Flamax

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Flamax

Quick Facts

Property Description
Active ingredient Ketoprofen (INN)
Pharmacological Class Nonsteroidal Anti-Inflammatory Drug (NSAID)
Common Uses Pain, inflammation, and fever relief
Origin Synthetic (Propionic Acid Derivative)
Available Forms Oral, Topical, and Parenteral preparations

1. What Kind of Medicine is Flamax and What Does It Contain?

Flamax is a pharmaceutical preparation whose primary active ingredient is Ketoprofen. This substance, which is a synthetic compound, belongs to the International Nonproprietary Name (INN) group of analgesic and anti-inflammatory agents. Ketoprofen is a widely studied compound belonging to the propionic acid derivative family. Flamax is a single-ingredient product, designed to focus its therapeutic action entirely on the established properties of Ketoprofen.

2. The Pharmacological Class and General Purpose

Flamax is officially classified as a Nonsteroidal Anti-Inflammatory Drug, or NSAID. This pharmacological classification means the medicine is defined by its ability to provide a combined analgesic (pain relief), anti-inflammatory (reduction of swelling), and antipyretic (fever-reducing) effect. Ketoprofen is clinically recognized for its potent anti-inflammatory properties. This means the drug helps ease discomfort often associated with musculoskeletal issues by actively reducing the underlying swelling and chemical signals of inflammation.

3. Flamax Availability and Identity

The medicine is generally made available in various high-level dosage forms, allowing for flexibility. These forms include oral preparations (like capsules or tablets), topical preparations (such as gels or creams), and parenteral preparations (injections). Flamax is commonly available across these diverse forms, allowing patients to choose between oral intake for systemic relief or topical (dermal application) for localized symptomatic relief.

What side effects are possible with Flamax?

Possible Side Effects and Safety Information

The official safety profile for Flamax (Ketoprofen) lists potential adverse effects categorized by the body system affected (System-Organ Class or SOC) and their documented frequency.


Documented Adverse Reactions and Frequencies

Adverse effects commonly reported in regulatory documents include Gastrointestinal Disorders such as nausea, vomiting, indigestion, and headache. Effects classified as Uncommon include dizziness, drowsiness, diarrhea, and local skin reactions (for topical formulations). Rare events include serious conditions such as peptic ulceration and photosensitivity reactions. The frequency for certain severe reactions, such as anaphylactic shock, may be classified as Not Known.


Serious Adverse Reactions

Government regulatory agencies mandate prominent warnings concerning rare but serious events. These include an increased risk of serious Cardiovascular Thrombotic Events, such as Myocardial Infarction and Stroke, which may begin early in treatment and increase with longer duration of use. Serious Gastrointestinal Events, including bleeding, ulceration, and perforation, are also documented risks that can occur at any time without warning. Additionally, severe Dermatological Reactions, like Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), are explicitly noted.


Key Safety Constraints

The official labeling contains specific restrictions. Flamax is contraindicated for treating peri-operative pain in the setting of Coronary Artery Bypass Graft (CABG) surgery. It is also contraindicated in patients with a history of aspirin-induced asthma or other NSAID-related allergic reactions. Furthermore, regulatory documents state that use is contraindicated during the third trimester of pregnancy due to risk to the fetus. The risk of serious GI events is generally elevated in older adults.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for Flamax (Ketoprofen) overdose documents specific manifestations primarily affecting the gastrointestinal (GI) and central nervous systems (CNS). Documented symptoms may include nausea, vomiting (potentially containing blood or looking like coffee grounds), stomach pain, diarrhea, lethargy, drowsiness, headache, and confusion. Overdose may escalate to serious, life-threatening outcomes such as severe GI bleeding, ulceration, or perforation, acute renal failure (severe kidney damage), and CNS depression leading to seizures or coma, typically following large ingestions.

Immediate medical help is required for any suspected overdose situation. Mandated emergency actions, as per regulatory guidance, include contacting emergency services or a poison control center right away and taking the medication container to the hospital. There is no specific antidote known for Ketoprofen toxicity, and management is limited to symptomatic and supportive care. This care may involve procedures such as gastric decontamination with activated charcoal or hospital monitoring that includes observation of vital signs, ECG, and blood/urine tests, as the drug's high protein binding limits the effectiveness of measures like hemodialysis. Patients with reduced renal function or low albumin may require especially close monitoring due to the risk of increased free drug levels.

Therapeutic Uses of Flamax

What Flamax Treats: Main Uses and Benefits

Flamax is commonly used to help manage symptoms related to inflammatory or irritative states and is applied across domains where additional symptomatic support is needed. It is considered relevant for easing symptoms that include pain, swelling, and stiffness. This medicine is relevant for managing conditions that present with systemic or localized discomfort, including chronic issues like Osteoarthritis and Rheumatoid Arthritis, and acute episodes such as dysmenorrhea (menstrual pain), post-traumatic discomfort, and fever (pyrexia).

This supportive relief provides support that helps ease the overall symptom burden and contributes to improved comfort during periods of heightened symptoms. The medication may assist with maintaining functional stability and supports patients during difficult episodes.


Quick Fact: Relief for Pain, Swelling, and Fever

Category Typical Symptom Domains
Primary Focus Inflammatory, Musculoskeletal, and Acute Pain
Symptom Reduction Pain, Swelling, Stiffness, and Elevated Body Temperature
Use Context Chronic Pain Management and Acute Symptomatic Episodes

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Who Must Not Use Flamax (Contraindications)

The use of Flamax (Ketoprofen) is strictly defined by regulatory documentation. The medicine is formally contraindicated in specific patient populations. You must not use Flamax if you have a known allergy to Ketoprofen or if you have experienced allergic reactions (e.g., asthma, hives) after taking aspirin or other Nonsteroidal Anti-Inflammatory Drugs (NSAIDs). Use is also prohibited for patients with a documented history of recurrent gastrointestinal (GI) ulceration or bleeding, and for managing peri-operative pain following Coronary Artery Bypass Graft (CABG) surgery. The medicine is contraindicated in the third trimester of pregnancy.

Restricted Use and Special Populations

Eligibility is restricted for several groups. Safety and efficacy are generally not established for the pediatric population. Older adults (aged 65 and over) are classified as a high-risk population for GI and kidney issues, requiring conditional use. Use is not recommended for nursing mothers as safety for the infant has not been established. Patients with impaired renal function or hepatic impairment must only use the medicine under conditional, monitored circumstances due to how the body processes the medication.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Flamax (Ketoprofen) is subject to officially documented interaction patterns that influence systemic exposure, clearance, and the risk of serious adverse events when co-administered with certain products. Regulatory labeling classifies the use of Flamax as contraindicated for the treatment of perioperative pain in the setting of Coronary Artery Bypass Graft (CABG) surgery.

Documented Pharmacodynamic and Pharmacokinetic Interactions

Co-administration with anticoagulants (e.g., Warfarin) or antiplatelet agents elevates the synergistic risk of serious gastrointestinal bleeding. Similarly, concurrent use with other NSAIDs is not generally recommended due to increased toxicity risk.

The medicine is documented to alter the clearance of certain substances. Co-administration with Lithium can cause an elevation of plasma lithium levels and a reduction in its renal clearance. Similarly, the simultaneous use of Probenecid is known to increase the systemic exposure of Ketoprofen by reducing its plasma clearance.

Flamax may also diminish the antihypertensive effect of ACE inhibitors and ARBs and reduce the natriuretic effect of diuretics. Patients with conditions such as impaired renal function are at greater risk of developing renal complications from this pharmacodynamic interaction. Daily alcohol use may increase the risk of stomach bleeding.

Mechanism of Action

Targeting Enzymes to Halt Mediator Production

Flamax's mechanism begins at the molecular level by acting as a non-selective inhibitor of the Cyclooxygenase (COX) enzymes, COX-1 and COX-2. By blocking these enzymes, the drug suppresses the arachidonic acid cascade, reducing the synthesis of signaling molecules known as prostaglandins throughout the body.

Modulating Peripheral Signaling and Inflammation

The resulting lower concentration of prostaglandins in the tissues directly affects peripheral nociception and inflammatory processes. This mechanistic domain results in a reduction of nerve ending sensitization and decreases the signals that trigger vasodilation (widening of blood vessels) and edema (fluid accumulation). This leads to physiological adjustments that contribute to the drug's profile of effects.

️ Adjusting Central Thermoregulation

A key part of the mechanism involves the drug's action on the central nervous system. By reducing the level of specific prostaglandins in the hypothalamus (the brain's thermal control center), Flamax engages mechanisms that result in a resetting of the body's elevated temperature set point. This targeted pathway adjustment contributes to a modified state within the thermoregulatory system, resulting in an adjustment of the thermal set point.

Dosage and Administration Information

How to Use Flamax: Official Administration Guidelines

Flamax, which contains Ketoprofen, is used according to specific instructions to ensure proper administration and dosing. This medicine is administered via several officially approved pathways, primarily based on the formulation being used.


Approved Administration and Dosage

Route of Administration Typical Dosage Form Standard Administration Frequency
Oral (Systemic Relief) Immediate-Release (IR) Capsules ( 50 mg, 75 mg) Multiple times a day (TID/QID)
Oral (Systemic Relief) Extended-Release (ER) Capsules ( 200 mg) Once daily (QD)
Topical (Localized Relief) Gel ( 2.5% w/w) 2 to 4 times a day

Standard oral dosing for adults typically ranges from 150 mg/ day to 300 mg/ day for immediate-release forms, with a maximum dose of 300 mg/ day. The extended-release form is fixed at 200 mg once daily.


Key Instructions for Proper Administration

Proper use requires adherence to specific label conditions, which govern how the medicine is taken:

  • Oral Intake: Oral preparations are often recommended to be taken with food, milk, or an antacid to minimize gastrointestinal discomfort.
  • Extended-Release Form: The extended-release capsules must be swallowed whole and must not be crushed, chewed, or divided to preserve their release properties.
  • Dose Adjustment: The starting dose should be the lowest effective dose and requires reduction for older adults and patients with known renal or hepatic impairment.
  • Duration: For all uses, treatment should employ the lowest effective dose for the shortest duration necessary.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Flamax (Ketoprofen)

This overview summarizes the type of research available for Flamax's active ingredient, Ketoprofen, focusing on the design of the studies, the outcomes that were measured, and the limitations documented in authoritative scientific sources. This information is purely descriptive and does not offer medical advice.


Evidence for Symptom Management in Chronic Inflammatory Conditions

Research has explored Flamax's active ingredient for use in conditions characterized by fluctuating or episodic manifestations like Rheumatoid Arthritis (RA) and Osteoarthritis (OA). The research primarily involves Randomized Controlled Trials (RCTs) and Systematic Reviews.

For chronic use, studies were conducted during periods of increased symptom activity and typically lasted up to 12 weeks. Researchers examined outcomes related to physical discomfort and observed patient-reported outcomes describing perceived discomfort. Evidence is limited regarding the long-term impact on the structural condition of the joint, as these studies mostly examined outcomes related to systemic or functional imbalance.

Research on Localized vs. Systemic Treatment

Research was studied for Flamax in two distinct forms: oral and topical. Studies on topical forms were applied in research contexts evaluating short-term or episodic symptom patterns for injuries like sprains, or conditions marked by functional limitations like knee OA. These trials research examined localized pain reduction. Data are still emerging on how much systemic absorption may contribute to the localized results, and follow-up durations were limited for many of these studies.


Evidence for Relief of Acute Pain Episodes

Evidence for the use of Flamax in conditions associated with acute or disruptive episodes, such as intense pain from minor surgery or dysmenorrhea, often comes from single-dose Randomized Controlled Trials. This research was observed in settings focusing on exploring short-term symptom changes.

For the antipyretic (fever-reducing) action, studies research examined the effects of a single dose on outcomes monitoring physiological strain or stress by measuring changes in body temperature over 4 to 8 hours. Evidence is limited regarding the effectiveness for unusual fevers or the impact of repeated dosing.

Key Studies & References

  1. Ketoprofen controlled release (CR) in the treatment of osteoarthrosis; a double blind, randomized multicentre study

Frequently Asked Questions (FAQ)

Common questions about Flamax (FAQ)


Q: Does Flamax contain a narcotic or an opioid?

According to official classification, Flamax is a Nonsteroidal Anti-Inflammatory Drug (NSAID). The medicine is not classified as a narcotic, opioid, or controlled substance.

Q: How long does it typically take before Flamax starts to relieve symptoms?

Studies and official information indicate that some patients may notice initial pain relief within 30 minutes after taking a single oral dose. However, the full analgesic and anti-inflammatory effects described in the documents may require continued use over a period of time.

Q: Is Flamax meant to be taken long-term for chronic conditions?

Studies and official information indicate that this medicine has been researched for chronic conditions like Rheumatoid Arthritis and Osteoarthritis over periods typically lasting up to 12 weeks. However, regulatory directions emphasize using the lowest effective dose for the shortest duration necessary to manage symptoms.

Q: Are there any signs of a serious reaction to Flamax I should be aware of?

Official labeling states that immediate medical attention is necessary if signs of a serious reaction are noticed. This includes signs of serious GI bleeding (such as black, tarry stools or vomiting material that looks like coffee grounds) or serious skin reactions (such as blistering, peeling skin, or rash).

Q: What is the connection between Flamax and blood pressure?

Official safety information indicates that an increase in blood pressure can occur with this medicine. It is also documented to potentially reduce the effectiveness of certain blood pressure medications when taken together.

Q: Can Flamax affect liver or kidney function?

Official labeling documents indicate that the medicine can affect both the renal (kidney) and hepatic (liver) systems. For individuals who already have existing impairment in these areas, the medicine is used under restricted circumstances and often requires a dose reduction.

Q: Can Flamax be taken at the same time as common over-the-counter cold and flu medicine?

Regulatory documents advise against co-administering Flamax with other Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), which are sometimes found in cold and flu products, due to an increased risk of toxicity. Reviewing the active ingredients of any over-the-counter medicine is important to avoid a known interaction.

Q: Can people who have high blood pressure or heart conditions use Flamax?

Because this class of medicine carries a risk of serious cardiovascular thrombotic events (such as heart attack or stroke), regulatory warnings exist for patients with high blood pressure or other heart conditions. Official documents indicate that the use of the drug for these patients is subject to conditional circumstances and monitoring by a healthcare professional.

Q: Does taking Flamax affect the ability to drive or operate machinery?

Because side effects such as drowsiness and dizziness have been reported, official safety information notes that patients should be aware of how the medicine affects them. Regulatory information indicates that driving or operating machinery is not advised until the patient understands the effects on concentration and alertness.

Q: What is meant when official documents refer to the 'contraindications' of Flamax?

In official medical documents, a contraindication is the term used to describe a condition or factor that makes the use of the medicine potentially harmful or strictly prohibited. For Flamax, this includes a history of certain allergies or serious gastrointestinal issues.

Q: Can Flamax cause weight gain or fluid retention?

Regulatory documents list peripheral edema (fluid retention) as a commonly reported effect, occurring in 1% to 10% of patients in studies. The adverse effect of weight gain is also listed in official information, but it is reported as a rare occurrence.

Q: Does Flamax interact with vitamin supplements or herbal remedies?

Official materials state that informing a healthcare provider about all medicines, including any vitamins, dietary supplements, and herbal remedies, is important. This caution exists because interactions with these products are possible and can influence the medicine's effects or safety profile.

Q: Is Flamax safe to take during the first trimester of pregnancy?

The medicine is explicitly contraindicated during the third trimester of pregnancy due to risk to the fetus. Regulatory guidance describes that for the first and second trimesters, the medicine is used based on a determination that the potential benefit outweighs the potential risk.

Q: Does the time of day I take Flamax matter for its effectiveness?

Regulatory pharmacokinetic data, which describes how the body handles the medicine, indicates that the fluctuation of plasma levels and absorption rates can be influenced by changes related to the time of day (circadian changes). This is a factor considered in the way the drug is administered.

Q: Is Flamax a drug that requires blood monitoring or lab tests?

For patients who are receiving long-term treatment or who have specific risk factors, official documents advise that monitoring of certain lab parameters may be necessary. This includes periodic checks of kidney function and hemoglobin/hematocrit levels.

Q: Can I take Flamax if I have diabetes?

Regulatory documents have noted that diabetes mellitus may be aggravated as a rare adverse effect. Furthermore, an increased risk of serious interactions exists if Flamax is used concurrently with certain medications used to treat diabetes.

Q: What steps are generally recommended if a mild side effect, like nausea, occurs with Flamax?

Official administration guidelines describe that taking the oral preparation with food, milk, or an antacid may help minimize general gastrointestinal discomfort, such as nausea, that can occur with the medicine.

Q: What distinguishes Flamax from a drug that works on the central nervous system?

Flamax is classified primarily as a Nonsteroidal Anti-Inflammatory Drug (NSAID), which works mainly by blocking certain chemical signals in the body's tissues (periphery). Its mechanism is distinct from drugs such as opioids, which target nerve receptors primarily in the central nervous system.

How should Flamax be stored and disposed of?

Storage and Disposal Conditions for Flamax (Ketoprofen)

Official regulatory documents define specific conditions for storing and disposing of Flamax to ensure product stability and safety.

Storage Requirements

Flamax must be stored at controlled room temperature, generally below 25 C, or in some cases below 30 C. The product must be protected from light and moisture and must not be frozen. To maintain its integrity, the medication must remain in its original container and be kept tightly closed.

Child Safety: Like all medicines, Flamax must be stored out of the sight and reach of children.

Disposal Instructions

Unused or expired Flamax must be disposed of according to local regulatory requirements. The official label for certain forms specifies that the product should not be thrown away with household waste or poured into the wastewater system, emphasizing the need for approved pharmaceutical waste disposal.

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

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