Fiera

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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 Fiera

Quick Facts: Fiera (Flurbiprofen)

Property Description
Active ingredient Flurbiprofen
Form Oral tablets, Topical solutions, Gels
Pharmacological class Nonsteroidal Anti-inflammatory Drug (NSAID)
General purpose Relief of pain and reduction of inflammation
Origin Synthetic propionic acid derivative

Fiera's Identity and Classification

Fiera is a medicinal product defined by its active component, Flurbiprofen, which is a synthetic organic compound with established anti-inflammatory and analgesic properties. Chemically, Flurbiprofen is a recognized propionic acid derivative, positioning it within a major subgroup of non-opioid pain relievers. Fiera is consistently a single-ingredient product, and its pharmacological effects stem entirely from the properties of Flurbiprofen. The medicine is available in multiple pharmaceutical preparations, including those for systemic absorption, such as oral tablets, and those for local application, such as topical gels or aqueous solutions.


Pharmacological Class and Mechanism

Fiera is categorized as a Nonsteroidal Anti-inflammatory Drug (NSAID), a pharmacological class widely utilized for its ability to reduce inflammation, pain, and fever. The action of Fiera is based on its function as a Cyclooxygenase inhibitor, which is the core mechanism shared across this class of compounds. This classification confirms that the drug operates by actively targeting the biological cascade that drives inflammation. As an analgesic and anti-inflammatory agent, Flurbiprofen is utilized in the management of pain and joint-related discomfort.


General Purpose of Fiera (Flurbiprofen)

The primary purpose of Fiera is to provide effective analgesic and anti-inflammatory activity by modulating chemical signals in the body. Flurbiprofen achieves this by inhibiting the synthesis of prostaglandins, which are the chemical messengers responsible for signaling and amplifying inflammation and pain. By suppressing the production of these inflammatory mediators, the drug serves the general goal of reducing pain and simultaneously calming the excessive biological responses that manifest as swelling and stiffness.

Regulatory References

  1. NIH LiverTox: Flurbiprofen

What side effects are possible with Fiera?

Possible Side Effects and Safety Information

The safety profile of Fiera is defined by regulatory limitations and specific warnings issued by government health authorities, primarily focused on the risks of severe low blood pressure and fainting.


Serious Adverse Reactions and Restrictions

Fiera carries a Boxed Warning regarding the risk of severe hypotension (low blood pressure) and syncope (fainting). This serious risk is significantly increased when the medication is used in certain settings:

  • Alcohol: Use of Fiera and alcohol close in time increases the risk of severe hypotension and syncope.
  • Moderate or Strong CYP3A4 Inhibitors: The concomitant use of these medications, which increase the concentration of Fiera in the body, is contraindicated due to the risk of severe hypotension and syncope.
  • Hepatic Impairment: The drug is contraindicated in patients with liver problems, as this condition also increases drug concentration and the risk of severe reactions.

The drug is subject to a Risk Evaluation and Mitigation Strategy (REMS) program, a restricted distribution system required by the U.S. FDA to manage the known serious risks.

Common Side Effects

The most frequently reported adverse reactions, documented in clinical trials and classified by frequency, involve the Nervous System and Gastrointestinal System.

Classification Adverse Reaction
Very Common Somnolence (excessive sleepiness)
Common Dizziness, Nausea, Fatigue, Insomnia, Dry mouth, Sedation

Central Nervous System (CNS) Depression, characterized by somnolence and sedation, is a clinically significant side effect that can occur even when Fiera is taken alone.

Use in Specific Populations

Safety and efficacy have been established only in premenopausal women. The medication is not indicated or studied in men or postmenopausal women. Patients with hepatic impairment are formally contraindicated from using the drug.

Overdose and Emergency Response

Fiera (Flurbiprofen) overdose is associated with documented clinical manifestations that primarily involve the gastrointestinal and central nervous systems. These include generalized symptoms such as nausea, vomiting, epigastric pain, and headache. Central nervous system signs documented in official labeling extend to drowsiness, lethargy, tinnitus, and, in severe cases, the possibility of loss of consciousness or coma.

Required Emergency Actions

Official regulatory information mandates that patients seek immediate medical attention for any suspected overdose due to the potential for severe, life-threatening complications. Urgent medical help is required when specific signs of severe systemic toxicity are present, such as vomiting blood or material that resembles coffee grounds, bloody or black/tarry stools, difficulty breathing, or the person has collapsed or had a seizure.

Regulatory Overdose Status

Overdose carries the risk of severe outcomes, including acute kidney injury and gastrointestinal bleeding or perforation. Regulatory profiles state that no specific antidote is known for acute Flurbiprofen toxicity. Management of overdose is therefore officially defined as symptomatic and supportive treatment. Elderly patients are noted in official prescribing information as a population at increased risk for serious adverse consequences during toxicity.

Therapeutic Uses of Fiera

Fiera (Flurbiprofen) is used in situations involving certain distressing symptoms, providing supportive relief across key domains involving discomfort and reduced functional stability.

The medication is used across domains involving symptomatic discomfort, including conditions characterized by periods of heightened symptoms such as Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis, or acute manifestations like Gout flare-ups, Tendonitis, Dysmenorrhea, and acute dental pain. It is applied in areas where short-term symptomatic assistance is appropriate, such as managing symptoms related to inflammatory or irritative states like sore throat pain, and is relevant in specific surgical scenarios, like managing postoperative inflammation after certain eye procedures.

Fiera helps address symptom clusters that may become intense or disruptive, such as joint pain, stiffness, and swelling, contributing to improved day-to-day comfort and supports general well-being during symptomatic phases.


Quick Fact: Relief for Inflammatory Discomfort

Symptom Domain Primary Symptom Axes Patient Benefit
Musculoskeletal Joint stiffness, Chronic pain, Swelling Supports maintaining functional stability
Acute/Episodic Acute localized pain, Tenderness Contributes to easing the overall symptom load
Localized Pharyngeal soreness, Dental aching Provides supportive relief when symptoms interfere with routine activities

Regulatory References

  1. NIH MedlinePlus overview on Flurbiprofen

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Fiera (Flurbiprofen) — Official Regulatory Information

This map describes the official rules governing population eligibility and non-eligibility for Fiera (Flurbiprofen), strictly based on governmental regulatory documents.


Eligibility Scope

Category Official Regulatory Statement
Populations for whom use is allowed Adults approved for the treatment of labeled conditions (e.g., rheumatoid arthritis, osteoarthritis) under standard labeled conditions.
Populations for whom use is contraindicated Known hypersensitivity to Fiera or any other nonsteroidal anti-inflammatory drug (NSAID), or a history of allergic-type reactions (e.g., asthma, urticaria) after taking aspirin or other NSAIDs. Active or recurrent peptic ulceration/hemorrhage or history of gastrointestinal bleeding/perforation related to previous NSAID therapy. Severe heart failure, severe renal impairment, or severe hepatic impairment. Use in the perioperative setting of Coronary Artery Bypass Graft (CABG) surgery. Use during the third trimester of pregnancy (starting at 30 weeks gestation).
Populations for whom use is not recommended/restricted Pregnancy (first and second trimester, especially after 20 weeks gestation). Breastfeeding women. Children and adolescents under 18 years for systemic use, as safety and efficacy have not been established. Older adults (65 years) who are at increased risk for serious adverse events. Patients with a recent myocardial infarction (MI).

Resulting Eligibility Structure

Official regulatory documents classify use restrictions based on severity. Fiera is contraindicated for specific high-risk populations, including those with severe organ failure or a history of NSAID-induced asthma. Use is not recommended or caution is required for groups with existing comorbidities, such as mild-to-moderate renal or hepatic impairment and certain cardiovascular risk factors. These documented classifications define the fixed, non-negotiable boundaries for who can and cannot use the medicine according to the regulatory label.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section describes the interactions of Fiera (Ferumoxytol) with other substances as documented in official government regulatory information.

Documented Interactions

Fiera has two primary areas of documented interaction: one affecting the absorption of other products and another involving combined risks with co-administered medications.

Interacting Product Category Type of Interaction and Outcome Procedural Constraint
Oral Iron Preparations Fiera may reduce the absorption of oral iron supplements, potentially diminishing their effectiveness. Not applicable
High-Risk Medications (e.g., Chemotherapeutic agents, Monoclonal antibodies) Increased pharmacodynamic risk of serious hypersensitivity reactions and hypotension (low blood pressure) when combined. Separate administration by at least 30 minutes.

Population-Specific Interaction Notes

Official labeling indicates that elderly patients with multiple or serious co-morbidities who experience hypersensitivity reactions or hypotension may have more severe outcomes compared to other patient groups. This note highlights the need for particular vigilance in this population when managing co-medication risks.

Interaction-Related Restriction

Fiera should not be administered to patients diagnosed with iron overload, as documented in the regulatory information.

Mechanism of Action

Molecular Action: Reversible Cyclooxygenase Inhibition

This domain covers Flurbiprofen's primary action: serving as a reversible, non-selective inhibitor of the Cyclooxygenase (COX) enzymes (COX-1 and COX-2). This molecular interaction prevents the enzymes from catalyzing the initial step of the Arachidonic Acid Cascade, thereby suppressing the synthesis of crucial physiological messengers.


Pathway Effect: Modulating Inflammatory Mediators

The inhibition of the COX enzymes directly reduces the formation of key inflammatory and pain-sensitizing prostaglandins (PGs), particularly PGE2. By lowering the concentration of these mediators, the drug alters localized physiological responses and modulates the processes involving vasodilation and vascular permeability in tissues.


️ Physiological Consequence: Adjusting Pain Threshold and Temperature

The resulting reduction in PGE2 concentration acts to decrease the sensitization of peripheral nociceptors (pain-sensing nerves), which results in an increase of the threshold required for pain signal transmission. Additionally, this effect extends to the central nervous system, where reduced PGE2 production in the hypothalamus is associated with a modification of the thermoregulatory set point.

Dosage and Administration Information

How Fiera is Used

Fiera (Flurbiprofen) administration follows specific protocols governing the route, dosage limits, and timing. The medication is available for use through two distinct routes: oral tablets for systemic effect, typically in strengths of 50 mg and 100 mg, and topical/ocular solution for localized application, such as before certain eye procedures.


Official Dosing and Frequency

Systemic use of Fiera (oral tablets) adheres to specific daily limits. The usual daily dosage range for adults is 200 mg to 300 mg per day, which should be divided into two, three, or four doses to maintain consistent levels in the body. The total intake must not exceed the 300 mg maximum daily dose. The core principle guiding use, particularly for chronic symptomatic conditions, is to employ the lowest effective dosage for the shortest duration necessary for control.


Administration Context and Adjustments

Oral tablets are administered preferably with or immediately following food or a substantial amount of water. This instruction is procedural and aims to optimize intake conditions. The tablets must be swallowed whole without being chewed or crushed. For specific patient populations, caution and dose assessment are required: the lowest effective dose principle is emphasized for older adults. Furthermore, the oral tablet form is not recommended for use in children under 12 years due to insufficient data on safety and efficacy in that age group. Adjustments may also be required for individuals with moderate to severe hepatic or renal impairment.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Fiera (Flurbiprofen)

This overview describes the types of research conducted on Fiera (Flurbiprofen) and what those studies focused on, without suggesting whether it is an appropriate treatment for any individual. The purpose here is to explain the structure of the available evidence.


Evidence for Use in Chronic Inflammatory Joint Conditions

Research exploring flurbiprofen was observed in research contexts involving fluctuating or unstable symptoms in conditions characterized by fluctuating or episodic manifestations like Rheumatoid Arthritis (RA) and Osteoarthritis (OA) and is often explored in short-term randomized controlled trials (RCTs) and Systematic Reviews. These studies were used in research exploring how symptoms change over time. The research examined outcomes related to physical discomfort and outcomes reflecting daily functioning or activity level. Researchers specifically monitored changes in patient-reported outcomes describing perceived discomfort and measures of physical function using specific indices relevant in trials assessing short-term or episodic symptom patterns.

What remains uncertain is the long-term characterization of these effects. There is limited information for long-term outcomes regarding sustained symptomatic changes beyond one year in the controlled trial setting. Furthermore, the existing research does not determine whether flurbiprofen is associated with changes in the progression of the disease or structural damage to the joints.

Research on Ankylosing Spondylitis (AS)

Short-term clinical trials have explored flurbiprofen's use in Ankylosing Spondylitis (AS), which is a condition involving periods of heightened symptoms. The research monitored outcomes related to physical discomfort, focusing on spinal pain and stiffness, using specific indices relevant in trials assessing short-term or episodic symptom patterns.

A key limitation is that follow-up durations were limited, often not extending past 12 weeks. Therefore, the available evidence provides limited insight into long-term effects.


Evidence for Use in Acute and Episodic Pain States

Flurbiprofen was observed in studies examining symptom intensity or variability relevant in trials assessing short-term or episodic symptom patterns, such as Gout flare-ups, Tendonitis, Dysmenorrhea (menstrual pain), and acute Dental Pain. The research was conducted during periods of increased symptom activity and focused heavily on single-dose or short-course randomized trials. The primary focus of these studies was on outcomes describing episodic or acute changes, specifically looking at patterns in the reported time to change in physical discomfort and the maximum level of change in discomfort intensity monitored in the immediate hours following administration.


Research on Localized Symptomatic Relief

Research explored flurbiprofen when applied in studies examining patient-reported experiences locally (such as lozenges or sprays) for conditions presenting with cycles of stability and flare-ups, like Sore Throat Pain. The primary outcomes linked to inflammatory or irritative states included measures of throat soreness intensity and difficulty swallowing.

This research provides context but not individual predictions regarding systemic absorption or long-term effects, as the trials focus strictly on short-term, localized relief.

Key Studies & References

  1. Flurbiprofen: MedlinePlus Drug Information (Regulatory/Authoritative Monograph)

Frequently Asked Questions (FAQ)

Common questions about Fiera (FAQ)


Q: How quickly does Fiera usually start to show an effect?

A: Fiera is known to be rapidly absorbed by the body. According to official product information, the time needed for the active ingredient, Flurbiprofen, to reach its maximum concentration in the blood is typically around 2 hours after taking the oral tablet in healthy adults. This concentration time describes the peak level the drug reaches in the bloodstream.

Q: If I stop taking Fiera, do the effects wear off immediately?

A: The effects of medication are reduced over time according to the drug's elimination rate. Official pharmacological data indicates that Fiera’s active component, Flurbiprofen, has an elimination half-life (t1/2) of approximately 7.5 hours. The half-life describes the rate at which the concentration of the medication decreases in the body.

Q: What happens if I take Fiera with alcohol?

A: Official prescribing information highlights that using Fiera with alcohol is associated with an increased risk of adverse effects. Specifically, official information documents an increased risk of stomach bleeding when Flurbiprofen is used concurrently with alcohol.

Q: Does Fiera affect driving or operating machinery?

A: Fiera is associated with adverse reactions that may affect mental alertness. Regulatory documents note potential side effects such as dizziness, somnolence (excessive sleepiness), and visual impairment. For this reason, caution is advised regarding performing tasks that require full mental focus, such as driving or operating machinery.

Q: Are headaches a commonly reported side effect of Fiera?

A: Yes, headache is a commonly reported adverse reaction documented in clinical trials for Fiera (Flurbiprofen). Official product information lists headache as a side effect that occurred with an incidence rate of 1% or greater.

Q: Is Fiera considered an antidepressant or something else?

A: Fiera (Flurbiprofen) is not an antidepressant. It is officially classified as a Nonsteroidal Anti-inflammatory Drug (NSAID). This pharmacological class is primarily utilized for its ability to reduce inflammation, pain, and fever.

Q: What kind of studies have been done on Fiera?

A: The medication's regulatory approval was based on data collected from various clinical studies. These include randomized controlled trials (RCTs), which evaluated the drug’s effects in specific inflammatory conditions such as rheumatoid arthritis and osteoarthritis.

Q: What if I take Fiera and forget a dose—is that a big problem?

A: Regulatory consumer information addresses missed doses. If a dose is forgotten, it should generally be taken as soon as it is remembered. However, if it is nearly time for the next scheduled dose, regulatory information indicates that the missed dose should not be taken, to avoid taking a double amount.

Q: Are there any common foods or drinks that interact with Fiera?

A: Regulatory information indicates that taking the oral tablets with food or antacids may affect the rate at which the drug is absorbed. While the speed of absorption might change, the total amount of drug absorbed by the body is generally not found to be significantly altered.

Q: Is it normal to feel a bit nauseous when first taking Fiera?

A: Nausea is a documented adverse reaction associated with Fiera (Flurbiprofen). Clinical trial data lists nausea as a common side effect, occurring in 1% or more of patients.

Q: What does the research say about Fiera's impact on quality of life?

A: Clinical research exploring Fiera's use in inflammatory joint conditions has examined patient outcomes related to daily functioning and activity level. These measures reflect outcomes related to daily functioning and activity level as assessed during the studies.

Q: What types of food should be avoided while on Fiera?

A: Administration of Fiera oral tablets with food or antacids may influence the rate of drug absorption. Official regulatory labeling does not specify food prohibitions other than the established warning related to alcohol.

Q: Is Fiera a new drug, or has it been around for a while?

A: The active component in Fiera, Flurbiprofen, has been in use for a significant period. The compound was patented in 1964 and was approved by the U.S. Food and Drug Administration (FDA) for medical use in 1988.

Q: What is the typical time frame for the maximum effect of Fiera?

A: The maximum concentration of the drug in the bloodstream occurs at approximately 2 hours after taking the oral tablet. This time marks when the drug reaches its highest concentration in the bloodstream (Tmax).

Q: Can Fiera cause changes in appetite?

A: Yes, regulatory documents list appetite changes among the documented adverse reactions associated with Fiera (Flurbiprofen). These observations often come from post-marketing reports or general clinical experience.

How should Fiera be stored and disposed of?

The official storage and disposal requirements for the medicinal product Fiera are not available in standard authoritative government drug regulatory documents such as the FDA Prescribing Information, EMA Summary of Product Characteristics (SmPC), or Health Canada monographs. Specific labeled instructions concerning temperature range, light and moisture protection, and in-use stability periods are therefore undetermined.


Storage & Disposal Constraints

Classification Regulatory Statement
Storage Conditions Not defined in official government drug labeling.
Child-Protection Not specified in official government drug labeling.
Disposal Instructions No product-specific rules found in official government drug labeling.

In the absence of specific drug label instructions, the general regulatory principle for disposal is to first check for community drug take-back programs or collection sites. If these are unavailable, unused medication should typically be mixed with an undesirable substance, placed in a sealed container, and thrown into the household trash, in accordance with general government-issued safe disposal guidelines.

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

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