Key takeaways
- In the SkinPen FDA study, the common responses were temporary and no serious adverse events were recorded.
- FDA's less common risks include pigment changes, cold sore reactivation and infection; some side effects may be permanent.
- FDA and AAD both list people who should skip or postpone microneedling, and they differ on isotretinoin timing.
- AAD links untrained providers to higher risk of infection, scarring and long-lasting discoloration.
- Ask whether a new needle cartridge is used for each patient and each session.
Is microneedling safe?
Microneedling devices are regulated as medical devices, and FDA has authorized specific products through its De Novo and 510(k) pathways — cleared or granted, not approved — for a short list of uses: improving the appearance of facial acne scars, facial wrinkles and abdominal scars in people aged 22 or older.
The most detailed safety data we reviewed is SkinPen's authorization study.
It enrolled 41 adults with moderate-to-severe atrophic acne scars, 20 of whom were treated with the final device in three treatments spaced about a month apart.
In that study the common treatment responses researchers logged were temporary — none persisted at 6 months, and no serious adverse events were recorded.
FDA's own patient summary is consistent with that picture: it says most side effects associated with microneedling occur shortly after a treatment and resolve, while also stating that some side effects may be permanent.
The American Academy of Dermatology (AAD) describes microneedling, done by a dermatologist, as minimally invasive and safe on all skin tones, working by stimulating collagen in a process it calls collagen induction therapy.
New to the treatment itself?
Our microneedling guide covers what it is, what it is authorized for and how to find a provider.
FDA states that the risks of off-label uses of microneedling devices, of combining them with other products, and of products FDA has not evaluated are not known. Targets you will see marketed that are not on the authorized list — stretch marks, enlarged pores, melasma, under-eye skin, hair loss — fall into that category, and so does combining the device with serums, platelet-rich plasma or exosome products.
Common side effects and how long they last
FDA's list of common microneedling risks reads like an aggravated skin report: dryness, rough skin, tightness, redness, itching, peeling, discomfort, burning, bruising, bleeding and crusting.
Recorded rates for five of those responses come from the SkinPen study.
Redness, itching, peeling, discomfort or tenderness was logged in 31% of subjects and lasted 1 to 3 days — the highest rate among the responses recorded.
Dryness followed at 12%, lasting 1 to 6 days, then burning at 9% (1 to 3 days), rough skin at 7% (1 to 2 days) and tightness at 4% (1 to 2 days).
Common responses in the SkinPen study
Share of subjects; all were temporary
Source: SkinPen De Novo study (DEN160029)
What it looks and feels like day to day: AAD describes skin that looks red on lighter skin tones or darker on deeper tones, feels sunburned, and usually clears in a few days to a week, with an immediate return to work or school and a 24-hour wait before makeup.
Cleveland Clinic puts redness and swelling at up to five days, adds tightness or dry, flaky skin that improves with moisturizer, and advises staying out of the sun until the skin heals.
During the session itself, Cleveland Clinic says a numbing cream such as lidocaine is applied 30 to 45 minutes beforehand, that you may feel warmth or a scratching sensation, that some people feel discomfort where the needles are near bony areas such as the cheekbones, and that deeper treatment may cause a little bleeding.
Rare complications: infection, granulomas, pigment changes
FDA's less common risk list is where the serious items live: pigment changes, with skin turning darker (hyperpigmentation) or lighter (hypopigmentation), lines on the face, cold sore (herpes) reactivation, swollen lymph nodes, infection, and stinging or itching when cosmetics are applied to treated skin.
FDA also states plainly that some side effects may be permanent.
Pigment change deserves a paragraph of its own, because Cleveland Clinic's patient page says microneedling "doesn't carry the risk of skin discoloration" the way heat and laser treatments do.
FDA's published list contradicts that, and the agency separately flags people with darker skin types because of the darkening or lightening risk, noting that some FDA-authorized devices were not studied in darker skin types.
SkinPen's study did include darker skin — 11 of its 41 subjects were Fitzpatrick type V or VI, with types II through VI studied and type I not studied — but coverage varies by device, which is a fair question to ask about any device used on you.
Foreign-body granulomas have been reported after microneedling when a topical product was pushed into the skin.
A 2014 JAMA Dermatology case series described three women, two of whom had a vitamin C serum applied during treatment; its authors wrote: "Application of topical products prior to microneedling can introduce immunogenic particles into the dermis and potentiate local or systemic hypersensitivity reactions." A case series of three shows what can happen, not how often; the sources we reviewed give no incidence rate.
CDC's disease investigators (MMWR, April 2024) linked HIV to platelet-rich plasma microneedling "vampire facials" at an unlicensed New Mexico spa: five spa-related cases were confirmed, four of them in patients who had received the treatment, and inspection found unsafe infection-control practices, including unlabeled blood tubes stored with food and no autoclave. Infection is on FDA's less common risk list; the CDC investigation is the extreme version of what lapses in sterile technique can cost.
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Who shouldn't get microneedling (rosacea, active acne, pregnancy)?
FDA publishes a long list of people and situations for which microneedling may not be suitable:
- Bleeding or clotting disorders, or blood thinners including low-dose aspirin
- Immune suppression or uncontrolled diabetes
- Active skin infection, hepatitis or HIV
- Eczema, psoriasis, vitiligo or autoimmune disease
- An active facial rash or a cold sore outbreak
- Isotretinoin (Accutane) now or within the past 6 months
- A history of keloids
- Actinic keratoses, warts or moles in the treatment area
- A tan or planned sun exposure in the next two weeks
- Cancer treatment
- Pregnancy or breastfeeding
- An allergy to stainless steel or anesthetics
The AAD list overlaps but is worded differently: it says microneedling usually should not be done in people who heal poorly, have or had keloids, are immunosuppressed, are being treated for skin cancer in the area, or are receiving radiation, and should be postponed for a tan or recent sun, a skin infection, painful, pus-filled or deep pimples, or isotretinoin use.
On isotretinoin the two sources disagree — FDA says within the past 6 months, AAD says at least one month after the last dose — so it is a specific question to put to your provider.
On active acne, the sourced trigger is AAD's: pimples that are painful, pus-filled or deep mean postponing, and FDA's list adds active skin infection and an active facial rash or cold sore outbreak.
On rosacea, there is no sourced answer: rosacea is not named on FDA's list, and we could not find a primary source that says whether microneedling flares it.
What AAD's rosacea material does say is that some skin and hair care products and some makeup are among common rosacea triggers.
Irritating treatments can trigger flares, so whether microneedling suits your skin is a question for a dermatologist who knows your rosacea.
On pregnancy and breastfeeding, FDA lists both among the situations where microneedling may not be suitable.
Why provider training and sterile technique matter
AAD is direct about the training gap: when microneedling is performed by someone lacking medical training, it says the risk of infection, scarring or long-lasting skin discoloration increases, and it recommends a board-certified dermatologist (certification is through the American Board of Dermatology).
It also draws a line around setting: at-home microneedling products and microneedling at a non-medical spa are not meant to puncture the skin and give less noticeable results, and at-home use risks overuse, infection, scarring and spreading warts or herpes.
Sterile technique has one bright-line question from FDA: whether a new needle cartridge is used for each patient and each session.
Re-use of the needle cartridge is unsafe and is not consistent with the agency's review and authorization, FDA says, even if the cartridge is cleaned.
Two equipment questions are worth asking before you book.
Depth: in SkinPen's authorization study, needle depths above 1.5 mm were not evaluated for safety or effectiveness, even though the device can be set up to 2.5 mm.
Add-ons: FDA says microneedling devices are not approved for delivering cosmetics, topical medications, vitamin solutions, drugs or blood products such as platelet-rich plasma into the skin, and in a December 2019 safety notification it stated that there are currently no FDA-approved exosome products, reporting serious adverse events in Nebraska patients given unapproved exosome products.
What to do if something goes wrong
The baseline expectation comes from FDA: most side effects associated with microneedling occur shortly after a treatment and resolve.
The call-now thresholds with a source behind them come from Cleveland Clinic: contact your provider if the treated area bleeds for longer than 24 hours, blisters, or stays swollen for longer than a week.
When to contact your provider (Cleveland Clinic)
| Sign | Threshold |
|---|---|
| Bleeding | Longer than 24 hours |
| Blisters | Any |
| Swelling | Longer than a week |
A reaction that keeps getting worse instead of better, or one that is not on any list above, is a question for the licensed provider who treated you.
For the general playbook — documenting what happened, contacting the practice, reporting to a board — see our guide to what to do after a complication.
Frequently asked questions
Does microneedling hurt?
Cleveland Clinic says a numbing cream such as lidocaine is applied 30 to 45 minutes before treatment, that you may feel warmth or a scratching sensation during the session, that some people feel discomfort where the needles are near bony areas such as the cheekbones, and that deeper treatment may cause a little bleeding.
In SkinPen's FDA study, burning was logged in 9% of subjects and lasted 1 to 3 days.
Can microneedling cause hyperpigmentation?
Yes — it is on FDA's list of less common risks, which names both darkening (hyperpigmentation) and lightening (hypopigmentation).
Cleveland Clinic's patient page says microneedling carries no discoloration risk the way heat or laser treatments do; FDA's published list contradicts that.
FDA also flags darker skin types because of the pigment-change risk and notes that some authorized devices were not studied in darker skin, so it is a fair question to ask about the specific device your provider uses.
Can you have microneedling while pregnant or breastfeeding?
FDA lists pregnancy and breastfeeding among the situations in which microneedling may not be suitable.
Beyond that list, our sources give no evidence on how microneedling affects a pregnancy, so the sourced answer is the FDA list itself: tell the practice before you book, and let a licensed provider judge your specific case.
Is PRP microneedling (a 'vampire facial') safe?
FDA says microneedling devices are not approved for delivering blood products such as platelet-rich plasma into the skin, and that the risks of combining microneedling devices with other products are not known.
Infection control is the documented hazard: CDC confirmed five spa-related HIV cases — four of them in people who had received the treatment — tied to PRP vampire facials at one unlicensed spa, where inspectors found unlabeled blood tubes stored with food and no autoclave.
If you consider PRP microneedling, the provider's licensing and sterile technique are the questions to press.
Sources
Every number on this page comes from one of these sources and was checked against it.
- Microneedling Devices · U.S. Food and Drug Administration
- accessdata.fda.gov · U.S. Food and Drug Administration
- Microneedling can fade scars, uneven skin tone, and more · American Academy of Dermatology
- Microneedling: What It Is, Uses, Benefits & Results · Cleveland Clinic
- Facial allergic granulomatous reaction and systemic hypersensitivity associated with microneedle therapy for skin rejuvenation · Soltani-Arabshahi et al., JAMA Dermatol, 2014
- cdc.gov · CDC
- Public Safety Notification on Exosome Products · U.S. Food and Drug Administration
- Dermatology Training Pathway · abderm.org
- Triggers could be causing your rosacea flare-ups · American Academy of Dermatology
Medical disclaimer. MedSpaStandard is for education only and is not medical advice. Talk to a licensed provider about your own health, and check any provider's license with your state board.