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Under-eye filler: what the FDA says about tear trough and under-eye hollow injections

Filler is used for hollows under the eyes. The FDA lists under-eye hollows among approved uses in one place and the area around the eyes among unapproved uses in another. What the FDA says, the risks and what to ask.

At a glance

FDA consumer update
Lists under-eye hollows
Among approved filler uses, for people 22 and older.
FDA device page
Lists the area around the eyes
Among uses the FDA recommends against.
Most serious risk
Filler in a blood vessel
Low chance. Can cause tissue death, stroke or blindness.
Taking it back
Can be hard
For some materials it may be difficult or impossible.

Filler is used to soften hollows under the eyes. The FDA's pages disagree on this area: one lists under-eye hollows among the approved uses of dermal fillers, and another lists the area around the eyes among uses the FDA says are not approved.12

Here is what each page says, the risks and what to ask. It gives no dose and no technique. Whether to have it is for you and a clinician.

What the FDA says

The FDA's consumer update says dermal fillers are approved for specific uses in people aged 22 and older, and lists increasing fullness of the lips, cheeks, chin, under-eye hollows, jawline and back of the hand.1

The FDA's device page lists, under uses it says are not approved, injecting the glabella (the area between the eyebrows), the nose, the periorbital area (around the eyes), the forehead or the neck.2 It says the FDA recommends against those.

Neither page says which products it means. Ask your provider which filler they would use, and whether it is approved for that area.

Myth

Any dermal filler is approved for use under the eyes.

Fact

The FDA lists under-eye hollows among approved uses, but also lists the area around the eyes among uses it says are not approved. Ask which product is approved for the area.

FDA, Dermal Filler Do's and Don'ts for Wrinkles, Lips and More, read 30 Oct 2026FDA, Dermal Fillers (Soft Tissue Fillers), read 30 Oct 2026

What it is for

The plastic surgeons' society lists decreasing or removing the shadow of the lower lids among the things dermal fillers can do.4 Dermal fillers are gel-like substances injected under the skin to create a smoother or fuller appearance. The FDA regulates them as medical devices, and they are prescription-only.13

The risks to ask about

Common risks include bruising, redness, swelling, pain, tenderness, itching and rash. Most appear shortly after injection and many resolve in days to weeks, though in some cases side effects emerge weeks, months or years later.1

The most serious risk is accidental injection into a blood vessel. The FDA says that can cause skin necrosis (death of tissue), stroke or blindness, and that while the chance is low, the complications can be serious and may be permanent.1 Because the eyes are close, ask any provider what they would do, and who you would call.

Filler can be hard to take back. The FDA says you may need further injections, surgery or other procedures to reduce or remove it, that these have their own risks, and that for some materials it may be difficult or impossible.12

Who injects, and what is in the syringe

The FDA's advice is a licensed provider who has experience in dermatology or plastic surgery and is trained to inject dermal fillers, using properly labeled, sealed vials or pre-filled syringes of FDA-approved filler. It also advises requesting and reading the patient labeling.1 The FDA warns against fillers sold directly to the public, which may be fake, contaminated or not approved in the US.13 Our lip filler provider guide goes through those checks.

Which licensed professionals may inject depends on your state. See our guide to who may inject.

Here is what to bring to a consultation.

Questions to bring

The product

The person and the plan

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Common questions

Is under-eye filler FDA-approved?

The FDA's pages differ. One lists under-eye hollows among approved uses for adults 22 and older. Another lists the area around the eyes among unapproved uses. Ask which product is approved for the area.

What are the risks of under-eye filler?

Common risks are bruising, redness, swelling, pain, tenderness, itching and rash. The most serious is filler entering a blood vessel, which the FDA says can cause tissue death, stroke or blindness.

Can under-eye filler be removed?

Sometimes, but the FDA says reducing or removing filler can need further injections or surgery, which carry their own risks, and may be difficult or impossible for some materials.

Who should inject filler?

The FDA advises a licensed provider with experience in dermatology or plastic surgery who is trained to inject dermal fillers. Who may legally inject depends on your state.

Sources (4)

  1. FDA, Dermal Filler Do's and Don'ts for Wrinkles, Lips and More · US Food and Drug Administration (content current as of 07/07/2023 per the page) · read 30 Oct 2026
  2. FDA, Dermal Fillers (Soft Tissue Fillers) · US Food and Drug Administration, medical devices page (content current as of 07/06/2023 per the page) · read 30 Oct 2026
  3. FDA, FDA-Approved Dermal Fillers · US Food and Drug Administration, medical devices page (content current as of 11/09/2020 per the page) · read 30 Oct 2026
  4. ASPS, Dermal Fillers · American Society of Plastic Surgeons (ASPS), a professional society of plastic surgeons · read 30 Oct 2026

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