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Flurbiprofen

Generic Name
Flurbiprofen
Drug Type
Small Molecule
Chemical Formula
C15H13FO2
CAS Number
5104-49-4
Unique Ingredient Identifier
5GRO578KLP

Overview

Flurbiprofen, a propionic acid derivative, is a nonsteroidal anti-inflammatory agent (NSAIA) with antipyretic and analgesic activity. Oral formulations of flurbiprofen may be used for the symptomatic treatment of rheumatoid arthritis, osteoarthritis and anklylosing spondylitis. Flurbiprofen may also be used topically prior to ocular surgery to prevent or reduce intraoperative miosis. Flurbiprofen is structurally and pharmacologically related to fenoprofen, ibuprofen, and ketoprofen.

Indication

Flurbiprofen tablets are indicated for the acute or long-term symptomatic treatment of rheumatoid arthritis, osteorarthritis and anklosing spondylitis. It may also be used to treat pain associated with dysmenorrhea and mild to moderate pain accompanied by inflammation (e.g. bursitis, tendonitis, soft tissue trauma). Topical ophthalmic formulations may be used pre-operatively to prevent intraoperative miosis.

Associated Conditions

  • Ankylosing Spondylitis (AS)
  • Back Pain, Acute
  • Chronic Back Pain
  • Menstrual Distress (Dysmenorrhea)
  • Muscle Spasms
  • Non-Articular Rheumatic Muscle Spasms
  • Osteoarthritis (OA)
  • Pain
  • Pain, Inflammatory
  • Post Traumatic Pain
  • Postoperative pain
  • Rheumatoid Arthritis
  • Spinal pain

Research Report

Published: Aug 19, 2025

Flurbiprofen (DB00712): A Comprehensive Pharmacological and Clinical Monograph

I. Introduction and Drug Profile

1.1. Overview and Classification

Flurbiprofen is a potent small molecule drug classified as a nonsteroidal anti-inflammatory drug (NSAID).[1] It is a member of the phenylalkanoic acid derivative family and, more specifically, a propionic acid derivative. This classification places it in the same chemical and pharmacological class as other widely used NSAIDs such as ibuprofen, naproxen, and ketoprofen.[1] As a member of this class, Flurbiprofen exhibits a triad of core therapeutic actions: anti-inflammatory, analgesic (non-narcotic), and antipyretic properties, making it a versatile agent for the management of a spectrum of conditions characterized by pain and inflammation.[1]

The drug's development traces back to the highly productive research period of the 1960s at the research arm of Boots UK, which also yielded the discovery of several other foundational NSAIDs, including ibuprofen.[2] Flurbiprofen was patented in 1964 and, following extensive clinical development, received its initial approval for medical use in 1987, with approval in the United States by the Food and Drug Administration (FDA) following in 1988.[2] This historical context establishes Flurbiprofen as one of the classic, well-characterized NSAIDs that form the bedrock of anti-inflammatory pharmacotherapy. It is available in diverse formulations, including oral tablets for systemic conditions, ophthalmic solutions for ocular surgery, and oromucosal preparations for localized throat pain, reflecting its broad clinical utility.[1]

1.2. Chemical Identity and Physicochemical Properties

A thorough understanding of Flurbiprofen's chemical and physical characteristics is fundamental to appreciating its formulation, pharmacokinetic behavior, and interaction with biological systems.

Nomenclature and Structure

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/11/03
Not Applicable
Not yet recruiting
2025/09/09
Not Applicable
Not yet recruiting
Kittitorn Supphapipat, MD
2024/08/22
Not Applicable
Not yet recruiting
2024/08/01
Not Applicable
Not yet recruiting
Beijing Tiantan Hospital
2024/02/02
Phase 4
Completed
Yuzuncu Yıl University
2023/09/18
Phase 4
Completed
2023/08/21
Not Applicable
Completed
2023/08/08
Phase 1
Completed
2023/07/21
Early Phase 1
Completed
2023/07/06
Phase 1
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
NuCare Pharmaceuticals,Inc.
68071-2480
ORAL
100 mg in 1 1
7/20/2021
Medsource pharmaceuticals
45865-918
ORAL
100 mg in 1 1
2/29/2024
Teva Pharmaceuticals USA, Inc.
0093-0711
ORAL
100 mg in 1 1
11/30/2021
Rebel Distributors Corp
42254-023
OPHTHALMIC
0.3 mg in 1 mL
6/2/2011
NuCare Pharmaceuticals,Inc.
68071-4436
ORAL
100 mg in 1 1
2/16/2021
PD-Rx Pharmaceuticals, Inc.
43063-992
ORAL
100 mg in 1 1
3/31/2023
STAT RX USA LLC
16590-096
ORAL
100 mg in 1 1
5/15/2009
Bryant Ranch Prepack
63629-8808
ORAL
100 mg in 1 1
11/30/2021
Proficient Rx LP
63187-937
OPHTHALMIC
0.3 mg in 1 mL
12/1/2018
Rebel Distributors Corp
21695-615
OPHTHALMIC
0.242 mg in 1 mL
3/4/2008

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
SULAN TABLETS 100MG
N/A
N/A
N/A
9/4/2024

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
RATIO-FLURBIPROFEN TABLETS 100MG
ratiopharm inc division of teva canada limited
00675199
Tablet - Oral
100 MG
12/31/1991
NOVO-FLURPROFEN SR
novopharm limited
02237859
Capsule (Sustained-Release) - Oral
200 MG / SRC
N/A
RATIO-FLURBIPROFEN TABLETS 50MG
ratiopharm inc division of teva canada limited
00675202
Tablet - Oral
50 MG
12/31/1991
NU-FLURBIPROFEN TAB 50MG
nu-pharm inc
02020661
Tablet - Oral
50 MG
12/31/1993
FLURBIPROFEN
aa pharma inc
01912046
Tablet - Oral
50 MG
12/31/1991
TEVA-FLURBIPROFEN
teva canada limited
02100517
Tablet - Oral
100 MG
12/31/1994
OCUFEN OPH SOLN 0.03%
00766046
Liquid - Ophthalmic
0.03 %
12/31/1988
ANSAID TABLETS 50 MG
00647942
Tablet - Oral
50 MG
12/31/1985
FROBEN SR
ABBOTT LABORATORIES, LIMITED
02223082
Capsule (Sustained-Release) - Oral
200 MG
1/28/1997
ANSAID TABLETS 100 MG
00600792
Tablet - Oral
100 MG
12/31/1985

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
ANGIFEN 8,75 MG PASTILLAS PARA CHUPAR SABOR MENTA
Alfasigma España, S.L.
81911
PASTILLA PARA CHUPAR
Sin Receta
Commercialized
LIZIFEN 8,75 MG PASTILLAS PARA CHUPAR SABOR MIEL Y LIMON
Opella Healthcare Spain S.L.
81912
PASTILLA PARA CHUPAR
Sin Receta
Commercialized
STREFEN 8,75 MG PASTILLAS PARA CHUPAR SABOR NARANJA
Reckitt Benckiser Healthcare S.A.
76902
PASTILLA PARA CHUPAR
Sin Receta
Commercialized
STREGAR 8,75 MG PASTILLAS PARA CHUPAR SABOR NARANJA
Reckitt Benckiser Healthcare S.A.
86799
PASTILLA PARA CHUPAR
Sin Receta
Not Commercialized
TANTUFEN 8,75 MG PASTILLAS PARA CHUPAR SABOR LIMON
Angelini Pharma Espana S.L.
86682
PASTILLA PARA CHUPAR
Sin Receta
Not Commercialized
STREFEN SPRAY 8,75 MG/DOSIS SOLUCION PARA PULVERIZACION BUCAL SABOR MENTA
Reckitt Benckiser Healthcare S.A.
79428
SOLUCIÓN PARA PULVERIZACIÓN BUCAL
Sin Receta
Commercialized
FLURBIPROFENO SEJMET 8,75 MG/DOSIS SOLUCION PARA PULVERIZACION BUCAL
Sejmet Pharmaceuticals S.L.
83997
SOLUCIÓN PARA PULVERIZACIÓN BUCAL
Sin Receta
Not Commercialized
FLURBIPROFENO SANDOZ CARE 8,75 MG PASTILLAS PARA CHUPAR SABOR NARANJA
Sandoz Farmaceutica S.A.
81995
PASTILLA PARA CHUPAR
Sin Receta
Not Commercialized
STREFEN 8,75 MG PASTILLAS PARA CHUPAR SABOR MIEL Y EUCALIPTO
Reckitt Benckiser Healthcare S.A.
86532
PASTILLA PARA CHUPAR
Sin Receta
Commercialized
STREFEN 8,75 mg PASTILLAS PARA CHUPAR SABOR MIEL Y LIMON
Reckitt Benckiser Healthcare S.A.
72938
PASTILLA PARA CHUPAR
Sin Receta
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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