The FDA advises against microneedling for people with a known malignancy or who are undergoing or about to undergo chemotherapy, radiotherapy, or steroid treatment, and for people who are pregnant or breastfeeding or allergic to stainless steel or topical/local anesthetics (or with a history of contact dermatitis to these products) Microneedling Devices (FDA — Aesthetic/Cosmetic Devices). This page reports that official advice for mechanical microneedling. It is not an exhaustive list of all possible contraindications, and it does not diagnose anyone or make an individual treatment decision. It is not extrapolated to radiofrequency (RF) microneedling.
Key takeaways
- The FDA advises against microneedling for people with a known malignancy or who are undergoing or about to undergo chemotherapy, radiotherapy, or steroid treatment.
- The FDA also advises against microneedling for people who are pregnant or breastfeeding.
- The FDA advises against microneedling for people allergic to stainless steel or topical/local anesthetics, or with a history of contact dermatitis to these products.
- These are FDA recommendations for mechanical microneedling devices; they are not an exhaustive list and do not apply to RF microneedling.
- A systematic review lists active infection, darker skin types, and metal allergies as factors that increase the risk of adverse events after microneedling; clinical screening is required.
What the FDA advises
The FDA advises against microneedling in people with a known malignancy or who are undergoing or about to undergo chemotherapy, radiotherapy, or steroid treatment, and in people who are pregnant or breastfeeding or allergic to stainless steel or topical/local anesthetics (or with a history of contact dermatitis to these products) Microneedling Devices (FDA — Aesthetic/Cosmetic Devices). This is the issuing organization's advice for mechanical microneedling devices and carries the medical review gate described at the end of this page.
Allergy sub-topics
People allergic to stainless steel or topical/local anesthetics, or with a history of contact dermatitis to these products, fall under the FDA advice above. The detailed allergy sub-intent — stainless steel and topical anesthetics — is owned by the dedicated allergy page.
Pregnancy and breastfeeding sub-topics
The FDA advises against microneedling for people who are pregnant or breastfeeding. The detailed pregnancy-and-breastfeeding sub-intent is owned by the dedicated pregnancy-and-breastfeeding page.
Other adverse-event risk factors
Beyond the FDA advice, a systematic review identifies active infections, darker skin types, and metal allergies as factors that increase the risk of adverse events after microneedling Safety Profile for Microneedling: A Systematic Review. These are registered risk factors, not absolute contraindications beyond the source wording, and clinical screening is required.
Scope and limits
- This page reports FDA advice for mechanical microneedling only; it is not extrapolated to RF microneedling.
- The list is not exhaustive: the FDA statement covers the groups above and does not claim to name every possible contraindication.
- This page does not provide an individual diagnosis or treatment decision; clinical screening is required.
- It does not reproduce the large sub-page content of the allergy page or the pregnancy-and-breastfeeding page; it links to them instead.
Frequently asked questions
Is this a complete list of microneedling contraindications? No. This page reports the FDA's advice for the named groups; it is not an exhaustive list and clinical screening is required.
Does this apply to radiofrequency (RF) microneedling? No. The FDA advice reported here concerns mechanical microneedling; it is not extrapolated to RF microneedling.
Does this page decide whether I can have microneedling? No. It reports official FDA advice and registered risk factors; it does not diagnose or make an individual treatment decision.
For education, not as medical advice: check with a qualified clinician and always follow the device's instructions-for-use.