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Two medicines, side by side

Tofacitinib vs sulfasalazine

Tofacitinib and sulfasalazine are both labeled for rheumatoid arthritis and crohn's disease and ulcerative colitis. Drugs@FDA records approvals of tofacitinib since 2012 and of sulfasalazine since 1950. Pharmacies paid $0.573 per tofacitinib 5 mg tablet and $0.199 per sulfasalazine 500 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, tofacitinib is a janus kinase inhibitor and sulfasalazine an aminosalicylate.

Check it at the source: the tofacitinib FDA label on DailyMed (effective July 13, 2026); the sulfasalazine FDA label on DailyMed (effective May 29, 2026).

Highlights of the tofacitinib record

Tofacitinib (Xeljanz) · label of July 13, 2026

Boxed warning

SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS See full prescribing information for complete boxed warning.

Increased risk of serious bacterial, fungal, viral, and opportunistic infections, including tuberculosis (TB), leading to hospitalization or death.

Used for

From the label: indications

XELJANZ (tablets and oral solution) and XELJANZ XR (extended-release tablets) are Janus kinase (JAK) inhibitors. XELJANZ tablets and XELJANZ XR are indicated for the treatment of adult patients with: • Moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers. […]

On the market

Earliest approval on file
November 6, 2012
Generic labelers
24 labelers
Pharmacy cost
$0.573 per tablet

Supply and safety

Shortage
No current entry
Recalls
0

Highlights of the sulfasalazine record

Sulfasalazine (Azulfidine) · label of May 29, 2026

Used for

From the label: indications

AZULFIDINE Tablets are indicated: • in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and • for the prolongation of the remission period between acute attacks of ulcerative colitis.

On the market

Earliest approval on file
June 20, 1950
Generic labelers
5 labelers
Pharmacy cost
$0.199 per tablet

Supply and safety

Shortage
No current entry
Recalls
0

Source: FDA drug labels via openFDA (Tofacitinib label of July 13, 2026, Sulfasalazine label of May 29, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do tofacitinib and sulfasalazine differ on the record?

In FDA's classes, tofacitinib is a janus kinase inhibitor and sulfasalazine an aminosalicylate.

Half-life, in each label's words: Tofacitinib, “12.3 Pharmacokinetics Following oral administration of XELJANZ (tablets and oral solution), peak plasma concentrations …”; Sulfasalazine, “The observed plasma half-life for intravenous sulfasalazine is 7.6 ± 3.4 hours.”

Only the tofacitinib label carries a boxed warning.

Generics: tofacitinib since 2021; sulfasalazine since 1973 (Drugs@FDA).

TofacitinibSulfasalazine
Labeled forRheumatoid arthritis, Crohn's disease and ulcerative colitisCrohn's disease and ulcerative colitis, Rheumatoid arthritis
Pharmacologic classJanus Kinase InhibitorAminosalicylate
How it works (label)Tofacitinib is a Janus kinase (JAK) inhibitor.n/a
Half-life (label)12.3 Pharmacokinetics Following oral administration of XELJANZ (tablets and oral solution), peak plasma concentrations were reached within 0.5 hour - 1 hour, elimination half-life was about 3 hours and a …The observed plasma half-life for intravenous sulfasalazine is 7.6 ± 3.4 hours.
Earliest approval on file (Drugs@FDA)November 6, 2012June 20, 1950
First generic approvedJune 1, 2021November 12, 1973
Generic labelers (NDC)24 labelers5 labelers
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$0.573 per tablet (Tofacitinib 5 mg tablet)$0.199 per tablet (Sulfasalazine 500 mg tablet)
12-month price changen/a+10%
Boxed warningYesNo
Shortage nowNo current entryNo current entry
Recalls recorded00
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)186,74677,784
DEA schedulenonenone

Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)

What next?

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