FDA.reportPublic FDA data

Mefloquine Hydrochloride

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Mefloquine Hydrochloride
Generic name
MEFLOQUINE HYDROCHLORIDE
Manufacturer
Chartwell RX, LLC
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
b884d22b-aae7-4f14-9a04-ae4029a229f0
SPL ID
2732839a-191a-570f-e063-6294a90a40a4
Version
1
Effective date
2024-11-18
Source export date
2026-09-28
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:36:25
Harmonized routes table
Harmonized routes
ORAL

Boxed warning cross-check#

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boxed warning

WARNING Mefloquine may cause neuropsychiatric adverse reactions that can persist after mefloquine has been discontinued. Mefloquine should not be prescribed for prophylaxis in patients with major psychiatric disorders. During prophylactic use, if psychiatric or neurologic symptoms occur, the drug should be discontinued and an alternative medication should be substituted (see WARNINGS ).

Warnings cross-check#

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warnings

WARNINGS In case of life-threatening, serious or overwhelming malaria infections due to P. falciparum, patients should be treated with an intravenous antimalarial drug. Following completion of intravenous treatment, mefloquine may be given to complete the course of therapy.

Adverse reactions cross-check#

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adverse reactions

ADVERSE REACTIONS

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.