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Updated: January 19, 2026

Procainamide Shortage: What Providers and Prescribers Need to Know in 2026

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Peter Daggett

Peter Daggett

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Overview

A clinical guide for providers managing procainamide availability, formulary planning, and patient transitions in light of ongoing supply and oral formulation challenges.

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Procainamide hydrochloride injection remains a key tool in the acute management of ventricular and supraventricular arrhythmias. However, its supply chain history—combined with the permanent discontinuation of commercial oral formulations—presents ongoing challenges for clinicians, pharmacists, and hospital formulary committees. This guide reviews the current availability landscape, clinical alternatives, and strategies for managing patients when procainamide is unavailable.

Current Availability Status (2026)

As of 2026, procainamide hydrochloride injection is not on the FDA's active drug shortage list. Multiple manufacturers—Amphastar Pharmaceuticals, Nexus Pharmaceuticals, and Pfizer—produce the injectable formulation, providing some supply chain redundancy. Available presentations include:

Amphastar: 100 mg/mL, 10 mL Luer Lock syringe (NDC 76329-3399-05)

Nexus Pharmaceuticals: 100 mg/mL, 10 mL multiple dose vial and 500 mg/mL, 2 mL multiple dose vial

Pfizer: 100 mg/mL, 10 mL vial and 500 mg/mL, 2 mL vial

While the injectable supply is currently stable, oral procainamide (Pronestyl tablets, Procanbid extended-release tablets) has been permanently discontinued from commercial manufacture in the US. Patients requiring oral maintenance therapy must rely on compounding pharmacies.

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Shortage History: The 2017 Episode and Its Lessons

In May 2017, Pfizer's manufacturing delays triggered an ASHP-documented national shortage of procainamide injection that lasted nearly 11 months. Hospitals relying heavily on procainamide for ventricular arrhythmia management were forced to adapt formularies and clinical protocols rapidly. Nexus Pharmaceuticals entered the market with their formulation in October 2017, helping alleviate the shortage, which was fully resolved by April 2018.

Key lessons from that episode for formulary and clinical planning:

Maintain a 30–60 day formulary buffer for critical antiarrhythmics when possible

Establish alternative procurement contracts with two or more manufacturers proactively

Have evidence-based substitution protocols preapproved by P&T committee

Monitor ASHP and FDA shortage databases routinely as part of pharmacy operations

Managing Patients on Oral Procainamide: The Compounding Gap

Patients who were previously managed on oral procainamide for chronic arrhythmia control represent a distinct challenge. With no commercially available oral formulation, these patients must be transitioned to either:

Compounded oral procainamide: Capsules or oral suspensions can be prepared by PCAB-accredited compounding pharmacies. These require a specific prescription, are typically not covered by insurance, and may have variable quality and availability. Clinical monitoring (CBC, ANA titers, ECG) remains essential.

Alternative antiarrhythmic medications: Transition to sotalol, amiodarone, flecainide, or propafenone depending on arrhythmia type, cardiac function, comorbidities, and tolerability.

Clinical Evidence: When to Choose Procainamide Over Alternatives

The PROCAMIO trial (2017) provided meaningful comparative data. In patients with stable ventricular tachycardia, IV procainamide outperformed IV amiodarone in terms of arrhythmia termination rate and fewer major cardiac adverse events at 40 minutes post-infusion. This supports procainamide as the preferred agent for hemodynamically stable VT when it is available.

A retrospective study in Circulation Journal also found procainamide to be more effective than lidocaine for terminating sustained VT in patients with structural heart defects. For WPW syndrome with atrial fibrillation (pre-excitation), procainamide is the preferred IV antiarrhythmic—AV node blocking agents (adenosine, verapamil, digoxin) are contraindicated in this setting.

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Evidence-Based Alternative Protocols When Procainamide Is Unavailable

When procainamide is unavailable, the following evidence-based alternatives may be appropriate depending on arrhythmia type:

Stable VT: IV amiodarone (150 mg over 10 min, then 1 mg/min x 6h, then 0.5 mg/min); synchronized cardioversion if refractory

Unstable VT/VF: Immediate defibrillation; amiodarone IV per ACLS protocol

Atrial fibrillation/flutter: IV ibutilide or electrical cardioversion; oral antiarrhythmics (flecainide, dronedarone, sotalol) for rhythm control depending on cardiac structure

WPW with pre-excited AF: Ibutilide IV is the recommended alternative; electrical cardioversion for unstable patients. Avoid adenosine, digoxin, verapamil, diltiazem.

How medfinder Helps Providers Locate Procainamide for Patients

For outpatient patients who need procainamide from a compounding or specialty pharmacy, medfinder for providers can call pharmacies in the patient's area and identify which ones have the medication or can prepare a compounded formulation. This saves clinical staff time and reduces the risk of treatment gaps. See also our patient-facing shortage update to share with your patients.

Frequently Asked Questions

No. As of 2026, procainamide hydrochloride injection is not on the FDA's active drug shortage list. Multiple manufacturers supply the injectable formulation. However, commercial oral formulations have been permanently discontinued.

Based on the PROCAMIO trial and ACLS guidelines, IV amiodarone (150 mg over 10 minutes followed by 1 mg/min for 6 hours) is the most commonly used alternative for stable VT. Synchronized cardioversion is also appropriate for refractory cases.

Yes. With commercial oral formulations no longer available, you can write a compounding prescription for procainamide capsules or oral suspension. PCAB-accredited compounding pharmacies can prepare these formulations. Note that compounded preparations are not FDA-approved and quality may vary by pharmacy.

CBC (including white cell count, differential, and platelet count) should be performed weekly for the first 3 months and periodically thereafter due to the risk of agranulocytosis. ANA titers should be monitored for drug-induced lupus. Serial ECGs (QRS width, QTc, PR interval) are essential, especially during IV infusion.

Yes. For pre-excited atrial fibrillation in WPW syndrome, procainamide IV is the preferred pharmacologic agent because it blocks accessory pathway conduction. Amiodarone may also be used, but AV node blockers (adenosine, digoxin, verapamil, diltiazem) are contraindicated and can trigger ventricular fibrillation in this setting.

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