Can tofacitinib (Xeljanz) cause or worsen acne?

Tofacitinib and Acne

Yes, tofacitinib (Xeljanz) can cause acne, and this is a recognized adverse effect listed in the FDA drug label as occurring in postmarketing surveillance. 1

Incidence and Clinical Characteristics

Acne is a documented cutaneous adverse event with tofacitinib, though the exact incidence varies by indication:

• The FDA label for tofacitinib lists acne as a common adverse reaction in ulcerative colitis patients, occurring in ≥2% of patients treated with 10 mg twice daily during induction trials 1
• Acne has also been identified as a postmarketing adverse reaction under "Skin and subcutaneous tissue disorders" 1
• In clinical practice treating alopecia areata, acne was among the most common adverse events reported with tofacitinib 2
• A case report documented significant worsening of pre-existing facial acne four months after initiating tofacitinib for alopecia totalis 3

Severity and Management

The acne associated with tofacitinib is typically mild to moderate and rarely requires drug discontinuation:

• Most cases do not require specific intervention or can be managed with standard topical acne therapies 2
• The acne exacerbation reported in the literature was successfully managed without discontinuing tofacitinib 3
• No severe cases requiring hospitalization have been reported in the available evidence 2

Clinical Context and Comparison

While acne is recognized with tofacitinib, it appears to be more prominently associated with other JAK inhibitors, particularly upadacitinib:

• The International Eczema Council guidelines note that acne and folliculitis were uncommonly reported in rheumatoid arthritis trials but are among the most common cutaneous adverse events in atopic dermatitis trials with JAK inhibitors 4
• Acne rates are lowest for baricitinib and highest for upadacitinib (up to 17% at 30 mg daily), with a clear dose-dependent trend 4
• JAK inhibitor-related acne typically presents with classical distribution and morphology (comedonal and inflammatory lesions on face, upper chest, and back) and responds well to common acne treatments 4

Practical Recommendations

When prescribing tofacitinib, counsel patients about the possibility of acne development and have a management plan ready:

• Inform patients that acne may develop during treatment, though it is generally mild 1, 2
• If acne develops, initiate standard topical acne therapies (topical antibiotics, benzoyl peroxide, or retinoids) without discontinuing tofacitinib 4
• Consider dermatology referral only if acne is severe or refractory to standard topical management 4
• Document any personal or family history of acne before initiating therapy, as this may be a risk factor 5

Important Caveats

Do not confuse the acne risk profile of tofacitinib with that of upadacitinib, which has substantially higher rates and dose-dependent acne occurrence 4, 6, 5. The evidence for tofacitinib-associated acne is primarily from postmarketing surveillance and case reports, whereas upadacitinib has well-documented acne rates from large phase 3 trials 4, 6.