Artofen

Ketoprofen

Method of action: Analgesic, Analgetic, Anti-Inflammatory, Antipyretic, Nonsteroidal Anti-Inflammatory, Pain Reliever, Reducing Aggregation Of Platelets, Topical Products For Joint And Muscular Pain

Treatment option: Ankylosing Spondylitis, Arthritis,Osteoarthritis, Pain, Pain, Back, Joint Pain, Bursitis, Gingivitis, Headache, Colic, Laryngitis

Medically reviewed

Laura Arias

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 Artofen

Property	Description
Active Ingredient	Ketoprofen
Pharmacological Class	Non-steroidal Anti-inflammatory Drug (NSAID)
Chemical Derivative	Propionic acid derivative
Origin	Synthetic
General Purpose	Symptomatic relief of pain, inflammation, and fever

What Type of Medicine is Artofen and What is its Composition?

Artofen is a brand name for a medicinal product containing the active substance Ketoprofen, which is broadly and consistently classified as a Non-steroidal Anti-inflammatory Drug (NSAID), belonging to the group of anti-rheumatic agents. Ketoprofen is a synthetic compound derived from propionic acid, a characteristic shared with other established NSAIDs.

Artofen is typically manufactured as a single-ingredient product, available by prescription (Rx) in many markets. This substance is manufactured into multiple high-level dosage forms, including capsules for oral systemic administration and gels for topical application. This formulation spectrum is clinically recognized for addressing both acute and chronic symptomatic needs via the appropriate route of administration.

How Does Ketoprofen Function to Provide Symptomatic Relief?

The core general purpose of Artofen is to provide effective symptomatic treatment by modulating the body's response to inflammation and pain. Ketoprofen achieves this by primarily functioning as a potent cyclooxygenase inhibitor, thereby reducing the biosynthesis of prostaglandins. This pharmacological mechanism functions to manage inflammatory processes.

By reducing these key pain and inflammation mediators, the drug delivers a reliable combination of effects: it is analgesic (pain-relieving), anti-inflammatory (reducing swelling), and antipyretic (fever-reducing). Ketoprofen is a recognized agent for reducing inflammation and pain by blocking chemical signals. A typical use scenario involves mitigating the pain and swelling associated with musculoskeletal injuries, where the medicine acts directly to ease discomfort and improve function.

Regulatory References

What side effects are possible with Artofen?

Possible Side Effects and Safety Information

The safety profile of Artofen (Ketoprofen) is formally classified by regulatory authorities based on the nature and frequency of possible adverse reactions and is defined by the risks inherent to its class as a Non-steroidal Anti-inflammatory Drug (NSAID).

Official Adverse Reaction Classification

Adverse reactions are formally grouped by the system-organ class affected, ranging from common, less severe effects to rare, serious adverse events. Common reactions, occurring in 1% to 10% of patients, typically involve the gastrointestinal system (e.g., dyspepsia, nausea, abdominal pain) and the nervous system (e.g., headache, dizziness, somnolence).

Serious Adverse Reactions and Safety Patterns

The most serious documented safety concerns include the risk of Cardiovascular Thrombotic Events (such as myocardial infarction and stroke) and Serious Gastrointestinal Adverse Events (including bleeding, ulceration, and perforation). Regulatory information notes that the risk of thrombotic events may occur early and increase with the duration of use. Serious gastrointestinal events can occur at any time without warning symptoms.

Population-Specific Considerations

The official labeling includes specific safety considerations for certain groups. Older adults are identified as having a greater risk for serious gastrointestinal and cardiovascular events. Patients with pre-existing renal or hepatic impairment may experience altered clearance and require careful regulatory consideration.

Safety-Related Restrictions

Artofen is strictly restricted from use following Coronary Artery Bypass Graft (CABG) surgery and is contraindicated in individuals who have experienced allergic-type reactions (such as asthma or hives) to aspirin or other NSAIDs.

Overdose and Emergency Response

Overdose Map: Overdose and when to seek help — official regulatory information for Artofen

Overdose Scope

Documented overdose presentations: Ketoprofen overdose is officially associated with common gastrointestinal symptoms, including nausea, vomiting (potentially with blood), and abdominal pain. Central nervous system (CNS) manifestations documented include drowsiness, dizziness, lack of energy, and confusion.

Physiological systems affected (as stated in label): The regulatory profile notes severe systemic effects on the gastrointestinal system (e.g., bleeding), Central Nervous System (e.g., coma, seizures), and Renal system (e.g., acute renal failure).

Dose-related or exposure-related factors (if applicable): Gastric decontamination procedures may be indicated following the ingestion of a large overdose.

Population-specific overdose notes (if applicable): A large overdose can cause serious damage to children and adults. Regulatory information notes that elderly patients face a greater risk of severe gastrointestinal bleeding complications.

Emergency-response statements (as written in official documents): Management is based on providing symptomatic and supportive care, as no specific antidote is known for acute NSAID toxicity.

When immediate medical help is required (label-derived phrasing only): Seek immediate medical attention right away for any suspected overdose; this requires contacting emergency services or the poison control helpline.

Overdose classifications (high-level)

Severity classification (as defined in official documents): Overdose can range from common symptomatic presentation to life-threatening events, including seizures, coma, and severe internal bleeding.

Regulatory basis (EMA / FDA / etc.): FDA Prescribing Information and NIH MedlinePlus Drug Information.

Overdose-context constraints (as defined in official documents): Hospital monitoring may involve procedures like ECG, blood/urine tests, and possibly specialized interventions like dialysis if severe kidney damage occurs.

Resulting overdose structure

Official overdose statements:

Severe outcomes include decreased level of consciousness (coma), seizures, and acute renal failure.
Management requires immediate medical help and consists primarily of symptomatic and supportive care.
Monitoring may require checking vital signs, blood/urine tests, ECG, and considering gastric decontamination.

Connection to the overall overdose profile (2–4 sentences): The official regulatory profile emphasizes that due to the potential for life-threatening events and the absence of a specific antidote, prompt professional medical help is mandatory. This immediate action supports the initiation of intensive monitoring and supportive measures to address severe outcomes such as CNS depression or kidney failure.

Therapeutic Uses of Artofen

What Artofen Treats: Main Uses and Benefits

Artofen (Ketoprofen) is an anti-inflammatory and pain-relieving medication used to provide supportive symptomatic relief across key therapeutic domains, aiming to ease symptoms of pain, stiffness, and localized swelling. Prescription ketoprofen is utilized to relieve pain, tenderness, swelling, and stiffness caused by various forms of arthritis.

Symptom Domains and Conditions

The medication is commonly used in conditions characterized by periods of heightened symptoms, including Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis, acute gouty arthritis, tendinitis, bursitis, sprains, strains, and primary dysmenorrhea. This broad applicability assists with managing symptoms related to physical discomfort and inflammatory or irritative states. Applied during phases when symptoms become more noticeable, Artofen supports patients during difficult episodes by easing distress and contributes to improved day-to-day comfort.

“The general use is aligned with clinical settings that involve acute or unstable symptom patterns, applied in scenarios where additional management of discomfort is required.”

Quick Fact: Relief for Joint Pain

Quick Fact: Relief for Joint Pain and Stiffness in Chronic Arthritis

Key Therapeutic Benefit

This supportive relief is relevant when symptoms interfere with daily functioning. This use assists with maintaining functional stability and may help patients cope more steadily with symptom fluctuations in chronic conditions. It also is relevant for easing systemic symptoms, including fever that may accompany inflammatory illness.

Regulatory References

NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Who Can and Cannot Use Artofen?

Artofen (Ketoprofen) eligibility is strictly defined by regulatory documentation based on patient history, age, and existing health conditions. The medicine is contraindicated and must not be used by several key populations:

Individuals with a known hypersensitivity to Ketoprofen, aspirin (ASA), or other Non-steroidal Anti-inflammatory Drugs (NSAIDs).
Patients with active peptic ulcers, gastrointestinal bleeding, or severe cardiac, hepatic, or renal disease.
Those in the third trimester of pregnancy.
Patients undergoing treatment for peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

Use is not established for children younger than 12 years of age. Special precautions are required for older adults due to a documented increased risk of serious effects.

Artofen is not recommended for nursing mothers, and its use in the first and second trimesters of pregnancy is generally advised only if clearly necessary.

Patients with pre-existing conditions like controlled heart failure, established cardiovascular disease, or non-severe impaired renal or hepatic function must use the medicine only after careful consideration, as specified in official labeling.

What should I know about interactions with other medicines?

Artofen Interactions with other medicines and products

Official regulatory information for Artofen (Ketoprofen) documents several types of interactions with other substances, classifying them based on the potential for altered drug exposure or enhanced pharmacodynamic risk.

Interaction-Related Restrictions

Artofen is contraindicated for treating perioperative pain in the setting of Coronary Artery Bypass Graft (CABG) surgery. Co-administration with other Non-steroidal Anti-inflammatory Drugs (NSAIDs), including high-dose salicylates, is officially documented as prohibited or strongly advised against due to the significantly increased risk of gastrointestinal haemorrhage and ulceration.

Consumption of Alcohol (Ethanol) and Tobacco/Smoking is advised to be avoided as they officially enhance the risk of gastrointestinal bleeding.

Interactions Affecting Drug Exposure

Artofen may cause an elevation of plasma levels of certain co-administered medicines, including Lithium and Methotrexate, by reducing their renal clearance. For Methotrexate, the regulatory documents mandate a timing rule: Artofen must not be administered less than 12 hours before or after a course of Methotrexate treatment.

Pharmacodynamic Risk and Specific Populations

Combination with Oral Anticoagulants (e.g., Warfarin), Parenteral Heparins, Antiplatelet Agents, and SSRIs is documented as increasing the risk of a haemorrhagic effect or bleeding. Separately, combining Artofen with Diuretics, ACE Inhibitors, or ARBs may result in a loss of their antihypertensive or diuretic effect and increases the risk of acute renal injury.

Regulatory documents note that the risk of acute renal injury associated with these combinations is officially heightened in susceptible populations, such as elderly patients and those with impaired renal function.

Mechanism of Action

Inhibition of Prostanoid Biosynthesis

The pharmacological action of Ketoprofen involves the non-selective, reversible inhibition of the Cyclooxygenase (COX-1 and COX-2) enzymes. By blocking these key enzymes, the drug prevents the conversion of arachidonic acid into various prostaglandins, which are lipid mediators responsible for mediating local tissue response and sensitizing nerve endings. This molecular action directly modulates the inflammatory cascade by reducing prostanoid formation.

Dual Modulation of Nociceptive and Temperature Signaling

The drug engages both peripheral and central mechanisms to influence physiological signaling. Peripherally, the reduction of prostaglandins directly lowers the sensitivity of nociceptors (pain receptors), reducing the transmission of nociceptive signaling. Centrally, the drug modifies prostaglandin activity in the hypothalamus, which facilitates the return of the elevated thermoregulatory set point to baseline, promoting systemic heat dissipation.

️ Mechanistic Trade-offs and Constraints

As a non-selective inhibitor, Ketoprofen's mechanism necessarily impacts both the inducible COX-2 enzyme, which drives inflammatory responses, and the constitutive COX-1 enzyme. This broad action means the mechanism also influences homeostatic functions regulated by COX-1, such as regulating gastrointestinal mucosal integrity. The overall mechanism is predominantly mediated by the drug's S(+)-enantiomer.

Dosage and Administration Information

Artofen, containing the active substance Ketoprofen, is administered via two primary official routes: orally, using immediate-release (IR) or extended-release (ER) capsules, or topically, utilizing a localized gel formulation. The choice of form and dose is defined by the intended use pattern, as specified in regulatory labeling.

Administration Scope and Official Dosing

The standard oral dosing schedule is defined by the formulation type. For long-term use in chronic conditions, an extended-release dose of 200 mg is typically taken once daily. For intermittent or acute needs, the immediate-release form is administered as a 25 mg to 50 mg dose every six to eight hours as needed. The regulatory ceiling for total oral administration is 300 mg per day.

Procedurally, the official instructions state that the oral forms may be taken with food, milk, or antacids to aid administration, and should be taken with a full glass of liquid. The general procedural principle mandates the use of the lowest effective dose for the shortest duration. Furthermore, the label advises that if an oral dose is missed, it should be skipped if it is close to the time for the next scheduled dose, and doses should not be doubled.

Population-Specific Use

Specific high-level dosing adjustments are officially designated for certain populations. These include the requirement for a lower initial dose in older adults due to altered clearance, and a restricted maximum daily dosage (e.g., not exceeding 100 mg) for patients with severe hepatic or renal impairment. The extended-release form is not indicated for managing acute pain episodes.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Artofen (Ketoprofen)

Evidence for Chronic Inflammatory and Rheumatic Conditions

Research involving Artofen (Ketoprofen) has examined conditions such as Rheumatoid Arthritis and Osteoarthritis, exploring how symptoms change over time. The core evidence comes from multiple short-term Randomized Controlled Trials (RCTs) and Systematic Reviews that included adults diagnosed with these conditions. In these studies, researchers monitored patient-reported outcomes describing perceived discomfort, focusing on the measurement of pain intensity, changes in joint swelling, and outcomes reflecting daily functioning or activity level.

Studies conducted during periods of increased symptom activity described measurements of pain and functional changes and reported the observed patterns in the populations during the short treatment period. Findings describe group patterns related to how symptoms are measured in trials that included active comparator arms.

Evidence for Acute Pain Management and Injuries

The research base for acute pain includes evidence describing how symptoms are measured following traumatic events like musculoskeletal sprains and strains, and after surgical procedures. Studies explored both the oral capsule and the topical gel formulations. For muscle and joint injuries, short-term RCTs typically included adults and compared the drug's effect to either a placebo or other common pain relievers. Studies monitored outcomes related to physical discomfort, such as the reduction of acute pain intensity and the observed amount of swelling over defined time intervals, usually lasting up to two weeks.

Studies reported observations where both the oral and topical formulations led to documented changes in pain intensity measurements during the short study period. Evidence derived from settings with varying symptom burdens provides insight into how patients reported their experience during episodes of heightened symptom activity.

What Remains Uncertain and Key Research Limitations

Regulatory reviews and scientific analyses describe that research is ongoing, but certain limitations are consistently noted across the evidence base. Research describing the specific influence of Ketoprofen on long-term disease progression or structural changes over many months or years is not broadly established in the core symptomatic RCTs.

Furthermore, the short-term nature of many core trials means there is limited information for long-term functional and safety outcomes. Studies confirm that this medicine is used for symptomatic relief, and the evidence does not support its use for reversing the functional limitations or disease progression associated with chronic inflammatory conditions.

Key Studies & References

Dose-Finding Studies of Ketoprofen in the Management of Fever in Children

Frequently Asked Questions (FAQ)

Common questions about Artofen (FAQ)

Q: Does Artofen affect the nervous system or cause drowsiness?

A: Regulatory information indicates that Artofen may, in some cases, cause effects related to the nervous system. These possible effects include dizziness or somnolence (drowsiness). Because of this potential, official sources advise caution when performing tasks that require full mental alertness, such as driving or operating machinery.

Q: Can I use Artofen if I have kidney issues?

A: Official product information advises caution regarding the use of Artofen in patients with certain kidney issues, such as mild to moderate renal impairment. For severe kidney impairment, regulatory sources generally advise against the use of Artofen. Regulatory sources advise that the prescribing physician should consider the patient's kidney function when assessing eligibility.

Q: Is it safe to drink alcohol while taking Artofen?

A: According to official documentation, the concurrent use of Artofen and alcohol is discouraged. This combination may increase the risk of certain side effects, particularly those affecting the gastrointestinal system and the central nervous system. For these reasons, official labeling generally recommends avoiding alcohol during treatment.

Q: Can Artofen be used by children?

A: Regulatory documents indicate that Artofen is approved for use in children aged 6 years and older. The precise use and required dosage are based on the child's weight and should be established by a healthcare professional. Artofen is generally not recommended for children under 6 years of age.

Q: Is there a maximum period of time Artofen should be taken for pain relief?

A: Studies and official information advise limiting the use of Artofen for pain relief to the shortest duration possible. While treatment for pain is typically short-term, prolonged use is associated with a greater risk of adverse effects. Regulatory information indicates that treatment duration should align with the recommendation of the prescribing physician.

Q: Is Artofen used for conditions other than general pain or fever?

A: Regulatory documents state that Artofen is also indicated for the management of rheumatoid arthritis, juvenile chronic arthritis, and osteoarthritis. This confirms that its uses extend beyond simple pain and fever, covering certain chronic inflammatory conditions as well. The dosage and duration of therapy are adjusted according to the specific condition for which the medication is prescribed.

Q: Should Artofen be taken with or without food?

A: Official regulatory sources recommend that Artofen should generally be taken with or immediately after food. Taking the medication alongside food helps to minimize the potential for irritation or discomfort in the stomach and digestive tract. This practice is noted in the official guidance to help minimize potential gastric issues.

Q: What should I do if I miss a dose of Artofen?

A: According to the official product information, if a dose of Artofen is missed, official product information states that double doses should not be taken to compensate for a missed dose. The recommendation is to resume the regular schedule at the time of the next intended dose. Maintaining a consistent schedule and avoiding over-dosing are essential practices documented in the safe use guidelines.

Q: Are there specific dietary restrictions while taking Artofen?

A: Regulatory documents do not mandate a long list of specific dietary restrictions while taking Artofen, other than the general advice to take it with food. However, official documents specifically mention avoiding or minimizing alcohol intake, as this is associated with a greater risk of side effects.

Q: Can Artofen cause stomach bleeding or ulcers?

A: Official information indicates that Artofen carries a risk of gastrointestinal side effects, which can include stomach irritation, ulcers, and, in rare but serious cases, bleeding or perforation. This risk is a known caution for this class of medicine, and it is why official sources advise taking the lowest effective dose for the shortest possible duration.

How should Artofen be stored and disposed of?

How to Store and Dispose of Artofen?

Artofen (Ketoprofen) must be stored according to official regulatory guidelines to maintain its stability and ensure safety. Storage conditions vary slightly by formulation, but all forms share core requirements for environmental protection and disposal.

Official Storage Requirements

Condition	Requirement
Temperature	Store at Controlled Room Temperature, typically 20 C to 25 C (68 F to 77 F). Topical gels are stored at or below 25 C or 30 C.
Handling	Keep from freezing and store away from excessive heat, moisture, and direct light.
Container	Keep in the original, tightly closed container with a child-resistant closure, and keep out of the reach of children.