Does Jardiance (empagliflozin) cause skin ulcers?

Does Jardiance Cause Skin Ulcers?

Jardiance (empagliflozin) is not known to directly cause skin ulcers, but it carries specific warnings about diabetic foot complications and requires heightened caution in patients with existing foot ulcers, peripheral vascular disease, or neuropathy.

FDA-Labeled Warnings and Contraindications

The FDA label for Jardiance does not list skin ulcers as a direct adverse effect, but includes important cautions relevant to wound healing 1:

• Necrotizing fasciitis of the perineum (Fournier's gangrene) is a rare but serious necrotizing infection requiring urgent surgical intervention that has been reported with SGLT2 inhibitors including Jardiance 1
• Volume depletion can occur, potentially compromising tissue perfusion in vulnerable patients 1
• Genital mycotic infections are common (occurring in approximately 4-5% of patients), but these are distinct from skin ulcers 1

SGLT2 Inhibitor Class Considerations

The ACC Expert Consensus specifically cautions against canagliflozin (not empagliflozin) in patients with diabetic foot ulcers 2:

• History of prior amputation, severe peripheral vascular disease, neuropathy, or diabetic foot ulcers is listed as a caution for canagliflozin and ertugliflozin
• The document explicitly states: "No increased risk of amputation has been seen for empagliflozin or dapagliflozin to date" 2

Recent pharmacovigilance data shows agent-specific differences 3:

• Canagliflozin demonstrated the highest signal for diabetic foot infection (ROR 162.84; 95% CI 134.14-197.68) 3
• Empagliflozin showed a protective signal (ROR 0.56) and did not meet positive disproportionality criteria 3
• The risk increased with duration of SGLT2 inhibitor exposure, rising from ROR 11.25 at ≤30 days to ROR 48.77 beyond 365 days 3

Rare Case Reports

One isolated case report documented bilateral finger gangrene in a 76-year-old man who sustained minor trauma and was started on empagliflozin one week later 4:

• Investigations were negative for vascular insufficiency, infection, and vasculitis 4
• Discontinuation of empagliflozin slowed progression and reduced neuropathic pain 4
• This represents the first reported case of empagliflozin-associated finger gangrene and the second case of any SGLT2 inhibitor causing upper extremity gangrene 4

Bullous pemphigoid has been reported with empagliflozin initiation, though causality is complicated by concurrent neuropsychiatric medications 5:

• A 59-year-old woman developed blistering rash one month after starting empagliflozin 5
• She was also on paliperidone (an atypical antipsychotic known to be associated with bullous pemphigoid) 5
• This represents a potential novel drug trigger, but the evidence is insufficient to establish causation 5

Clinical Implications for Diabetic Foot Care

Patients on Jardiance with diabetic neuropathy or foot complications require standard diabetic foot surveillance 6, 7:

• Screen patients at IWGDF risk level 1 every 6-12 months, risk level 2 every 3-6 months, and risk level 3 every 1-3 months 6
• Patients must never walk barefoot, wear only socks without shoes, or use thin-soled slippers 6
• Daily foot inspection is mandatory, with immediate medical contact for any temperature increase, blisters, cuts, or color changes 7
• For patients with healed plantar ulcers (IWGDF risk 3), prescribe therapeutic footwear achieving ≥30% plantar pressure reduction 6, 7

Common Pitfalls to Avoid

• Do not confuse empagliflozin with canagliflozin: The amputation and foot ulcer signals are specific to canagliflozin, not empagliflozin 2, 3
• Do not overlook volume depletion risk: Dehydration from Jardiance can compromise tissue perfusion in patients with peripheral vascular disease 1
• Do not dismiss Fournier's gangrene: Though rare, this life-threatening infection requires immediate recognition—any genital or perineal pain, tenderness, erythema, or swelling with fever mandates urgent evaluation 1
• Do not attribute all skin complications to the drug: In diabetic patients, foot ulcers are multifactorial and most commonly related to neuropathy, vascular disease, and mechanical stress rather than medication 6, 7