Ketorolac FG

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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 Ketorolac FG

Property Description
Active ingredient Ketorolac tromethamine
Form Tablet, injectable solution, ophthalmic solution
Pharmacological class Non-Steroidal Anti-Inflammatory Drug (NSAID)
Common purpose Systemic analgesic and anti-inflammatory agent
Origin Synthetic compound

Defining Ketorolac FG: Substance and Source

Ketorolac FG is a specific pharmaceutical preparation containing the active ingredient, ketorolac tromethamine. This substance is a potent, synthetic compound that is chemically classified as a pyrrolizine carboxylic acid derivative. The preparation is categorized as a Non-Steroidal Anti-Inflammatory Drug (NSAID). Its composition, featuring the single active ingredient ketorolac, is consistent across various delivery systems, including the oral tablet, the injectable solution, and the topical ophthalmic solution, which allows for different routes of administration.


What Type of Medicine is Ketorolac FG and Why is it Classified That Way?

Ketorolac FG is officially classified as a powerful systemic analgesic and NSAID because its primary function is to serve as a prostaglandin synthesis inhibitor. This class of medication works to provide relief by blocking the chemical creation of substances responsible for pain and inflammation. Its analgesic efficacy is clinically recognized for treating moderate to severe pain across various medical settings, establishing a clear differentiation from lower-potency, over-the-counter NSAIDs. The drug’s classification and high potency are critical factors considered by regulatory bodies.


What is the General Purpose of Ketorolac FG?

The general purpose of Ketorolac FG is to deliver effective, non-narcotic relief by addressing both the sensation of pain (anti-nociception) and the body's inflammatory response. Ketorolac acts as a potent inhibitor of cyclooxygenase and is used in medical practice to manage acute pain. Consequently, the core utility of the drug is defined by its ability to resolve strong pain signals and associated symptoms like swelling and tissue tenderness without engaging the central nervous system pathways targeted by opioids, positioning it as a powerful short-term pain relief option.

Regulatory References

  1. Ketorolac Tromethamine injection, solution - DailyMed - NIH
  2. DailyMed - NIH
  3. Omidria (Ketorolac/Phenylephrine) - EMA

What side effects are possible with Ketorolac FG?

Possible Side Effects and Safety Information

Ketorolac FG carries official warnings about the potential for serious, life-threatening events, which govern its use and safety profile. The total combined use of this medicine, including oral and injectable forms, is strictly limited to a maximum of five days due to increased risks with longer exposure.

Major Safety Concerns (Boxed Warnings)

Official regulatory documents emphasize two primary severe risks:

  • Gastrointestinal (GI) Risk: A serious potential for GI bleeding, ulceration, and perforation of the stomach or intestines. These events can occur without prior warning symptoms and may be fatal.
  • Cardiovascular (CV) Thrombotic Risk: An increased risk of serious blood clot events, including heart attack (myocardial infarction) and stroke, which can also be fatal. This risk may increase with duration of use.

Common Adverse Reactions

The most frequently reported side effects (occurring in ge 1% to 10% of patients) include gastrointestinal symptoms such as abdominal pain, dyspepsia, nausea, and diarrhea. Other common reactions are dizziness, drowsiness, headaches, and swelling (edema).

Contraindications and Restrictions

The medicine is strictly contraindicated (should not be used) in several situations due to heightened risk:

  • For patients with advanced kidney (renal) impairment.
  • If there is active peptic ulcer disease or recent gastrointestinal bleeding.
  • For suspected or confirmed bleeding in the brain (cerebrovascular hemorrhage).
  • For pain management in the setting of Coronary Artery Bypass Graft (CABG) surgery.
  • In pregnant women from 30 weeks gestation onward.

Population-Specific Notes

Elderly patients (65 years and older) are at an officially recognized greater risk for developing serious GI and renal adverse events when using this medicine.

Overdose and Emergency Response

The regulatory documentation defines the Ketorolac FG overdose profile by classifying expected manifestations against rare, potentially fatal outcomes. Symptoms following acute overdosage of this NSAID are often limited and include lethargy, drowsiness, nausea, vomiting, and epigastric pain. Additional presentations may involve abdominal pain, hyperventilation, or signs of peptic ulcers and erosive gastritis. These initial manifestations are generally reversible with necessary supportive care.

When to Seek Urgent Medical Help

Immediate emergency help must be sought if any signs of a severe or life-threatening reaction occur. Rare, serious outcomes documented in the official labeling include gastrointestinal bleeding, acute renal failure, respiratory depression, and coma. Anaphylactoid reactions are also documented as a risk following overdose, explicitly requiring prompt medical intervention.

Management and Antidote Status

Overdose management is directed entirely by symptomatic and supportive care. No specific antidote is known for Ketorolac tromethamine. In cases of large oral overdose reported within four hours of ingestion, regulatory guidance states that procedural measures such as administering activated charcoal and/or an osmotic cathartic may be considered. Measures like forced diuresis or hemodialysis are documented as not generally useful.

Therapeutic Uses of Ketorolac FG

Ketorolac FG is generally considered relevant for the short-term management of acute pain and is applied across domains where additional symptomatic support is needed. Its primary therapeutic value is to help ease distressing symptoms and supports the management of symptoms related to inflammatory or irritative states. This medication is reserved for acute, high-intensity discomfort.


Potent Relief for Acute, High-Intensity Pain

The medication is commonly used across conditions presenting with acute episodes and helps address symptom clusters that may become intense or disruptive, such as pronounced physical discomfort or severe symptoms of increased neurological activity. It is applied in clinical settings that involve unstable symptom patterns, including postoperative pain, acute musculoskeletal trauma, and severe pain related to renal or biliary colic. It provides support that may assist with maintaining functional stability during these periods of heightened symptoms.


Managing Inflammation and Specialized Acute Scenarios

This therapeutic assistance is especially relevant in scenarios where the symptom load is high, such as pain following surgical procedures or symptoms linked to organ-specific functional stress. It generally contributes to easing the overall symptom load and may help patients cope more steadily with symptom fluctuations during the symptomatic phases.

Quick Fact: Relief for Heightened Symptoms Ketorolac FG is commonly used to manage acute pain in situations where symptoms create noticeable physiological strain, often in contexts where supportive symptom management is appropriate.

Regulatory References

  1. NIH MedlinePlus overview of Ketorolac

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Ketorolac FG

Eligibility Scope

Systemic Ketorolac FG is officially permitted for Adults and Adolescents (generally ge 16 years of age) for the short-term management of moderately severe acute pain. Use is not recommended for children under 16 years of age as safety and efficacy are not established for the systemic formulations. Older adults (ge 65 years) or patients weighing less than 50 kg are subject to a restricted maximum daily dose as a condition of use.


Absolute Contraindications (Non-Eligibility)

The medicine is contraindicated (must not be used) in several high-risk populations, primarily due to the risk of bleeding, GI toxicity, and renal compromise.

Non-Eligibility Domain Examples of Contraindication
GI & Bleeding Risk Active peptic ulcer disease; history of GI bleeding; high risk of bleeding; peri-operative pain in CABG setting.
Organ Function Advanced or severe renal impairment; severe hepatic or heart failure.
Special States Pregnancy (labor/delivery); lactation; known hypersensitivity to NSAIDs/aspirin; concomitant use with other NSAIDs or anticoagulants.

Regulatory Summary

Regulatory documents define the eligible population by establishing stringent, system-specific exclusions, primarily linked to the potential of this potent Non-Steroidal Anti-Inflammatory Drug (NSAID) to affect gastrointestinal integrity and renal function. These formal restrictions limit standard use to defined adult and adolescent populations under regulated conditions.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Formally Contraindicated Combinations

The regulatory profile for Ketorolac FG mandates several contraindicated combinations, which must be strictly avoided. Co-administration with other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including aspirin in analgesic doses, is prohibited due to the cumulative risk of gastrointestinal bleeding. Similarly, concurrent use with Probenecid is forbidden because it decreases ketorolac clearance, resulting in significantly increased plasma concentrations. The combination with Lithium salts is also contraindicated, as Ketorolac decreases lithium clearance, elevating plasma lithium levels and increasing the risk of toxicity. Finally, co-treatment with Anticoagulants (such as Warfarin) is prohibited due to a heightened pharmacodynamic risk of hemorrhage.


Clinically Significant Exposure and Functional Interactions

Several other medicines have documented interactions. Ketorolac may diminish the therapeutic effect of Diuretics and ACE Inhibitors/ARBs, and this combination can increase the risk of acute renal function deterioration, particularly in elderly or volume-depleted patients. Concomitant use with Methotrexate increases its toxicity by reducing its renal clearance. Furthermore, the injectable solution is physically incompatible with certain agents like Promethazine Hydrochloride and Hydroxyzine Hydrochloride, meaning they should not be mixed. The official label also imposes a mandatory restriction: the total combined duration of all Ketorolac formulations must not exceed 5 days.

Mechanism of Action

Ketorolac FG (ketorolac tromethamine) functions as a non-selective inhibitor within the body’s signaling pathways, primarily through the interruption of the synthesis of local chemical mediators. The mechanism of action is entirely distinct from central pathways that rely on mu-opioid receptor engagement.

Non-Selective Inhibition of Cyclooxygenase (COX) Enzymes

The mechanism centers on the active S-enantiomer of ketorolac, which competitively blocks the activity of two key enzymes, Cyclooxygenase-1 (COX-1) and Cyclooxygenase-2 (COX-2). By occupying the enzyme’s active site, the drug prevents the conversion of its substrate, arachidonic acid, thereby limiting an early step in the synthesis of downstream chemical mediators.

Cascade to Anti-Nociception and Anti-Inflammation

This molecular blockade results in a reduction in the body's local production of prostaglandins, particularly PGE2. Since these lipid mediators naturally enhance the sensitivity of pain receptors, their reduced concentration affects the sensitivity of nociceptive pathways. This physiological consequence involves both the reduction of prostaglandin-mediated sensitization (anti-nociception) and the attenuation of the local inflammatory process.

Dosage and Administration Information

Administration of Ketorolac tromethamine is strictly defined, specifying the allowable routes, dosing schedules, and duration constraints. The medicine is formally indicated for systemic delivery via intravenous (IV) or intramuscular (IM) injection, or through an oral tablet; it also exists in topical ophthalmic and topical nasal spray formulations.

Official Administration Guidelines

Systemic therapy is governed by a Sequential Use Requirement: treatment must be initiated using the parenteral route (IV or IM). The oral tablet is prescribed exclusively as continuation therapy following this initial injectable phase. The overall combined duration of use for all systemic formulations (IV, IM, and Oral) must not exceed five days.

Standard Systemic Dosing Patterns

Route/Phase Frequency & Dose Maximum Daily Dose
IV/IM Multiple-Dose 30 mg every six hours 120 mg
Oral Continuation 10 mg every four to six hours 40 mg

Population-Specific Adjustments are a mandatory procedural step. For patients who are 65 years and over or who have low body weight (less than 50 kg), the maximum daily parenteral dose is reduced to 60 mg. Patients with moderate renal impairment also require dose reduction. Procedurally, the IV bolus must be administered over no less than 15 seconds, and the injection solution must not be mixed with certain other solutions to prevent precipitation.

Connection to the Overall Use Protocol

The official instructions establish a rigid, short-term protocol where all systemic administration must be initiated parenterally before transitioning to a limited oral continuation phase. This protocol defines the maximum allowable duration of five days for combined use and enforces strict dosage reductions for vulnerable populations, standardizing the delivery method and frequency.

Recent Clinical Evidence

Ketorolac FG: Recent Clinical Evidence

Evidence for Use in Postoperative Pain Management

Research exploring the medicine was studied for acute pain following surgery primarily relies on short-term Randomized Controlled Trials (RCTs) and systematic reviews. These studies were used in research exploring how symptoms change over time and focused on patient-reported outcomes describing perceived discomfort and the monitoring of rescue analgesic use. Findings indicated patterns in which less rescue medication was monitored in patients receiving the medicine compared to those receiving other agents. A key limitation is the strict regulatory constraint, which limits research to a maximum total treatment duration of five days. Long-term effects and functional patterns after this period are not fully established.

Evidence for Use in Acute Pain in Emergency Settings

Research has also explored the medicine was evaluated in single-dose studies observing sudden, high-intensity pain episodes such as renal colic or musculoskeletal trauma. These trials monitored patient-reported outcomes describing perceived discomfort within a few hours of administration. Findings indicated that measured outcomes were comparable to those observed with other standard, non-opioid medications used in these settings. Follow-up durations were limited to the immediate post-dose period, and uncertainty remains low regarding comparative findings in all clinical scenarios.

Evidence in Special Populations and Research Limitations

The majority of evidence is based on the general adult population. Research has been conducted on pediatric patients (children aged 6 years and older) and older adults, but data for pediatric groups remain limited and sometimes inconsistent. Overall, the research landscape is constrained by the maximum five-day administration period, meaning limited information for long-term outcomes is available, and evidence quality varies across studies due to differences in design or modest sample sizes.

Frequently Asked Questions (FAQ)

Common questions about Ketorolac FG (FAQ)


Q: What is Ketorolac FG actually used for besides pain?

A: According to official documents, the medicine's general purpose is defined by both its pain-relieving (analgesic) action and its ability to manage inflammation. These two effects result from the medicine blocking the synthesis of certain chemical mediators in the body. It is primarily indicated for the short-term management of moderately severe acute pain.


Q: Is Ketorolac FG known to cause stomach problems?

A: Official warnings address the potential for serious gastrointestinal (GI) risks, including bleeding or ulcers. Regulatory text explains that, as a type of NSAID medicine, it affects the protective lining of the stomach by blocking the COX-1 enzyme, which is the mechanism linked to these safety concerns.


Q: Can Ketorolac FG affect the kidneys or liver?

A: Regulatory documents caution about the risk of severe renal (kidney) function deterioration, and the medicine is strictly contraindicated for individuals with advanced kidney impairment. Severe hepatic (liver) failure is also listed in official information as a condition that prevents its use. Regulatory documents emphasize the importance of monitoring organ function due to these risks.


Q: Does Ketorolac FG interact with blood pressure medicine?

A: Yes, official labels list functional interactions with several common blood pressure medicines, including ACE inhibitors, ARBs, and diuretics. These combinations may reduce the effectiveness of the blood pressure medicine. They can also increase the risk of declined kidney function, especially in certain patient groups.


Q: How quickly does Ketorolac FG start working for pain?

A: Studies and official product information indicate that pain relief typically begins within 30 to 60 minutes after the injection (parenteral) form is administered. The maximum pain-relieving effect is generally observed within one to two hours following application.


Q: How long does the effect of Ketorolac FG typically last?

A: Official pharmacokinetics data show that the analgesic (pain-relieving) effect of a single application usually lasts for a duration of four to six hours. The effect lasting this duration is the basis for the recommended interval between applications, as specified in regulatory information.


Q: Is Ketorolac FG safe for older adults or seniors?

A: Official labeling states that patients 65 years and older have an increased risk for serious side effects involving the stomach and kidneys. While use is permitted for this population, use in this population may be subject to a restricted maximum daily amount, as specified in official product labeling.


Q: Can women use Ketorolac FG during pregnancy or while breastfeeding?

A: The medicine is strictly contraindicated (must not be used) in pregnant women beginning at 30 weeks of gestation, and during labor or delivery. It is also contraindicated during lactation (breastfeeding) because studies confirm the presence of the medicine in human milk.


Q: Is Ketorolac FG suitable for children or teenagers?

A: According to official regulatory documents, the systemic forms of the medicine are generally not recommended for children under 16 years of age. This status reflects that safety and effectiveness for systemic treatment in this younger population are not yet established in regulatory materials.


Q: Is Ketorolac FG a high-risk medication?

A: Official regulatory documents list two Major Safety Concerns, also known as Boxed Warnings, highlighting serious potential risks. These include the potential for fatal gastrointestinal (GI) bleeding or perforation, and serious cardiovascular (CV) blood clot events like heart attack or stroke. These warnings govern the restrictive use conditions.


Q: Does Ketorolac FG cause drowsiness or affect alertness?

A: Official documents list common side effects that include dizziness and drowsiness. Official warnings state that these effects may temporarily impair functional ability, which is a factor to consider for tasks requiring alertness.


Q: Is it normal to feel dizzy or lightheaded after using Ketorolac FG?

A: Official documents list dizziness as a common adverse reaction reported by users of the medicine. The feeling of lightheadedness is a closely related effect that has been noted in association with dizziness.


Q: What is the risk of an allergic reaction to Ketorolac FG?

A: The medicine is strictly contraindicated (must not be used) if a person has a known hypersensitivity or allergic reaction to ketorolac, aspirin, or any other NSAID medicine. Hypersensitivity to NSAIDs is a stated contraindication to its use.


Q: What happens if I miss a scheduled use of Ketorolac FG?

A: Official patient information generally suggests using the medication as soon as it is remembered. If it is nearly time for the next scheduled application, the missed use is generally skipped, as outlined in official guidelines.


Q: Can Ketorolac FG interact with alcohol?

A: Official patient materials advise that consuming alcohol while using this medication may increase the risk of stomach irritation. This combination is noted to potentially raise the risk of gastrointestinal bleeding.


Q: Why do doctors often start with an injection of Ketorolac FG?

A: Official protocol requires the parenteral (injection) route for initiation before subsequent short-term continuation with the oral form. This procedure is based on studies showing that injection often provides a more rapid and potent pain-relieving effect, which is preferred for managing acute pain.


Q: What is the 'Black Box Warning' associated with Ketorolac FG?

A: The Boxed Warning is the formal term used by regulatory bodies to highlight the serious risks associated with the medicine. This warning specifically concerns the potential for fatal Gastrointestinal bleeding or ulcers and serious Cardiovascular blood clot events.


Q: Is Ketorolac FG known to cause fluid retention or swelling?

A: Yes, the official documents list both fluid retention and edema (swelling) as common adverse reactions associated with this medicine.


Q: Are there any known issues with taking Ketorolac FG before surgery?

A: Yes, the medicine is contraindicated before major surgeries where the ability to stop bleeding (hemostasis) is critical, due to its effects on platelet function. It is specifically prohibited for managing pain associated with Coronary Artery Bypass Graft (CABG) surgery.


Q: Is Ketorolac FG the same as the eye drops version (Acular)?

A: The medicine is officially available in a topical ophthalmic (eye drop) solution in addition to its systemic forms. Acular is a registered brand name for a version of the medicine that is applied as an ophthalmic solution.


Q: What types of allergic reactions are most common with Ketorolac FG?

A: Official labels list severe, potentially life-threatening reactions that have been reported, such as anaphylaxis and angioedema (swelling beneath the skin). Hypersensitivity to NSAIDs is also a strict contraindication to its use.


Q: Is Ketorolac FG known by any other brand names globally?

A: Yes, the active ingredient, ketorolac tromethamine, is globally marketed and recognized under various trade names. Toradol is one of the most widely known brand names for this medicine.


Q: Is Ketorolac FG a prescription-only medicine?

A: Yes, the systemic formulations (injection and tablet) are classified for use only under the supervision of a licensed practitioner. This means that these forms of the medicine legally require a prescription (Rx).


Q: Why do some people call Ketorolac FG 'Toradol'?

A: Toradol is a registered brand name under which the active ingredient, ketorolac tromethamine, is widely marketed and recognized internationally. People often use the most recognizable brand name when referring to the medicine.


Q: Can Ketorolac FG affect mood or cause confusion?

A: Official documents list less common side effects affecting the nervous system, which have included reports of confusion and abnormal thinking. Official documents also list more common nervous system effects, such as dizziness and drowsiness.

How should Ketorolac FG be stored and disposed of?

Official Storage and Disposal Requirements

The storage and disposal of Ketorolac FG (Ketorolac Tromethamine) must comply strictly with official regulatory labeling to ensure product stability and safety.

Storage Constraints

Condition Requirement
Temperature Store at Controlled Room Temperature (20 to 25 C / 68 to 77 F).
Protection Must be protected from light and stored away from excess moisture and excessive heat.
Packaging Injection vials should be kept in the original carton; tablets should be kept in a closed container.
Safety The medication must be kept out of the reach and sight of children and pets.

Stability and Disposal

The injectable solution should be visually inspected for any particulate matter before use, and the unused portion of single-dose vials must be discarded. Disposal of expired or unused medicine must be carried out according to local regulations. Official guidance recommends utilizing drug take-back programs or following approved procedures for household disposal.

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

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