Ketoprofen Mylan

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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 Ketoprofen Mylan

Quick Facts

Property Description
Active Ingredient Ketoprofen (INN)
Pharmacological Class Non-Steroidal Anti-Inflammatory Drug (NSAID)
Common Forms Immediate-release and Extended-release capsules
Origin Synthetic (Propionic acid derivative)

Ketoprofen Mylan is a medicine containing the active ingredient ketoprofen, and it belongs to the major class of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). It is primarily used to relieve pain and reduce inflammation. As a widely recognized generic product from Mylan, its identity is based on the established chemical properties of the INN (International Nonproprietary Name), ketoprofen.


1. What Type of Medicine is Ketoprofen Mylan?

Ketoprofen Mylan is an NSAID clinically recognized for its potent anti-inflammatory and analgesic properties. It belongs to the propionic acid derivative class of NSAIDs, sharing its core function with other medicines like ibuprofen, but with its own distinct profile.

Its general purpose is to provide dual action relief for symptoms arising from inflammatory conditions by managing both the pain and the underlying swelling. Pharmacological studies support that ketoprofen is effective at inhibiting the synthesis of prostaglandins, the chemical messengers that trigger pain and inflammation. This confirms the medication acts strongly at the source of inflammation to suppress symptoms.


2. Ketoprofen Mylan's Composition and Form

The core of Ketoprofen Mylan is the active ingredient ketoprofen, a standardized synthetic compound. This synthetic origin ensures reliable purity and measurable strength in every dose. A key feature of this generic formulation is its availability in specialized forms, including extended-release (ER) capsules.

Unlike immediate-release versions, the extended-release capsules are designed to resist dissolution in the stomach and release the drug at a controlled rate in the small intestine. This controlled delivery aims to prolong the duration of the medication's effect. The final product also includes inactive ingredients (excipients) necessary for stability and proper drug delivery.

Regulatory References

  1. Ketoprofen - LiverTox - NCBI Bookshelf - NIH
  2. KETOPROFEN capsule, extended release Label - DailyMed - NIH

What side effects are possible with Ketoprofen Mylan?

Possible Side Effects and Safety Information

This section outlines the officially documented safety profile of Ketoprofen Mylan, including adverse reactions and regulatory constraints, as defined in authoritative governmental sources (such as FDA and European regulatory labels).

Ketoprofen Mylan is associated with serious regulatory warnings related to two major organ systems:

  • Serious Cardiovascular Thrombotic Events: The drug may increase the risk of serious, potentially fatal, cardiovascular events, including myocardial infarction (MI) and stroke. This risk may increase with the duration of use.
  • Serious Gastrointestinal Events: The medicine increases the risk of serious (sometimes fatal) gastrointestinal bleeding, ulceration, and perforation of the stomach or intestines. These events can occur without warning symptoms.

Frequency-Classified Adverse Reactions

Side effects are categorized by their documented rate of occurrence:

Classification Examples of Reactions
Common (1%–10%) Nausea, dyspepsia, abdominal pain, diarrhea, constipation, headache, dizziness.
Uncommon (0.1%–1%) Fatigue, peripheral edema.
Rare (< 0.1%) Clinically apparent liver injury, paresthesia.

Safety Restrictions and Contraindications

Specific safety restrictions officially define when the medicine must not be used:

  • Coronary Artery Bypass Graft (CABG) Surgery: The drug is contraindicated for the treatment of pain right before or after CABG surgery.
  • Pregnancy: It is contraindicated during the third trimester of pregnancy due to the risk of harm to the fetus.
  • Older Adults: This population is at greater risk for serious GI and cardiovascular events, necessitating particular caution and use of the lowest effective dose.
  • Severe Skin Reactions: Serious skin conditions, including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), have been documented.

Overdose and Emergency Response

Overdose and when to seek help

Overdose with ketoprofen, the active ingredient in Ketoprofen Mylan, is officially documented as potentially presenting with a range of clinical and systemic manifestations. Documented presentations include gastrointestinal effects such as nausea, vomiting, and epigastric pain, alongside central nervous system symptoms like headache, dizziness, and lethargy. More severe signs may involve the central nervous system, resulting in seizures, profound drowsiness, confusion, or coma in large ingestions, sometimes accompanied by respiratory depression.

The official regulatory profile classifies the risk of severe, life-threatening outcomes, including major gastrointestinal bleeding and perforation, and serious organ toxicity such as acute kidney failure and systemic effects like hypotension. Elderly patients and individuals with pre-existing renal impairment are officially noted to be at a heightened risk for these severe consequences following overdose exposure.

Immediate medical attention must be sought for any suspected overdose. Regulator-mandated action requires contacting emergency services or a Poison Control Center immediately upon accidental or intentional ingestion. Treatment is strictly symptomatic and supportive, as regulatory documents explicitly state that no specific antidote is known. Management procedures described in official labeling may include gastric emptying and the administration of activated charcoal, with mandatory monitoring of renal and cardiac function required in a clinical setting.

Therapeutic Uses of Ketoprofen Mylan

What Ketoprofen Mylan Treats: Main Uses and Benefits

Ketoprofen Mylan is commonly used to provide symptomatic relief in clinical settings that involve acute or unstable symptom patterns where pain and inflammation are the dominant, disruptive symptoms. It is relevant across multiple therapeutic domains, including rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, and primary dysmenorrhea (menstrual cramps).

It is applied across domains where additional symptomatic support is needed to ease the overall symptom burden. The medication is used for managing symptoms related to physical discomfort and systemic imbalance, supporting patients during episodes of heightened discomfort.

“This medicine is commonly used in contexts where symptoms related to physical discomfort and underlying inflammation are creating noticeable physiological strain, and addresses symptoms related to both pain and inflammation.”

Managing Symptom Clusters

Ketoprofen Mylan is generally applied in conditions characterized by periods of heightened symptoms. It is used for managing symptom clusters that include joint pain, swelling, tenderness, and stiffness. It may assist with maintaining functional stability and contributes to easing the overall symptom load. It is also relevant when supportive symptom management is appropriate for acute episodes like soft tissue injuries or postoperative pain.

Quick Fact: Relief for Inflammatory Symptoms
Therapeutic focus: Provides supportive relief from pain and inflammation.
Relevant contexts: Chronic inflammatory joint diseases and acute musculoskeletal discomfort.
Key benefit: Helps maintain a sense of stability when symptoms are more noticeable.

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Ketoprofen Mylan, containing the active ingredient ketoprofen, is subject to specific population eligibility rules defined by regulatory bodies. Eligibility is strictly limited to adults for authorized indications, while several patient groups are formally prohibited from use.

Eligibility Structure

Category Regulatory Status Status Details
Pediatric Patients (typically < 18 years) Use Not Established Safety and efficacy have not been formally established in this population (Health Canada, Mayo Clinic).
Severe Organ Impairment Contraindicated Prohibited in cases of severe renal impairment, severe hepatic impairment, or severe uncontrolled heart failure (Health Canada).
Hypersensitivity Contraindicated Must not be used in patients with known allergies to ketoprofen or any history of asthma, hives, or allergic reactions following aspirin or other NSAIDs (FDA).
Late Pregnancy Contraindicated Use is prohibited from 30 weeks gestation (third trimester) onward due to risk of fetal cardiovascular harm (FDA).
CABG Surgery Contraindicated Prohibited for the treatment of peri-operative pain in the setting of Coronary Artery Bypass Graft surgery (FDA).

Eligibility-Related Restrictions

Use is highly restricted and requires close monitoring in other populations, including older adults (due to increased risks of organ issues) and patients with existing gastrointestinal ulceration, hypertension, or established cardiovascular disease (FDA). Individuals in the first or second trimester of pregnancy and those who are breastfeeding are generally advised against use unless the potential benefit is determined to outweigh the potential risks.

What should I know about interactions with other medicines?

Ketoprofen Mylan’s interaction profile is officially structured around pharmacokinetic and pharmacodynamic constraints documented in regulatory labeling. The medicine is contraindicated for use in the setting of perioperative pain related to Coronary Artery Bypass Graft (CABG) surgery, and it should be avoided by patients with a history of hypersensitivity to other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or Aspirin.

A major pharmacodynamic constraint involves the additive risk of hemorrhage and ulceration. This risk is clinically significant when co-administering with Anticoagulants, SSRIs, Oral Corticosteroids, or anti-platelet agents. Concomitant use with Diuretics or ACE Inhibitors/ARBs is documented to reduce the efficacy of these agents and increase the formal risk of renal impairment.

Pharmacokinetic interactions include the inhibition of clearance for specific agents: Ketoprofen may lead to elevated plasma concentrations of Lithium and Methotrexate due to reduced renal clearance, and co-administration with Probenecid is not recommended as it significantly increases ketoprofen exposure. The drug’s absorption is officially affected by food, which delays and reduces the peak plasma concentration (Cmax), although total exposure (AUC) is unchanged. Alcohol co-administration increases the documented risk for serious gastrointestinal adverse events. Furthermore, elderly or debilitated patients are noted in regulatory information to be at greater susceptibility for severe adverse interaction outcomes.

Mechanism of Action

Ketoprofen's action is defined by a multi-pronged inhibition of the body's inflammatory signaling pathways, resulting in altered eicosanoid and mediator levels.


Core Mechanism: Inhibiting Prostaglandin Synthesis

The primary action involves the non-selective, reversible inhibition of the Cyclooxygenase enzymes ( COX-1 and COX-2). By blocking these enzymes, Ketoprofen interrupts the arachidonic acid cascade, which is necessary for generating prostaglandins. This molecular suppression limits the chemical mediators that fuel local tissue irritation and swelling, modulating peripheral nociception and vascular permeability.


Secondary Mechanism: Dual Pathway Modulation

Ketoprofen engages mechanisms beyond the primary COX route by also modulating the Lipoxygenase (LOX) pathway and interfering with bradykinin signaling. This broader mechanistic scope means the drug targets inflammatory mediators from two distinct enzyme cascades ( COX and LOX) and directly interferes with the action of a key pain mediator (bradykinin). This complementary modulation alters the signaling profile within peripheral pathways.


Central Action: Thermoregulatory Control

The mechanism extends to the hypothalamus (the brain's temperature control center), where it acts to reduce the synthesis of PGE2 that elevates the body's temperature set point. By modifying this key molecular step centrally, the drug modulates the body's core temperature set point. This central inhibitory activity influences the hypothalamic thermoregulatory response.

Dosage and Administration Information

How to Use Ketoprofen Mylan

This section outlines the administration and dosing instructions for ketoprofen (e.g., as Ketoprofen Mylan) as specified in official product information.

Ketoprofen Mylan is available for Oral and Topical/Cutaneous administration. The use protocol must strictly adhere to the dose and schedule determined by a healthcare provider, utilizing the lowest effective dose for the shortest possible duration.

Official Dosing and Administration Rules

Administration Component Regulatory Instructions
Route of Administration Oral (Immediate-Release and Extended-Release Capsules/Tablets) and Topical (Gel).
Standard Oral Dosing Immediate-Release forms are typically taken 50 mg to 75 mg per dose, multiple times per day. Extended-Release forms are typically taken 200 mg once daily.
Timing in Relation to Meals Oral forms should be taken with food, milk, or an antacid to reduce the risk of gastrointestinal irritation.
Special Handling Extended-Release capsules must be swallowed whole; they should not be crushed, chewed, or divided.

Population-Specific Adjustments

Elderly Patients and those with renal or hepatic impairment require dose modification. The standard guidance is to initiate treatment at the lowest authorized dose and monitor closely. The use of oral ketoprofen in pediatric patients is not generally authorized or recommended due to insufficient data on safety and efficacy.

If a dose is missed, it should be taken as soon as remembered. However, if it is near the time of the next scheduled dose, the missed dose should be skipped, and the regular schedule resumed. Do not take a double dose to make up for a missed one.

Recent Clinical Evidence

Research evidence / Overview of studies for Ketoprofen Mylan

Evidence for use in Chronic Pain

Ketoprofen Mylan was studied for use in research exploring how symptoms change over time for conditions characterized by fluctuating or episodic manifestations such as chronic non-cancer pain. Research examined adult populations, primarily through short-term randomized controlled trials (RCTs) and some observational studies. The studies monitored patient-reported outcomes describing physical discomfort, as well as outcomes reflecting daily functioning or activity level.

Research reported measurements of participants' self-reported pain intensity scores during the study period. Findings describe patterns observed in the studies where measurements described patterns across the study arms over the short observation periods. The evidence derived from settings with varying symptom burdens contributes to the broader evidence landscape regarding short-term symptom patterns.

Evidence for use in Inflammation

Research examined the studied agent in pre-clinical laboratory models and a small number of exploratory human trials applied in research contexts involving fluctuating or unstable symptoms linked to inflammatory or irritative states. Research focused on measuring surrogate markers of inflammation, which are blood or tissue substance levels, as outcomes related to systemic imbalance. This was used in studies examining symptom intensity or variability rather than clinical disease progression.

Studies report how specific inflammatory markers evolved in the observed populations following the intervention. Research highlights changes measured during the study period, where certain surrogate markers, such as specific cytokines or blood proteins, was observed in some studies to change in some participants. The connection between these laboratory measurements and patient-reported outcomes describing perceived discomfort is not established.

What is still uncertain about Ketoprofen Mylan

The existing research has certain limitations. The evidence quality varies across studies, and findings were mixed in some areas, meaning the data show patterns related to different observed outcomes depending on the specific study design. There is limited information for long-term outcomes and safety profiles. Comparative evidence is lacking to fully understand the context of the reported short-term changes, and sample sizes were modest in many trials. Overall, research provides context but not individual predictions, and findings describe group patterns, not personal outcomes.

Key Studies & References

  1. Clinical Guideline for the Management of Chronic Pain (Relevant NSAID Section)

Frequently Asked Questions (FAQ)

Common questions about Ketoprofen Mylan (FAQ)

Q: Is Ketoprofen Mylan the same type of medicine as ibuprofen?

A: Official drug classifications indicate that ketoprofen belongs to the propionic acid derivative group of Nonsteroidal Anti-inflammatory Drugs (NSAIDs).

This class includes other well-known medicines like ibuprofen and naproxen, meaning they share a similar overall chemical structure and mechanism of action.

Q: What are the main things Ketoprofen Mylan is used for?

A: Official uses for prescription-strength ketoprofen are for managing the signs and symptoms associated with chronic conditions, such as osteoarthritis and rheumatoid arthritis.

Over-the-counter versions may be authorized for the temporary relief of minor aches, pains, and fever.

Q: Does Ketoprofen Mylan cause drowsiness or make you sleepy?

A: Yes, official product information lists drowsiness (somnolence) and sleepiness among the possible central nervous system side effects.

Due to potential central nervous system side effects, official warnings advise caution when operating machinery or driving until the effects of the medication are known.

Q: How quickly does Ketoprofen Mylan start to relieve pain?

A: For chronic conditions, it may take up to two weeks to experience the full benefit, according to official information.

For acute pain, this type of medicine is generally described in information resources as being most helpful when used at the onset of pain.

Q: Is it possible for Ketoprofen Mylan to cause stomach problems?

A: Yes, common side effects that are reported in official documents involve the gastrointestinal system.

These include indigestion (dyspepsia), general stomach pain, nausea, and diarrhea.

Q: Can Ketoprofen Mylan affect blood pressure?

A: Drug information resources note that this type of medication may affect blood pressure by causing an increase.

This is a known class effect that is described in the official safety information.

Q: What is the difference between Ketoprofen and Ketoprofen Mylan?

A: Ketoprofen is the name of the active drug ingredient itself, which performs the anti-inflammatory action.

'Mylan' denotes the specific pharmaceutical company that manufactures and markets that particular generic version of the drug.

Q: Can I take Ketoprofen Mylan if I have asthma?

A: Official labeling states that the medication is generally restricted for use by patients who have a history of aspirin-sensitive asthma or other aspirin sensitivities.

This is an important regulatory warning related to potential severe reactions.

Q: How long does the effect of Ketoprofen Mylan last?

A: The duration of effect can be inferred from the typical dosing instructions provided in the official product information.

For the immediate-release oral form, the dosing schedule is typically set for administration every four to six hours.

Q: Can Ketoprofen Mylan be used for period pain?

A: Yes, official regulatory indications include the temporary relief of minor aches and pains, including those due to menstrual cramps (dysmenorrhea).

This is a common authorized use described in product labeling.

Q: What types of pain is Ketoprofen Mylan typically prescribed for?

A: Prescription-strength ketoprofen is officially authorized for the management of pain and symptoms associated with chronic inflammatory conditions.

These specifically include osteoarthritis and rheumatoid arthritis.

Q: Why is Ketoprofen Mylan sometimes prescribed over other NSAIDs?

A: Official documents describe the mechanism of action as having a broader scope than simple pain relief.

This dual-action mechanism involves non-selective COX inhibition alongside additional modulation of the LOX pathway and anti-bradykinin activity.

Q: Is Ketoprofen Mylan addictive in any way?

A: Ketoprofen is officially classified as a Nonsteroidal Anti-inflammatory Drug (NSAID).

It is not designated as a controlled or habit-forming substance by regulatory bodies in the way that some other pain medications are.

Q: Does taking Ketoprofen Mylan affect liver function tests?

A: Studies have examined the effect of the medication on liver enzymes.

Research indicates that a small percentage of patients (1-2%) may experience transient (temporary) elevations in their serum aminotransferase levels while undergoing therapy.

Q: Is Ketoprofen Mylan available over the counter in some countries?

A: Regulatory summaries confirm that ketoprofen has been available without a prescription internationally for over a decade.

Available doses in other countries are generally lower than prescription strengths.

Q: Can Ketoprofen Mylan cause changes in mood or anxiety?

A: The label lists central nervous system (CNS) effects as possible adverse reactions.

These can include nervousness, insomnia (trouble sleeping), and in rare instances, depression.

Q: Is it normal to feel slightly dizzy after taking Ketoprofen Mylan?

A: Yes, dizziness is a possible side effect that is listed on the official product information for the drug.

Feeling slightly dizzy or somnolent (sleepy) after taking the medication is a known reaction.

Q: What are the most common reported side effects of Ketoprofen Mylan?

A: The most frequently reported side effects are primarily gastrointestinal in nature.

These include indigestion (dyspepsia), stomach pain, and nausea.

Q: Is Ketoprofen Mylan known to cause headaches?

A: Yes, headache is listed among the possible side effects of the medication in official safety documents.

Q: What are the signs of an allergic reaction to Ketoprofen Mylan?

A: Signs of a serious allergic reaction, as described in drug information resources, may include fever, rash, or persistent itching.

More severe signs described in drug information resources include swelling of the face, tongue, or throat, severe dizziness, or trouble breathing.

Q: Is Ketoprofen Mylan suitable for managing pain from arthritis?

A: Yes, prescription-strength ketoprofen is specifically authorized for the management of the signs and symptoms of both osteoarthritis and rheumatoid arthritis.

This is one of the primary official indications for the drug.

Q: Why does the packaging for Ketoprofen Mylan include a warning about driving?

A: Regulatory warnings regarding operating machinery, such as driving, are typically included due to potential side effects that may impair attention or motor skills.

These warnings are related to listed side effects like dizziness and drowsiness (somnolence).

Q: Can Ketoprofen Mylan cause sensitivity to light?

A: Yes, photosensitivity is listed as a potential skin-related side effect on the regulatory label.

This means the skin may become more sensitive to sunlight, sometimes resulting in photoallergic dermatitis.

Q: Does Ketoprofen Mylan contain any gluten or common allergens?

A: The official regulatory label provides a complete listing of all inactive ingredients used in the formulation.

These may include components such as gelatin, corn starch, sucrose, and various color additives.

Q: What does official guidance say about using Ketoprofen Mylan during pregnancy?

A: Regulatory guidance indicates restrictions on the use of NSAIDs at 20 weeks gestation or later due to the documented risk of fetal kidney and heart problems.

Use is generally contraindicated after 30 weeks of pregnancy.

Q: Is Ketoprofen Mylan a steroid medication?

A: No, ketoprofen is officially classified as a Nonsteroidal Anti-inflammatory Drug, or NSAID.

This classification confirms that it does not belong to the group of medicines known as steroids.

Q: Are there any studies looking at Ketoprofen Mylan for muscle spasms?

A: Official indications for the temporary relief of minor aches and pains include those due to muscular aches.

Relief of mild-to-moderate muscle pain is an authorized use described in regulatory documents.

Q: What is the risk of swelling (edema) with Ketoprofen Mylan?

A: Edema (swelling) is a possible side effect that is listed on the official product information.

Specifically, peripheral edema (swelling of the limbs) is mentioned among the adverse reactions.

Q: Can Ketoprofen Mylan affect fertility?

A: Official warnings include a statement that the drug's use is to be discussed with a healthcare provider if a woman is attempting to conceive.

Regulatory documents mention that this type of medicine may potentially impair female fertility.

How should Ketoprofen Mylan be stored and disposed of?

How to Store and Dispose of Ketoprofen Mylan?

Ketoprofen Mylan must be stored strictly according to regulatory standards to maintain product integrity and safety.

Storage Requirements

Condition Requirement
Temperature Store at Controlled Room Temperature, 20 to 25 C (68 to 77 F).
Protection Keep the container tightly closed and protect the product from freezing.
Safety Keep the medicine out of the reach and sight of children.

Disposal Instructions

Unused or expired Ketoprofen Mylan should be handled according to official guidelines. Patients are instructed to use a community drug take-back program when available. If a take-back program is not accessible, the product may be disposed of in household trash only after being mixed with an undesirable substance, such as coffee grounds, and placed in a sealed container. The medicine must not be flushed down the toilet or poured down the sink unless explicitly directed by the product labeling.

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

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