Prescription medicine
Mexiletine First approved as Mexitil
Mexiletine (Mexitil) is a prescription medicine with an FDA approval on record since 1985. FDA's NDC Directory lists it from 14 generic labelers, and pharmacies paid $0.222 per mexiletine 150 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the mexiletine FDA label on DailyMed (effective May 14, 2026, Macleods Pharmaceuticals Limited); the NDA 18873 record on Drugs@FDA; every mexiletine label on DailyMed.
Highlights of the record
FDA label of May 14, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageMexiletine hydrochloride capsules are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening.
Forms and strengths
- 150 mg
- 200 mg
- 250 mg
Capsule.
On the market
- Earliest approval on file
- December 30, 1985 Mexitil, Boehringer Ingelheim; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 12 first May 16, 1995; 10 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 14 of which 14 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.222 per capsule Mexiletine 150 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2013 0 Class I among all firms' recalls; 2 more by firms not listed as its makers
- FAERS reports
- 420 through July 30, 2026
What is mexiletine used for?
From the label: indications and usageMexiletine hydrochloride capsules are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of mexiletine, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of mexiletine treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.
FDA pharmacologic class: Antiarrhythmic.
Source: FDA drug label (Mexiletine Hydrochloride), Macleods Pharmaceuticals Limited, effective May 14, 2026 (SPL set a61a07f6-0b48-4dcd-ad42-5d90f6e69ab1), via openFDA; the full label on DailyMed
Is there a generic for mexiletine (Mexitil)?
The FDA approved the first generic mexiletine on May 16, 1995. 12 generic applications are approved; 10 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 mexiletine from 14 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.
- 1985 earliest approval on file
- 1995 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 mexiletine (Mexitil)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.222 per Mexiletine 150 mg capsule, down 14% from $0.259 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.
- Mexiletine 150 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Mexiletine 150 mg capsule | Generic | $0.222 per capsule | $6.67 | -14% |
| Mexiletine 200 mg capsule | Generic | $0.257 per capsule | $7.72 | -13% |
| Mexiletine 250 mg capsule | Generic | $0.387 per capsule | $11.62 | -9% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has mexiletine been recalled?
The FDA's Enforcement Report lists 2 recalls naming mexiletine since 2013: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of mexiletine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: MEXILETINE HCL, Capsule, 150 mg may have potentially been mislabeled as the following drug: CALCIUM ACETATE, Capsule, 667 mg, NDC … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: MEXILETINE HCL, Capsule, 200 mg may have potentially been mislabeled as the following drug: ISOSORBIDE DINITRATE, Tablet, 10 mg, NDC … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the mexiletine label say about other medicines?
The mexiletine label names 12 other medicines in its interaction, contraindication or warning sections. The labels of 22 other medicines name mexiletine. 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 |
|---|---|---|
| Caffeine | drug interactions | Additionally, in one controlled study in five normal subjects and seven patients, the clearance of caffeine was decreased 50% following the administration of mexiletine. |
| Cimetidine | drug interactions | Concurrent administration of cimetidine and mexiletine has been reported to increase, decrease, or leave unchanged mexiletine plasma levels; therefore patients should be followed carefully during concurrent therapy. |
| Digoxin | drug interactions | ECG intervals (PR, QRS, and QT) were not affected by concurrent mexiletine and digoxin, diuretics, or propranolol. |
| Flecainide | warnings | … excessive mortality or non-fatal cardiac arrest rate (7.7%) was seen in patients treated with encainide or flecainide compared with that seen in patients assigned to carefully matched placebo-treated groups (3.0%). |
| Fluvoxamine | drug interactions | In a formal, single-dose interaction study (n = 6 males) the clearance of mexiletine was decreased by 38% following the coadministration of fluvoxamine, an inhibitor of CYP1A2. |
| Phenobarbital | drug interactions | When phenytoin or other hepatic enzyme inducers such as rifampin and phenobarbital have been taken concurrently with mexiletine, lowered mexiletine plasma levels have been reported. |
| Phenytoin | drug interactions | When phenytoin or other hepatic enzyme inducers such as rifampin and phenobarbital have been taken concurrently with mexiletine, lowered mexiletine plasma levels have been reported. |
| Propafenone | drug interactions | Addition of mexiletine to propafenone did not lead to further electrocardiographic parameters changes of QRS, QTc, RR, and PR intervals than propafenone alone. |
| Propranolol | drug interactions | ECG intervals (PR, QRS, and QT) were not affected by concurrent mexiletine and digoxin, diuretics, or propranolol. |
| Quinidine | drug interactions | A variety of antiarrhythmics such as quinidine or propranolol were also added, sometimes with improved control of ventricular ectopy. |
| Rifampin | drug interactions | When phenytoin or other hepatic enzyme inducers such as rifampin and phenobarbital have been taken concurrently with mexiletine, lowered mexiletine plasma levels have been reported. |
| Theophylline | drug interactions | Concurrent use of mexiletine and theophylline may lead to increased plasma theophylline levels. |
Other labels that name mexiletine
Source: FDA drug label (Mexiletine Hydrochloride), Macleods Pharmaceuticals Limited, effective May 14, 2026 (SPL set a61a07f6-0b48-4dcd-ad42-5d90f6e69ab1), via openFDA; the full label on DailyMed
What do FAERS reports show for mexiletine?
The FDA Adverse Event Reporting System holds 420 reports that list mexiletine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 76 are coded as a death and 255 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 antiarrhythmics
- the pharmacologic class, with prices and generics
- Mexiletine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other