Prescription medicine
Pralidoxime Brand names: Protopam; first approved as Protopam Chloride
Pralidoxime (Protopam) is a prescription medicine with an FDA approval on record since 1964. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the pralidoxime FDA label on DailyMed (effective April 1, 2026, Baxter Healthcare Corporation); the NDA 14134 record on Drugs@FDA; every pralidoxime label on DailyMed.
Highlights of the record
FDA label of April 1, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usagePROTOPAM Chloride is indicated as an antidote: (1) in the treatment of poisoning due to those pesticides and chemicals (e.g., nerve agents) of the organophosphate class which have anticholinesterase activity and (2) in the control of overdosage by anticholinesterase drugs used in the treatment of myasthenia gravis.
Forms and strengths
- 1 g/20ml
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- March 11, 1964 Protopam Chloride, Baxter Hlthcare Corp; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 26 through July 30, 2026
What is pralidoxime used for?
From the label: indications and usagePROTOPAM Chloride is indicated as an antidote: (1) in the treatment of poisoning due to those pesticides and chemicals (e.g., nerve agents) of the organophosphate class which have anticholinesterase activity and (2) in the control of overdosage by anticholinesterase drugs used in the treatment of myasthenia gravis. The principal indications for the use of PROTOPAM Chloride are muscle weakness and respiratory depression. In severe poisoning, respiratory depression may be due to muscle weakness.
FDA pharmacologic class: Cholinesterase Reactivator.
Source: FDA drug label (Protopam Chloride), Baxter Healthcare Corporation, effective April 1, 2026 (SPL set 2741d8fd-51c2-46be-880b-99f2b20a6137), via openFDA; the full label on DailyMed
Is there a generic for pralidoxime (Protopam)?
No generic pralidoxime is approved (Drugs@FDA, October 8, 2026).
- 1964 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the pralidoxime label say about other medicines?
The pralidoxime label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name pralidoxime. 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 |
|---|---|---|
| Aminophylline | drug interactions | … anticholinesterases, they should be used cautiously in the treatment of convulsions; morphine, theophylline, aminophylline, reserpine, and phenothiazine-type tranquilizers should be avoided in patients with organophosphate poisoning. |
| Atropine | drug interactions | Drug Interactions When atropine and pralidoxime chloride are used together, the signs of atropinization (flushing, mydriasis, tachycardia, dryness of the mouth and nose) may occur earlier than might be expected when atropine is used alone. |
| Morphine | drug interactions | … are potentiated by the anticholinesterases, they should be used cautiously in the treatment of convulsions; morphine, theophylline, aminophylline, reserpine, and phenothiazine-type tranquilizers should be avoided in patients with organophosphate poisoning. |
| Succinylcholine | drug interactions | Prolonged paralysis has been reported in patients when succinylcholine is given with drugs having anticholinesterase activity; therefore, it should be used with caution. |
| Theophylline | drug interactions | … potentiated by the anticholinesterases, they should be used cautiously in the treatment of convulsions; morphine, theophylline, aminophylline, reserpine, and phenothiazine-type tranquilizers should be avoided in patients with organophosphate poisoning. |
Other labels that name pralidoxime
Source: FDA drug label (Protopam Chloride), Baxter Healthcare Corporation, effective April 1, 2026 (SPL set 2741d8fd-51c2-46be-880b-99f2b20a6137), via openFDA; the full label on DailyMed
What do FAERS reports show for pralidoxime?
The FDA Adverse Event Reporting System holds 26 reports that list pralidoxime among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 10 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?
- Pralidoxime side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other