Ultradol

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Ultradol

Treatment option: Pain, Chronic Pain

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 Ultradol

Ultradol is a trade name for a medication containing the active ingredient Tramadol Hydrochloride, which is classified as a centrally acting analgesic primarily used for the relief of moderate to moderately severe pain.

Property Description
Active ingredient Tramadol Hydrochloride
Form Tablet, Capsule, Solution, Injection
Pharmacological class Synthetic Opioid Analgesic
Common use Relief of moderate to moderately severe pain
Origin Synthetic compound

What Type of Medicine is Ultradol?

Ultradol is classified pharmacologically as a synthetic opioid agonist that works within the central nervous system (CNS). This compound is manufactured chemically and is structurally related to other opioid pain relievers, though it possesses unique properties. Its primary function is to modify the transmission of pain signals in the brain and spinal cord, making it an effective choice for managing pain that is often not adequately controlled by non-opioid medications. As a controlled prescription-only substance, its use is globally regulated, confirming its classification as a powerful analgesic agent.

Composition and Available Forms of Tramadol Hydrochloride

The core substance is Tramadol Hydrochloride, which is always administered as a racemic mixture of two enantiomers, both integral to its analgesic profile. This medication is available primarily as a single-ingredient product in various pharmaceutical preparations to suit different patient needs, including immediate-release and extended-release tablets and capsules, an oral solution, and forms for injection. This range of available forms ensures flexibility for managing both acute episodes and continuous painful conditions.

The Dual Action Principle (High-Level Explanation)

The pharmacological utility of Tramadol stems from its dual or multimodal mechanism of action, a feature that modulates pain through two complementary functional pathways. One involves the compound and its active metabolite binding to the μ-opioid receptors to directly inhibit pain signaling. The second pathway contributes to its efficacy by weakly inhibiting the reuptake of the neurotransmitters norepinephrine and serotonin. This combined action strengthens the body's natural descending inhibitory pain pathways, providing a comprehensive method of pain control.

What side effects are possible with Ultradol?

Possible Side Effects and Safety Information

The safety profile for Ultradol (Tramadol Hydrochloride) is defined by officially documented adverse reactions categorized by frequency and the body system affected, as established by government regulatory authorities.

Category Regulatory Documentation
Adverse reaction scope Central Nervous System, Gastrointestinal, Psychiatric, and Respiratory effects.
Frequency classification (Very Common / Common) Very Common (in 10%) includes Nausea, Dizziness, and Somnolence. Common (in 1% to < 10%) includes Vomiting, Constipation, Dry mouth, Headache, and Sweating.
Serious adverse reactions The product carries the documented risk of life-threatening Respiratory Depression, Serotonin Syndrome (especially when co-administered with certain other medications), and Seizures. Other serious events include Drug Dependence, Adrenal Insufficiency, and Neonatal Opioid Withdrawal Syndrome if used during pregnancy.
Population-specific safety Pediatric patients under 12 years of age are contraindicated. Caution is required in older adults (over 75 years) due to increased potential for adverse events. Use during pregnancy is associated with the risk of NOWS in the newborn.
Exposure-related patterns The greatest risk for life-threatening respiratory depression occurs during the initiation of therapy or following a dosage increase. Prolonged use is associated with the development of physical dependence and withdrawal symptoms upon cessation.
Safety restrictions Use is strictly contraindicated in cases of acute intoxication with alcohol, hypnotics, or other centrally-acting depressants, and in patients with uncontrolled epilepsy. Caution is advised in patients with severe hepatic or renal impairment.

Regulatory Safety Summary

The regulatory safety structure explicitly frames the use of this medicine around the potential for high-frequency, non-severe gastrointestinal and CNS effects, while strictly defining the boundaries of use to mitigate the risk of serious events. This includes precise contraindications for specific patient groups and conditions. The safety profile also mandates awareness that risks such as respiratory depression and dependence are closely linked to the duration of use and changes in the regimen.

Overdose and Emergency Response

Overdose and When to Seek Help

This information is based strictly on the official overdose sections within government-authorized prescribing documents for Ultradol (Tramadol Hydrochloride).

Classification Documented Signs and Outcomes
Central Nervous System Somnolence progressing to coma, convulsions (seizures), and miosis (pinpoint pupils).
Life-Threatening Respiratory depression (serious or fatal), cardiovascular collapse, and death are explicitly documented severe outcomes.

Required Emergency Actions

Seek immediate medical attention for any suspected overdose. The regulatory documents state that the patient must be transferred immediately to a specialized unit for the treatment of acute intoxication.

  • Antidote: Naloxone is available to reverse the life-threatening respiratory depression. However, caution is advised as it may increase the risk of seizures.
  • Supportive Measures: Management includes maintaining respiratory and circulatory function, and controlling seizures with appropriate medication (e.g., diazepam). Haemodialysis is generally deemed ineffective for detoxification.
  • Pediatric Risk: Accidental ingestion of even one dose by a child can result in a fatal overdose and requires immediate emergency medical care.

Overdose manifestations relate to both the opioid effects and the drug's unique seizure-lowering properties, demanding immediate and specialized medical care.

Therapeutic Uses of Ultradol

Quick Facts

  • Therapeutic Domain: Pain management
  • Primary Use: Supports the relief of moderate to moderately severe pain
  • Applicable Context: Utilized when an extended duration of pain support is needed

What Ultradol Treats: Main Uses and Benefits

Ultradol is a therapeutic option authorized for the management of pain in adult patients. Its primary role is in providing relief for discomfort categorized as moderate to moderately severe. This medication is typically considered when the patient requires daily, around-the-clock support for their pain over an extended period.

The goal of therapy with Ultradol is to support the patient's ability to manage their condition and to promote an improvement in comfort levels. It serves as a tool in a comprehensive pain management strategy. Use of this medication should be guided by the patient's individual needs and the prescribing healthcare professional's assessment.

This treatment is not intended for use as an as-needed analgesic, but rather to sustain pain relief consistently.

Eligibility and Restrictions for Use

Ultradol (Tramadol Hydrochloride) is authorized for use primarily in adult patients (18 years of age and older) for pain management, as defined by regulatory authorities. The drug’s eligibility profile strictly prohibits use in certain populations and imposes major restrictions based on age, health status, and other concurrent treatments.

Contraindications and Restrictions

Population Status Regulatory Rule (Official Classification)
Absolute Contraindication Children younger than 12 years of age must not use this medicine.
Children younger than 18 following tonsillectomy/adenoidectomy must not use it.
Patients with significant respiratory depression or acute severe asthma.
Patients using Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of stopping them.
Conditional Use / Avoidance Adolescents 12 to 18 years with risk factors like severe lung disease or sleep apnea should avoid use.
Older adults (over 75) should use the medicine with greater caution [Source 1.10].
Organ Function Restriction Use of extended-release formulations is not recommended in patients with severe hepatic or severe renal impairment [Source 1.9].
Pregnancy/Lactation Use is not recommended during pregnancy due to the risk of Neonatal Opioid Withdrawal Syndrome with prolonged exposure, and not recommended while breastfeeding [Source 1.4].

What should I know about interactions with other medicines?

Interactions with other medicines and products

Contraindicated Combinations and Timing Rules

Co-administration with Monoamine Oxidase Inhibitors (MAOIs) is formally documented as contraindicated and requires a mandatory separation period of 14 days following the last dose of an MAOI. Ultradol is also contraindicated in cases of acute intoxication involving alcohol, other opioids, hypnotics, or psychotropic medicinal products.

Pharmacodynamic Reinforcement

The combination with other Central Nervous System (CNS) depressants (such as benzodiazepines or certain sedative medicines) is restricted due to the potentiation of effects, documented to lead to serious outcomes like profound sedation and respiratory depression. Similarly, co-administration with other Serotonergic Drugs (including SSRIs, SNRIs, and Triptans) increases the risk of Serotonin Syndrome due to additive activity. Use with other drugs that lower the seizure threshold (e.g., certain antipsychotics) also raises the risk of seizures.

Metabolic and Exposure Alterations

Interactions based on metabolism involve the cytochrome P450 enzymes. CYP3A4 inducers like Carbamazepine are documented to increase Ultradol's metabolism, which may result in a reduced analgesic effect. Conversely, CYP2D6 inhibitors may increase the plasma concentration of Ultradol while decreasing the formation of its active M1 metabolite. Caution is advised when co-administering with Coumarin derivatives (e.g., Warfarin) due to post-marketing reports of an increased International Normalized Ratio (INR).

Population-Specific Notes

Official labeling notes that in individuals with hepatic or renal impairment, drug clearance is delayed, requiring specific consideration regarding the dosing interval. Additionally, CYP2D6 ultra-rapid metabolizers are noted to be at risk for high exposure to the active metabolite.

Mechanism of Action

Ultradol is an antagonist of the X-Receptor family (X-R). Following binding to the X-R complex, Ultradol alters its conformational structure, which inhibits the subsequent interaction with specific intracellular adaptor proteins. This signaling blockade prevents the phosphorylation of Intracellular Kinase Z, an enzyme positioned upstream of the NF-kappa B pathway. The resulting decrease in nuclear translocation of the NF-kappa B dimer modifies the transcription of genes that regulate immune responses. This molecular cascade leads to a controlled decrease in the release of Pro-Inflammatory Mediators. Furthermore, Ultradol modulates the expression of Matrix Metalloproteinases (MMPs) within the synovial fluid, influencing extracellular matrix turnover and cellular signaling in localized tissue environments. The mechanism is confined to intracellular process modification and pathway modulation.

Dosage and Administration Information

Ultradol (Tramadol Hydrochloride) is approved for administration via the oral route, available as immediate-release (IR) and extended-release (ER) solid forms, and as an oral solution. It is also available as a solution for injection, supporting intravenous, intramuscular, or subcutaneous administration, typically used in a supervised setting. The specific dosing regimen is determined by the formulation and the treatment need.

The standard adult dose for IR tablets is typically 50 mg to 100 mg, taken every 4 to 6 hours, up to a maximum daily dose of 400 mg. For chronic pain management, ER forms are taken once daily, often starting at 100 mg, and must be swallowed whole to preserve the controlled release of the medicine. The dose may be adjusted in fixed increments over a period of several days until an adequate maintenance level is reached. Ultradol may be taken with or without food.

Dosing modifications are required for specific patient populations. For adults over 75 years, the total daily dose is generally limited to 300 mg. For patients with severe renal impairment (creatinine clearance less than 30 mL/min), the dosing interval for IR forms must be extended to 12 hours; ER forms are not recommended for severe hepatic or renal dysfunction. The need for continued use must be regularly reassessed, and following long-term use, the medicine should be gradually tapered during discontinuation to conclude the treatment course.

Recent Clinical Evidence

Ultradol: Recent Clinical Evidence

Evidence for Use in Acute Pain Management

This section summarizes what was learned in randomized controlled trials (RCTs) that examined patterns of change in pain intensity measures over brief observation periods, such as in the context of postoperative pain. These short-term RCTs typically compared Ultradol to a placebo (an inactive substance) or other existing analgesic options. Researchers observed how symptoms evolved in the treated group compared to the placebo group. Research describes changes measured during the study period for outcomes related to physical discomfort and the use of supplemental pain medication. Long-term effects are not fully established for acute use, and comparative evidence against some other treatments remains limited.

Evidence for Use in Chronic Pain Conditions

Research was studied for its role in chronic non-cancer pain, including cohorts with chronic low back pain and osteoarthritis. Systematic reviews and intermediate-term trials focused on changes in pain intensity over time and functional measures. Research describes how symptoms evolved for the treated group compared to those receiving an inactive substance. However, evidence quality varies across studies, and systematic analyses have often indicated that the size of the measured differences in pain scores was generally small.

Long-Term Research and Uncertainties

The follow-up durations for chronic pain trials are generally limited to around 12 to 16 weeks, meaning long-term effects are not fully established for ongoing use. The certainty remains low for outcomes over many months or years of use. Similarly, data from randomized controlled research remain limited for certain patient populations, such as pediatric patients. The evidence highlights what is known—and what is still uncertain—about Ultradol's role in complex, chronic pain conditions.

Frequently Asked Questions (FAQ)

Common questions about Ultradol (FAQ)


Q: How quickly does Ultradol start working?

Official information indicates that the pain relief from an immediate-release oral form of Ultradol generally begins in less than one hour after administration. The medicine typically reaches its highest level of effect, known as its peak concentration, within two to four hours.

Q: How long do the effects of Ultradol last?

The analgesic effects of a single dose of the immediate-release formulation of Ultradol are typically reported to last for approximately six hours. Extended-release formulations are designed to maintain effect over a longer period, supporting the dosing regimen described in the official instructions.

Q: Does alcohol interact with Ultradol?

Yes, official regulatory documents state that taking Ultradol at the same time as alcohol is formally contraindicated in cases of acute intoxication. Combining the two carries a serious warning because it significantly increases the risk of severe depression of the central nervous system (CNS), which can lead to profound sedation and breathing difficulties.

Q: What kind of interactions should I be aware of when taking Ultradol?

Official labeling documents describe important interactions with several classes of medicines. These include other drugs that depress the Central Nervous System (CNS) (like sedatives), medicines that increase serotonin levels (like some antidepressants), and certain substances that affect how Ultradol is broken down by the body's CYP enzymes. Reviewing all medications with a healthcare provider remains a foundational step in safe use.

Q: What makes Ultradol different from similar over-the-counter options?

Ultradol is classified as a synthetic opioid analgesic that works in the central nervous system, meaning it affects how the brain and spinal cord manage pain signals. Unlike over-the-counter (OTC) pain relievers, official pharmacological data indicates Ultradol's unique action on opioid receptors and certain neurotransmitters. It is classified as a controlled, prescription-only medication.

Q: Are there any known withdrawal symptoms if Ultradol is stopped suddenly?

Official information advises that following long-term use, physical dependence may develop, and stopping suddenly can result in withdrawal symptoms. Reported symptoms can include nervousness, panic attacks, sweating, difficulties with sleep, and, in rare instances, confusion or hallucinations. Official documentation advises that the medicine is gradually tapered during discontinuation.

Q: Is Ultradol the same as other medicines with similar names?

Ultradol is the trade name for the active ingredient Tramadol Hydrochloride. While it is structurally related to some other opioid pain medicines, the official pharmacological studies confirm it has a unique dual mechanism of action. Therefore, it is not chemically or functionally identical to other pain relievers.

Q: Does Ultradol cause drowsiness or make you tired?

Yes, regulatory documentation lists somnolence (a medical term for drowsiness or sleepiness) as a very common adverse reaction, meaning it occurred in ge 10% of patients in studies. Safety warnings regarding driving or operating machinery are included in official product information due to this common side effect.

Q: Is it possible to have an allergic reaction to Ultradol?

Yes, official labeling notes that hypersensitivity (allergy) to the drug is a formal contraindication. Furthermore, reports have described serious and rarely fatal anaphylactoid reactions (severe allergic responses) in some patients, sometimes immediately after the first dose.

Q: Can Ultradol be taken with pain relievers like ibuprofen or aspirin?

Official regulatory documents do not list non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or aspirin as having a formal contraindication with Ultradol. Consultation with a healthcare provider is noted to be an essential step in managing any pain strategy.

Q: What are the concerns about using Ultradol while breastfeeding?

Official warnings state that use while breastfeeding is generally not recommended. Regulatory data indicates that Ultradol and its active metabolite do pass into breastmilk. This transfer poses a risk to the infant, which may include symptoms like increased drowsiness, limpness, or difficulty with breathing.

Q: Does Ultradol affect birth control pills?

Official regulatory data generally suggests that Ultradol does not directly reduce the effectiveness of hormonal contraception, such as the combined oral contraceptive pill. However, if the medicine causes you to experience severe vomiting or severe diarrhea, the effectiveness of oral contraceptives may be reduced.

Q: Can Ultradol affect mood or cause anxiety?

Yes, regulatory adverse event summaries indicate that changes in mood and nervousness have been reported. Due to the medicine's activity involving the neurotransmitters serotonin and norepinephrine, some individuals may also experience feelings of agitation or anxiety.

Q: Does Ultradol interfere with blood pressure medication?

The official product information notes that Ultradol administration may cause hypotension (low blood pressure) in some patients. This side effect may affect the management of existing blood pressure conditions and requires special consideration when used alongside other blood pressure-lowering medications.

Q: What happens if I forget to take a dose of Ultradol?

Regulatory guidance for missed doses generally directs that the forgotten dose should be skipped. Regulatory guidance specifies the conditions under which the next scheduled dose is taken, noting that the forgotten dose should be skipped.

Q: Do any common supplements or herbs interact with Ultradol?

Yes, official safety data cautions specifically against the co-administration of Ultradol with the herbal supplement St. John's Wort. This combination is noted to potentially reduce the effectiveness of Ultradol and increase the risk of a serious condition called Serotonin Syndrome.

Q: Does Ultradol show up on drug screening tests?

Yes, as Ultradol (Tramadol) is classified as a controlled substance, official laboratory reference information confirms that standard urine drug screening tests are designed to detect its presence and that of its primary active breakdown product, O-desmethyltramadol (M1).

Q: Is there a maximum time someone should use Ultradol?

Official regulatory documentation states that Ultradol should not be administered for longer than absolutely necessary. The need for continued treatment when managing chronic conditions is advised to be assessed at regular intervals to prevent the development of dependence.

Q: What are the signs of taking too much Ultradol?

The regulatory safety section describes that signs of taking too much Ultradol can include slow or shallow breathing (respiratory depression), extreme drowsiness or inability to wake up, decreased pupil size, and potentially seizures or slowed heartbeat. If an overdose is suspected, emergency medical attention is the recommended course of action.

Q: Do genetic factors influence how Ultradol works for someone?

Yes, official labeling specifically advises against using the medicine in certain individuals identified as CYP2D6 ultra-rapid metabolizers. This genetic difference causes the body to process the drug too quickly, leading to much higher levels of the active metabolite, which significantly increases the risk of serious side effects like life-threatening breathing difficulty.

Q: Does Ultradol affect sleep patterns?

Regulatory information indicates that Ultradol can affect sleep. Somnolence (drowsiness) is documented as a very common side effect. Additionally, difficulty falling asleep or staying asleep (insomnia) is also listed in official documentation as a reported adverse reaction.

Q: Does Ultradol contain any common allergens like gluten or lactose?

Official regulatory information on inactive ingredients confirms that the immediate-release tablet formulation of Ultradol is documented to contain lactose monohydrate (a common sugar found in milk products) as an excipient. The product label does not specify the inclusion or exclusion of gluten.

Q: Can Ultradol cause problems with stomach upset?

Yes, the official safety profile documents that nausea is a very common side effect, and vomiting is a common side effect. These gastrointestinal issues, along with other reported effects on motility, can lead to general stomach discomfort and upset.

Q: Why is Ultradol not recommended for people with a history of seizures?

Regulatory safety documents state that the medicine itself lowers the seizure threshold. This means it increases the likelihood of a seizure occurring. The risk is heightened in patients who already have a history of seizures or certain pre-existing conditions.

Q: Does taking Ultradol affect blood sugar levels?

Regulatory adverse event summaries list hypoglycemia (abnormally low blood sugar) as a very rare serious adverse reaction that has been reported. This means it has been linked to the drug in official data, but occurs infrequently.

Q: Are there any known interactions with grapefruit or grapefruit juice?

Yes, official regulatory information advises that patients avoid consuming grapefruit and grapefruit juice while taking Ultradol. This is because grapefruit can interfere with the way the body breaks down the medicine, which may lead to an increase in its blood levels and overall effects.

How should Ultradol be stored and disposed of?

The storage and disposal of Ultradol (tramadol hydrochloride) must comply strictly with official regulatory conditions to ensure stability and public safety.

Requirement Official Statement
Temperature Store at controlled room temperature (typically 20 C to 25 C); Do not store above 30 C and keep from freezing.
Protection Keep in the original, tightly closed container and protect from light and moisture.
Child Safety Keep out of the sight and reach of children; accidental ingestion can cause a fatal overdose.
Disposal Unused medicine must be disposed of immediately via a drug take-back program (preferred) or by mixing with an undesirable substance (e.g., used coffee grounds) in a sealed bag before placing it in the trash. Avoid release to the environment.

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

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