Adolor

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Medically reviewed

Marina Burgos

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 Adolor

Property Description
Active Ingredient(s) Acetaminophen (Paracetamol) and Caffeine
Form Oral Solid (Tablet or Capsule)
Pharmacological Class Analgesic Combination
Common Use Rationale Enhanced symptomatic relief of discomfort
Origin Synthetic

What Type of Medicine is Adolor? (Identity and Classification)

Adolor is a synthetic, fixed-dose combination medication that belongs to the pharmacological class of Analgesic Combinations. This product is administered via the oral route, typically provided as an oral solid form, such as a capsule or tablet. The core component, Acetaminophen, is globally recognized and often recommended as a first-line therapy for pain and fever by authoritative health organizations, underscoring its established efficacy. This indicates that the primary ingredient is clinically recognized for its ability to reduce both pain signals and fever.


Adolor's Composition: Acetaminophen and Caffeine (Components and Form)

The core composition of Adolor includes Acetaminophen and Caffeine, combining a non-opioid analgesic with a Central Nervous System (CNS) Stimulant. Acetaminophen serves as the primary agent for pain relief. The secondary component, Caffeine, is included as an adjuvant, an ingredient known to enhance the therapeutic effects of other drugs. The combination of acetaminophen and caffeine provides superior pain relief compared to acetaminophen alone. Therefore, the combination is recognized as effective for relieving discomfort, such as common tension headaches. These synthetic compounds are integrated with inert excipients necessary for the final oral dosage form.


What is the General Purpose of This Combination? (Therapeutic Rationale)

The general purpose of this specific combination is to utilize synergistic action to achieve enhanced symptomatic relief from discomfort. This rationale relies on the principle that the mild CNS Stimulant component, Caffeine, helps to accelerate or boost the efficacy of the Acetaminophen component. This makes Adolor a therapeutically designed option for providing attenuation of discomfort that aims to be more potent than utilizing the non-opioid analgesic ingredient alone.

Regulatory References

  1. Acetaminophen: MedlinePlus Drug Information

What side effects are possible with Adolor?

Possible side effects and safety information

The officially documented safety profile for this combination medication (Acetaminophen and Caffeine) is based on adverse reactions and safety constraints classified by global regulatory authorities.

Adverse reactions are classified into system-organ classes, with effects most frequently reported in the Nervous System and Gastrointestinal System. Common adverse reactions, often linked to the CNS stimulant component, include insomnia (trouble sleeping), nervousness, restlessness, and headache, along with nausea and abdominal pain. Cardiac effects, such as palpitations and increased heart rate, are also commonly documented.


Serious Adverse Reactions and Major Safety Constraints

Official regulatory documents highlight the potential for rare but serious adverse reactions, primarily associated with the Acetaminophen component:

  • Hepatotoxicity: A major safety constraint is the risk of severe liver damage, acute liver failure, or hepatic necrosis, which can be fatal. This risk increases significantly with co-exposure to other Acetaminophen-containing products or chronic, heavy consumption of alcohol.
  • Severe Dermatological Reactions: Acetaminophen is associated with the rare occurrence of severe skin reactions, including Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).
  • Hypersensitivity: Rare, severe allergic reactions (anaphylaxis) are documented.

Population and Exposure-Related Safety Notes

Safety constraints require caution for individuals with pre-existing impaired hepatic or renal function. Furthermore, the safety profile notes that the caffeine component can lead to physical dependence with prolonged, continuous use, potentially resulting in withdrawal symptoms like headache upon abrupt cessation. The label strictly restricts the concomitant use of this medication with any other products containing Acetaminophen due to the severe risk of additive toxicity.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose of Adolor involves distinct toxicological risks documented in official regulatory sources from its active components. Early acetaminophen toxicity may present with non-specific symptoms such as nausea, vomiting, abdominal pain, and diaphoresis (sweating). The absence of these initial signs does not exclude potential toxicity. Severe outcomes are formally documented and include delayed, progressive liver damage leading to acute liver failure, which may result in the need for a liver transplant or death. The caffeine component is associated with distinct manifestations such as restlessness, tremor, and rapid or pounding heartbeat (tachycardia). Excessive exposure to caffeine can lead to serious central nervous system effects, including seizures, and life-threatening cardiac arrhythmias.

Regulatory bodies explicitly state that immediate medical attention must be sought for any suspected overdose, regardless of whether the individual appears symptomatic. Individuals must be prepared to contact a Poison Help hotline immediately. If the affected person has collapsed, experienced a seizure, has trouble breathing, or cannot be awakened, emergency services must be called immediately. Management procedures, as described in official documents, involve clinical and laboratory monitoring and the prompt administration of the documented antidote, N-acetylcysteine (NAC), to prevent or lessen hepatic injury from the acetaminophen component. Individuals with pre-existing liver disease or those with chronic alcohol consumption are noted to have an increased risk for severe liver damage.

Therapeutic Uses of Adolor

What Adolor Treats: Main Uses and Benefits

Adolor is a medication generally used in situations involving certain distressing symptoms where short-term symptomatic assistance is needed. The active component is generally considered relevant for addressing acute and intense manifestations.

Therapeutic Focus

This medication is applied in clinical settings that involve acute or unstable symptom patterns, such as those associated with acute or episodic changes, often following a surgical procedure or injury. It is also relevant for easing discomfort in conditions characterized by periods of heightened symptoms related to inflammatory or irritative states in soft tissue and joints.

Adolor is applied during phases of increased distress or discomfort where supportive relief is needed. It helps address symptom clusters that may become intense or disruptive, and provides support that helps ease the overall symptom burden.

Quick Fact: Relief for Acute Discomfort

Adolor is relevant for easing discomfort in conditions characterized by periods of heightened symptoms where short-term stabilization is important. It is used during phases of increased distress, and supports general well-being during symptomatic periods.

Eligibility and Restrictions for Use

Alvimopan (formerly associated with Adolor Corporation) is subject to strict eligibility rules defined by government regulatory agencies for short-term, in-hospital use only.

Contraindications and Restrictions

The medicine is contraindicated in patients who have taken therapeutic doses of opioids for more than seven consecutive days immediately prior to administration. Use in this population is explicitly prohibited by official labeling.

Populations Not Recommended for Use

Use is not recommended in patients with:

  • Severe hepatic impairment (Child-Pugh Class C).
  • End-stage renal disease.
  • Complete gastrointestinal obstruction or those having surgery for correction of a complete obstruction.
  • Pancreatic or gastric anastomoses.

Conditional Eligibility

The medicine is restricted to a maximum of 15 doses and is only available through a restricted safety program (REMS). It must not be dispensed to patients after they leave the hospital.

Specific Eligibility Groups

  • Pediatric Use: Safety and effectiveness have not been established in children.
  • Pregnancy/Lactation: There are no adequate and well-controlled studies in pregnant women, and it is not known if the drug is excreted in human milk.

What should I know about interactions with other medicines?

Adolor's regulatory interaction profile defines specific requirements and restrictions based on its active components, Acetaminophen and Caffeine.

Interaction Restrictions

Co-administration with any other paracetamol-containing product is strictly prohibited to prevent accidental overdose and subsequent fatal liver damage. Other combinations to be avoided include Lithium, Disulfiram, and Theophylline due to documented pharmacokinetic interferences that affect clearance rates.

Pharmacokinetic and Metabolic Interactions

Interactions are documented with substances that alter drug exposure. Long-term use of Liver Enzyme Inducers (e.g., Carbamazepine, Rifampicin) is a risk factor for paracetamol-related hepatotoxicity. Conversely, CYP1A2 Inhibitors (e.g., Fluvoxamine) reduce caffeine clearance, increasing plasma concentration. Absorption of paracetamol may be increased by Metoclopramide but reduced by Cholestyramine.

Pharmacodynamic and Substance Interactions

The caffeine component has an antagonistic effect toward sedatives and tranquilizers and may enhance the effects of sympathomimetic drugs. Prolonged, regular daily use of the paracetamol component may enhance the anticoagulant effect of Warfarin and other Coumarins. Regular excessive intake of Alcohol (Ethanol) is an established risk factor for liver damage. Additionally, a mandatory timing rule requires the caffeine component to be discontinued at least 5 days prior to administration of injectable Dipyridamole for myocardial imaging.

Specific population notes caution that the overdose hazard is greater in patients with non-cirrhotic alcoholic liver disease or those in glutathione depleted states.

Mechanism of Action

Central Modulation of Prostaglandin Synthesis

The primary mechanism of Acetaminophen involves non-competitive inhibition of the Cyclooxygenase (COX) pathway specifically within the Central Nervous System (CNS). This suppression of key mediators like Prostaglandins ( PGE2) regulates the hypothalamic set-point and diminishes the sensitivity of nociceptive neurons. Furthermore, a metabolite reinforces the body's own descending inhibitory pathways by modulating TRPV1 receptors and the endocannabinoid system, supporting central pain signal modulation.

Adenosine Receptor Antagonism and Synergy

The adjuvant component, Caffeine, acts as a competitive antagonist of adenosine receptors ( A1 and A2A). This distinct mechanism complements central COX inhibition and influences cerebral vascular tone. Caffeine may also accelerate the delivery of the primary component to its CNS targets, influencing the rate of central mechanism engagement.

Mechanistic Constraint

This mechanism is limited by the component's low efficacy against peripheral COX enzymes found in local inflammatory environments. This physiological constraint means the drug does not contribute significant peripheral anti-inflammatory effects, defining the boundary of its action relative to peripheral inflammatory mediator suppression.

Dosage and Administration Information

How to Use Adolor (Ketorolac) — Administration Guidelines

Adolor (Ketorolac) is used according to specific instructions that define the route, duration, and dosage. Treatment is limited by a maximum total duration of 5 days for all administration routes combined.

Approved Routes and Forms

Ketorolac is available for administration via several routes, including Intramuscular (IM) injection, Intravenous (IV) bolus injection, and Oral tablets (typically 10 mg strength). The Oral tablets are intended only for continuation therapy following an initial injection, and must not be used as the starting dose of treatment.

Standard Dosing and Administration

Dosing is subject to patient factors, particularly age, weight, and kidney function:

  • Standard Adults (under 65 years and 50 kg or more): The maximum daily dose is 120 mg for IV/IM multiple-dosing, and 40 mg for oral continuation therapy.
  • Elderly, Low Body Weight, or Moderate Renal Impairment: Patients 65 years of age or older, those under 50 kg, or those with moderately elevated serum creatinine are subject to a reduced maximum daily dose of 60 mg/day for IV/IM administration. The multiple-dose regimen in this population is typically 15 mg every 6 hours.

Procedural Requirements

For injectable administration, the IV bolus must be delivered no less than 15 seconds. Dosing frequency is generally every 4 to 6 hours, depending on the route, and must adhere to the maximum daily dose limits. The combined use of all formulations must not exceed the 5-day limit.

Recent Clinical Evidence

Adolor: Recent Clinical Evidence

The information presented here is a summary of the scientific research and clinical studies conducted on Adolor. It explains what researchers have examined, what the findings describe so far, and what aspects of the evidence remain limited or uncertain.

Evidence for use in Opioid-Induced Constipation (OIC)

The evidence base for Adolor's use for Opioid-Induced Constipation (OIC) consists mainly of randomized, controlled clinical trials. These studies involved adult patients experiencing OIC, which are conditions characterized by fluctuating or episodic manifestations. The studies monitored outcomes related to physical discomfort and changes in bowel movement patterns, such as the weekly average number of spontaneous bowel movements (SBMs).

Data show patterns related to measured SBM frequency in the group receiving Adolor when compared to the placebo group over the short-term study periods; however, long-term effects are not fully established. The findings help contextualize how patients reported their experience.

Evidence for use in Moderately Severe Acute Pain

Adolor was studied for use in conditions associated with acute or disruptive episodes, specifically short-term pain. Researchers examined the change in pain intensity using standard measurement scales and monitored the requirement for additional pain relief medication. Follow-up durations were limited to very brief periods.

The data show patterns related to outcomes reflecting daily functioning or activity level over the initial days of treatment, such as changes in pain intensity scores. The research provides insight into short-term changes.

What is Still Uncertain About Adolor

Key evidence gaps exist in the research landscape. Evidence remains limited concerning its use for OIC over many months, and certainty remains low for long-term outcomes. Comparative evidence is limited for certain situations. Sample sizes were modest in some studies, and data are still emerging for various patient characteristics. Research is ongoing to provide a more complete picture of Adolor’s outcomes.

Frequently Asked Questions (FAQ)

Common questions about Adolor (FAQ)

Q: What is Adolor used for?

Adolor is a medication primarily used to relieve moderate to severe pain.

It belongs to a class of drugs known as opioid analgesics. It works in the brain and nervous system to change how your body feels and responds to pain.

Q: How should I take Adolor?

Take Adolor exactly as your doctor prescribes.

  • Do not take more than the prescribed amount or take it more often than directed.
  • It can be taken with or without food. If it causes an upset stomach, taking it with food may help.
  • Swallow the tablet or capsule whole. Do not crush, chew, or break extended-release forms of this medication, as this can lead to a dangerous dose being released all at once.

If you miss a dose, take it as soon as you remember, unless it is almost time for your next scheduled dose. Do not take two doses at the same time to make up for a missed dose.

Q: What are the common side effects of Adolor?

Common side effects of Adolor may include:

  • Drowsiness or dizziness
  • Nausea and vomiting
  • Constipation
  • Sweating

If these side effects are persistent or bothersome, talk to your healthcare provider. Constipation is very common with this type of medication, and your doctor may recommend a stool softener or laxative to help manage it.

Q: Can I drink alcohol while taking Adolor?

No, you should not drink alcohol while taking Adolor.

Both Adolor and alcohol can cause drowsiness, dizziness, and slow breathing. Combining them significantly increases the risk of severe and potentially fatal side effects, including:

  • Extreme sedation
  • Respiratory depression (dangerously slow or shallow breathing)
  • Coma

Q: Is Adolor habit-forming?

Yes, Adolor can be habit-forming (addictive).

Because it is an opioid, using Adolor, even exactly as prescribed, carries a risk of physical dependence and addiction.

  • Physical dependence means your body gets used to the drug, and you may experience withdrawal symptoms if you stop using it suddenly.
  • Addiction is a chronic disease characterized by compulsive drug-seeking and use, despite harmful consequences.

Only use this medication for the shortest time necessary and at the lowest effective dose. Do not share this medication with anyone else.

How should Adolor be stored and disposed of?

Adolor (Acetaminophen and Caffeine oral solid) must be stored strictly according to regulatory labeling to maintain product stability and ensure household safety.

Official Storage Conditions

The medication should be kept in the original container, tightly closed, at room temperature and away from excess heat and moisture (e.g., not in the bathroom). It must be stored in a safe location, out of the sight and reach of children, and secured with a locked safety cap immediately after use. The product must be kept from freezing and should be discarded after the expiration date printed on the packaging.

Disposal Instructions

Expired or unused Adolor must be disposed of via an official drug take-back program. If a take-back option is unavailable, the product must not be flushed down the toilet. Instead, mix the medication with an undesirable substance (such as used coffee grounds or dirt), place the mixture in a sealed container, and dispose of it in the household trash. Personal information on the packaging must be scratched out before disposal.

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

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