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Halaven

eribulin mesylate · Halaven is a prescription drug containing eribulin mesylate, made by 2 manufacturers.

Type
Prescription
Drug class
Not classified
Route
Intravenous
Manufacturers
2

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Forms and strengths

From the FDA NDC Directory · 2 product codes

Dosage formStrengthRouteNDCs
Injection.5 mg/mLintravenous1
Injection1 mg/2mLintravenous1

Side effect reports to FDA

FDA Adverse Event Reporting System (FAERS), 3,719 reports that list eribulin mesylate, data through 07/30/2026

Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.

Most often reported reactions

  • Neutropenia537
  • Malignant neoplasm progression382
  • Febrile neutropenia330
  • Myelosuppression310
  • Pyrexia215
  • Neuropathy peripheral214
  • Leukopenia208
  • Interstitial lung disease181
  • White blood cell count decreased176
  • Neutrophil count decreased170

To report a side effect, use FDA MedWatch.

Manufacturers and labels

2 FDA labels

  • BSP Pharmaceuticals SpAShown hereNDA201532 · Label 01/26/2026 · NDC 43624-002Full label
  • Eisai Inc.NDA201532 · Label 11/07/2025 · NDC 62856-389Full label

Halaven: common questions

Is Halaven a prescription drug?
Yes. Halaven is a prescription (Rx) drug.
Are there other products with the same active ingredient as Halaven?
Yes. Other FDA-listed products with the same active ingredients include Eribulin Mesylate.
Who makes Halaven?
2 manufacturers list Halaven with the FDA, including BSP Pharmaceuticals SpA, Eisai Inc.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 01/26/2026 · Label text is shown as published by the manufacturer. Not medical advice

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