Is Capecitabine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 14 valid registrations of Capecitabine, including Aceda 150mg F.C.Tablet (150 mg, Film-coated tablet, SAR 122.90); Aceda 500mg F.C.Tablet (500 mg, Film-coated tablet, SAR 658.40); CAPECITABINE SPC 150 mg Film Coted Tablet (150 mg, Film-coated tablet, SAR 177.35); CAPECITABINE SPC 500 mg Film Coted Tablet (500 mg, Film-coated tablet, SAR 1060.55); Capecitabine NEAPOLIS (500 mg, Film-coated tablet, SAR 577.85).

Is Capecitabine approved by the US FDA?

Drugs@FDA lists 15 application product lines for Capecitabine, including CAPECITABINE (Prescription); CAPECITABINE (Prescription); CAPECITABINE (Prescription); CAPECITABINE (Prescription); CAPECITABINE (Prescription).

Is Capecitabine authorised in the European Union?

EMA lists 5 centrally authorised medicines containing Capecitabine: Xeloda, Capecitabine Teva, Capecitabine Accord, Ecansya (previously Capecitabine Krka), Capecitabine Medac.

Is Capecitabine on the WHO Model List of Essential Medicines?

Yes — 8.2.1. Cytotoxic medicines (complementary list): Malignant neoplasms of rectum; Malignant neoplasm metastasis in large intestine; Malignant neoplasms of colon; Other specified malignant neoplasms of breast.

Are there safety signals or safety updates for Capecitabine?

EMA PRAC: 4 entries; US FDA: 1 entry; MHRA: 1 entry (latest 2025-10-03).

Active substance

Capecitabine

SFDA 15
US FDA 15
EMA 6
Health Canada 11
US price lines 2
NHS prices 1
WHO EML 1
Safety 6

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Aceda 150mg F.C.Tablet	150 mg	Film-coated tablet · Oral use	60 Blister	SAR 122.90	Generic · Prescription	Accord Healthcare Limited	Valid
Aceda 500mg F.C.Tablet	500 mg	Film-coated tablet · Oral use	120 Blister	SAR 658.40	Generic · Prescription	Accord Healthcare Limited	Valid
CAPECITABINE SPC 150 mg Film Coted Tablet	150 mg	Film-coated tablet · Oral use	60 Blister	SAR 177.35	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
CAPECITABINE SPC 500 mg Film Coted Tablet	500 mg	Film-coated tablet · Oral use	120 Blister	SAR 1060.55	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Capecitabine NEAPOLIS	500 mg	Film-coated tablet · Oral use	120 Blister	SAR 577.85	Generic · Prescription	LES LABORATORIES NEAPOLIS PHARMA	Valid
Catabina	500 mg	Film-coated tablet · Oral use	120 Blister	SAR 978.80	Generic · Prescription	SPIMACO ADDWAEIH	Valid
Catabina	150 mg	Film-coated tablet · Oral use	60 Blister	SAR 163.70	Generic · Prescription	SPIMACO	Valid
DIROGIT 500 MG F. C. TABLET	500 mg	Film-coated tablet · Oral use	120 Blister	SAR 954.50	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Emcap	500 mg	Tablet · Oral use	100 Blister	SAR 556.80	Generic · Prescription	Boston Oncology Arabia	Valid
Pitacro	150 mg	Tablet · Oral use	120 Blister	SAR 257.70	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Pitacro	500 mg	Tablet · Oral use	120 Blister	SAR 859.05	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
XELODA 500MG TABLET	500 mg	Film-coated tablet · Oral use	120 Blister	SAR 1174.75	NCE · Prescription	CHEPLAPHARM Arzneimittel GmbH	Valid
Xelobine	500 mg	Film-coated tablet · Oral use	120 Blister	SAR 853.05	Generic · Prescription	Saudi Amarox	Valid
Xelobine	150 mg	Film-coated tablet · Oral use	60 Blister	SAR 149.25	Generic · Prescription	Saudi Amarox	Valid
XELODA 150MG TABLET	150 mg	Film-coated tablet · Oral use	60 Blister	SAR 218.30	NCE · Prescription	ROCHE	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ANAL CANCER; BILIARY TRACT CANCER; BLADDER CANCER; BREAST CANCER EARLY HER-2 -VE; BREAST CANCER MET.HER-2 +VE; BREAST CANCER MET.HER-2 -VE; Cervical Cancer; COLORECTAL CANCER-EARLY & ADVANCED; ESOPHAGEAL CANCER; GASTRIC CANCER; HEAD AND NECK CANCER; MALIGNANT NEOPLASM OF THE PANCREAS; NEUROENDOCRINE TUMORS; OVARIAN CANCER; VAGINAL AND VULVAR CANCERS

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

Product	Strength	Form · route	Applicant	Status	First approved
CAPECITABINE	150MG; 500MG	tablet · oral	TEVA PHARMS USA	Prescription	16 Sep 2013
CAPECITABINE	150MG; 500MG	tablet · oral	RISING	Prescription	8 Aug 2014
CAPECITABINE	150MG; 500MG	tablet · oral	ACCORD HLTHCARE	Prescription	23 Apr 2015
CAPECITABINE	150MG; 500MG	tablet · oral	SHILPA	Prescription	12 Dec 2016
CAPECITABINE	150MG; 500MG	tablet · oral	ALKEM LABS LTD	Prescription	27 Nov 2017
CAPECITABINE	150MG; 500MG	tablet · oral	EUGIA PHARMA	Prescription	17 Apr 2018
CAPECITABINE	150MG; 500MG	tablet · oral	MSN	Prescription	2 Jul 2018
CAPECITABINE	150MG; 500MG	tablet · oral	RELIANCE LIFE	Prescription	27 Apr 2020
CAPECITABINE	150MG; 500MG	tablet · oral	DR REDDYS	Prescription	4 Dec 2020
CAPECITABINE	150MG; 500MG	tablet · oral	TEYRO LABS	Prescription	23 Oct 2023
CAPECITABINE	150MG; 500MG	tablet · oral	HETERO LABS LTD V	Prescription	5 Mar 2024
XELODA	150MG; 500MG	tablet · oral	CHEPLAPHARM	Discontinued	30 Apr 1998
CAPECITABINE	150MG; 500MG	tablet · oral	HIKMA PHARMS	Discontinued	14 Jul 2016
CAPECITABINE	150MG; 500MG	tablet · oral	AMNEAL PHARMS	Discontinued	28 Feb 2017
CAPECITABINE	150MG; 500MG	tablet · oral	SUN PHARM	Discontinued	21 Jun 2019

EMA European Union — centrally authorised medicines

Xeloda CHEPLAPHARM Arzneimittel GmbH · Authorised · authorised 2 Feb 2001 · ATC L01BC06

Therapeutic indication (EMA)

Xeloda is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes' stage C) colon cancer. Xeloda is indicated for the treatment of metastatic colorectal cancer. Xeloda is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen. Xeloda in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Xeloda is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.

Capecitabine Teva Teva Pharma B.V. · Authorised · authorised 20 Apr 2012 · ATC L01BC06

Therapeutic indication (EMA)

Capecitabine Teva is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer. Capecitabine Teva is indicated for the treatment of metastatic colorectal cancer. Capecitabine Teva is indicated for first?line treatment of advanced gastric cancer in combination with a platinum?based regimen. Capecitabine Teva in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Capecitabine Teva is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.

Capecitabine Accord Accord Healthcare S.L.U. · Authorised · authorised 20 Apr 2012 · ATC L01BC06

Therapeutic indication (EMA)

Capecitabine Accord is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer. Capecitabine Accord is indicated for the treatment of metastatic colorectal cancer. Capecitabine Accord is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen. Capecitabine Accord in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Capecitabine Accord is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.

Ecansya (previously Capecitabine Krka) Krka, d.d., Novo mesto · Authorised · authorised 20 Apr 2012 · ATC L01BC06

Therapeutic indication (EMA)

Ecansya is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer. Ecansya is indicated for the treatment of metastatic colorectal cancer. Ecansya is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen. Ecansya in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Ecansya is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.

Capecitabine Medac medac Gesellschaft für klinische Spezialpräparate mbH · Authorised · authorised 19 Nov 2012 · ATC L01BC06

Therapeutic indication (EMA)

Capecitabine Medac is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer. Capecitabine Medac is indicated for the treatment of metastatic colorectal cancer. Capecitabine Medac is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen. Capecitabine Medac in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Capecitabine Medac is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.

Capecitabine SUN Sun Pharmaceutical Industries Europe B.V. · Withdrawn · authorised 21 Jun 2013 · ATC L01BC06

Therapeutic indication (EMA)

Capecitabine is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer. Capecitabine is indicated for the treatment of metastatic colorectal cancer. Capecitabine is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen. Capecitabine in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Capecitabine is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ACH-CAPECITABINE	02426757	150 MG	TABLET · ORAL	ACCORD HEALTHCARE INC
ACH-CAPECITABINE	02426765	500 MG	TABLET · ORAL	ACCORD HEALTHCARE INC
CAPECITABINE	02514982	150 MG	TABLET · ORAL	SANIS HEALTH INC
CAPECITABINE	02514990	500 MG	TABLET · ORAL	SANIS HEALTH INC
CAPECITABINE	02519879	150 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
CAPECITABINE	02519887	500 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
MINT-CAPECITABINE	02508028	500 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
SANDOZ CAPECITABINE	02421917	150 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ CAPECITABINE	02421925	500 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
TARO-CAPECITABINE	02457490	150 MG	TABLET · ORAL	TARO PHARMACEUTICALS INC
TARO-CAPECITABINE	02457504	500 MG	TABLET · ORAL	TARO PHARMACEUTICALS INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	CAPECITABINE 150 MG TABLET	$0.36154	per EA	17 Jun 2026
US NADAC	CAPECITABINE 500 MG TABLET	$0.45556	per EA	23 Sep 2026
NHS Drug Tariff	Capecitabine 500mg tablets	£225.72	120 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.

WHO WHO Model List of Essential Medicines (2025)

8.2.1. Cytotoxic medicines · complementary
Malignant neoplasms of rectum; Malignant neoplasm metastasis in large intestine; Malignant neoplasms of colon; Other specified malignant neoplasms of breast
Oral > Solid > tablet: 150 mg; 500 mg

Safety signals and safety-related labeling changes

US FDA 3 Oct 2025 XELODA — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 26 Nov 2020 PRAC signal: Anaphylactic reaction
Action for MAH: update of the product information: Yes
EMA PRAC 11 Jun 2020 PRAC signal: Anaphylactic reaction
Action for MAH: update of the product information: No
MHRA 11 Dec 2014 Capecitabine: risk of severe skin reactions - discontinue treatment
Severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported during treatment with capecitabine.
EMA PRAC 13 Jun 2013 PRAC signal: Acute renal failure
Action for MAH: update of the product information: No
EMA PRAC 16 May 2013 PRAC signal: Convulsion
Action for MAH: update of the product information: No

All safety entries for capecitabine →

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.