Aqualyx in the Philippines: FDA advisory, evidence and risks

What is Aqualyx?

Aqualyx is an injectable product used to try to reduce small areas of fat. It is not a peptide, and it is not an approved medicine.

The authors of a 2022 case report describe it as "a deoxycholate, aqueous gelatinous solution mixed with saline and buffering compounds". They say it was originally developed in Italy and has been commercially available since 2009. Intralipotherapy is the name used for injecting it into fat.

How it is proposed to work

A 2016 review, by authors who advise Aqualyx distributors, explains the proposed mechanism:

• Sodium deoxycholate is a bile acid surfactant.
• Injected into fat, it "induces necrosis by means of emulsification (micelles) of the adipocytes".
• Formulations containing it "induce adipocytolysis and not lipolysis". This means they destroy fat cells rather than release fat from them.

This mechanism is proposed by the authors. It has not been confirmed in controlled trials of Aqualyx.

Is Aqualyx a drug or a device?

In Europe, published papers describe Aqualyx as a medical device, not an approved medicine. No EU regulator source was found to confirm its current status.

• 2016 review: calls it "a Class III CE-marked medical device (approved in 2009) for the reduction of localized fat in combination with ultrasound therapy". The same review says phosphatidylcholine and deoxycholate preparations "still have not been endorsed by the competent authorities for the treatment of localized fat".
• 2017 letter (Rauso): says Aqualyx "is not recorded as a drug but only as a medical device, although it is a DC-based solution". It calls this an "anomaly" and says a claim on the issue "has been raised with the Italian Ministry of the Health".
• Inconsistent descriptions: a 2022 case report calls it "the only drug approved by the European Union for the reduction in localized fat". A 2019 study calls it both a "Class III CE-marked device" and "a CE-marked drug".

These descriptions come from journal authors, not from a regulator. Whether Aqualyx holds a certificate under the EU's current medical device rules is not known from the sources found.

What did FDA Philippines say about Aqualyx?

FDA Philippines has named Aqualyx in one advisory.

FDA Philippines has also warned against other unregistered injectable products of the same type in 2026. Those advisories do not name Aqualyx.

What the verification portal shows

A search of the FDA Philippines verification portal for "aqualyx" on 7 October 2026 found:

A cosmetic notification is not a drug registration.

What does the evidence show?

Human data on Aqualyx are limited to uncontrolled case series and retrospective reports. Several were written by doctors linked to its distributors. No randomized controlled trial of Aqualyx was found, and a ClinicalTrials.gov search for "aqualyx" on 7 October 2026 returned no registered studies.

The disclosure in the Amore et al. 2016 report reads: "All authors, except Vincenza Leonardi, are external medical advisors for distributors of Aqualyx and trainers for intralipotherapy."

What side effects and complications are reported?

Swelling and redness are common, and serious complications such as skin necrosis have been reported.

In case series

In the 2015 report of 186 patients, all had mild to moderate swelling and redness that cleared in 3 to 5 days.

The 2016 report lists rare major adverse events: hyperpigmentation (under 0.002%), permanent paresthesia or dysesthesia (under 0.01%), skin necrosis (under 0.01%), permanent nodules (0.005%) and skin irregularities (under 0.03%). Its authors list incorrect injection technique, age over 60 and overdosing among risk factors.

In case reports

• Skin necrosis: a 2017 letter says necrosis after Aqualyx "has also been described ... although this complication is not described as side effect in the package leaflet". A 2016 report is titled "Skin Necrosis Following Adipocitolitic Solution Injections".
• Infected nodules (UK, 2022): a patient injected with a product "advertised as Aqualyx", by someone who was not a trained health professional, developed severe pain, localized skin necrosis and painful nodules that broke open into pus-filled and bleeding lesions.

Other case reports describe infections and liver injury after injection lipolysis in general. Those reports do not name Aqualyx.

What does the US FDA say?

The US FDA names Aqualyx among unapproved fat-dissolving injections. Its consumer page (content current as of 20 December 2023) says these products "are being marketed and sold online under brand names such as Aqualyx" and others.

• Ingredients: common ones are phosphatidylcholine (PPC) and sodium deoxycholate (DC). FDA says these are unapproved and that it has not evaluated them.
• Harms reported to FDA: "permanent scars, serious infections, skin deformities, cysts, and deep, painful knots".
• Where people got them: some at clinics or med spas from staff who might not have been properly licensed; some online, injecting themselves.
• Advice: "Do not purchase fat-dissolving products from websites and attempt to inject them yourself."

How is Aqualyx different from Kybella?

Kybella is a different product. It is deoxycholic acid injection, an approved prescription drug in the US (and sold as Belkyra in Canada). Aqualyx is not approved as a drug.

The 2017 letter makes the same contrast: ATX-101 (Kybella in the US, Belkyra in Canada) "is recorded as a drug", while Aqualyx is recorded as a device.

The Kybella trial results and label apply only to Kybella. The Kybella label warns of nerve injury causing an uneven smile, difficulty swallowing, and ulcers, necrosis and infection at the injection site.

How to check and report a product

FDA Philippines tells the public to check products on its verification portal, verification.fda.gov.ph, or its list of verified unregistered health products.