Keradol

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Keradol

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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 Keradol

Quick Facts about Keradol

Property Description
Active Ingredient Ketorolac tromethamine
Pharmacological Class Nonsteroidal Anti-inflammatory Drug (NSAID)
Primary Forms Oral tablets, Injection solution, Nasal spray, Ophthalmic solution
General Purpose Powerful pain relief and anti-inflammatory action
Origin Synthetic compound

What Type of Medicine is Keradol (Ketorolac)?

Keradol is a prescription-only medication classified as a Nonsteroidal Anti-inflammatory Drug (NSAID), belonging specifically to the pyrrolo-pyrrole chemical group. The medicine contains the active ingredient Ketorolac tromethamine and is clinically recognized for its high analgesic potency, which is often considered comparable to that of certain opioids. This indicates the medicine is a strong option for handling significant temporary pain. Keradol is intended exclusively for the short-term management of moderately severe acute pain, such as in a post-surgical setting, and is not used for chronic or minor painful conditions.

Composition, Origin, and Available Forms

The active component, Ketorolac tromethamine, is a synthetic compound that functions as a single agent product. This component is presented in multiple pharmaceutical dosage forms to facilitate diverse routes of administration, including oral tablets, a sterile solution for injection (intramuscular and intravenous use), a nasal spray, and an ophthalmic solution. The versatility across these distinct preparations—particularly the availability of parenteral and intranasal forms—represents a key differentiating factor, ensuring effective delivery options beyond standard oral administration.

General Benefit: Why is Ketorac Used?

The primary general benefit of Keradol is its capacity to deliver powerful pain relief by inhibiting the body’s production of substances that cause pain and inflammation. This action involves blocking the cyclooxygenase (COX) enzyme system, which is essential for synthesizing prostaglandins—the chemical messengers responsible for signaling pain and fever. By targeting this fundamental chemical process, Keradol provides a fast and robust reduction in acute pain sensation.

Regulatory References

  1. Ketorolac: MedlinePlus Drug Information

What side effects are possible with Keradol?

Possible Side Effects and Safety Information

Keradol (Ketorolac tromethamine) has an official safety profile categorized by adverse reaction frequency and the physiological system affected, consistent with its classification as a potent Nonsteroidal Anti-inflammatory Drug (NSAID).

Frequency and System-Organ Classes

The most frequent adverse reactions reported in regulatory documentation include nausea and headaches, classified as having an incidence greater than 10%. Common reactions (1% to 10% incidence) include dizziness, drowsiness, dyspepsia, diarrhea, abdominal pain, and edema. Side effects are categorized by System-Organ Class (SOC), heavily involving the Gastrointestinal System, Cardiovascular System, Renal System, and Nervous System.

Serious Adverse Reactions and Safety Constraints

Official labeling highlights the risk of serious adverse reactions, including potentially fatal gastrointestinal ulceration, bleeding, and perforation and cardiovascular thrombotic events (such as myocardial infarction and stroke). These serious events may occur at any time during treatment, with risk increasing with higher doses and prolonged duration of use.

Keradol is contraindicated in specific patient populations and clinical contexts due to safety concerns. These restrictions include patients with advanced renal impairment, those at high risk for bleeding, individuals with a history of NSAID-induced asthma or allergic reactions, and during late pregnancy (from 30 weeks gestation) due to fetal risk.

Overdose and Emergency Response

Overdose Manifestations and Complications

Overdose following acute nonsteroidal anti-inflammatory drug (NSAID) ingestion, including Keradol, is typically associated with common, reversible signs. These documented manifestations include lethargy, drowsiness, nausea, vomiting, and epigastric pain. Single overdoses have also been associated with hyperventilation or mild renal dysfunction, which generally resolve after discontinuing the medicine.

Severity Classification Documented Overdose Outcomes
Gastrointestinal Risk Gastrointestinal bleeding (e.g., bloody, black, or tarry stools), peptic ulcers, and erosive gastritis.
Severe/Rare Outcomes Acute renal failure, hypertension, respiratory depression, and coma. Anaphylactoid reactions may also occur.
High-Risk Note Elderly patients are explicitly documented to be at greater risk for serious gastrointestinal events.

Emergency Action and Management

Official regulatory guidance mandates that patients or caregivers seek immediate emergency medical help right away for any suspected overdose. Urgent attention is required for signs of severe gastrointestinal bleeding (vomit resembling coffee grounds) or sudden, severe allergic reactions. No specific antidote is known for Keradol overdose. Management is strictly by symptomatic and supportive care. Due to the medicine's high protein binding, measures like forced diuresis or hemodialysis are generally not considered useful in treatment. In cases where the ingestion is confirmed to have occurred within a 4-hour window, the administration of activated charcoal or an osmotic cathartic may be considered to limit absorption.

Therapeutic Uses of Keradol

What Keradol Treats: Main Uses and Benefits

Keradol is relevant for easing symptoms in acute scenarios that involve significant discomfort, and may be part of symptomatic management when symptoms are more noticeable. This medication is commonly used when short-term symptomatic assistance is needed for symptoms related to heightened physiological activity.

Therapeutic Focus and Scenarios

The medication is primarily applied in clinical settings that involve acute or unstable symptom patterns, such as managing the pronounced discomfort of acute renal colic, severe episodes of migraine headaches, and especially pain and inflammatory or irritative states that arise immediately after operative procedures. Keradol is commonly used to help with the opioid-sparing effect, and may assist in managing pain when supportive symptomatic support is needed. The medication helps address symptoms that interfere with daily comfort and supports patients during episodes of heightened discomfort.

“The medication is used when severe, short-term symptomatic assistance is required, providing supportive relief for symptoms that create noticeable physiological strain.”

QuickFact Block

Quick Fact: Symptomatic Support Description
Symptom Type Intense, acute pain and associated inflammation.
Severity Relevance Moderately severe pain where short-term symptomatic assistance is needed.
Primary Context Post-surgical recovery and acute pain events like renal colic.
Core Benefit Contributes to improved comfort and eases the overall symptom load.

Regulatory References

  1. U.S. National Institutes of Health (NIH) DailyMed

Eligibility and Restrictions for Use

Who Can and Cannot Use Keradol: Population Eligibility Rules

Keradol (Ketorolac tromethamine) eligibility is highly restricted and defined strictly by official regulatory documentation. The medicine is indicated solely for the short-term management (not to exceed 5 days total) of moderately severe acute pain in adults (typically 18 to 64 years of age).


Absolute Contraindications

Keradol is absolutely contraindicated and must not be used in patients with several serious conditions, including:

  • Gastrointestinal Risk: Active peptic ulcer disease, recent GI bleeding, or perforation.
  • Organ Function: Advanced or severe renal impairment and severe heart failure.
  • Hemorrhage Risk: Confirmed or suspected cerebrovascular bleeding or other high bleeding risk.
  • Hypersensitivity: Known hypersensitivity to ketorolac, aspirin, or any other Nonsteroidal Anti-inflammatory Drug (NSAID).

Restrictions by Age and Physiological Status

Population Regulatory Status
Pediatric Patients Safety and efficacy have not been established; generally not indicated for use under 17 years.
Older Adults (≥65) Not recommended unless strict dosage reduction is applied due to increased risk.
Pregnancy/Lactation Contraindicated in the third trimester of pregnancy and in breastfeeding women.

Use is also prohibited with concomitant use of aspirin or other NSAIDs, and for obstetric analgesia or prophylactic pain relief before major surgery.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation defines specific constraints and prohibited combinations for Keradol (ketorolac tromethamine) based on documented interaction patterns.

Formally Contraindicated Combinations

Co-administration with several substances is formally contraindicated due to the high risk of serious adverse events:

  • Aspirin and Other NSAIDs: Concurrent use with aspirin or any other Nonsteroidal Anti-inflammatory Drug (NSAID) is prohibited due to the cumulative and synergistic risk of gastrointestinal bleeding and ulceration.
  • Probenecid: This combination is contraindicated because probenecid decreases the renal clearance of ketorolac, leading to significantly increased plasma exposure and toxicity risk.
  • Pentoxifylline and Anticoagulants: Concomitant use with pentoxifylline and certain anticoagulants, such as warfarin, increases the documented risk of bleeding.

Documented Pharmacokinetic and Pharmacodynamic Interactions

Interactions that alter drug exposure or produce additive effects are officially noted:

  • Exposure-Modifying Effects: Keradol reduces the renal clearance of both lithium and methotrexate, which can elevate their plasma concentrations and potentially increase the risk of toxicity.
  • Efficacy Reduction: The medicine may reduce the natriuretic and antihypertensive efficacy of diuretics (like furosemide) and certain antihypertensives (like ACE inhibitors or ARBs) by interfering with renal prostaglandin synthesis.
  • Food and Alcohol: Oral administration after a high-fat meal may delay the rate of absorption. Alcohol consumption is noted to increase the risk of gastrointestinal bleeding.

Mechanism of Action

How Keradol Works

Keradol (ketorolac tromethamine) functions through a non-selective enzyme inhibition mechanism that modulates key biological pathways. Its primary molecular action is blocking the Cyclooxygenase ( COX) enzyme system, including both the constitutive ( COX-1) and inducible ( COX-2) isoforms. This interaction arrests the conversion of arachidonic acid into prostaglandins ( PGs), which are crucial local chemical mediators.

This molecular event initiates a dual peripheral and central anti-nociception cascade. Peripherally, the reduction in PG production decreases the sensitization of nociceptors at the site of tissue changes. Centrally, the drug's ability to cross the blood-brain barrier allows for COX inhibition in the spinal cord, leading to the modulation of PG-mediated signal amplification in the central nervous system.

As an inherent consequence of its non-selective mechanism, Keradol also modulates COX-1 dependent homeostatic pathways. This functionally impacts the production of Thromboxane A2 ( TXA2) in platelets, and interferes with the PGs that maintain compensatory renal blood flow under specific physiological conditions.

Dosage and Administration Information

How to Use Keradol (Ketorolac Tromethamine)

Keradol is an analgesic intended exclusively for short-term management, with the total duration of use for all forms combined not exceeding 5 days in adults. Its administration is structured sequentially, beginning with a parenteral form for initiation and transitioning to the oral form for continuation therapy.


Official Administration Routes and Schedules

The medicine is approved for several routes, including Intravenous (IV) and Intramuscular (IM) injection, Oral tablets, Intranasal spray, and Ophthalmic solution. The standard parenteral multiple-dose regimen is 30 mg IV or IM administered every 6 hours. Oral continuation therapy is dosed at 10 mg every 4 to 6 hours as needed, and this route is not to be used for treatment initiation.


Dosing Limits and Special Conditions

Usage Constraint Instruction Detail
Maximum Daily Dose (Standard) Must not exceed 120 mg/day (combined parenteral and oral use).
Dose for Special Populations A mandatory dose reduction applies to adults 65 years or older or those weighing <50 kg, where the maximum total daily dose is capped at 60 mg/day.
Oral Administration Tablets must be taken with food or an antacid to aid administration conditions.
IV Administration The injection must be given as a bolus over no less than 15 seconds.

The overall use protocol emphasizes a limited, short-course application, requiring strict adherence to defined dosing intervals and maximum daily limits that differ based on patient-specific factors such as age and body weight.

Recent Clinical Evidence

Research Evidence: Overview of Studies for Keradol


Evidence for Use in Acute Post-Surgical Pain

The research exploring how Keradol was studied for pain management after operations primarily includes high-quality Randomized Controlled Trials (RCTs) and scientific reviews that combine the results of multiple trials (Systematic Reviews). These studies research examined the medicine in the context of pain management after various operative procedures, such as orthopedic or general surgeries.

The research focused on outcomes related to physical discomfort, monitoring the intensity of symptoms using standard pain scales over specific, short-term intervals after surgery. Researchers also explored whether the medicine was associated with changes in how much supplemental opioid medication patients requested during the study period, which is one of the patient-reported outcomes describing perceived discomfort that was measured. Findings describe patterns observed in the studies describing patterns of lower opioid medication use in patients who received Keradol as part of their post-surgical care.

What remains uncertain is that the follow-up durations were limited in these studies. The evidence is derived mostly from research exploring short-term symptom changes within the maximum five-day period the medicine is approved for use. Therefore, long-term effects are not fully established, and information on functional recovery or pain management outcomes beyond the initial five days is limited. Data is limited regarding the medicine's use in patients excluded from some comparative trials.


Evidence for Use in Acute Renal Colic

The available evidence relies primarily on Randomized Controlled Trials (RCTs) conducted in emergency settings for acute renal colic, a condition involving periods of heightened symptoms associated with kidney stones. These studies was evaluated in adult patients presenting with outcomes capturing phases of heightened symptom activity, such as severe flank pain.

The research examined outcomes related to physical discomfort very quickly, with measurements often taken within the first hour after administering the injectable form of the medicine. Studies monitored the speed and degree of change in symptom intensity reported by patients. Findings describe patterns observed in the studies where data showed patterns related to rapid changes in measured outcomes following injectable administration.


Study Focus on Long-Term Outcomes and Follow-Up

The scientific literature indicates that Keradol is intended exclusively for short-term use, and this is reflected in the research design. The studies available consistently show follow-up durations were limited, typically lasting no more than five days, which reflects the limits established for research duration.

Consequently, there is limited information for long-term outcomes or durability of effect related to the medicine. The evidence concentrates on acute-phase symptom management; questions regarding any effects beyond the immediate period of administration, such as sustained functional outcomes, are not well characterized by the existing research landscape.

Key Studies & References

  1. Ketorolac Tromethamine Injection / Tablets: Official FDA-Approved Labeling (Pharmacology, Clinical Studies, Special Populations)

Frequently Asked Questions (FAQ)

Common questions about Keradol (FAQ)


Q: Is Keradol a type of antibiotic?

A: Keradol is classified by regulatory agencies as a Nonsteroidal Anti-inflammatory Drug (NSAID). It works by inhibiting the cyclooxygenase (COX) enzyme system, which helps reduce pain and inflammation. It is not an antibiotic, which is a type of medicine specifically used to treat bacterial infections.


Q: Is a metallic taste in the mouth a common side effect of Keradol?

A: While a metallic taste itself is not typically listed among the most common adverse effects (like nausea or headache), the official safety data does include reports of taste abnormality related to the nervous system. This effect has been noted in post-marketing experience.


Q: Does Keradol have a black box warning in the U.S.?

A: Yes, official U.S. regulatory labeling includes a Boxed Warning. The purpose of this Boxed Warning is to describe the risk of serious adverse events, specifically potential gastrointestinal bleeding or ulceration, and cardiovascular thrombotic events (myocardial infarction and stroke).


Q: Does Keradol affect sleep patterns?

A: Official safety documents indicate that Keradol may affect sleep and wakefulness. The safety profile includes reports of both insomnia (difficulty sleeping) and somnolence (drowsiness) as reported adverse effects within the nervous system category.


Q: Can Keradol interact with alcohol?

A: Official documentation notes that consuming alcohol is a documented factor that can increase the risk of developing gastrointestinal bleeding while using Keradol. This increased risk is associated with the medication’s documented effects on the gastrointestinal tract.


Q: How quickly should I expect to notice any effect from Keradol?

A: Research indicates that the median time to reach maximal concentration in the blood is approximately 30 to 40 minutes after taking the oral tablet and 45 to 50 minutes following an intramuscular injection. These times are based on pharmacokinetic studies.


Q: How long does Keradol stay in your system after stopping?

A: The mean plasma elimination half-life is approximately 5 to 6 hours for the active substance. The scientific principle of pharmacokinetics suggests that a substance is largely eliminated from the system after a period equivalent to approximately five half-lives.


Q: Are there any specific foods or drinks that should be avoided with Keradol?

A: In addition to alcohol, official product information notes that taking the oral tablet after a high-fat meal may delay the speed at which the medicine is absorbed into the body. No other specific food restrictions are typically listed in the regulatory documents.


Q: Can Keradol affect my ability to drive?

A: Because adverse effects such as dizziness and drowsiness have been reported, official guidance emphasizes caution regarding driving or operating complex machinery until a person is aware of how the medicine affects their personal alertness level.


Q: What should be reported to a doctor right away after starting Keradol?

A: Regulatory documents describe serious adverse events that require immediate attention. These include signs of serious gastrointestinal bleeding (such as vomiting blood or having black, tarry stools) or symptoms of a potential heart problem (such as chest pain, shortness of breath, or unusual sweating).


Q: Can I take Keradol if I have liver problems?

A: Official documentation states that Keradol warrants caution and close observation in individuals with a history of impaired hepatic function or liver disease. The regulatory label notes that rare severe hepatic reactions, including liver failure, have been reported.


Q: What happens if I miss taking Keradol?

A: The content in patient information guides often describes that if a scheduled dose is missed, the dose should be skipped. The recommended practice is to take the next dose at its regular time, without attempting to take extra medicine to compensate for the skipped amount.


Q: Why do some people report Keradol making them feel restless?

A: The official side effect profile lists severe restlessness as an adverse reaction that has been reported, although it is not categorized as a common effect. This means it has been noted in the clinical or post-marketing experience for the medication.


Q: Does Keradol have a potential for dependency?

A: Keradol is not classified as a controlled substance by U.S. regulatory bodies. Official documents indicate that the medicine is not considered to be habit-forming and does not carry a risk of abuse or dependence, unlike opioid medications.


Q: Is there a generic version of Keradol available?

A: Yes, the active ingredient in Keradol, known as ketorolac tromethamine, is available in a generic version.


Q: What kind of research has been done on Keradol for long-term use?

A: Regulatory documents define the intended use of Keradol for a short duration, not exceeding five days. Research reflecting this regulatory use means that the available studies have consistently limited follow-up durations. Consequently, data on long-term effects beyond this short duration are limited and not well characterized.


Q: Is it normal for the color of the Keradol tablet to vary slightly?

A: Official drug descriptions specify the physical attributes of the medicine, such as the injectable solution being clear and slightly yellow in color. Minor variations in the physical appearance of manufactured products like tablets are generally expected, provided they meet strict quality control standards.


Q: How soon after stopping Keradol can I use [Interacting Substance]?

A: The necessary clearance time for the medicine to exit the body is estimated using its half-life, which is approximately 5 to 6 hours. It is generally estimated that the medicine is largely cleared from the system after a period equivalent to about five half-lives.


Q: Is Keradol available over the counter in any country?

A: In the United States, Keradol is regulated as a prescription-only medication. The official status in other international jurisdictions would need to be checked via their specific national health authorities.


Q: What is the half-life of Keradol?

A: The mean plasma elimination half-life for the active ingredient is approximately 5 to 6 hours. This is the time it takes for the concentration of the medicine in the blood to decrease by half.


Q: How is Keradol eliminated from the body?

A: The medicine is primarily eliminated from the body renally, meaning it is processed and removed via the kidneys. Most of the administered dose is recovered in the urine, partly as the unchanged drug and partly as its metabolic breakdown products.


Q: Does Keradol cause any significant weight changes?

A: The official safety profile includes edema (fluid retention or swelling) as a common adverse reaction. Unusual weight gain is also reported in the safety information.

How should Keradol be stored and disposed of?

Storage and Disposal of Keradol (Ketorolac Tromethamine)

Keradol must be stored at controlled room temperature, typically 20 C to 25 C (68 F to 77 F). The medication must be protected from light, excess heat, and moisture. The container must be kept tightly closed, and the injection solution must not be frozen. It is mandatory to keep this medicine out of the sight and reach of children at all times.

Specific in-use periods apply: for instance, unused contents of single-use injection vials must be discarded immediately, and the ophthalmic solution must be discarded within 4 weeks of opening. Disposal of expired or unused product should be handled through medicine take-back programs or by following secure household trash procedures (mixing with an unappealing substance and sealing). The product must not be disposed of via wastewater (sinks or toilets).

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

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