

Molecular Cascade and Pathway Modulation

The mu-OR agonism initiates a molecular cascade involving G i proteins, which leads to cellular hyperpolarization. This reduces neuronal excitability and decreases the presynaptic release of excitatory neurotransmitters. Concurrently, the inhibition of monoamine reuptake increases the concentration and duration of serotonin and norepinephrine in the synaptic cleft. This chemical enhancement amplifies the function of the descending inhibitory pain pathway, thereby increasing the central inhibition of nociceptive transmission. The resulting physiological effect is a combined modulation of ascending pain signal transmission and descending regulatory signaling.

Dosage and Administration Information

How to Use Analtram (Tramadol)

Administration of Analtram, a brand name for tramadol, is based on established protocols for use. The medication is administered via the oral route in either immediate-release (IR) or extended-release (ER) formulations.

Dosing and Frequency

Formulation Standard Dosing Regime Maximum Daily Dose
Immediate-Release (IR) 50 mg to 100 mg every 4 to 6 hours as needed for relief 400 mg
Extended-Release (ER) Usually initiated at 100 mg, taken once daily 300 mg

For IR titration, the starting dose may be 25 mg once daily, increasing gradually every three days to reach the maintenance regimen. The extended-release formulation is intended for scheduled, around-the-clock administration and is not to be used on an as-needed basis. The medication can be taken without regard to food.

Specific Administration Requirements

Extended-Release (ER) Tablets/Capsules must be swallowed whole with liquid. They must not be broken, cut, crushed, or dissolved to prevent the rapid release of the ingredient, which can result in an overdose. The oral solution must be measured precisely using the provided dosing syringe.

Population-Specific Use

Specific dosage adjustments are required for certain populations. The use of Analtram is contraindicated in children under 12 years of age.

  • Geriatric Patients (Over 75): For the IR formulation, the maximum daily dose is typically reduced to 300 mg per day.
  • Renal or Hepatic Impairment: Patients with severe kidney problems (creatinine clearance less than 30 mL/min) must increase the IR dosing interval to 12 hours, and ER formulations must be avoided.

Recent Clinical Evidence

Research evidence / Overview of studies for Analtram

Evidence for Acute Moderate to Severe Pain Signals

The evidence base for acute pain signals largely relies on short-term, randomized, double-blind, placebo-controlled trials (RCTs). These trial designs are the standard used in research exploring how symptoms change over time when evaluating outcomes related to physical discomfort. Research examined study groups of adult patients experiencing pain following standardized events like surgical procedures. Study outcomes measured focused on immediate effects, including Pain Intensity scores on established scales and the Duration of observed changes.

Findings describe patterns observed in these studies, which monitored changes in outcomes related to physical discomfort over the immediate observation period. Evidence contributes to the broader evidence landscape by highlighting that the fixed-dose combination data show patterns related to the predefined primary measures that differed from those observed in the individual component or placebo groups. What remains uncertain is the full context of recovery, as the core efficacy trials provide limited insight into long-term outcomes, with research focus largely on the first few hours or days.


Evidence for Chronic Moderate to Severe Pain Management

The evidence landscape relevant to the study of chronic pain associated with conditions like Osteoarthritis and Chronic Low Back Pain was established through Phase III Randomized, Double-blind, Placebo-Controlled Trials (RCTs). These studies were designed to monitor outcomes reflecting daily functioning or activity level over several weeks of use. Trials enrolled adult patients with chronic pain lasting three months or more. Research examined Change in Pain Intensity from a baseline measure and the impact on Physical Functioning.

Studies exploring short-term symptom changes reported changes in both pain intensity measures and functional scores over the treatment period. Findings describe patterns observed, including that the combination data show patterns related to changes in pain scores in the observed populations. However, the durability and consistency of reported outcomes over prolonged, long-term use (e.g., greater than six months) are not fully established, and evidence detailing patient outcomes beyond the typical 4 to 8-week trial duration for chronic conditions is limited.

Key Studies & References

  1. An Efficacy and Safety Study of Acetaminophen Plus Tramadol Hydrochloride (JNS013) in Participants With Chronic Pain | ClinicalTrials.gov (NCT00736853)

Frequently Asked Questions (FAQ)

Common questions about Analtram (FAQ)


Q: How long after starting Analtram might I notice its effect?

According to official product information, the active compounds of Analtram reach their peak concentrations in the bloodstream at slightly different times. Tramadol and its active metabolite typically peak approximately 2 to 3 hours after administration, while the acetaminophen component peaks within the first hour. This combined action influences how quickly the overall effect of the medication is observed.


Q: Can Analtram cause changes in mood or anxiety?

Official safety information indicates that changes in mood or behavior have been reported with this medication. These changes can include bfanxiety, new or increased bffeelings of depression, and in rare cases, bfsuicidal thoughts or actions. Changes in mood or psychological state while taking Analtram may require consultation with a healthcare provider.


Q: Are there any common foods or drinks that should be avoided when taking Analtram?

The medication can generally be taken without regard to food, which means it can be taken on an empty stomach or after eating. However, regulatory documents state that use with bfalcohol is bfcontraindicated. This combination significantly increases the risk of severe side effects, including profound sedation and dangerous breathing problems.


Q: Does Analtram interact with common over-the-counter cold medicines?

Yes, caution is necessary as Analtram is contraindicated (forbidden) for use with any other product containing bfacetaminophen to avoid accidentally taking too much. Furthermore, many cold medicines contain ingredients like dextromethorphan, which can interact with the tramadol component and increase the risk of a serious condition called bfSerotonin Syndrome.


Q: What are the signs that Analtram might be affecting my liver?

The acetaminophen component carries a risk of liver damage (bfhepatotoxicity), especially in cases of overdose. Signs that may indicate liver problems include a bfyellowing of the bfskin or the whites of the bfeyes (bfjaundice), bfdark urine, nausea, vomiting, or pain in the stomach area. These symptoms are considered serious and are typically addressed quickly by a healthcare provider.


Q: What is the typical time frame for Analtram's effect to wear off?

The time required for the medication's effect to diminish is related to the elimination half-lives of the active compounds, which are approximately 5 to 7 hours. The duration of pain relief for the immediate-release formulation is officially indicated to be between 4 to 6 hours. This duration can be subject to individual patient variability.


Q: Is there a limit to how long someone can safely use Analtram?

Official labeling often indicates that this fixed-dose combination product is generally intended for short-term use, often specified as five days or less, for acute pain. Repeated or long-term use of the medication is typically accompanied by the need for careful and regular bfmedical monitoring, as described in regulatory documents.


Q: What are the known potential interactions between Analtram and herbal supplements?

The official product information specifically warns against using Analtram alongside the herbal supplement bfSt. John’s Wort. This is because St. John's Wort can increase the risk of bfSerotonin Syndrome when combined with tramadol. The discussion of all medications, including any herbal products, with a healthcare professional is considered necessary.


Q: Does Analtram affect fertility or hormones?

Official warnings note that prolonged use of opioids, including the tramadol component, may be associated with bfandrogen deficiency (low hormone levels). This condition can cause symptoms such as decreased energy and tiredness. The full effects on fertility are not typically detailed in the patient summaries provided by regulatory agencies.


Q: Is Analtram available generically, or only as a brand name?

Analtram, which contains both tramadol hydrochloride and acetaminophen, is available under a generic name. Regulatory records indicate that the product has been approved through an Abbreviated New Drug Application (ANDA). The generic version is typically listed as Tramadol Hydrochloride and Acetaminophen tablets.


Q: Can Analtram cause constipation, and if so, what is the cause?

Yes, bfconstipation is classified as a very common adverse reaction listed in regulatory documents. This effect occurs because the bfopioid component (bftramadol) acts on specific receptors in the gastrointestinal tract as well as the brain. This action slows the movement of waste through the digestive system.


Q: How quickly can Analtram be stopped, or does it require tapering?

Regulatory guidelines caution that in patients who are physically dependent on the medication, it should not be stopped abruptly. Instead, a bfgradual dose reduction, known as bftapering, may be necessary. This process helps to prevent possible withdrawal symptoms.


Q: Can Analtram cause a serious skin reaction?

Yes, the acetaminophen component of the drug has been associated with rare but potentially bffatal skin reactions. These serious conditions include bfStevens-Johnson Syndrome (SJS), bfToxic Epidermal Necrolysis (TEN), and bfAcute Generalized Exanthematous Pustulosis (AGEP). Patients should be aware of this rare but critical risk.


Q: Why is it important to follow the directions exactly when taking Analtram?

The importance of following directions exactly relates directly to the risk of bfaccidental overdose. This can occur if the medication is not administered as intended, leading to the rapid release of the active ingredients and potentially causing fatal respiratory depression or severe liver damage.


Q: Is it safe to use Analtram for menstrual cramps?

The official indication for Analtram is for the management of bfacute pain severe enough to require an opioid analgesic. Regulatory documents do not typically specify every type of acute pain it must treat, but rather focus on the pain's severity. The determination of the medication’s appropriateness for a specific pain type is based on clinical evaluation and prescribing criteria.


Q: Is there an official patient medication guide for Analtram?

Yes, the regulatory authority for the U.S. requires that a bfPatient Medication Guide be dispensed with the product. The purpose of this guide is to inform patients about the essential details and critical safety risks, such as addiction, dependence, and respiratory depression.


Q: Can I take Analtram if I have a history of addiction?

Official regulatory warnings state that the medication is not recommended for prescription to bfaddiction-prone patients. Because Analtram carries a significant risk of bfabuse and bfaddiction, official information indicates that a history of a bfsubstance use disorder is a necessary consideration for individuals and their healthcare providers regarding the associated risks.

How should Analtram be stored and disposed of?

How to Store and Dispose of Analtram

Analtram (Tramadol Hydrochloride and Acetaminophen) must be stored and disposed of according to official regulatory requirements to ensure stability and safety.

Storage Requirements

Condition Requirement
Temperature Controlled Room Temperature (20 C to 25 C)
Protection Keep from moisture, excessive heat, and freezing.
Packaging Store in the original, closed, tight container.
Child Safety Must be kept strictly out of the sight and reach of children.

Disposal Instructions

Official disposal procedures recommend taking unused or expired tablets to a drug take-back location or an authorized collector. Due to the high-risk opioid component, U.S. guidance permits flushing this product down the toilet if a take-back option is unavailable. Unused medicine must not be disposed of via household waste or wastewater, as per most international regulations.

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

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