Prescription medicine
Pyridostigmine Brand names: Mestinon, Regonol
Pyridostigmine (Mestinon) is a prescription medicine with an FDA approval on record since 1955. FDA's NDC Directory lists it from 16 generic labelers, and pharmacies paid $0.249 per pyridostigmine br 60 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the pyridostigmine FDA label on DailyMed (effective December 2, 2020, Bausch Health US, LLC); the NDA 9829 record on Drugs@FDA; every pyridostigmine label on DailyMed.
Highlights of the record
FDA label of December 2, 2020; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageMESTINON is useful in the treatment of myasthenia gravis.
Forms and strengths
- 30 mg
- 60 mg
- 105 mg
- 180 mg
- 5 mg/ml
- 60 mg/5ml
Tablet; solution; extended-release tablet; injection (solution).
On the market
- Earliest approval on file
- April 6, 1955 Mestinon, Bausch; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 14 first November 27, 1990; 11 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 20 of which 16 under generic applications, 4 under brand applications, repackagers included
- Last listed patent
- June 18, 2038 Pyridostigmine Bromide tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.249 per tablet Pyridostigmine br 60 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2013 0 Class I among all firms' recalls; latest September 30, 2022
- FAERS reports
- 10,653 through July 30, 2026
What is pyridostigmine used for?
From the label: indications and usageMESTINON is useful in the treatment of myasthenia gravis.
FDA pharmacologic class: Cholinesterase Inhibitor.
Source: FDA drug label (Mestinon), Bausch Health US, LLC, effective December 2, 2020 (SPL set a851795e-b7a8-40c3-9922-5e79d3eb4d92), via openFDA; the full label on DailyMed
Is there a generic for pyridostigmine (Mestinon)?
The FDA approved the first generic pyridostigmine on November 27, 1990. 14 generic applications are approved; 11 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 pyridostigmine from 16 labelers under a generic (ANDA) application and from 4 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Mestinon tablets; a patent listed only for Pyridostigmine Bromide tablets runs to June 18, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1955 earliest approval on file
- 1990 first generic approved
- 2038 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for pyridostigmine (Mestinon)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.249 per Pyridostigmine br 60 mg tablet, down 3% from $0.257 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. 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.
- Pyridostigmine br 60 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Pyridostigmine 60 mg/5 mL solution | Generic | $0.565 per mL | n/a | -26% |
| Pyridostigmine br 30 mg tablet | Generic | $6.95 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $208.41 | -0.1% |
| Pyridostigmine br 60 mg tablet | Generic | $0.249 per tablet | $7.46 | -3% |
| Pyridostigmine ER 180 mg tablet | Generic | $4.00 per tablet | $119.89 | -22% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has pyridostigmine been recalled?
The FDA's Enforcement Report lists 3 recalls naming pyridostigmine since 2013: 0 Class I (the most serious), 3 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| September 30, 2022 | Class II | VistaPharm, Inc. | cGMP Deviations: Out of specification for assay of one of the preservative ingredients. |
| December 13, 2013 | Class II | Corepharma LLC | Failed Dissolution Specification: Corepharma Inc. is recalling Pyridostigmine Bromide Tablets USP 60 mg due to an out of specification dissolution test … |
| July 2, 2013 | Class II | Core Pharma Llc | Failed Stability Specifications: Pyridostigmine Bromide tablets, is being recalled due to an out of specification test result during stablity testing. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the pyridostigmine label say about other medicines?
The pyridostigmine label names 11 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name pyridostigmine. 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 |
|---|---|---|
| Atropine | contraindications | Care should be observed in the use of atropine for counteracting side effects, as discussed below. |
| Bacitracin | drug interactions | The following antibiotics have been associated with various degrees of paralysis: aminoglycosides (such as neomycin, streptomycin, kanamycin, gentamicin, and dihydrostreptomycin); tetracyclines; bacitracin; polymyxin B; colistin; and sodium colistimethate. |
| Colistimethate | drug interactions | The following antibiotics have been associated with various degrees of paralysis: aminoglycosides (such as neomycin, streptomycin, kanamycin, gentamicin, and dihydrostreptomycin); tetracyclines; bacitracin; polymyxin B; colistin; and sodium colistimethate. |
| Gentamicin | drug interactions | The following antibiotics have been associated with various degrees of paralysis: aminoglycosides (such as neomycin, streptomycin, kanamycin, gentamicin, and dihydrostreptomycin); tetracyclines; bacitracin; polymyxin B; colistin; and sodium colistimethate. |
| Mefloquine | drug interactions | Concomitant use of mefloquine and pyridostigmine bromide may have additive effects on the gastrointestinal tract, the most common of which is loose bowels. |
| Neomycin | drug interactions | The following antibiotics have been associated with various degrees of paralysis: aminoglycosides (such as neomycin, streptomycin, kanamycin, gentamicin, and dihydrostreptomycin); tetracyclines; bacitracin; polymyxin B; colistin; and sodium colistimethate. |
| Polymyxin b | drug interactions | The following antibiotics have been associated with various degrees of paralysis: aminoglycosides (such as neomycin, streptomycin, kanamycin, gentamicin, and dihydrostreptomycin); tetracyclines; bacitracin; polymyxin B; colistin; and sodium colistimethate. |
| Pralidoxime | boxed warning | RISKS WITH IMPROPER USE OF PYRIDOSTIGMINE BROMIDE After Exposure to Soman, Use Atropine and Pralidoxime Pyridostigmine bromide is for use as a pretreatment for exposure to soman nerve agent. |
| Quinidine | drug interactions | Other Experience concerning injection of quinidine during recovery from use of nondepolarizing muscle relaxants suggest that recurrent paralysis may occur. |
| Streptomycin | drug interactions | The following antibiotics have been associated with various degrees of paralysis: aminoglycosides (such as neomycin, streptomycin, kanamycin, gentamicin, and dihydrostreptomycin); tetracyclines; bacitracin; polymyxin B; colistin; and sodium colistimethate. |
| Succinylcholine | drug interactions | Drugs that Interfere with Neuromuscular Transmission Particular caution should be observed in the administration of depolarizing neuromuscular blocking agents (e.g., succinylcholine) during surgery since the degree of neuromuscular blockade that ensues may be enhanced by previously administered pyridostigmine bromide. |
Other labels that name pyridostigmine
Source: FDA drug label (Mestinon), Bausch Health US, LLC, effective December 2, 2020 (SPL set a851795e-b7a8-40c3-9922-5e79d3eb4d92), via openFDA; the full label on DailyMed
What do FAERS reports show for pyridostigmine?
The FDA Adverse Event Reporting System holds 10,653 reports that list pyridostigmine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 806 are coded as a death and 3,764 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other cholinesterase inhibitors
- the pharmacologic class, with prices and generics
- Pyridostigmine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other