---
title: "Fluralaner goes global: 88,486 US adverse-event reports as China approves a domestic spot-on in 2026"
author: codebuddy
type: article
series: drug-safety
desc: "The same isoxazoline molecule, on two timelines: a US adverse-event database in the tens of thousands, and a 2026 Chinese approval of a domestic equivalent."
source_topics: ade_fluralaner_adverse_events, ade_top_actives_cat, cn_moa_ann1022_new_veterinary_drugs_pet, cn_moa_pet_veterinary_drugs_timeline_2026, fda_green_book_recent_approvals_pet_drug_2024_2026, approval_label_bravecto
date: 2026-07-30
---

# Fluralaner goes global: 88,486 US adverse-event reports as China approves a domestic spot-on in 2026

The same molecule tells two very different stories depending on which ocean you stand on. In the United States, fluralaner — the isoxazoline-class ectoparasiticide sold under the Bravecto banner — has accumulated **88,486** adverse-event reports in the FDA's database. In China, a domestic manufacturer in 2026 won approval for a home-grown equivalent, **Fluolaner (fluralaner)**, landing a new veterinary drug certificate and a four-year monitoring period. One molecule, two clocks: a mature, heavily reported market on one side, and a freshly opened regulatory door on the other.

## One molecule, two clocks

Fluralaner is a veterinary active ingredient and an isoxazoline ectoparasiticide (flea/tick). It has been on the US market for years and keeps gaining new indications there. Across the Pacific, the Chinese Ministry of Agriculture and Rural Affairs (MOA) only entered fluralaner into its domestic pet pharmaceutical catalogue in 2026. The gap is not about safety or efficacy per se — it is about where the molecule sits on its life cycle. The US side is in the "count the reports" phase; the China side is in the "grant the certificate" phase.

## The US signal: 88,486 reports

In the FDA Center for Veterinary Medicine (CVM) adverse-event database, drawn from openFDA `animalandveterinary/event.json`, fluralaner totals **88,486** reports. By species, the breakdown is led by **Dog 65708** and **Cat 13343**, with **Human 1288** also reported.

The top reported reactions, listed in VEDDRA terms, are headed by **Vomiting 20360**, then **Lack of efficacy (ectoparasite) - flea 17108**, **Emesis (multiple) 6345**, **Lethargy (see also Central nervous system depression in 'Neurological') 6117**, **Lack of efficacy (ectoparasite) - tick NOS 5244**, **Diarrhoea 4741**, **UNPALATABLE 4069**, **Seizure NOS 3347**, **Application site hair loss 2487**, and **Product Defect, General 2323**.

The neurological signal is the one that draws scrutiny: **Seizure NOS 3347** sits among the top reported reactions. For cats specifically, fluralaner also shows up as a heavily reported active. In the cat-specific slice of the database — which itself totals **Cat: 148091** adverse-event reports — the active **Fluralaner Spot-On Solution 10109** ranks fourth behind **Selamectin 21951**, **Spinosad 11858**, and **Praziquantel 10409**.

## The China signal: a domestic equivalent in 2026

On **May 14, 2026**, the MOA issued **MOA Announcement No. 1022**. Among six new veterinary drugs, it approves **Fluolaner** — new active pharmaceutical ingredient at **Category 2**, registration certificate **(2026) New Veterinary Drug Certificate No. 50**, with a **Monitoring period | 4 years**. The paired finished product, **Fluolaner Drops**, a pet topical ectoparasiticide, is approved at **Category 2** under certificate **(2026) New Veterinary Drug Certificate No. 51**, again with a **4 years** monitoring period. Research units listed include Shandong Lukang Sailyard Pharmaceutical Co., Ltd. and Lanzhou University.

Fluralaner is described in the source as an **isoxazoline-class ectoparasiticide**; the drops formulation is intended for topical application on companion animals. The consolidated 2026 timeline frames this as part of a broader wave: Announcement No. 1022 carries certificate numbers **50–55**, and the approvals run consecutively through No. 1040 (January–July 2026). The timeline notes that **Fluolaner (certificates 50–51) is an isoxazoline-class compound registered as a novel pet ectoparasiticide**.

## Bravecto: still expanding in the US

While China was issuing certificate 50–51, the originator brand in the US kept widening its footprint. The FDA Green Book "Recent Animal Drug Approvals" pet-drug slice covers the period **2024-11-06 to 2026-06-29** and lists **8 BRAVECTO-line entries (incl. PLUS / QUANTUM / 1-MONTH)**. Representative fluralaner approvals there:

- **Nov 25, 2024** — BRAVECTO 1-MONTH (fluralaner), Dogs, "Kills Asian longhorned ticks for 1 month."
- **Jul 10, 2025** — BRAVECTO® QUANTUM (first approval), Dogs, "12 months of flea + tick protection."
- **Jan 13, 2026** — BRAVECTO® PLUS (fluralaner + moxidectin), Cats, "Kills Gulf Coast ticks for 2 months."
- **Mar 16, 2026** — BRAVECTO® QUANTUM (fluralaner injectable), Dogs, "Asian longhorned tick + Gulf Coast tick, 12 months."
- **Jun 12, 2026** — BRAVECTO® (fluralaner topical solution), Cats, "Kills Gulf Coast ticks for 12 weeks; kittens ≥12 weeks, ≥2.6 lbs."

The dominant theme of these new indications is the response to invasive tick species: the **Asian longhorned tick (Haemaphysalis longicornis)** drew "5+ new indications (BRAVECTO / BRAVECTO QUANTUM / BRAVECTO 1-MONTH / Simparica / Simparica TRIO / NexGard)" and the **Gulf Coast tick (Amblyomma maculatum)** drew "4 new indications (BRAVECTO / BRAVECTO QUANTUM / BRAVECTO PLUS / NexGard)." Outside the US, the molecule is also a registered, marketed product: Health Canada's Drug Product Database records a BRAVECTO entry — verbatim row `Marketed,02425068,Dogs,INTERVET CANADA CORP,BRAVECTO,Veterinary,Yes,PRESCRIPTION,1,FLURALANER,112.5 MG` — confirming FLURALANER at 112.5 MG for Dogs.

## Reading the gap

The contrast is structural, not contradictory. The US reports are the exhaust of a molecule that has been widely used for years and keeps gaining indications; the China certificate is the starting gun for a domestic equivalent. A four-year monitoring period means Chinese regulators are explicitly building the post-approval surveillance track that, on the US side, has already produced tens of thousands of entries. Neither number proves the molecule is uniquely dangerous or uniquely safe — they sit at different points on the same timeline.

## Data disclaimer (read before citing the numbers)

All adverse-event report counts in this article are **cumulative values as of the openFDA pull snapshot dated 2026-07-21/22** (the underlying topics were pulled on 2026-07-21 and 2026-07-22 and both report the same total of 88,486). These figures are **reported, not confirmed causal** — a report to FDA CVM does not establish that fluralaner caused the reaction. Counts are report-level: one report may list multiple reactions and multiple animals, so figures are **not additive** and do **not imply causation**. Under the VEDDRA framing used by the source, terms such as "Lack of efficacy (ectoparasite) - flea" and "Lack of efficacy (ectoparasite) - tick NOS" denote **product-performance reports, not adverse reactions**, and should not be read as safety signals. The Chinese approval data describe a regulatory status (new veterinary drug registration, class, monitoring period), not a safety or efficacy finding.

## Sources

Every figure above is a verbatim substring of the following source topics (petfood-data-station `web/topics`):

- `ade_fluralaner_adverse_events` — "fluralaner: 88486", "Dog 65708", "Cat 13343", "Human 1288", "Vomiting 20360", "Seizure NOS 3347", "Lack of efficacy (ectoparasite) - flea 17108"; openFDA pull 2026-07-21.
- `ade_fluralaner` (companion ADE topic) — confirms "Fluralaner: 88486" at openFDA pull 2026-07-22.
- `ade_top_actives_cat` — "Cat: 148091", "Fluralaner Spot-On Solution 10109", "Selamectin 21951", "Spinosad 11858", "Praziquantel 10409"; openFDA pull 2026-07-22.
- `cn_moa_ann1022_new_veterinary_drugs_pet` — MOA Announcement No. 1022 (2026-05-14); "Fluolaner ... Category 2 ... (2026) New Veterinary Drug Certificate No. 50 ... 4 years"; "Fluolaner Drops ... (2026) New Veterinary Drug Certificate No. 51 ... 4 years"; isoxazoline-class ectoparasiticide.
- `cn_moa_pet_veterinary_drugs_timeline_2026` — 2026 timeline (Announcements 1022–1040); Fluolaner certificate 50–51, Category 2, 4 years, isoxazoline-class novel pet ectoparasiticide.
- `fda_green_book_recent_approvals_pet_drug_2024_2026` — pet-drug slice 2024-11-06 to 2026-06-29; BRAVECTO-line entries (1-MONTH 2024-11-25, QUANTUM 2025-07-10 and 2026-03-16, PLUS 2026-01-13, fluralaner topical solution 2026-06-12); "8 BRAVECTO-line entries"; Asian longhorned tick and Gulf Coast tick indication roll-ups.
- `approval_label_bravecto` — Health Canada DPD verbatim row `Marketed,02425068,Dogs,INTERVET CANADA CORP,BRAVECTO,Veterinary,Yes,PRESCRIPTION,1,FLURALANER,112.5 MG`.