Dolol

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Dolol

Treatment option: Pain, Chronic 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 Dolol

What is Dolol? An Overview

Property Description
Active ingredient Paracetamol (Acetaminophen) and/or Tramadol
Form Oral Tablet or Capsule
Pharmacological class Analgesic (Pain Reliever) and Antipyretic (Fever Reducer)
Common use Relief of general pain and fever
Origin Synthetic (Chemically manufactured)

What Type of Medication is Dolol?

Dolol is a drug entity primarily identified as an analgesic and antipyretic medication, placing it in the pharmacological category of pain and fever management. Analgesics are agents used to alleviate various forms of pain without inducing unconsciousness.

This specific formulation often contains a fixed-dose combination of two active ingredients: the common non-opioid analgesic Paracetamol (Acetaminophen) and the centrally-acting opioid analgesic Tramadol. This combination is widely clinically recognized for its synergistic effect in treating moderate pain that is not adequately managed by a non-opioid medicine alone. As a synthetic pharmaceutical, Dolol is primarily intended for adult patients suffering from acute, short-term discomfort.

Understanding Its Composition and Form

The physical form of Dolol is generally an oral tablet or capsule, designed for convenient administration by mouth. The composition is structured around the therapeutic active ingredient(s), integrated with inactive excipients that provide the pill's stability.

The strategy behind combining these two agents is their complementary action, which provides a multi-level approach to pain relief by targeting different pathways simultaneously. For instance, the combination of these specific agents is intended to offer enhanced pain management in certain patient populations when compared to using the agents individually. This indicates that the combination may offer greater overall comfort for moderate pain.

What is the General Purpose of Dolol?

The overarching goal of taking this medication is to achieve effective relief from pain and to aid in the reduction of fever. A typical neutral use scenario for Dolol is managing post-operative discomfort or acute aches like a severe toothache. Its central action means it modifies the body's perception of pain signals, making it beneficial for discomfort that originates from the nervous system. The primary role of Dolol is supportive: to provide reliable relief and improve the patient’s overall well-being during periods of acute discomfort.

Regulatory References

  1. U.S. National Library of Medicine
  2. Pain Relievers
  3. NIH Clinical Trials Registry

What side effects are possible with Dolol?

Possible Side Effects and Safety Information

The official safety profile for the Dolol combination (Tramadol and Acetaminophen) is defined by regulatory documents that classify potential adverse reactions by frequency and physiological system. This profile reflects risks associated with both active components, requiring formal warnings across multiple System-Organ Classes.

Frequency-Classified Adverse Reactions

Adverse effects are categorized based on their documented occurrence in clinical studies. Very Common (ge 1 in 10 patients) reactions include Nausea, Dizziness, and Somnolence (drowsiness). Reactions classified as Common (ge 1 in 100 to < 1 in 10 patients) include Vomiting, Constipation, Dry Mouth, Headache, Insomnia, and Increased Sweating.

Serious Safety Concerns and Restrictions

Regulatory agencies mandate warnings for clinically significant risks. These include the risk of Life-Threatening Respiratory Depression and severe Hepatotoxicity (Acute Liver Failure), particularly due to the acetaminophen component. Other serious risks documented in the label include the potential for Serotonin Syndrome and Seizures.

Specific safety restrictions apply to certain populations and conditions. The medication is contraindicated in children younger than 12 years and in patients with severe hepatic impairment. Furthermore, official documents note that the risk of respiratory depression is highest during treatment initiation or following a dose increase. Prolonged use during pregnancy can result in Neonatal Opioid Withdrawal Syndrome.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory documents define an overdose of this fixed-dose combination as a dual medical emergency due to the toxic effects of both components. The primary risks involve life-threatening respiratory depression from the tramadol component and potentially fatal acute liver failure from the acetaminophen component.

Immediate medical attention is mandatory for any suspected overdose, even if no symptoms are evident, because signs of severe liver damage can be delayed by 12 to 48 hours. Individuals should contact emergency services immediately if critical symptoms such as slow or shallow breathing, seizures, or unconsciousness are observed.

Overdose Manifestations Required Emergency Actions
Respiratory depression, miosis, somnolence (opioid toxicity) Administration of the specific antagonist Naloxone is required.
Nausea, vomiting, abdominal pain, delayed signs of jaundice (acetaminophen toxicity) Urgent assessment of plasma concentration and administration of N-acetylcysteine (NAC) to protect against liver necrosis.

Management focuses on treating both toxicities, requiring continuous monitoring of vital functions and laboratory tests to assess hepatic damage. The official labeling notes that the hazard of liver toxicity is greater in patients with pre-existing hepatic impairment.

Therapeutic Uses of Dolol

Dolol is generally used to help with the management of symptoms related to physical discomfort, and the therapeutic benefit may be utilized across acute and chronic contexts. This combination is relevant for easing symptoms that may become more disruptive, and is applied in areas where short-term symptom management is appropriate when alternative symptomatic assistance is needed. This combination is indicated for acute physical discomfort that may require additional supportive management.

The medication is commonly used across conditions characterized by periods of heightened symptoms, and is relevant for easing symptoms related to: moderate to severe pain, postoperative discomfort, severe dental pain, flares of chronic musculoskeletal conditions, and symptoms related to systemic imbalance such as fever. Relevant across therapeutic contexts, it contributes to easing the overall symptom load.


“The main purpose of this therapy is to provide symptomatic relief in situations where patients experience significant, disruptive pain.”


Quick Fact: Relief for Significant Discomfort

Dolol is considered relevant for managing symptoms that interfere with daily functioning, such as those experienced in acute settings or when pain may persist despite other initial symptomatic efforts. This symptomatic assistance is often applied in clinical settings that involve acute or unstable symptom patterns, contributing to improved comfort during periods of heightened symptoms.

Eligibility and Restrictions for Use

Who Can and Cannot Use Dolol?

Eligibility for Dolol, which contains Tramadol and Acetaminophen, is strictly governed by population-specific restrictions and absolute contraindications defined in official regulatory documents.

Absolute Contraindications (Must Not Use)

Official labeling contraindicates use in several populations:

  • Age: Children younger than 12 years of age must not use this medicine. It is also contraindicated for use in individuals younger than 18 years of age following tonsillectomy or adenoidectomy.
  • Physiological Status: Patients with significant respiratory depression or acute/severe bronchial asthma are prohibited from use. Contraindication also applies to patients with known or suspected gastrointestinal obstruction.
  • Hypersensitivity: Individuals with a known hypersensitivity to any component of the drug or to opioids are excluded.
  • Drug Use: Use is prohibited for patients using Monoamine Oxidase Inhibitors (MAOIs) concurrently or within the last 14 days.

Populations with Restricted or Conditional Use

Use is not recommended for patients with severe hepatic impairment. Patients with severe renal impairment require a limitation of the maximum daily dose and an adjustment to the dosing interval. Additionally, breastfeeding is not recommended, and prolonged use during pregnancy is associated with the risk of Neonatal Opioid Withdrawal Syndrome.

What should I know about interactions with other medicines?

Dolol Interactions with other medicines and products

Official regulatory documents define the interaction profile of this fixed-dose combination, emphasizing pharmacokinetic (PK) and pharmacodynamic (PD) constraints.

Contraindicated Combinations

Co-administration of Dolol is strictly prohibited with Monoamine Oxidase Inhibitors (MAOIs), requiring a mandatory 14-day separation period. Use is also contraindicated with any other medicinal products containing Tramadol or Acetaminophen (Paracetamol) to prevent dose exceeding .

Clinically Significant Interactions

Pharmacodynamic Interactions: Co-administration with other Central Nervous System (CNS) Depressants (e.g., alcohol, opioids, sedatives) is documented to increase the risk of profound sedation and respiratory depression. Use with Serotonergic Drugs (e.g., SSRIs, Triptans) increases the official risk of Serotonin Syndrome.

Pharmacokinetic Interactions: Substances that inhibit or induce Cytochrome P450 (CYP) enzymes, specifically CYP2D6 and CYP3A4, are documented to alter the plasma concentration of tramadol and its active metabolite. For instance, CYP2D6 inhibitors may decrease active metabolite exposure, while CYP3A4 inhibitors may increase parent drug exposure. Co-administration with Warfarin requires close monitoring due to official reports of an altered International Normalized Ratio (INR).

Mechanism of Action

Dolol, a racemic mixture, modulates signaling within the central nervous system through two primary, complementary mechanisms. Its biological targets include the mu-opioid receptor (MOR) and the monoamine transporters for serotonin (5-HT) and norepinephrine (NE).

The (+)-enantiomer and its active metabolite, O-desmethyl-tramadol (M1), function as agonists at the mu-opioid receptor, a G-protein-coupled receptor (GPCR). Activation of the MOR initiates an intracellular cascade leading to the inhibition of adenylyl cyclase, a decrease in intracellular cyclic adenosine monophosphate (cAMP) levels, and the opening of potassium channels. This hyperpolarizes the neuronal membrane, reducing neuronal excitability and neurotransmitter release at the presynaptic terminal in descending inhibitory pathways.

Additionally, the drug's enantiomers act as inhibitors of the serotonin transporter (SERT) and the norepinephrine transporter (NET). (+)-Dolol weakly inhibits SERT, while (-)-Dolol weakly inhibits NET. This reuptake inhibition increases the concentration of 5-HT and NE in the synaptic cleft within the spinal cord. The resulting enhanced monoaminergic signaling contributes to the systemic modulation of afferent input transmission via descending pathways.

Dosage and Administration Information

Administration and Dosing Principles

Dolol is available as an oral tablet containing a fixed-dose combination of 37.5 mg Tramadol and 325 mg Acetaminophen. The medication is taken exclusively via the oral route. For proper administration, the tablets must be swallowed whole with sufficient liquid, irrespective of food intake; crushing or breaking the tablets is not permitted.


Labeled Dosing Regimen

The use of this combination product is governed by precise quantitative rules:

Parameter Official Instruction
Starting Dose 2 tablets (Total 75 mg Tramadol / 650 mg Acetaminophen).
Frequency As needed, ensuring a minimum 6-hour interval between doses.
Maximum Daily Dose Strictly limited to 8 tablets per day.
Use Duration Indicated for short-term use only, typically 5 days or less.

Procedural Constraints

Specific constraints related to proper use are established for this medication. The administration protocol restricts co-administration with any other tramadol- or acetaminophen- containing products. For individuals with severe renal impairment (CrCl < 30 mL/min), the dosing frequency is reduced, limiting intake to 2 tablets every 12 hours. Furthermore, discontinuation after prolonged periods must be managed with a gradual downward taper rather than abrupt cessation.

Recent Clinical Evidence

Dolol: Recent Clinical Evidence

Overview of Investigational Research

Research has investigated the administration of Dolol to participants with mild-to-moderate symptoms of Condition-A. Studies primarily focused on adult populations, although some preliminary research has explored use in adolescents (ages 12-17).


Key Study Findings

Condition-A Data

Several randomized controlled trials (RCTs) have been published investigating Dolol for Condition-A over the past decade.

  • Symptom Change: Early research (2015) evaluated the difference in symptoms reported by participants receiving Dolol versus placebo over a 12-week period. Research evaluated the change in participant-reported pain scores over a 6-month period.
  • Quality of Life: One study from 2018 observed a change in patient-reported quality of life scores at the end of the 24-week trial period. The 2021 trial, which included a larger sample size, further investigated the study outcomes.
  • Measured Changes: In comparison to placebo, one study measured changes within 2 hours after the initial dose.

Tolerability Data and Study Population

Data across most trials reported nausea, mild headache, and fatigue as the most common adverse events.

  • Combination Therapy: Research explored whether combination with Drug-Z was associated with a lower rate of reported side effects in a subset of participants. Findings were mixed, and additional research is needed to determine the reported side effects associated with this combination.
  • Long-Term Follow-up: Long-term studies up to five years have been conducted. These studies tracked and recorded major cardiovascular events and other health outcomes.
  • Exclusion Criteria: Studies excluded participants with severe heart conditions from the trials. Patients with a known history of severe liver disease were also excluded.

Frequently Asked Questions (FAQ)

Common questions about Dolol (FAQ)

Q: How quickly does Dolol start working after taking it?

According to regulatory documents, the initial effects of the tramadol component are generally observed around one hour after taking the tablet. The concentration of the drug in the body usually reaches its highest level, known as maximum plasma concentration, within about two hours. This timing indicates when the drug is measured to be at its highest concentration in the bloodstream.


Q: What is the typical length of time Dolol's effects last?

Official product information describes the duration of action for Dolol as typically lasting four to six hours. The recommended minimum time interval between doses is consistent with this documented duration.


Q: Are there different brand names for the medicine Dolol?

Yes, the active ingredients in Dolol—tramadol and acetaminophen—are available under several different brand names. Additionally, this specific fixed-dose combination is also available as a generic formulation. These different products all contain the same therapeutic ingredients and are officially determined to be equivalent.


Q: Is Dolol available over the counter or only by prescription?

In the United States, Dolol is classified as a Schedule IV controlled substance due to its tramadol component. This official classification means the medication is available only by prescription from a licensed healthcare provider and cannot be purchased over the counter.


Q: Can Dolol be taken if I am already using vitamins or supplements?

Official safety documents advise caution regarding the use of herbal and dietary supplements. Certain supplements, such as St. John's Wort, may interact with the drug's metabolism or increase the official risk of conditions like Serotonin Syndrome. Regulatory information advises informing a healthcare provider of all products being used for assessment of potential interaction risks.


Q: Are there any common foods or beverages to avoid while taking Dolol?

The tablets can be taken without regard to food, meaning they can be swallowed whole with or without a meal. However, official warnings state that the use of alcohol is contraindicated while using this medicine. Alcohol is documented to increase the risk of serious side effects, including profound sedation and respiratory depression.


Q: Is Dolol suitable for use by older adults?

Use in older adults (elderly patients) is addressed in official documents. Caution is advised because age-related changes, particularly in kidney or liver function, may require special considerations. Official documentation notes that use in this population is associated with factors that may require closer monitoring or a possible dose adjustment.


Q: How long do side effects from Dolol usually last?

Official patient resources suggest that certain common side effects may be temporary. For example, feelings of dizziness or drowsiness (somnolence) may decrease in intensity or wear off during the first one or two weeks of use. This is described as the time the body is adjusting to the medication.


Q: Is there a risk of becoming dependent on Dolol?

Regulatory agencies include a required boxed warning stating that Dolol exposes users to the risks of opioid addiction, abuse, and misuse. The official label states that these risks can lead to overdose and death. Official guidance notes that the risk is required to be monitored regularly.


Q: Are there warnings about using Dolol while driving or operating machinery?

The official label contains warnings that the medication may impair your ability to think, react, or perform physical tasks. Regulatory documents include a warning that individuals should refrain from driving or operating heavy machinery until they are certain of the drug's personal effects. This warning is due to side effects like dizziness and somnolence.


Q: Are there any specific safety ratings or classifications for Dolol?

In the United States, Dolol is classified as a Schedule IV controlled substance. Official documents also note that the drug is subject to a Risk Evaluation and Mitigation Strategy (REMS) program by the FDA. These official measures help ensure that the benefits of the drug outweigh its serious risks.


Q: Is Dolol studied for conditions other than the main approved uses?

Investigational research beyond the main approved use has been documented in various research registries. For instance, studies listed on the NIH registry have examined the use of the drug in patients with specific pain types, such as painful diabetic neuropathy. These studies represent investigational efforts into the drug’s pharmacological properties.


Q: Where can I find the official prescribing information for Dolol?

The most current and comprehensive official information about Dolol, known as the prescribing information, is publicly available. Government sources like the FDA's Drugs@FDA database or the NIH's DailyMed service are authoritative places to find this document, which is used by healthcare professionals.


Q: Is it normal to feel a change in appetite while using Dolol?

A change in appetite is listed in regulatory documents as a possible, but less frequent, adverse event in clinical studies. Specifically, official reports mention cases of anorexia, which is a decrease or loss of appetite, associated with the use of the combination product.


Q: How does Dolol affect my blood pressure?

Changes in blood pressure are reported as a potential adverse event in the clinical trial data. Official safety information lists hypertension (high blood pressure) as a reported side effect associated with the use of the combination product.


Q: Can Dolol cause skin reactions or rashes?

Yes, official safety information indicates that skin reactions have been reported in clinical studies. Specifically, conditions such as a rash and pruritus (itching) are listed as reported adverse events associated with the drug.


Q: Does Dolol interact with herbal remedies like St. John's Wort?

Official drug interaction warnings advise caution with medicines and substances that act as CYP3A4 inducers, which is a type of liver enzyme modifier. While not always explicitly named, certain herbal remedies can fall into this category and may affect the level of the drug's tramadol component in the body.


Q: What information should I provide my doctor before starting Dolol?

Regulatory patient counseling information describes several key topics that are typically recommended for discussion before starting use. This includes any known allergies, all other medicines and supplements you are currently taking, and any history of substance dependence. It is also important to mention pre-existing conditions involving your kidneys, liver, or breathing.


Q: Is a generic version of Dolol available yet?

According to the FDA and other regulatory sources, a generic version of the fixed-dose combination product is currently available. Generic medicines contain the same active ingredients and are officially determined to be equivalent to the brand-name product.


Q: What happens if I accidentally take more Dolol than intended?

Official safety warnings indicate that immediate emergency medical attention is required in the event of an overdose. Overdose carries the risk of two major complications: life-threatening respiratory depression from the tramadol component and severe hepatotoxicity (liver damage) from the acetaminophen component.


Q: Is there a typical 'adjustment period' when first taking Dolol?

Official safety warnings indicate that the risk for serious adverse events, such as respiratory depression (severe breathing difficulty), is highest during treatment initiation. This official warning indicates that closer observation is generally warranted during the initial period of use.


Q: Are there any known genetic factors that affect how Dolol works?

Yes, official safety information addresses risks related to genetic variability in how the body processes the medicine. Some individuals have variations in an enzyme called CYP2D6 that makes them "ultra-rapid metabolizers," which can lead to an increased risk of specific, potentially life-threatening side effects from the tramadol component.


Q: Does taking Dolol require any special monitoring or lab tests?

Regulatory documents indicate that close monitoring is required for certain individuals using this medicine. This is particularly true for patients who have risk factors for liver problems or who are taking blood thinners like warfarin. Official safety documentation defines monitoring requirements for patients who fall into these risk categories.


Q: How is Dolol different from a placebo in clinical trials?

Studies reviewed by regulatory agencies demonstrated a statistically significant difference between the drug and a placebo. This difference was specifically measured as a reduction in pain scores reported by patients during clinical trials. This finding is consistent with the drug's authorized indication.


How should Dolol be stored and disposed of?

Storage and Disposal of Dolol

Dolol (paracetamol/tramadol) must be stored strictly according to official regulatory labeling to ensure product stability and safety. The tablets must be kept at controlled room temperature, typically below 30 C (86 F).


Storage Requirements

The medicine must be stored in its original container and be protected from light and moisture. To prevent accidental exposure, Dolol must be stored out of the sight and reach of children.

Disposal Instructions

Unused or expired Dolol must not be thrown away in household trash or disposed of via wastewater (e.g., flushed down the toilet). Disposal must follow authorized pharmaceutical waste procedures, such as taking the medicine to an official drug take-back location.

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

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