Is Piroxicam registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 4 valid registrations of Piroxicam, including DISPERCAM 20MG-ML AMP.FOR I-M USE (20 mg/ml, Solution for injection, SAR 2.65); DISPERCAM GEL 0.5% (0.5 %, Gel, SAR 2.80); FELDENE 20MG DISPERSABLE TAB (20 mg, Dispersible tablet, SAR 22.50); FELDENE 20MG-ML AMP. (20 mg/ml, Solution for injection, SAR 29.20).

Is Piroxicam approved by the US FDA?

Drugs@FDA lists 23 application product lines for Piroxicam, including FELDENE (Prescription); PIROXICAM (Prescription); PIROXICAM (Prescription); PIROXICAM (Prescription); PIROXICAM (Prescription).

Are there safety signals or safety updates for Piroxicam?

US FDA: 1 entry; MHRA: 1 entry (latest 2024-11-21).

Active substance

Piroxicam

SFDA 17
US FDA 23
Health Canada 4
US price lines 2
NHS prices 5
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
DISPERCAM 20MG-ML AMP.FOR I-M USE	20 mg/ml	Solution for injection · Intramuscular use	3 Ampoule	SAR 2.65	Generic · Prescription	MEDICAL UNION PHARMACEUTICALS CO	Valid
DISPERCAM GEL 0.5%	0.5 %	Gel · Topical	1 Tube	SAR 2.80	Generic · OTC	MEDICAL UNION PHARMACEUTICALS CO	Valid
FELDENE 20MG DISPERSABLE TAB	20 mg	Dispersible tablet · Oral use	10 Blister	SAR 22.50	NCE · Prescription	SPIMACO ADDWAEIH	Valid
FELDENE 20MG-ML AMP.	20 mg/ml	Solution for injection · Intramuscular use	5 Ampoule	SAR 29.20	NCE · Prescription	SPIMACO ADDWAEIH	Valid
BREXIN 20MG TABLETS	20 mg	Tablet · Oral use	10 Blister	SAR 8.65	Generic · Prescription	CHIESI FARMACEUTICIS	Withdrawn by MAH · Not Marketed
FELDENE 10MG CAPS	10 mg	Capsule · Oral use	20 Blister	SAR 26.00	Generic · Prescription	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed
FELDENE 10MG DISPERSABLE TAB	10 mg	Dispersible tablet · Oral use	20 Blister	SAR 22.50	NCE · Prescription	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed
FELDENE 20MG CAPS	20 mg	Capsule · Oral use	10 Blister	SAR 22.65	Generic · Prescription	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed
FELDENE 20MG SUPPOSITORY	20 mg	Suppository · Rectal use	20 Blister	SAR 22.55	NCE · Prescription	PFIZER	Withdrawn by MAH · Not Marketed
FELDENE GEL 0.5%	0.5 %	Gel · Topical	1 Tube	SAR 13.35	NCE · OTC	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed
NOVO-PIROCAM 10MG CAPS	10 mg	Capsule · Oral use	20 Blister	SAR 20.75	NCE · Prescription	NOVOPHARM	Withdrawn by MAH · Not Marketed
ORTHOCAM 0.5% GEL	0.5 %	Gel · Topical	1 Tube	SAR 10.65	Generic · OTC	Tabuk Pharmaceutical Manufacturing Company	Withdrawn by MAH · Not Marketed
ORTHOCAM 10 CAPS	10 mg	Capsule · Oral use	20 Blister	SAR 21.60	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Withdrawn by MAH · Not Marketed
ORTHOCAM 20 CAPS	20 mg	Capsule · Oral use	10 Blister	SAR 18.85	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Withdrawn by MAH · Not Marketed
ORTHOCAM DT 10MG	10 mg	Dispersible tablet · Oral use	20 Blister	SAR 18.95	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Withdrawn by MAH · Not Marketed
ORTHOCAM DT 20MG	20 mg	Dispersible tablet · Oral use	10 Blister	SAR 18.95	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Withdrawn by MAH · Not Marketed
SHIFA PIROXICAM 20 MG-ML I.M AMP	20 mg/ml	Injection · Intramuscular use	5 Ampoule	SAR 3.85	NCE · Prescription	SHIFA PHARMACEUTICAL INDUSTRIES	Invalid · Not Marketed

Indications — CHI Daman Drug Formulary

ACUTE PANCREATITIS-PAIN MANAGEMENT; ENDOMETRIOSIS; LOW BACK PAIN; PAIN MANAGEMENT IN CANCER PATIENTS; POSTOPERATIVE PAIN; RENAL AND URETERIC STONES; RHEUMATOID ARITHRITIS

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
FELDENE	10MG; 20MG	capsule · oral	PFIZER	Prescription	6 Apr 1982
PIROXICAM	10MG; 20MG	capsule · oral	TEVA	Prescription	11 Dec 1992
PIROXICAM	20MG; 10MG	capsule · oral	SOLIS PHARMS	Prescription	15 Jun 1993
PIROXICAM	10MG; 20MG	capsule · oral	MICRO LABS	Prescription	29 Dec 2017
PIROXICAM	10MG; 20MG	capsule · oral	STRIDES PHARMA	Prescription	26 Jan 2018
PIROXICAM	10MG; 20MG	capsule · oral	ZYDUS LIFESCIENCES	Prescription	17 Jul 2018
PIROXICAM	10MG; 20MG	capsule · oral	SCS	Discontinued	29 May 1992
PIROXICAM	10MG; 20MG	capsule · oral	PHARMOBEDIENT	Discontinued	31 Jul 1992
PIROXICAM	10MG; 20MG	capsule · oral	TEVA PHARMS	Discontinued	28 Aug 1992
PIROXICAM	10MG; 20MG	capsule · oral	MYLAN	Discontinued	22 Sep 1992
PIROXICAM	20MG; 10MG	capsule · oral	SUN PHARM INDUSTRIES	Discontinued	12 Mar 1993
PIROXICAM	10MG	capsule · oral	TEVA	Discontinued	28 Jan 1994
PIROXICAM	20MG	capsule · oral	TEVA	Discontinued	28 Jan 1994
PIROXICAM	10MG; 20MG	capsule · oral	WATSON LABS	Discontinued	29 Sep 1995
PIROXICAM	10MG; 20MG	capsule · oral	WATSON LABS	Discontinued	16 May 1996
PIROXICAM	10MG; 20MG	capsule · oral	IVAX SUB TEVA PHARMS	Discontinued	3 Jun 1996
PIROXICAM	10MG; 20MG	capsule · oral	EGIS	Discontinued	8 Jul 1997
PIROXICAM	10MG; 20MG	capsule · oral	FLAMINGO PHARMS	Discontinued	9 Sep 2016
PIROXICAM	10MG; 20MG	capsule · oral	UNICHEM	Discontinued	13 Apr 2017
PIROXICAM	10MG; 20MG	capsule · oral	STRIDES PHARMA	Discontinued	20 Jun 2017
PIROXICAM	10MG; 20MG	capsule · oral	HIKMA	Discontinued	11 Aug 2017
PIROXICAM	10MG; 20MG	capsule · oral	BRECKENRIDGE	Discontinued	21 Feb 2018
PIROXICAM	10MG; 20MG	capsule · oral	CYCLE	Discontinued

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO PIROXICAM CAP 10MG	00642886	10 MG	CAPSULE · ORAL	APOTEX INC
APO PIROXICAM CAP 20MG	00642894	20 MG	CAPSULE · ORAL	APOTEX INC
TEVA-PIROXICAM	00695696	20 MG	CAPSULE · ORAL	TEVA CANADA LIMITED
TEVA-PIROXICAM	00695718	10 MG	CAPSULE · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	PIROXICAM 10 MG CAPSULE	$0.15768	per EA	23 Sep 2026
US NADAC	PIROXICAM 20 MG CAPSULE	$0.21465	per EA	23 Sep 2026
NHS Drug Tariff	Piroxicam 0.5% gel	£1.49	60 gram	1 Oct 2026
NHS Drug Tariff	Piroxicam 0.5% gel	£2.78	112 gram	1 Oct 2026
NHS Drug Tariff	Piroxicam 10mg capsules	£16.00	56 capsule	1 Oct 2026
NHS Drug Tariff	Piroxicam 20mg capsules	£24.00	28 capsule	1 Oct 2026
NHS Drug Tariff	Piroxicam 20mg orodispersible tablets sugar free	£10.53	30 tablet	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 21 Nov 2024 FELDENE — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
MHRA 11 Dec 2014 Piroxicam: new restrictions, including specialist initiation
Systemic piroxicam should be initiated only by specialists as a second-line treatment for arthritis, with patients who currently take piroxicam reassessed at a routine appointment.

All safety entries for piroxicam →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.