Let’s face it: treating vitiligo isn’t exactly a walk in the park. For years, dermatologists have cobbled together treatments using tools designed for other conditions—because vitiligo didn’t have much in the way of official, FDA-approved options. That changed in 2022 with the approval of ruxolitinib cream, the first treatment specifically greenlit for repigmenting skin in people with non-segmental vitiligo.

TL;DR:

A new study analyzed 10 years of safety reports for three common vitiligo creams—tacrolimus, pimecrolimus, and ruxolitinib—using FDA’s FAERS database.

• Tacrolimus had the most serious reported issues, including rare cases of hospitalization, anemia, and heart rhythm changes.
• Pimecrolimus showed mostly mild, skin-related side effects—plus one oddball: tooth fractures.
• Ruxolitinib, though new, already logged more reports than the others—but most were mild. 

The takeaway? These treatments are generally safe, but not risk-free.

But how safe are these creams, really?

That’s what a new study set out to explore, using a big—but messy—public database known as FAERS (FDA Adverse Event Reporting System). It’s where doctors, pharmacists, and even patients can report when things go sideways with a medication.

Let’s unpack what the researchers found—and what it means for the millions of people living with vitiligo.

First, a Quick Recap on the Creams

Three main topical treatments are in the spotlight:

• Tacrolimus – A calcineurin inhibitor originally designed for organ transplant patients. Used off-label for years in vitiligo, especially on the face.
• Pimecrolimus – Similar to tacrolimus, but generally considered milder.
• Ruxolitinib – A JAK inhibitor approved in 2022 for non-segmental vitiligo, making it the new kid on the block with a lot of hype.

Each has a different mechanism of action, but the same basic goal: stop the immune system from attacking pigment-producing cells and give melanocytes a chance to recover.

What Did the Study Actually Do?

The research team analyzed 844 adverse event reports related to these three creams, spanning a decade (2013–2023) and involving 388 patients aged two and up. They separated side effects into two buckets:

• Dermatological (stuff happening on the skin)
• Systemic (everything else—i.e., inside your body) 

Importantly, they didn’t just cherry-pick scary cases. They included all reports where the medication was listed as the primary suspect and the indication was vitiligo.

So… What Went Wrong?

Tacrolimus had the most eyebrow-raising stats:

• 12 hospitalizations
• 2 life-threatening events
• 4 reported disabilities 

Some of the more serious issues? Aplastic anemia, hemorrhage, and heart rhythm issues (QT prolongation). That said, these are extremely rare and often based on self-reporting—so it’s hard to prove cause and effect.

Pimecrolimus, on the other hand, came through with a cleaner safety profile. The most common complaints were relatively tame: skin irritation, burning, pigmentation issues, and even a strange entry—tooth fracture (yes, really).

Ruxolitinib, despite being the newest and most promising player, wasn’t spotless either. The cream racked up 406 adverse events in just two years, including:

• Pericarditis (inflammation around the heart)
• Anemia
• Urosepsis (a severe urinary tract infection) 

But here’s the important bit: none of these ruxolitinib cases led to hospitalization, disability, or death—at least, not according to the FAERS reports.

Wait—Aren’t These Creams Supposed to Stay on the Skin?

Yes. In theory, topical medications like these should act locally, without entering the bloodstream. But in practice? Systemic absorption can happen, especially if:

• The cream is applied to large or broken areas of skin
• It’s used over long periods
• The patient is very young or has compromised skin barriers 

One earlier study even found detectable levels of tacrolimus in the blood in nearly 40% of users—compared to about 12% for pimecrolimus. So while we can say these creams mostly stay local, we can’t guarantee they never go systemic.

What Does This Mean for People with Vitiligo?

Here’s the bottom line: The creams are generally safe. Most side effects are mild and localized.

• Tacrolimus may carry a higher systemic risk than the others—though again, these are rare.
• Ruxolitinib looks promising in both efficacy and safety—but we need more real-world data.
• Pimecrolimus is the quiet achiever, with few severe reports but possibly less potent results in clinical practice.

So no, you don’t need to panic if your dermatologist prescribes one of these. But you should always report anything unusual—especially systemic symptoms like fatigue, fever, or heart palpitations.

What the Study Didn’t Tell Us

Because FAERS relies on voluntary reporting, there are huge gaps in the data. The database doesn’t include:

• Dosages
• Treatment durations
• Patient histories or comorbidities
• How many people used the drugs versus how many had issues 

In other words, it’s great for spotting red flags—but terrible for estimating risk. Think of it as a metal detector: it beeps when there’s something odd, but it can’t tell you what’s buried, how deep, or how dangerous it is.

Final Thoughts

For a long time, vitiligo patients were treated with whatever was lying around—repurposed transplant drugs, steroids, and folk remedies. Now, with more targeted treatments and ongoing safety monitoring, we’re inching closer to a new standard of care.

This study reminds us that safety monitoring doesn’t stop after FDA approval. It’s an ongoing process—and one where patients, clinicians, and researchers all play a role.

Dig deeper

• Descriptive Analysis of Reported Adverse Events Associated with Vitiligo Medications Using FDA Adverse Event Reporting System (FAERS) Databases 2013–2023
• Clinical Trials: An Important Step in Drug Development
• Vitiligo Drug Pipeline Analysis and Market Insights

Listen

• Inside Vitiligo Clinical Trials: Why, What and How? (Ep. 25)