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Last update 24 Oct 2026

Diclofenac Sodium

Last update 24 Oct 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryDiclofenac sodium, a benzene-acetic acid derivative, is a nonsteroidal anti-inflammatory drug (NSAID) ,has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of Diclofenac sodium, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). The FDA approved diclofenac sodium as VOLTAREN on July 28, 1988, and its originator was the Ciba-Geigy Corporation, which is now a part of Novartis. This drug has been used for many years to manage a wide range of painful conditions and is widely available in both prescription and over-the-counter formulations.

Drug Type

Small molecule drug

Synonyms

Diclfenac Sodium, Diclofanac Sodium, DICLOFENAC

+ [121]

Target

COXs

Action

inhibitors

Mechanism

COX inhibitors(Cyclooxygenases inhibitors)

Therapeutic Areas

Immune System DiseasesNervous System DiseasesSkin and Musculoskeletal Diseases+ [7]

Active Indication

Mild painModerate painSevere pain+ [31]

Inactive Indication

Actinic KeratosisAdvanced Malignant Solid NeoplasmAnkle Injuries+ [10]

Originator Organization

Novartis Pharma AG

Active Organization

Jiangsu Simiao Pharmaceutical Technology Co., Ltd.

Amzell Ltd.

Sichuan Tiande Pharmaceutical Co. Ltd.

+ [12]

Inactive Organization

Novartis Pharmaceuticals Corp.

Fougera Pharmaceuticals, Inc.

E Fougera & Co

+ [10]

License Organization

Dr. Reddy's Laboratories Ltd.

Mundipharma International Ltd.

Sayre Therapeutics Pvt Ltd.

+ [9]

Drug Highest PhaseApproved

First Approval Date

Japan (08 Aug 1973),

InflammationPain

Regulation-

Structure/Sequence

Molecular FormulaC14H11Cl2NNaO2

InChIKeyVSFBPYWDRANDLM-UHFFFAOYSA-N

CAS Registry15307-79-6

781

Clinical Trials associated with Diclofenac Sodium

CTRI/2026/07/113350

/ Not yet recruitingNot ApplicableIIT

A Prospective Comparative study on the Analgesic Effect of Intradermal Sterile Water Vs Intramuscular Diclofenac Sodium in Patients with Acute Renal Colic at a Tertiary Care Hospital in Chennai - NIL

Start Date31 Mar 2027

Sponsor / Collaborator-

CTRI/2025/12/098816

/ Not yet recruitingNot ApplicableIIT

A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF CHANGERI GHRITA SUPPOSITORY WITH DICLOFENAC SODIUM SUPPOSITORY IN THE MANAGEMENT OF POST OPERATIVE HAEMORRHOIDECTOMY PAIN.

Start Date10 Dec 2026

Sponsor / Collaborator-

ACTRN12626001220358

/ Not yet recruitingPhase 4IIT

Topical Diclofenac Gel for Acute Non-Specific Low Back or Neck Pain: A Decentralised Pragmatic Randomised Controlled Trial Assessing Pain Severity

Start Date30 Nov 2026

Sponsor / Collaborator

University of Sydney Union

100 Clinical Results associated with Diclofenac Sodium

100 Translational Medicine associated with Diclofenac Sodium

100 Patents (Medical) associated with Diclofenac Sodium

15,576

Literatures (Medical) associated with Diclofenac Sodium

01 Feb 2027·JOURNAL OF ETHNOPHARMACOLOGY

Phytochemical analysis and biological activities of Aegle marmelos unripe fruit: An integrated in vitro, in vivo and in silico study

Article

Author: Parvin, Mst Shahnaj ; Shakib, Md Sayedul Islam ; Kuddus, Abdul ; Islam, Md Ekramul ; Sinthi, Ayesha Tasnim

ETHNOPHARMACOLOGICAL RELEVANCE:

In India, Bangladesh and other South Asian countries, unripe fruits of Aegle marmelos are traditionally consumed as decoctions, powders, or dried preparations for the management of diarrhea, dysentery, abdominal inflammation, gastric irritation, and inflammatory bowel conditions. Despite its long-standing ethnomedicinal use, systematic studies correlating phytochemical composition, fraction-specific bioactivity and computational pharmacological prediction of unripe fruit extracts remain limited.

AIM OF THE STUDY:

The present study aimed to comparatively evaluate the antioxidant and anti-inflammatory activities of solvent fractions obtained from unripe Aegle marmelos fruit, identify the most bioactive fraction through a bioactivity-guided approach, and characterize its phytochemical constituents. In addition, computational analyses were performed to explore the potential interactions of selected phytochemicals with the cyclooxygenase-2 (COX-2) enzyme.

MATERIALS AND METHODS:

Sequential extraction of unripe A. marmelos fruit was performed using n-hexane, dichloromethane (DCMF), chloroform, ethyl acetate, and methanol. Total phenolic and flavonoid contents were quantified, and antioxidant activity was assessed using 2,2-Diphenyl-1-picrylhydrazyl (DPPH) radical scavenging, total antioxidant capacity, and iron-reducing power assays. Anti-inflammatory activity was evaluated via heat- and 2,2'-azobis (2-amidinopropane) dihydrochloride (AAPH)-induced erythrocyte membrane stabilization assays and the carrageenan-induced paw edema model in vivo. The most active fraction (DCMF) underwent GC-MS analysis for chemical profiling. In silico studies, including PASS prediction, ADMET profiling, molecular docking, and molecular dynamics simulations, were performed to investigate interactions of identified compounds with COX-2. Elemental composition and heavy metal content were also determined.

RESULTS:

DCMF exhibited the highest total phenolic (20.85 ± 0.30 mg GAE/g) and flavonoid (25.84 ± 1.62 mg CE/g) contents, as well as the greatest total antioxidant capacity and reducing power among the tested fractions. In contrast, EAF showed the strongest DPPH radical scavenging activity (IC₅₀ = 16.22 μg/mL). DCMF demonstrated substantial membrane stabilization (75.47 ± 0.47% inhibition at 400 μg/mL) and significantly inhibited carrageenan-induced paw edema (62% inhibition at 5 h; 100 mg/kg), approaching the effect of diclofenac sodium (67.66% at 5 h; 10 mg/kg). GC-MS/MS analysis of DCMF identified 29 compounds, with methyl palmitate (34.61%), methyl oleate (22.04%), caryophyllene oxide (17.90%), and β-sitosterol (7.62%) as the predominant constituents. Computational analyses suggested favorable predicted interactions of selected compounds with the COX-2 binding site, which remained relatively stable during molecular dynamics simulations. Elemental analysis detected essential minerals, including Fe (1.32 ppm) and K (0.4788 ppm), while toxic heavy metals were not detected.

CONCLUSIONS:

The integrated phytochemical, pharmacological and computational findings highlight unripe A. marmelos fruit as a valuable source of bioactive compounds with significant antioxidant and anti-inflammatory properties. The results provide scientific support for the traditional use of A. marmelos in inflammatory conditions and highlight the unripe fruit as a promising source of bioactive phytochemicals for future investigation. Further studies focusing on the isolation of active constituents and clinical validation are warranted.

01 Jan 2027·INTERNATIONAL JOURNAL OF PHARMACEUTICS

Effect of human skin storage on stratum corneum drug penetration assessed by confocal Raman spectroscopy

Article

Author: Elbe-Bürger, Adelheid ; Klang, Victoria ; Freystätter, Christian ; Schmolz, Jakob ; Barker, Stefanie ; Cerbu, Diana

Fresh human skin is the preferred model for ex vivo dermal penetration studies. However, limited availability often necessitates frozen storage. We investigated whether storage for two months at -20 °C or -80 °C affects skin barrier function, selected Raman-derived skin properties, and drug penetration. For each of six donors, paired full-thickness abdominal skin samples were analyzed fresh or after frozen storage. Barrier integrity was assessed by transepidermal water loss, while quantitative confocal Raman spectroscopy was used to determine water concentration profiles and the amount of caffeine, diclofenac sodium, and salicylic acid within the upper 15 µm after application of 2% (w/w) hydrogels for 1 h. Transepidermal water loss varied across storage conditions, although neither frozen-storage condition differed significantly from fresh skin. Raman-derived water content was significantly higher after storage at -80 °C than in fresh or -20 °C-stored skin, whereas no consistent storage-related differences were detected in the fingerprint spectra or combined ceramide and fatty acid signal. Superficial caffeine uptake was 18.57, 19.82, and 21.51 µg/cm² in fresh, -20 °C-stored, and -80 °C-stored skin, respectively, with significantly higher uptake in -80 °C-stored skin than in fresh skin. No significant differences were detected for diclofenac sodium or salicylic acid. Under these conditions, storage at -20 °C did not significantly alter the Raman-derived stratum corneum parameters or superficial drug uptake outcomes, whereas storage at -80 °C altered the superficial Raman-derived water signal and caffeine uptake. Storage conditions should therefore be standardized for each compound and experimental endpoint.

31 Dec 2026·Libyan Journal of Medicine

Selenium/Zinc nanocomposite (Se/Zn NC) bioengineered by Bacillus rugosus metabolites: physicochemical characterization, anti-inflammatory, and antidiabetic activities

Article

Author: Alyousfi, Dareen ; Al-Sharqi, Anes A. ; Aldoski, Vin ; Alashari, Rawabi A. ; Abdelkhalig, Sozan M. ; Zabermawi, Nidal Mohammed ; Albureikan, Mona Othman I. ; Ghareeb, Ahmed ; Alghamdi, Mohammed K. ; Alatawi, Zinab ; Albaqami, Faisal Miqad K. ; Alahmadi, Hanadi A. ; Ibrahim, Ibrahim M.

This study reports the biosynthesis of a Selenium/Zinc nanocomposite (Se/Zn NC) using a marine bacterial extract from Bacillus rugosus SYG20. FT-IR detected Zn-O stretching vibrations at 614.81, 500.71, and 463.61 cm⁻¹, together with shifts in biomolecule peaks. XRD revealed a hexagonal wurtzite structure with an average crystallite size of 14.9 nm, and UV-Vis spectroscopy gave an optical band gap of 3.46 eV. TEM showed spherical particles of 10-80 nm, while HRTEM lattice fringes and a polycrystalline diffraction pattern matching cubic ZnSe planes confirmed strong interfacial Se-Zn coordination. DLS indicated a hydrodynamic diameter of 87 nm with a polydispersity index of 0.28. EDX confirmed Se incorporation at 7.0 wt% (Zn:Se atomic ratio ≈ 1.6:1). XPS showed Zn in the divalent state and Se bound to the metal centers rather than as elemental selenium, with a Zn 2p binding-energy shift indicating interfacial coordination rather than a native oxide layer. Hemolysis remained below 1.5% even at 1000 μg/mL, and cytotoxicity against WI-38 normal fibroblasts showed a wide safety margin (IC₅₀ = 392.64 ± 4 μg/mL). The nanocomposite exhibited strong antioxidant activity, with IC₅₀ values of 11.85 ± 0.11 μg/mL (DPPH) and 11.46 ± 0.05 μg/mL (ABTS⁺^•), reaching 94.4% and 93.9% inhibition, respectively. Anti-inflammatory assays gave IC₅₀ values of 6.67 ± 0.5 μg/mL for COX-1 and 14.12 ± 0.1 μg/mL for COX-2. Protein denaturation was inhibited with an IC₅₀ of 2.04 ± 0.05 μg/mL, nearly matching diclofenac sodium (2.01 ± 0.04 μg/mL). Antidiabetic screening showed α-amylase and α-glucosidase inhibition with IC₅₀ values of 5.24 and 7.84 μg/mL, and 95.4% and 95.7% blockade at 1000 μg/mL. These in vitro findings support the potential of B. rugosus-derived Se/Zn NC against oxidative stress-related metabolic disorders.

News (Medical) associated with Diclofenac Sodium

01 Jul 2026

·www.businesswire.com

Haleon to Accelerate AI-powered Transformation With New Five-year Microsoft Collaboration

LONDON--(BUSINESS WIRE)--Haleon, a consumer health company solely focused on better everyday health, today announces a new five-year collaboration with Microsoft to scale digital, data and AI capabilities across the business and accelerate delivery of its global Win as One strategy. By combining Microsoft’s cloud and AI capabilities with Haleon’s deep consumer health expertise, we’re accelerating our AI progress — simplifying how we work, unlocking more value from our data, accelerating innovation and helping our teams make faster. The new agreement builds on Haleon’s existing use of Microsoft 365 Copilot and further supports the wider adoption of AI-powered tools across the business, helping teams automate routine tasks, collaborate more effectively and focus on higher-value work. Importantly, it will also further strengthen Haleon’s digital and AI-enabled infrastructure through further adoption of Microsoft’s agentic AI, security and identity capabilities, helping the company to scale AI securely and responsibly. Haleon and Microsoft will co-create high-impact AI use cases which deliver value across multiple critical functions, from consumer insights and innovation to supply chain and commercial execution. This will ultimately enable Haleon to deliver better everyday health to consumers globally, for example, through faster scientific research and clinical content development, enhanced marketing content creation and personalisation, and improved forecasting and decision-making across the business. By harnessing advanced AI capabilities, Haleon will gain deeper insights into evolving consumer needs, drive product innovation at pace, and streamline operations from supply chain through to commercial execution. This will enable Haleon to meet rising consumer demand more quickly, offer personalised health products, and ensure its trusted, science-backed brands are available in the right place, at the right time, to millions more people globally. In turn, this will support Haleon’s global ambitions of reaching one billion more consumers by 2030 and delivering industry-leading shareholder returns. Claire Dickson, Chief Digital and Technology Officer, Haleon, said: “This collaboration marks a major step forward in how we use digital, data and AI to deliver our global strategy - driving growth, improving productivity and building a more agile, performance-focused culture. We’re already embedding AI capabilities across the business, delivering measurable results and efficiencies in areas including consumer insights, marketing, R&D and supply chain. By combining Microsoft’s cloud and AI capabilities with Haleon’s deep consumer health expertise, we’re accelerating our AI progress — simplifying how we work, unlocking more value from our data, accelerating innovation and helping our teams make faster, smarter decisions to benefit our consumers.” Darren Hardman, CEO, Microsoft UK & Ireland, said: “Haleon is moving with real pace and purpose on its AI journey, using Microsoft cloud and AI capabilities to turn ambition into impact across the entire organisation. From consumer insights and marketing to R&D, supply chain and decision-making, Haleon is already showing how AI can help teams work smarter, innovate faster and deliver meaningful benefits for consumers. We’re proud to support Haleon as it scales AI securely and responsibly, helping the company unlock more value from its data and accelerate its mission to deliver better everyday health to millions more people around the world.” By using Microsoft Azure as its core cloud platform and Microsoft Copilot as part of its enterprise AI foundations, Haleon will benefit from scalable infrastructure, advanced analytics and Microsoft’s enterprise-grade security capabilities. This includes strengthened identity, governance and threat protection to help safeguard data, systems and AI-powered workflows as Haleon deploys AI responsibly, safely and at scale. The agreement supports Haleon’s ambition to build an AI-powered, decision-intelligent enterprise, where data and insights flow seamlessly to enable faster, smarter, more consumer-centric decisions. This includes advancing next-generation agentic AI capabilities, to allow Haleon’s digital and technology teams to manage, govern and secure intelligent digital agents. These agents will work alongside Haleon’s teams to help them spot opportunities earlier, respond more quickly, and deliver better outcomes for consumers, customers and health professionals. About Haleon Haleon (LSE/NYSE: HLN) is a consumer company that is solely focused on better everyday health. Our people, our brands, our research, our investment and our innovation are aimed at improving the everyday health of consumers. Our product portfolio spans six major categories - Oral Health, Vitamins, Minerals and Supplements (VMS), Pain Relief, Respiratory Health, Digestive Health and Therapeutic Skin Health and Other. Our superior brands - such as Advil, Centrum, Otrivin, Panadol, parodontax, Polident, Sensodyne, Theraflu and Voltaren – are trusted by more than one billion consumers and are recommended by health professionals around the world. For more information, please visit www.haleon.com.

13 May 2026

·www.fiercepharma.com

Haleon tackles sports injuries with latest soccer play

The Haleon initiatives are part of the broader embrace of soccer by the pharma industry. Haleon has completed a hat-trick of recent soccer initiatives, inking a pain management partnership with the organization responsible for protecting the health and safety of players in Europe. London-based Haleon, a consumer health company that spun out of GSK in 2022, struck a deal in March to make its painkiller Voltaren an official UEFA Champions League licensed product. The next month, the company began a soccer-focused marketing campaign for Voltaren and other products as part of its pact with the U.S. Soccer Federation.Haleon’s latest deal adds another strand to its relationship with UEFA. The agreement makes Haleon the first health partner of UEFA Medical, the organization tasked with protecting the health and safety of everyone involved in European soccer. Through the multiyear scientific partnership, Haleon and UEFA Medical aim to strengthen the scientific understanding of pain management and recovery across football and other sports. The collaboration will include educational tools such as webinars and digital learning modules. The company’s role in the alliance is “to bring medical expertise that strengthens the scientific guidance available to healthcare professionals managing pain in active individuals,” Eran Gefen, head of medical and scientific affairs, OTC at Haleon, said in a statement. Haleon and UEFA Medical recently co-authored an analysis of the use of non-steroidal anti-inflammatory drugs—a class that includes Voltaren—to provide early pain relief in sports injuries. The analysis was the first evidence jointly developed by the organizations and “helps lay a stronger scientific foundation for future guidance,” Haleon said.The Haleon initiatives are part of the broader embrace of soccer by the pharma industry in the year that the World Cup comes to North America. This year, Bristol Myers Squibb has run ads starring a U.S. Soccer Hall of Famer and drawing a link between the sport and drug development, while Sanofi backed Boston’s preparations to host World Cup matches and Amgen penned a sports pact with Los Angeles.

30 Apr 2026

·www.biospace.com

YARAL Pharma Launches 15-Count Diclofenac Epolamine Topical System 1.3%, Offering Pharmacists a Flexible, Space-Saving Option

Compact packaging helps simplify storage, ease inventory concerns, and make daily pharmacy operations more manageable PARSIPPANY, N.J.--(BUSINESS WIRE)-- YARAL Pharma Inc. (YARAL Pharma), the rapidly growing U.S. generics subsidiary of IBSA (Institut Biochimique SA), today announced that its Diclofenac Epolamine Topical System 1.3% , the authorized generic of Flector ® (diclofenac epolamine) topical system 1.3%, is now available in a 15-count carton. Designed to meet the operational needs of today’s pharmacies, the new 15-count configuration helps pharmacists reduce clutter, optimize storage space, and manage inventory with greater flexibility, while continuing to provide patients with the same trusted therapy. “As pharmacy shelves, drawers, and bins become increasingly crowded, thoughtful packaging makes a difference,” said Stephen Beckman, CEO of YARAL Pharma. “Our 15-count Diclofenac Epolamine Topical System delivers the same product patients and pharmacists rely on, now in a smaller footprint that can save up to 50% of shelf space compared to the 30-count carton.” With its compact size and practical design, the 15-count Diclofenac Epolamine Topical System offers several advantages for pharmacies: Space-Saving & Organized Storage – A smaller carton height reduces clutter, simplifies stacking, and fits easily into limited shelf, drawer, or bin space. Streamlined Workflow – Easier to locate, stock, and access during daily operations, helping reduce time spent managing inventory. Flexible Inventory Management – The smaller pack size supports more efficient stocking, helps prevent over-ordering, and allows pharmacies to better match inventory to demand – especially when space is limited. Product Information YARAL Pharma’s Diclofenac Epolamine Topical System 1.3% is a nonsteroidal anti-inflammatory drug (NSAID) and is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older. Product NDC Number Dimensions 15-Count (3 envelopes per carton) * NDC 82347-0405-6 8.25” x 6.124” x 1.375” 30-Count (6 envelopes per carton) * NDC 82347-0405-5 8.25” x 6.124” x 2.375” *Packaged 5 topical systems per envelope YARAL Pharma’s Diclofenac Epolamine Topical System 1.3% 15-count is now available. For more information, email info@yaralpharma.com or call (866) 218-9009. USE DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is prescription medication that is applied to the skin to treat acute pain from minor strains, sprains, and contusions (bruises) in adults and pediatric patients 6 years and older. DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% contains diclofenac epolamine (a non-steroidal anti-inflammatory drug or NSAID). IMPORTANT SAFETY INFORMATION What is the most important information I should know about DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3%? DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is a nonsteroidal anti-inflammatory drugs (NSAID). NSAIDs can cause an increased risk of heart attack or stroke that can lead to death. This may happen early in treatment and may increase with increasing doses of NSAIDs and with longer use of NSAIDs. Do not take DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% right before or after a heart surgery called “coronary artery bypass graft” (CABG). Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. NSAIDs can cause an increased risk of bleeding, ulcers, and tears (perforation) of the esophagus, stomach, and intestines: at any time during treatment without warning may cause death. The risk of getting an ulcer or bleeding increases with: a history of stomach ulcers, or stomach or intestinal bleeding with the use of NSAIDs taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs” increasing doses of NSAIDs longer use of NSAIDs smoking drinking alcohol older age poor health advanced liver disease bleeding problems NSAIDS should only be used: exactly as prescribed at the lowest dose possible for your treatment for the shortest time needed Who should not take DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3%? Do NOT take DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% if you have a known hypersensitivity reaction to diclofenac or any component of the drug product. Do NOT take DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% if you have had an asthma attack, hives, or other allergic reactions to aspirin or any other NSAID medicine. DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% should never be used right before or after heart bypass surgery. Do NOT apply DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% to open wounds, cuts, burns, infected, or damaged skin. Before taking NSAIDS, tell your healthcare provider about all of your medical conditions, including if you: have liver or kidney problems have high blood pressure have asthma are pregnant or plan to become pregnant. Taking NSAIDs at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take NSAIDs for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not take NSAIDs after 30 weeks of pregnancy. are breastfeeding or plan to breast feed. Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins, or herbal supplements . NSAIDs and some other medicines can interact with each other and cause serious side effects. Avoid using DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% with other NSAIDs or salicylates (e.g., diflunisal, salsalate). NSAIDs may be available as over-the-counter medications for treatment of colds, fever, or insomnia. Do not start taking any new medicine without talking with your healthcare provider first. Especially tell your doctor if you take: aspirin--Do not use low dose aspirin with DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% until you talk to your healthcare provider. any anticoagulant medicine such as warfarin steroid medications including corticosteroids antidepressant medicines including “SSRIs” or “SNRIs” Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine. What are the possible side effects of NSAIDs? See “What is the most important information I should know about DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3%?” NSAIDs can cause serious side effects, including: new or worse high blood pressure heart failure liver problems including liver failure kidney problems including kidney failure low red blood cells (anemia) life-threatening skin reactions life-threatening allergic reactions Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness The most common side effects of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% were itching and nausea in adults, and headache and itching in pediatric patients. Get emergency help right away if you get any of the following symptoms: shortness of breath or trouble breathing, slurred speech, chest pain, swelling of the face or throat, or weakness in one part or side of your body. Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms: nausea vomit blood more tired or weaker than usual there is blood in your bowel movement, or it is black and sticky like tar diarrhea itching unusual weight gain your skin or eyes look yellow skin rash or blisters with fever indigestion or stomach pain swelling of the arms, legs, hands, and feet flu-like symptoms If you take too much of your NSAID, call your healthcare provider or get medical help right away. These are not all the possible side effects of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% or NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs or for advice about side effects. You are encouraged to report side effects to YARAL Pharma Professional Information Service at 1-866-218-9009 or FDA at 1-800-FDA-1088 or . Please see the Full Prescribing Information, including BOXED WARNING and Patient Information at About YARAL Pharma YARAL Pharma Inc. (Parsippany, N.J.) is the U.S. generics subsidiary of IBSA, a global pharmaceutical company headquartered in Switzerland. By focusing on people and innovating the ways they’re cared for, YARAL Pharma is proud to offer the same values and expertise of its parent company to the U.S. market. Dedicated to ensuring access to affordable authorized generics (AGs) and complex generic medicines that enhance healthcare outcomes, YARAL Pharma offers its customers high-quality products across a range of therapeutic areas, continuity of supply, and a commitment to exceptional customer service. For more information, visit or contact info@yaralpharma.com or 866-218-9009. About IBSA IBSA (Institut Biochimique SA) is a Swiss pharmaceutical multinational with 20 subsidiaries across Europe, China, and the United States. Its products are available in over 90 countries, and its R&D activities focus on 10 therapeutic areas. In 2025, IBSA celebrated the 40 th anniversary of its acquisition by current President and CEO, Arturo Licenziati, who has transformed the company into a multinational corporation employing over 2,500 personnel worldwide. IBSA’s growth and development can be attributed to its ability to innovate by refining well-known molecules, as well as to its commitment to looking to the future responsibly and transparently, thanks to the dedication and dynamism of its people. Flector ® is a registered trademark of IBSA Institut Biochimique S.A. YPM-1500-EN-v1 Contacts Media Daina Basile Kovak-Likly Communications dbasile@klcpr.com

Acquisition

100 Deals associated with Diclofenac Sodium

External Link

KEGG	Wiki	ATC	Drug Bank
D00904	Diclofenac Sodium	M02AA15 D11AX18 M01AB05	DB00586

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Mild pain	United States	-	25 Sep 2026
Moderate pain	United States	-	25 Sep 2026
Severe pain	United States	-	25 Sep 2026
Soft Tissue Injuries	Australia	Arrotex Pharmaceuticals Pty Ltd.	22 Apr 2026
Soft tissue rheumatism	Australia	Arrotex Pharmaceuticals Pty Ltd.	22 Apr 2026
Osteoarthritis, Knee	United States	Horizon Therapeutics Ireland DAC	16 Jan 2014
Osteoarthritis	Japan	Dojin Iyaku-Kako Co., Ltd.	27 Feb 2004
Periarthritis	Japan	Dojin Iyaku-Kako Co., Ltd.	27 Feb 2004
Tenosynovitis	Japan	Dojin Iyaku-Kako Co., Ltd.	27 Feb 2004
Actinic Keratosis	United States	E Fougera & Co	16 Oct 2000
Actinic Keratosis	United States	Fougera Pharmaceuticals, Inc.	16 Oct 2000
Hypersensitivity	United States	Fougera Pharmaceuticals, Inc.	16 Oct 2000
Hypersensitivity	United States	E Fougera & Co	16 Oct 2000
Pregnancy	United States	Fougera Pharmaceuticals, Inc.	16 Oct 2000
Pregnancy	United States	E Fougera & Co	16 Oct 2000
Visible Lesion	United States	Fougera Pharmaceuticals, Inc.	16 Oct 2000
Visible Lesion	United States	E Fougera & Co	16 Oct 2000
Bursitis	Japan	Hisamitsu Pharmaceutical Co., Inc.	28 Jan 2000
Cancer Pain	Japan	Hisamitsu Pharmaceutical Co., Inc.	28 Jan 2000
Cervicobrachial syndrome	Japan	Hisamitsu Pharmaceutical Co., Inc.	28 Jan 2000

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Myalgia	Phase 3	United States	Novartis AG	01 Oct 2014
Contusions	Phase 3	Germany	Novartis AG	01 Jan 2011
Limb injury	Phase 3	Germany	Novartis AG	01 Jan 2011
Ankle Injuries	Phase 3	United States	Novartis AG	01 Nov 2010
Chronic pelvic pain syndrome	Phase 3	France	Novartis AG	01 Nov 2006
Sunburn	Phase 3	France	Novartis AG	01 Nov 2006
Biliary Tract Neoplasms	Phase 2	Japan	Hisamitsu Pharmaceutical Co., Inc.	18 Sep 2026
Colorectal Cancer	Phase 2	Japan	Hisamitsu Pharmaceutical Co., Inc.	18 Sep 2026
Esophageal Carcinoma	Phase 2	Japan	Hisamitsu Pharmaceutical Co., Inc.	18 Sep 2026
Pancreatic Cancer	Phase 2	Japan	Hisamitsu Pharmaceutical Co., Inc.	18 Sep 2026

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06693648 (AMZ001, CTgov)	Phase 3	Pain \| Osteoarthritis, Knee	549	AMZ001 Diclofenac gel (AMZ001 Diclofenac Gel)	hlerymcxsr(polmmdednu) = kxucjgusak zimrjhohdp (gmousarlmh, ekfpcevpme - ksryazgsmo) View more	-	15 Jul 2026
				Placebo gel (Placebo Gel)	hlerymcxsr(polmmdednu) = mjxfxasldp zimrjhohdp (gmousarlmh, ehfxcvkqey - nicugdjhue) View more
NCT02417337 (NSAID, CTgov)	Phase 2	Pulpitis \| Pain, Postoperative	185	Paracetamol (Group I)	gubvrnumgm(fkwyscqxms) = xagdelwpvl lysgyjrfgl (huwrdnxgoy, kbleldbapj - jakgacpulq) View more	-	25 Jun 2026
				Paracetamol+Ibuprofen (Group II)	gubvrnumgm(fkwyscqxms) = krfnsedzkq lysgyjrfgl (huwrdnxgoy, sxanptymvy - ilfabgdsld) View more
NCT06954181 (CTgov)	Not Applicable	-	33	Voltaren (Voltaren® Schmerzgel Forte; 2.32% Applied With Applicator (Method 3))	jenokupbkg(jrfvzvvdka) = oconrsoefh ngwmqkufff (bmjdsmxwhp, 0.02) View more	-	16 Jun 2026
				Voltaren (Voltaren® Schmerzgel Forte; 2.32% Applied Without Applicator (Method 1))	tcfhhmxrgf(wwymkdhmcy) = mvuakkyqmf lhxjgzrfms (oiwpmafmlu, vslmcuxcvm - bfymzldenm) View more
NCT06918340 (Pubmed \| J Emerg Med)	Phase 4	Pain	150	10% Lidocaine	kqotnfwcpu(vwaklpjebz) = zudkjsekox atkvgqikbt (gajiedukbc, 2.09)	Negative	01 Feb 2026
				1% Diclofenac	kqotnfwcpu(vwaklpjebz) = idyzghxtxb atkvgqikbt (gajiedukbc, 2.7)
NCT06379893 (CTgov)	Phase 4	Pain \| Osteoarthritis, Knee	196	Voltaren Gel	iorrrcypgc(gvfpkkzfas) = ldylaltyda vczqsmvwxf (sazplknosy, 92.99) View more	-	20 Jan 2026
NCT06729073 (AMZ001, CTgov)	Phase 1	-	34	Diclofenac sodium gel (AMZ001)	gwahfjleiw(sddcssiqlc) = eqqdfywrtb rnznifzinp (sfqzjitzfb, 67.1) View more	-	06 Jan 2026
				Diclofenac diethylamine 1.16% gel (Diclofenac Diethylamine 1.16%)	gwahfjleiw(sddcssiqlc) = klhpysktqe rnznifzinp (sfqzjitzfb, 57.2) View more
NCT04199572 (Pubmed \| Pain Res Manag)	Phase 4	Limb injury	162	Diclofenac + Oral Paracetamol	auxzlotfbn(vouybunuei) = no adverse events were reported in any group mmirojurgt (xqutnwzvkl ) View more	Negative	01 Jan 2026
				Diclofenac + Placebo
NCT06632015 (Pubmed \| Odontology)	Not Applicable	Pain	90	Calcium hydroxide	jmfagjsbxv(mojngnyare) = DCS was more effective at reducing post-treatment pain when used alone than were DCH + CH and CH (p < 0.05). fkvplelgtd (crpnjhhiah ) View more	Positive	09 Nov 2025
				Diclofenac sodium
UEGW2025	Not Applicable	Post-ERCP Pancreatitis	378	Rectal diclofenac	qywedxwqrt(opbdqbetqy) = abfkeixyiv lepsyjtebq (ulagaxksul ) View more	Positive	05 Oct 2025
				Peripapillary epinephrine injection + Rectal indomethacin	dyhojczhqd(smxkfwfmhg) = dkzoaievis ylknqbykbv (cxctcqmhbb ) View more
NCT04552327 (Pubmed \| J Eur Acad Dermatol Venereol)	Phase 3	Actinic Keratosis	631	KOH 5% solution	avbtxtqtya(idfveglhpz) = dsymkgvcby nfeurvybju (zvnwzzxmje ) View more	Positive	25 Sep 2025
				Diclofenac 3% gel	avbtxtqtya(idfveglhpz) = sjlxnhwemw nfeurvybju (zvnwzzxmje ) View more

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