Is Microneedling Safe? Risks, Side Effects and Who Shouldn’t Do It

Not yet medically reviewed. This page has not been reviewed by a licensed professional. It summarises published research, cited below, and is not medical advice. Medical disclaimer

Done by a trained practitioner with a sterile, single-use needle cartridge, microneedling has a good safety record in published studies. Most side effects are redness, swelling, dryness and peeling that clear within about a week. Lasting problems (dark or light patches, track-shaped scars, granulomas, infection) are documented mainly in case reports, which show they happen but not how often. For microneedling at home, there is very little evidence either way: one small uncontrolled study and a set of case reports. The FDA says it has not authorized any microneedling device for over-the-counter sale.

The second half of the answer is who is excluded. The FDA publishes a list of people for whom microneedling “may NOT be suitable”, and most of the clinical trials behind the safety record left those same people out. So the reassuring numbers describe healthy volunteers, and for most of the excluded groups there is no study data at all.

Common side effects, and how often they happen

Three systematic reviews agree on the shape of the picture:

  • A 2021 review in Dermatologic Surgery (Chu and colleagues, University of California, Irvine) pooled 85 articles. The most common adverse events were expected, short-lived ones lasting up to 7 days: redness and swelling, pain, post-inflammatory hyperpigmentation (PIH), dryness and peeling, swollen lymph nodes and irritant contact dermatitis.
  • A 2021 review in the Journal of Clinical and Aesthetic Dermatology (Gowda and colleagues) covered 51 articles and 1,029 patients treated with rollers, stamps, pens and radiofrequency (RF) microneedling. It found the procedure “relatively safe” whatever the device, with expected redness, pain, swelling and temporary irritation.
  • A 2025 meta-analysis of facial rejuvenation (Foppiani and colleagues, 21 studies, 723 patients) put numbers on it: transient redness in 6.8% of patients, scaling 1.7%, a burning sensation 1.5% and itching 0.4%.

Those rates look low next to the one pivotal device trial the FDA reviewed. In the SkinPen Precision study behind the first microneedling authorization (De Novo DEN160029, granted to Bellus Medical in March 2018), 41 participants (20 treated with the final SkinPen, 21 with a prototype) kept daily symptom diaries. Thirteen of them (31%) recorded redness, itching, peeling, discomfort and tenderness lasting 1 to 3 days; 12% had dryness for up to 6 days and 9% had burning for 1 to 3 days. All of it resolved, and no adverse event persisted at six months. The difference from the meta-analysis is mostly about what gets counted: diaries catch every expected reaction, while many published studies record only what investigators class as an adverse event.

The FDA’s own list for authorized devices splits the same effects into common (dryness, rough skin, tightness, redness, itching, peeling, discomfort, burning, bruising, bleeding, crusting) and less common (pigment changes, lines on the face, cold-sore reactivation, swollen lymph nodes, infection, and stinging when cosmetics are applied).

The rare but lasting complications

Pigment changes. PIH is the persistent complication reviews mention most, and Chu’s review names darker skin as one of the factors that raise the risk. The other direction also exists: the FDA lists loss of pigment (hypopigmentation).

Track-shaped scars. “Tram-track” scarring is a pattern of lines following the path of the needles. It was described in a 2012 report from New Delhi titled “‘Tram track effect’ after treatment of acne scars using a microneedling device”, and Chu’s review lists it among the persistent serious events. No review gives a rate. In the SkinPen trial, one participant developed linear marks on the forehead and both sides of the face, which investigators judged possibly related to the device and attributed to sun exposure soon after treatment against study instructions; it resolved.

Texture complaints are a recurring theme in user discussions. A thread titled “Microneedling regrets?” in r/30PlusSkinCare has a search snippet describing skin “almost orange peel like” with lines of enlarged pores where the needle went. That is one person’s account, and nothing in it identifies the device, depth or who did the treatment.

Microneedling regrets?
byu/oldgrowthcedar in30PlusSkinCare

Granulomas. Foreign-body and allergic granulomas are firm, persistent lumps that form when material reaches the dermis. A 2025 systematic review found 15 patients across 13 studies, and most cases involved a product applied around the time of needling, most often a vitamin C serum. Our aftercare and topicals guide covers those cases and what the evidence says about products on freshly needled skin.

Infection. Infection is listed by every regulator, and the worst documented outcome is an infection-control failure rather than a device fault. A CDC investigation published in 2024 linked five HIV cases to an unlicensed New Mexico spa offering platelet-rich plasma microneedling facials (“vampire facials”). The CDC concluded that three of those people were likely infected at the spa; for a couple among the five, the infections probably predated their visits. The first case came to light in 2018. Our PRP microneedling guide covers the investigation in detail. The spa did not follow recommended infection control or keep client records. Separately, a 2026 case report describes a scalp abscess that spread to the skull bone after microneedling for hair loss.

Metal reactions. Chu’s review lists metal allergy as a risk factor. A 2026 study of used needles from five microneedling brands found that three released nickel and at least four were gold-coated; the aftercare guide has the details.

Who shouldn’t microneedle

The FDA’s microneedling device page lists 16 situations in which the procedure “may NOT be suitable”. Health Canada’s 2021 advisory on Dr. Pen devices names most of the same ones. These lists are regulatory guidance. They are not drawn from trials that tested each group, and for most of them no such trial exists.

Condition Who lists it What the studies show
Active skin infection (bacterial, viral, fungal) FDA; Health Canada Chu’s 2021 review names active infection as a risk factor for adverse events. No trial deliberately treated infected skin.
Current cold-sore (herpes) outbreak FDA; Health Canada lists cold-sore reactivation as a risk Reactivation is a listed side effect. The FDA advises providers to consider antiviral prophylaxis for people with a history of herpes simplex. We found no trial measuring how often it happens.
Active acne Clinic convention; the SkinPen trial excluded anyone with more than 5 active inflammatory lesions. The FDA lists “active rash” and active infection rather than acne by name Contested: a 2023 pilot study treated acne with microneedling and reported no post-treatment complications (details below).
Eczema, psoriasis, vitiligo or autoimmune disease (now or in the past) FDA For vitiligo there is trial data: in a 2022 study of 20 patients, half of the patches given microneedling showed koebnerization, meaning the vitiligo spread where the skin was injured. We found no equivalent study for eczema or psoriasis.
Keloids or a history of keloid scars in the area FDA; Health Canada The SkinPen trial excluded anyone with a current or past hypertrophic or keloid scar, so it produced no data on them. No trial of keloid-prone people was found.
Clotting or bleeding disorders (e.g. hemophilia) FDA; Health Canada Convention, based on the pinpoint bleeding the procedure causes; we found no outcome data.
Blood thinners (warfarin, heparin, low-dose aspirin) FDA; Health Canada The SkinPen trial excluded anticoagulants, antiplatelet drugs and chronic NSAID use, so it says nothing about them.
Isotretinoin (Accutane) now or within 6 months FDA Reviewed evidence now points the other way (see the next section).
Pregnancy or breastfeeding FDA; Health Canada No published study of microneedling in pregnancy was found. The restriction is precautionary.
Immune deficiency or suppression; HIV or hepatitis FDA; Health Canada (compromised immune system) Convention; nothing microneedling-specific found.
Uncontrolled diabetes FDA; Health Canada Convention; no microneedling study found.
Darker skin types FDA; Health Canada Studied, with mixed findings (see below).
Actinic keratoses, warts, moles or birthmarks in the area FDA; Health Canada (warts, moles, birthmarks) Convention. The SkinPen trial excluded cancerous or pre-cancerous lesions in the treatment area.
Cancer, or chemotherapy, radiotherapy or steroid treatment FDA; Health Canada (treatments for cancer) Convention only.
A tan, or sun exposure planned in the next 2 weeks FDA One SkinPen trial participant’s facial marks were attributed to sun exposure after treatment.
Allergy to stainless steel or to topical or local anesthetics FDA; Health Canada Chu’s review lists metal allergy as a risk factor; nickel release from needles has been measured.

The SkinPen trial also excluded people with active or past systemic granulomatous disease (such as sarcoidosis or tuberculosis) and connective tissue disease (such as lupus). Neither appears on the FDA’s consumer list.

One reader-reported pattern sits close to the autoimmune row. A thread titled “Microneedling potentially harmful?” in r/30PlusSkinCare has a snippet describing serious damage (inflammation, trauma, scars) in some people with sensitive skin and various autoimmune skin diseases. A thread title and snippet cannot show what happened or why.

Microneedling potentially harmful?
byu/TruthIsABiatch in30PlusSkinCare

Keloids: excluded as patients, studied as a treatment

Microneedling has been investigated as a treatment for hypertrophic scars and keloids. A 2018 systematic review (Ramaut and colleagues, Ghent) lists them among the conditions it was tested on, and a 2017 review of all skin types (Bonati and colleagues) reports benefit in keloids. The FDA list and the SkinPen trial treat a keloid history as a reason not to treat. Nobody has published a study that reconciles the two, and we could not find data on people who form keloids being needled elsewhere on the body.

Active acne: the exclusion is being tested

A 2023 pilot study in Skin Health and Disease treated acne vulgaris with microneedling on two schedules and reported a 37% to 58% fall in inflammatory lesions, with no post-treatment complications. Its authors conclude there is “no scientific reason” for microneedling to be contraindicated in acne. All three authors were employees of Crown Laboratories, which funded the study. It is a single pilot and does not change the FDA’s list or clinic practice.

Isotretinoin: the rule the evidence has overtaken

The FDA list still says to avoid microneedling during isotretinoin treatment or within 6 months of stopping it. Three published reviews disagree:

  • A 2017 task force of the Association of Cutaneous Surgeons of India found insufficient evidence for the delay and concluded that dermaroller treatment and fractional RF microneedling are safe in people currently or recently taking isotretinoin.
  • A 2025 review of 34 studies covering 1,563 isotretinoin patients found insufficient evidence to delay dermaroller or fractional RF microneedling treatment, while still advising against fully ablative lasers and mechanical dermabrasion during treatment.
  • A 2026 updated review (Ghali and colleagues, University of South Florida) found the 6-month rule rests mostly on older case reports and small case series, and that studies of microneedling and other procedures generally showed normal healing without more keloid or hypertrophic scarring.

The 2026 authors still call for prospective studies in darker skin and in people prone to abnormal scarring, the two groups the evidence covers least. Isotretinoin timing is a decision for the prescribing doctor.

Is microneedling safe for darker skin?

The evidence is mixed rather than missing. A 2016 review in the Journal of the American Academy of Dermatology (Cohen and Elbuluk, NYU) concluded that microneedling may have a better safety profile than lasers, peels and dermabrasion in Fitzpatrick skin types IV to VI, which carry a higher risk of pigment problems and scarring with those treatments. A 2022 meta-analysis of 12 randomized trials of microneedling for acne scars (414 participants) reported no secondary scarring or infection, and its pooled PIH result favored microneedling over the comparison treatments.

Against that, Chu’s 2021 review lists darker skin as a factor that increases the risk of adverse events, and the FDA notes that some authorized devices “were not studied in subjects with darker skin types”. The SkinPen trial did include them: 11 of its 41 participants had Fitzpatrick skin type V or VI. Separately, a University of Iowa study found that microneedle channels take longer to close in darker skin, which the aftercare guide covers.

Is at-home microneedling safe?

No study answers this. What exists:

  • Regulators. The FDA says it “has not authorized any microneedling medical devices for over-the-counter sale”. All 26 FDA clearances under product code QAI in our verification file are for prescription use only. Health Canada’s advisory says no microneedling device is authorized there for home use either, because home use carries “higher health risks associated with inappropriate use, contamination, and infection”. See what FDA clearance means and our device lookup.
  • One small study. A 2022 study in the Journal of Cosmetic Dermatology had 11 women use a 0.2 mm home microneedling device twice a week for 3 months alongside a growth-factor serum. No serious adverse effects were reported. It had no control group, and 0.2 mm is far shallower than the depths sold in many home pens.
  • Case reports. The 2014 JAMA Dermatology granuloma report singled out home use, and a 2025 case describes a necrotic chin ulcer after vitamin E oil was used with an at-home device. Both are in the aftercare guide.

Not every home roller is a medical device. The FDA’s consumer page explains that a roller with short, blunt needles that only claims to exfoliate or improve the look of skin is generally not regulated as one. Those products are outside the safety data above in both directions: they are not cleared, and they are not studied.

No published study compares complication rates between home and professional microneedling.

RF microneedling carries different risks

On 15 October 2025 the FDA issued a safety communication on RF microneedling, which uses needles that deliver heat. It said it was aware of reports of burns, scarring, fat loss, disfigurement and nerve damage, some needing surgical repair, and stated that these devices “should not be used at home”. The FDA’s evaluation was described as ongoing. The side-effect rates earlier on this page come mostly from plain (non-RF) microneedling studies and should not be read across.

What the FDA’s adverse event database shows

The FDA’s MAUDE database collects reports of problems with medical devices from manufacturers, clinicians and the public. Through openFDA (data updated 29 September 2026), 60 reports carry product code QAI, the microneedling code: 47 injuries, 12 malfunctions and 1 “other”.

Fewer than half are about microneedling pens. Sorting the reports by the brand name on each (our classification):

Device type named in the report Reports
Micro-coring systems (Ellacor, Cytrellis), a different technology that shares the code 28
Microneedling pens (SkinPen, Dermapen, Rejuvapen, Dr. Pen and others) 25
RF microneedling 4
Plasma pens 2
Microneedle patch 1

The most frequent patient problems coded across all 60 are skin discoloration (10), scar tissue (9), redness (7), hyperpigmentation (6) and skin infection (6). One 2023 report from a purchaser of a Dr. Pen A6S says its needle cartridges had no seal against fluid running back into the pen; that is the reporter’s account and has not been verified.

These figures cannot show that a device caused an injury, and they cannot be turned into a rate. Reports are unverified, the FDA does not know how many treatments were given, many problems are never reported, and RF microneedling devices are generally cleared under a different product code (GEI), so their reports are not in this count. To file one, see how to report a problem.

FAQ

Is microneedling safe? For healthy adults treated by a trained provider with sterile single-use cartridges, studies report mostly mild side effects that clear within a week. Serious complications appear in case reports without a known rate, and many groups were excluded from the trials.

What are the side effects of microneedling? Redness, swelling, dryness, peeling, tightness, itching, burning and pinpoint bleeding are the common ones and usually clear within days. Less common are pigment changes, track-shaped marks, cold-sore flare-ups, swollen lymph nodes, infection and granulomas.

Is at-home microneedling safe? Unknown. No microneedling device is FDA-authorized for home use, and the only home study had 11 participants and no control group.

Can you microneedle while pregnant? The FDA and Health Canada both list pregnancy and breastfeeding as reasons it may not be suitable. We found no published study of microneedling in pregnancy, so there is no data either way.

How long after Accutane can you microneedle? The FDA list says 6 months. Reviews from 2017, 2025 and 2026 found the evidence for that delay weak and reported normal healing in most studies; the prescribing doctor makes the call.

Sources

  • PMID 34448760: Chu S et al. Safety Profile for Microneedling: A Systematic Review. Dermatol Surg, 2021. https://pubmed.ncbi.nlm.nih.gov/34448760/
  • PMID 33584968: Gowda A et al. A Systematic Review Examining the Potential Adverse Effects of Microneedling. J Clin Aesthet Dermatol, 2021. https://pubmed.ncbi.nlm.nih.gov/33584968/
  • PMID 40542236: Foppiani JA et al. Microneedling for Facial Rejuvenation: A Systematic Review. Aesthetic Plast Surg, 2025. https://pubmed.ncbi.nlm.nih.gov/40542236/
  • PMID 22587597: Pahwa M et al. “Tram track effect” after treatment of acne scars using a microneedling device. Dermatol Surg, 2012. https://pubmed.ncbi.nlm.nih.gov/22587597/
  • PMID 38662678: Stadelman-Behar AM et al. Investigation of Presumptive HIV Transmission Associated with Receipt of Platelet-Rich Plasma Microneedling Facials at a Spa Among Former Spa Clients – New Mexico, 2018-2023. MMWR Morb Mortal Wkly Rep, 2024. https://pubmed.ncbi.nlm.nih.gov/38662678/
  • PMID 42829587: Jain R et al. Subpericranial and epidural abscess with skull osteomyelitis as a complication of microneedling for alopecia: A singular case report. Surg Neurol Int, 2026. https://pubmed.ncbi.nlm.nih.gov/42829587/
  • PMID 41081333: Rigali S et al. Nickel Secretion and the Allergenic Potential of Cosmetic Microneedles. Dermatol Surg, 2026. https://pubmed.ncbi.nlm.nih.gov/41081333/
  • PMID 35373693: Esmat S et al. Evaluation of needling/microneedling as an adjunct to phototherapy in the treatment of stable acral vitiligo: a comparative clinical and immunohistochemical study. J Dermatolog Treat, 2022. https://pubmed.ncbi.nlm.nih.gov/35373693/
  • PMID 28690124: Ramaut L et al. Microneedling: Where do we stand now? A systematic review of the literature. J Plast Reconstr Aesthet Surg, 2018. https://pubmed.ncbi.nlm.nih.gov/28690124/
  • PMID 28403263: Bonati LM et al. Microneedling in All Skin Types: A Review. J Drugs Dermatol, 2017. https://pubmed.ncbi.nlm.nih.gov/28403263/
  • PMID 37799356: Alqam ML et al. Study to determine the safety and efficacy of microneedling as an effective treatment for acne vulgaris. Skin Health Dis, 2023. https://pubmed.ncbi.nlm.nih.gov/37799356/
  • PMID 29491653: Mysore V et al. Standard Guidelines of Care: Performing Procedures in Patients on or Recently Administered with Isotretinoin. J Cutan Aesthet Surg, 2017. https://pubmed.ncbi.nlm.nih.gov/29491653/
  • PMID 39568321: Latifaltojar R et al. Keloid Formation and Any Skin Complications in Patients Treated With Isotretinoin and Undergone Any Skin-Related Procedures. J Cosmet Dermatol, 2025. https://pubmed.ncbi.nlm.nih.gov/39568321/
  • PMID 42522519: Ghali H et al. Examining the safety of dermatological and surgical procedures in patients undergoing systemic isotretinoin therapy: An updated review. Dermatol Online J, 2026. https://pubmed.ncbi.nlm.nih.gov/42522519/
  • PMID 26549251: Cohen BE, Elbuluk N. Microneedling in skin of color: A review of uses and efficacy. J Am Acad Dermatol, 2016. https://pubmed.ncbi.nlm.nih.gov/26549251/
  • PMID 35426044: Shen YC et al. Microneedling Monotherapy for Acne Scar: Systematic Review and Meta-Analysis of Randomized Controlled Trials. Aesthetic Plast Surg, 2022. https://pubmed.ncbi.nlm.nih.gov/35426044/
  • PMID 33144596: Ogunjimi AT et al. Micropore closure time is longer following microneedle application to skin of color. Sci Rep, 2020. https://pubmed.ncbi.nlm.nih.gov/33144596/
  • PMID 34951101: Quinlan DJ et al. Topical growth factors and home-based microneedling for facial skin rejuvenation. J Cosmet Dermatol, 2022. https://pubmed.ncbi.nlm.nih.gov/34951101/
  • PMID 39584690: Friedmann DP et al. Granulomatous Reactions From Microneedling: A Systematic Review of the Literature. Dermatol Surg, 2025. https://pubmed.ncbi.nlm.nih.gov/39584690/
  • PMID 24258303: Soltani-Arabshahi R et al. Facial allergic granulomatous reaction and systemic hypersensitivity associated with microneedle therapy for skin rejuvenation. JAMA Dermatol, 2014. https://pubmed.ncbi.nlm.nih.gov/24258303/
  • PMID 41363966: Huang C et al. Destructive Facial Granuloma Following Self-Treatment With Vitamin E Oil and an At-Home Microneedling Device. Cutis, 2025. https://pubmed.ncbi.nlm.nih.gov/41363966/
  • FDA, De Novo decision summary DEN160029, SkinPen Precision System (Bellus Medical, granted 2018-03-01; clinical study, exclusion criteria and adverse events): https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN160029.pdf
  • FDA, Microneedling Devices (risks; “The procedure may NOT be suitable for you if you”; content current as of 2025-10-15, checked 2026-10-06): https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices/microneedling-devices
  • FDA Consumer Update, Microneedling Devices: Getting to the Point on Benefits, Risks and Safety (content current as of 2025-10-15, checked 2026-10-06): https://www.fda.gov/consumers/consumer-updates/microneedling-devices-getting-point-benefits-risks-and-safety
  • FDA Safety Communication, Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling (2025-10-15, checked 2026-10-06): https://www.fda.gov/medical-devices/safety-communications/potential-risks-certain-uses-radiofrequency-rf-microneedling-fda-safety-communication
  • openFDA device adverse events, product code QAI, counts by event type (data last updated 2026-09-29, queried 2026-10-06): https://api.fda.gov/device/event.json?search=device.device_report_product_code:QAI&count=event_type.exact
  • openFDA device adverse events, product code QAI, all 60 records (brand names and narratives, queried 2026-10-06): https://api.fda.gov/device/event.json?search=device.device_report_product_code:QAI&limit=100
  • openFDA device adverse events, product code QAI, counts by patient problem (queried 2026-10-06): https://api.fda.gov/device/event.json?search=device.device_report_product_code:QAI&count=patient.patient_problems.exact
  • Health Canada advisory, Dr. pen microneedling devices are not authorized for sale and may pose health risks (2021-12-16, checked 2026-10-06): https://www.newswire.ca/news-releases/advisory-dr-pen-microneedling-devices-are-not-authorized-for-sale-and-may-pose-health-risks-898811970.html
  • FDA clearance records for product code QAI: this site’s verification file (26 clearances, all prescription use), see microneedling FDA clearance.