Is Baricitinib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Baricitinib, including OLUMIANT 2 mg Film Coated Tablet (2 mg, Film-coated tablet, SAR 3776.55); OLUMIANT 4 mg Film Coated Tablet (4 mg, Film-coated tablet, SAR 3776.55).

Is Baricitinib approved by the US FDA?

Drugs@FDA lists 3 application product lines for Baricitinib, including OLUMIANT (Prescription); OLUMIANT (Prescription); BARICITINIB (Discontinued).

Is Baricitinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Baricitinib: Olumiant.

Are there safety signals or safety updates for Baricitinib?

EMA PRAC: 8 entries; US FDA: 1 entry; MHRA: 2 entries (latest 2026-09-25).

Active substance

Baricitinib

SFDA 4
US FDA 3
EMA 1
Health Canada 2
US price lines 2
NHS prices 2
Safety 11

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
OLUMIANT 2 mg Film Coated Tablet	2 mg	Film-coated tablet · Oral use	28 Blister	SAR 3776.55	NCE · Prescription	ELI LILLY NEDERLAND B.V.	Valid
OLUMIANT 4 mg Film Coated Tablet	4 mg	Film-coated tablet · Oral use	28 Blister	SAR 3776.55	NCE · Prescription	ELI LILLY NEDERLAND B.V.	Valid
OLUMIANT 2 mg Film Coated Tablet	2 mg	Film-coated tablet · Oral use	98 Blister	SAR 13168.60	NCE · Prescription	ELI LILLY NEDERLAND B.V.	Withdrawn by MAH · Not Marketed
OLUMIANT 4 mg Film Coated Tablet	4 mg	Film-coated tablet · Oral use	98 Blister	SAR 13168.60	NCE · Prescription	ELI LILLY NEDERLAND B.V.	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ECZEMA; RHEUMATOID ARITHRITIS

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

Product	Strength	Form · route	Applicant	Status	First approved
OLUMIANT	2MG; 1MG; 4MG	tablet · oral	ELI LILLY AND CO	Prescription	31 May 2018
OLUMIANT	1MG; 2MG; 4MG	tablet · oral	MSN	Prescription	8 Aug 2025
BARICITINIB	1MG; 2MG	tablet · oral	AUROBINDO PHARMA LTD	Discontinued	22 Jul 2024

EMA European Union — centrally authorised medicines

Olumiant Eli Lilly Nederland B.V. · Authorised · authorised 13 Feb 2017 · ATC L04AA37

Therapeutic indication (EMA)

Rheumatoid arthritis Baricitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Olumiant may be used as monotherapy or in combination with methotrexate. Atopic Dermatitis Olumiant is indicated for the treatment of moderate to severe atopic dermatitis in adult and paediatric patients 2 years of age and older who are candidates for systemic therapy. Alopecia areata Baricitinib is indicated for the treatment of severe alopecia areata in adult and adolescent patients 12 years of age and older. Juvenile idiopathic arthritis Baricitinib is indicated for the treatment of active juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response or intolerance to one or more prior conventional synthetic or biologic DMARDs: Polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [RF+] or negative [RF-], extended oligoarticular), Enthesitis related arthritis, and Juvenile psoriatic arthritis. Baricitinib may be used as monotherapy or in combination with methotrexate.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
OLUMIANT	02480018	2 MG	TABLET · ORAL	ELI LILLY CANADA INC
OLUMIANT	02544768	4 MG	TABLET · ORAL	ELI LILLY CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	OLUMIANT 2 MG TABLET	$92.54333	per EA	23 Sep 2026
US NADAC	OLUMIANT 4 MG TABLET	$184.66233	per EA	1 Jan 2026
NHS Drug Tariff	Baricitinib 2mg tablets	£805.56	28 tablet	1 Oct 2026
NHS Drug Tariff	Baricitinib 4mg tablets	£805.56	28 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 25 Sep 2026 OLUMIANT — 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 16 May 2024 PRAC signal: Hypoglycaemia in diabetic patients
Action for MAH: update of the product information: Yes
EMA PRAC 11 Jan 2024 PRAC signal: Hypoglycaemia in diabetic patients
Action for MAH: update of the product information: No
EMA PRAC 28 Sep 2023 PRAC signal: Interstitial lung disease
Action for MAH: update of the product information: No
EMA PRAC 12 May 2023 PRAC signal: Interstitial lung disease
Action for MAH: update of the product information: No
MHRA 26 Aug 2020 Baricitinib (Olumiant▼): increased risk of diverticulitis, particularly in patients with risk factors
Use baricitinib with caution in patients with diverticular disease and in those concomitantly treated with medications associated with an increased risk of diverticulitis.
EMA PRAC 14 May 2020 PRAC signal: Diverticulitis
Action for MAH: update of the product information: Yes
MHRA 18 Mar 2020 Baricitinib (Olumiant▼): risk of venous thromboembolism
Discontinue baricitinib treatment permanently if clinical features of deep vein thrombosis or pulmonary embolism occur. Prescribers are reminded to use caution if using baricitinib in patients with risk factors for deep vein thrombosis or pulmonary embolism in addition to rheumatoid arthritis.
EMA PRAC 16 Jan 2020 PRAC signal: Diverticulitis
Action for MAH: update of the product information: No
EMA PRAC 8 Feb 2018 PRAC signal: Pneumonia
Action for MAH: update of the product information: Yes
EMA PRAC 29 Sep 2017 PRAC signal: Pneumonia
Action for MAH: update of the product information: No

All safety entries for baricitinib →

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.