Proflam

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Proflam

What is Proflam? (Ketoprofen Composition)

Property Description
Active ingredient Ketoprofen
Form Available as capsules, tablets, gels, and injections
Pharmacological class Nonsteroidal Anti-inflammatory Drug (NSAID)
Common use Relieving pain, reducing inflammation, and lowering fever
Origin Synthetic compound (propionic acid derivative)

What Type of Medicine is Proflam (Ketoprofen)?

Proflam is a medication whose active component, Ketoprofen, is universally classified as a Nonsteroidal Anti-inflammatory Drug (NSAID). Its use for relieving pain, reducing inflammation, and lowering fever is clinically recognized across global regulatory frameworks. Ketoprofen is a synthetic compound derived from the propionic acid group, a chemical lineage it shares with other well-known NSAIDs. This identity, as a propionic acid derivative, is supported by pharmacological studies confirming its effectiveness in managing inflammatory symptoms.

Composition, Forms, and General Purpose

Proflam is typically supplied as a single active ingredient product, focusing entirely on the therapeutic actions of Ketoprofen. This formulation is available in various dosage forms, facilitating different routes of administration, including capsules and tablets for oral ingestion and gels for localized topical use. For instance, the topical gel formulation is frequently positioned for managing localized musculoskeletal discomfort.

Its general therapeutic purpose is achieved by inhibiting the biosynthesis of prostaglandins, which are key biochemicals responsible for triggering pain and inflammation signals in the body. By interrupting this mechanism, Proflam serves to mitigate the symptoms of swelling, stiffness, and pain, providing a comprehensive symptomatic benefit as an essential analgesic.

Regulatory References

  1. FDA label for Ketoprofen

What side effects are possible with Proflam?

Possible Side Effects and Safety Information for Proflam

Serious Safety Risks (NSAID Class Warnings)

As a non-steroidal anti-inflammatory drug (NSAID), Proflam (Diclofenac) carries important regulatory warnings regarding serious systemic risks. Regulatory bodies, including the FDA and EMA, mandate that users be informed of the potential for two main serious adverse event categories:

  1. Cardiovascular Thrombotic Events: NSAIDs, particularly when used at high doses and for long-term treatment, may increase the risk of serious events such as myocardial infarction (heart attack) and stroke, which can be fatal. This risk may be increased in patients with pre-existing heart disease or cardiovascular risk factors.
  2. Gastrointestinal Adverse Events: NSAIDs can cause bleeding, ulceration, and perforation of the stomach or intestines, which can also be fatal. This risk is present throughout treatment and may be higher with prolonged use.

Common and Other Documented Side Effects

Commonly reported, usually mild and transient adverse reactions include effects on the gastrointestinal system (e.g., abdominal pain, nausea, dyspepsia, diarrhea) and the nervous system (e.g., headache, dizziness). Skin reactions like rash or eczema may also occur.

Safety Restrictions and Contraindications

Use is contraindicated in patients with established congestive heart failure (NYHA class II-IV), ischaemic heart disease, peripheral arterial disease, or cerebrovascular disease. It is also contraindicated following coronary artery bypass graft (CABG) surgery and in patients with known hypersensitivity to diclofenac, aspirin, or other NSAIDs that precipitate asthma, urticaria, or acute rhinitis. Due to systemic absorption, the risk of adverse cardiovascular events with oral formulations dictates that the lowest effective dose for the shortest duration possible should be used. Older patients require close observation.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory guidance for Proflam (Ketoprofen) focuses on the immediate recognition of acute overdose manifestations and mandated emergency actions. Since no specific antidote is known, management described in official documents is purely symptomatic and supportive.

Documented Overdose Manifestations

Symptoms following an acute overdose, typically associated with large ingestions, are often extensions of known adverse effects and may include lethargy, drowsiness, nausea, vomiting (potentially with blood), epigastric pain, headache, dizziness, and shallow breathing [NIH MedlinePlus]. Severe or life-threatening outcomes documented in regulatory labeling include acute renal failure, coma, seizures, and the risk of gastrointestinal perforation or massive bleeding, which can be fatal [FDA Label]. The elderly are at greater risk for serious gastrointestinal events.

When to Seek Immediate Medical Help

Regulatory authorities mandate that immediate medical attention must be sought if an overdose is suspected. The instruction is to call emergency services (such as 911) or the local Poison Control Center immediately [NIH MedlinePlus]. Procedures described in regulatory information for hospital management may involve gastrointestinal decontamination (e.g., activated charcoal or gastric lavage) for large or symptomatic ingestions, alongside continuous monitoring of vital signs and laboratory parameters.

Therapeutic Uses of Proflam

What Proflam Treats: Main Uses and Benefits

Proflam (Ketoprofen) is a medication used in situations involving certain distressing symptoms, such as pain, inflammation, and fever. It is generally considered relevant across domains where short-term or chronic symptomatic assistance is needed to ease overall distress. The medication is applied in addressing multiple symptom axes related to inflammatory or irritative states.


Key Therapeutic Applications

Proflam is relevant for easing symptoms across domains, including conditions presenting with systemic or localized discomfort, such as Osteoarthritis and Rheumatoid Arthritis, acute painful episodes like gout flares and dental pain, and conditions involving inflammatory processes like soft tissue injuries (sprains and strains). It is also relevant in situations involving recurrent or episodic manifestations, such as the cramping associated with primary dysmenorrhea, and discomfort following procedures like postoperative pain.

“It supports the handling of distressing manifestations and contributes to improved comfort during periods of heightened symptoms.”

This broad application helps address symptom clusters that may become intense or disruptive, assisting in maintaining functional stability by easing symptoms that may interfere with routine activities.


Quick Fact

Quick Fact: Symptom Management Support
The therapeutic benefit supports the management of physical discomfort (pain), localized swelling (inflammation), and elevated body temperature (fever).

Regulatory References

  1. NIH MedlinePlus Drug Information overview

Eligibility and Restrictions for Use

Who Can and Cannot Use Proflam?

The official eligibility profile for Proflam (Ketoprofen) strictly defines which population groups are permitted, restricted, or prohibited from use according to regulatory authorities.

Absolute Contraindications

Use is strictly prohibited (contraindicated) for patients with a known hypersensitivity to Ketoprofen, aspirin, or any NSAID, or a history of NSAID-induced asthma. It is also contraindicated in patients with active gastrointestinal bleeding or ulcers, severe cardiac insufficiency, or severe renal impairment.

Proflam must not be used for pain following Coronary Artery Bypass Graft (CABG) surgery or during the third trimester of pregnancy (after 30 weeks gestation).

Age and Restricted Use

Systemic use is not recommended for children under 12 years of age, as safety and efficacy are not established. Elderly patients require close monitoring due to increased susceptibility to gastrointestinal and renal adverse effects. Use in the first and second trimesters of pregnancy and while breastfeeding is restricted and generally avoided unless clearly necessary.

Conditional Eligibility

Patients with mild-to-moderate hepatic or renal impairment, uncontrolled hypertension, or a recent myocardial infarction (MI) must use the medicine only under limited conditions and require careful supervision, as stated in regulatory labeling.

What should I know about interactions with other medicines?

Proflam, which contains the non-steroidal anti-inflammatory drug (NSAID) diclofenac, can interact with several other medicinal products, increasing the risk of adverse effects or altering the effectiveness of either drug. It is crucial to inform a healthcare provider about all prescription medications, over-the-counter products, and supplements being used.

Key Interacting Medicinal Product Categories

Product Category Potential Effect of Interaction
Anticoagulants/Antiplatelets (e.g., Warfarin, Aspirin, SSRIs) Significantly increased risk of serious gastrointestinal (GI) bleeding and ulceration. This includes concurrent use with low-dose aspirin for cardiovascular protection, which increases GI risk without providing consistent cardiovascular risk mitigation.
Other NSAIDs (e.g., Ibuprofen, Naproxen) Avoid co-administration due to an additive risk of serious GI adverse events and potential kidney damage. Combination does not offer enhanced benefit.
Antihypertensives (e.g., ACE Inhibitors, Diuretics, Beta-blockers) Can reduce the blood pressure-lowering effect and may increase the risk of kidney dysfunction, particularly in dehydrated or elderly patients.
Methotrexate Can increase the concentration of methotrexate in the blood, leading to enhanced toxicity, including severe blood and kidney reactions.
Lithium Can elevate plasma lithium levels, potentially leading to lithium toxicity.
Cyclosporine and Tacrolimus Increased risk of nephrotoxicity (kidney damage).

Other Interaction Notes

Food/Substance: Alcohol consumption while taking Proflam increases the risk of stomach irritation and bleeding. Timing: For patients taking low-dose aspirin, a doctor should be consulted to determine appropriate spacing, as diclofenac may interfere with aspirin's antiplatelet effect when taken concurrently.

Mechanism of Action

The mechanism of Proflam (Ketoprofen) centers on the modulation of key biochemical pathways involved in inflammation and nociceptive signaling throughout the body. The drug's core action is defined by a composite mechanism that affects both the synthesis of inflammatory mediators and the activity of pain receptors.


Inhibition of Prostaglandin Synthesis

This primary mechanism involves the non-selective, reversible inhibition of the Cyclooxygenase (COX) enzymes, specifically COX-1 and COX-2. By preventing these enzymes from converting arachidonic acid into prostaglandin precursors, Proflam reduces the generation of chemical mediators involved in the inflammatory cascade. This disruption of the eicosanoid pathway induces physiological alterations including modulation of vascular permeability and attenuation of nociceptive signaling.


Modulation of Central Thermoregulation

The central nervous system component of the mechanism involves the drug's action in the CNS, where it inhibits prostaglandin synthesis within the hypothalamus. By limiting the production of Prostaglandin E2 (PGE2) in this region, the mechanism induces the resetting of the body's elevated temperature set-point. This action facilitates the physiological process of returning core body temperature to baseline.


Secondary Influence on Pain Mediators

Beyond the COX pathway, the mechanism includes supplementary actions that target other inflammatory mediators. Proflam modulates the activity of key nociceptive mediators, such as bradykinin, and contributes to stabilizing lysosomal membranes within cells. These secondary mechanisms influence the overall cascade of inflammatory propagation, resulting in an altered activity state within the local pain signaling pathway.

Dosage and Administration Information

How to Use Proflam (Ketoprofen) Administration Principles

Ketoprofen administration is governed by official instructions covering dosage form, route, and frequency, based on regulatory standards. The route of administration determines the application, which includes oral (capsules/tablets), topical (gel), intramuscular (IM) injection, and intravenous (IV) infusion.


Dosing and Frequency Guidelines

Standard adult oral dosing for immediate-release (IR) forms ranges from 25 mg to 75 mg per dose, with the total daily amount generally not exceeding 300 mg. This regimen is typically administered in divided doses every 6 to 8 hours. Extended-release (ER) forms are scheduled for once-daily intake, with a recommended maximum of 200 mg per day.

Administration Detail Official Requirement
Oral Intake Context May be taken with food, milk, or an antacid to mitigate local effects.
Parenteral Limit IV or IM use is often limited to 2 to 3 days before transitioning to oral use.
ER Form Handling Must be swallowed whole and not crushed or chewed.

Use Duration and Population Adjustments

Regulatory principles mandate that Proflam should be used at the lowest effective dose for the shortest possible duration. For certain populations, dose adjustments are necessary: Older adults must be initiated on the lowest available dose. Patients with renal or hepatic impairment also require a reduced maximum daily dose due to altered drug clearance.

Recent Clinical Evidence

Research evidence / Overview of studies for Proflam


Evidence for use in Chronic Inflammatory Conditions (Rheumatoid and Osteoarthritis)

The body of research investigating Proflam (Ketoprofen) for chronic joint discomfort is primarily composed of controlled scientific trials, specifically Randomized Controlled Trials (RCTs) and subsequent large-scale Systematic Reviews and Meta-analyses. Research examined conditions characterized by functional limitations, such as Rheumatoid Arthritis and Osteoarthritis. Studies evaluated outcomes related to physical discomfort and outcomes reflecting daily functioning over defined time intervals. The research evaluated how symptoms evolved in the observed adult populations when compared against other treatments or an inactive substance (placebo). Findings describe patterns observed in the studies related to patient-reported outcomes describing perceived discomfort and functional scales that were studied for mobility.


Evidence for Acute Musculoskeletal Pain and Trauma

Research in this area has commonly explored topical (skin application) formulations of Proflam, such as gels or patches, in addition to oral forms. This evidence was observed in trials assessing short-term or episodic symptom patterns linked to inflammatory or irritative states. Research examined conditions associated with acute or disruptive episodes, such as soft tissue injuries (like sprains or strains) and acute episodes of pain. Research explored patterns related to outcomes related to physical discomfort observed during the study interval. Research examined patterns observed in the studies related to outcomes linked to inflammatory or irritative states over follow-up durations that were limited due to the acute nature of the condition.


Research Gaps and Areas of Uncertainty

A consistent pattern across indications is that the majority of research focused on short-term symptom changes. The evidence structure contains more data related to rapid changes in measured symptoms than for sustained or durable responses. Long-term effects are not fully established regarding the durability of measured outcomes. Data for certain groups remain insufficient, especially for those with severe, complex underlying conditions. Studies help show what has been observed so far, but findings describe group patterns, not personal outcomes.

Key Studies & References

  1. Ketoprofen 10% Cream for Treatment of Pain Associated With Mild to Moderate Acute Soft Tissue Injury (ClinicalTrials.gov Identifier: NCT00765700)

Frequently Asked Questions (FAQ)

Common questions about Proflam (FAQ)


Q: How quickly does Proflam usually start working?

Official clinical data suggest that immediate-release forms of the medication tend to have a faster onset of action when higher doses are administered compared to lower doses. The time it takes for an individual to feel the effect can vary widely.


Q: What are the most common side effects of Proflam that people report?

According to the official product information, some of the commonly reported side effects include gastrointestinal issues such as upset stomach, nausea, diarrhea, and constipation. Central nervous system effects like headache, dizziness, and drowsiness are also frequently noted.


Q: Can I take Proflam if I am already taking aspirin?

Regulatory warnings state that using this drug concurrently with aspirin, including low-dose aspirin taken for heart protection, significantly increases the risk of serious stomach bleeding and ulceration. Due to this heightened risk, concurrent use is generally discouraged and typically requires guidance from a healthcare provider.


Q: Can Proflam be taken on an empty stomach?

Official labeling advises that while taking the medication with food does not significantly change how much of the drug is absorbed, it can help reduce the possibility of stomach upset. Taking it with food, milk, or an antacid is a method suggested on the label to potentially reduce gastrointestinal effects.


Q: Can teenagers take Proflam for pain?

Systemic use (pills or capsules) is generally not recommended for children under 12 years of age because its safety and effectiveness have not been adequately established in this younger population. For patients aged 12 and older, use and dosage are determined by a healthcare provider.


Q: Is Proflam recommended for managing period pain?

Yes, regulatory documents list the management of menstrual cramps, or primary dysmenorrhea, as an approved indication. Clinical studies have shown the immediate-release form of this medication to be effective for this type of pain.


Q: Is Proflam safe for people with kidney issues?

Official warnings state that the medication is strictly prohibited for patients with severe kidney impairment. For those with mild-to-moderate kidney issues, careful supervision is required, and dosage adjustments may be necessary.


Q: Is it normal to feel dizzy after taking Proflam?

Dizziness is a commonly documented central nervous system side effect of this medication, often reported in the official labeling. Patients are generally advised to monitor for this effect, especially when beginning the medication.


Q: Are there any foods or drinks to avoid while on Proflam?

Regulatory documents explicitly advise against consuming alcohol while taking this medication. Alcohol significantly increases the risk of irritation and bleeding in the stomach and intestines.


Q: What happens if I miss a dose of Proflam?

If a dose is missed, official instructions suggest taking it as soon as possible, unless it is almost time for the next scheduled dose. If so, skipping the missed dose is recommended. The label advises against taking a double dose to make up for the one that was missed.


Q: Is Proflam the same as ibuprofen?

No, the active ingredient in Proflam is Ketoprofen. While both belong to the same class of medications, Nonsteroidal Anti-inflammatory Drugs (NSAIDs), they are distinct chemical compounds. They are not considered interchangeable.


Q: Does Proflam cause drowsiness?

Yes, drowsiness is one of the potential side effects listed in the medication's official labeling, along with other central nervous system effects like dizziness and headache. This is a potential effect noted in the product information.


Q: Why is Proflam sometimes prescribed after dental procedures?

This medication is known to be effective as an analgesic and anti-inflammatory agent. Regulatory reviews and clinical studies have examined its use in managing acute pain and swelling following procedures like oral surgery.


Q: Can taking Proflam change the color of my urine?

Official post-marketing reports have documented changes in urine, including bloody, cloudy, or discolored urine, as well as changes in the amount of urine produced. These signs are noted to require prompt communication with a healthcare provider if they occur.


Q: Is Proflam available over the counter in some countries?

In some international markets, the active ingredient, Ketoprofen, has been approved for both prescription use and for over-the-counter (OTC) use. The OTC forms are typically available in lower doses and are intended for the temporary relief of minor pain and aches.


Q: Can Proflam make you feel tired or fatigued?

Yes, official adverse event reports list excessive tiredness, lack of energy, and generalized fatigue as potential side effects associated with this medication.


Q: Does Proflam contain any common allergens like gluten or lactose?

Some oral formulations of this drug, specifically certain capsules, are known to contain inactive ingredients such as lactose monohydrate. Individuals with known allergies may wish to review the inactive ingredient list for their specific medication formulation.


Q: Why does Proflam sometimes cause water retention or swelling?

Official regulatory warnings advise that all NSAIDs, including this medication, have been associated with fluid retention and peripheral edema (swelling). Regulatory documents state that patients with pre-existing heart conditions are monitored for symptoms like unexplained weight gain, as fluid retention may be an important clinical sign.


Q: Is it safe to drive after taking Proflam?

Official medication information notes that caution is warranted for activities like driving or operating heavy machinery. Because side effects such as dizziness and drowsiness are known to occur, the medication label recommends assessing individual reaction before engaging in activities that require full mental alertness.


Q: What should I do if a minor side effect from Proflam doesn't go away?

If a commonly reported, but minor side effect such as an upset stomach, mild headache, or dizziness persists or worsens over time, official guidance states that prompt communication with a prescribing doctor or pharmacist is necessary.


Q: Can Proflam be crushed or split?

For extended-release (ER) capsules, regulatory instructions are clear that the dose must be swallowed whole. Crushing, chewing, or opening these specific capsules can cause the medication to be released too quickly, which is contrary to the labeling instructions.

How should Proflam be stored and disposed of?

Storage and Disposal Requirements for Proflam

Proflam (Ketoprofen) must be stored according to regulatory specifications to ensure stability and integrity. The oral dosage forms are typically required to be kept at Controlled Room Temperature, defined as 20 C to 25 C (68 F to 77 F). The medicine must be protected from light, moisture, and excessive heat, and must never be frozen.

The container must be kept tightly closed and stored with a child-resistant closure. A mandatory regulatory instruction requires the product be kept out of the reach of children.

Expired or unused Proflam should not be kept. Disposal procedures require that the product be discarded via approved methods, such as utilizing local drug take-back programs, or following specific instructions for safe household trash disposal.

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

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