Prescription medicine
Mefloquine First approved as Lariam
Mefloquine (Lariam) is a prescription medicine with an FDA approval on record since 1989. FDA's NDC Directory lists it from 3 generic labelers, and pharmacies paid $3.97 per mefloquine HCl 250 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the mefloquine FDA label on DailyMed (effective November 18, 2024, Chartwell RX, LLC); the NDA 19591 record on Drugs@FDA; every mefloquine label on DailyMed.
Highlights of the record
FDA label of November 18, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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 ).
Used for
The label in openFDA carries no indications section.
Forms and strengths
- 250 mg
Tablet.
On the market
- Earliest approval on file
- May 2, 1989 Lariam, Roche; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 4 first February 20, 2002; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 3 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $3.97 per tablet Mefloquine HCl 250 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2012 0 Class I among all firms' recalls; latest April 2, 2012
- FAERS reports
- 156 through July 30, 2026
What does the patient leaflet for mefloquine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about mefloquine?Mefloquine can cause serious side effects, including: 1. Heart Problems. Do not take halofantrine (used to treat malaria) or ketoconazole (used for fungal infections) with mefloquine or within 15 weeks of your last dose of mefloquine. You may get serious heart problems (problems with the electrical system of your heart called QT prolongation) that can lead to death. Do not take quinine (Qualaquin) or quinidine (used to treat malaria or irregular heart beat) with mefloquine. You may get serious heart problems. 2. Mental problems. Symptoms of serious mental problems may include: severe anxiety paranoia (feelings of mistrust towards others) hallucinations (seeing or hearing things that are not there) depression feeling restless unusual behavior feeling confused Some people who take mefloquine think about suicide (putting an end to their life). Some people who were taking mefloquine committed suicide. It is not known if mefloquine was responsible for those suicides. If you have any of these serious mental problems, or you develop other serious side effects or mental problems, you should contact your doctor right away as it may be necessary to stop taking mefloquine and use a different medicine to prevent malaria. 3. Problems with your body’s nervous system. Symptoms of serious nervous system problems may include: dizziness a feeling that you or things around you are moving or spinning (vertigo) loss of balance ringing sound in your ears (tinnitus) convulsions (seizures) in people who already have seizures (epilepsy) convulsions (seizures) in people who take quinine or chloroquine (used to treat malaria) with mefloquine. […]
From the patient leaflet: What should I avoid while taking mefloquine?Avoid activities such as driving a car or using heavy machinery or other activities needing alertness and careful movements (fine motor coordination) until you know how mefloquine affects you. You may feel dizzy or lose your balance. This could happen for months or years after you stop taking mefloquine and can be permanent in some cases. See “What are the possible side effects of mefloquine?”
From the patient leaflet: How should I store mefloquine?Store mefloquine at room temperature between 68ºF to 77ºF (20ºC to 25ºC) Safely throw away medicine that is out of date or no longer needed. Keep mefloquine and all medicines out of the reach of children.
Source: FDA drug label (Mefloquine Hydrochloride), Chartwell RX, LLC, effective November 18, 2024 (SPL set b884d22b-aae7-4f14-9a04-ae4029a229f0), via openFDA; the full label on DailyMed
Is there a generic for mefloquine (Lariam)?
The FDA approved the first generic mefloquine on February 20, 2002. 4 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists mefloquine from 3 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1989 earliest approval on file
- 2002 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for mefloquine (Lariam)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $3.97 per Mefloquine HCl 250 mg tablet, down 21% from $5.03 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Mefloquine HCl 250 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Mefloquine HCl 250 mg tablet | Generic | $3.97 per tablet | $119.23 | -21% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has mefloquine been recalled?
The FDA's Enforcement Report lists 1 recall naming mefloquine since 2012: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 2, 2012 | Class II | Teva Pharmaceuticals USA, Inc. | Tablet Thickness: Product is being recalled due to the potential of being underweight or overweight. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the mefloquine label say about other medicines?
The mefloquine label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 13 other medicines name mefloquine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Quinidine | contraindications | CONTRAINDICATIONS Use of mefloquine hydrochloride tablets is contraindicated in patients with a known hypersensitivity to mefloquine or related compounds (eg, quinine and quinidine) or to any of the excipients contained in the formulation. |
| Quinine | contraindications | CONTRAINDICATIONS Use of mefloquine hydrochloride tablets is contraindicated in patients with a known hypersensitivity to mefloquine or related compounds (eg, quinine and quinidine) or to any of the excipients contained in the formulation. |
Other labels that name mefloquine
Source: FDA drug label (Mefloquine Hydrochloride), Chartwell RX, LLC, effective November 18, 2024 (SPL set b884d22b-aae7-4f14-9a04-ae4029a229f0), via openFDA; the full label on DailyMed
What do FAERS reports show for mefloquine?
The FDA Adverse Event Reporting System holds 156 reports that list mefloquine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 14 are coded as a death and 53 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other antimalarials
- the pharmacologic class, with prices and generics
- Mefloquine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other