Procainamide
Procainamide injection is a heart rhythm medicine (a Group 1A antiarrhythmic) used in the hospital to treat life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 13 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Procainamide is an older injectable heart rhythm medicine (a Group 1A antiarrhythmic), around since about 1950 and available as a generic, used in the hospital for life-threatening ventricular arrhythmias (dangerous rhythms from the lower heart chambers) such as sustained ventricular tachycardia. It is not a gentle drug, and a drop in blood pressure during an IV dose is the most common problem, along with nausea, a bitter taste or dizziness. The boxed warning covers new rhythm problems, dangerously low blood counts and a lupus-like illness with longer use, so report fever, sore throat, mouth sores, bruising or bleeding right away.
Clinical pearls
- Blood counts are checked weekly for the first three months, when most serious drops in white cells happen.
- The injection contains sodium metabisulfite, so mention any sulfite allergy or asthma, and any allergy to procaine or similar numbing medicines.
- Before surgery, remind the anesthesia team you are on procainamide, since muscle relaxants like succinylcholine may need lower doses.
- Kidney problems let procainamide build up, so tremor, extreme drowsiness or slowed breathing can mean the dose is too high.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Procainamide is reserved for life-threatening ventricular arrhythmias because antiarrhythmic drugs can raise the risk of death and dangerous rhythm problems in people with less serious arrhythmias. In a large study of related drugs (encainide and flecainide) in people after a heart attack, deaths or cardiac arrests were more common than with placebo (7.7% vs. 3.0%).
It can also cause serious blood problems, such as dangerously low white blood cells, low platelets and bone marrow depression, in about 0.5% of patients. Most cases occur in the first 12 weeks, and some have been fatal. Blood counts are checked weekly for the first three months and periodically afterward. Tell your care team right away about fever, chills, sore throat, mouth sores, bruising or bleeding.
Long-term use often causes a positive ANA blood test, with or without a lupus-like illness. If this happens, your doctor will weigh the benefits and risks of continuing.
Patient information guide A plain-language walkthrough of Procainamide, written from its FDA label.
What Procainamide is used for
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Procainamide injection is used for serious heart rhythm problems.
- Documented ventricular arrhythmias that your doctor judges to be life-threatening, such as sustained ventricular tachycardia (Procainamide Hydrochloride and Procainamide Hci injection products, given into a vein or muscle).
- It is generally not recommended for lesser arrhythmias.
- It should be avoided for asymptomatic ventricular premature contractions.
How Procainamide works
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Procainamide is a Group 1A antiarrhythmic. It lengthens the time heart tissue needs to recover between beats and slows electrical signals moving through the heart. It also makes heart muscle less excitable and reduces abnormal pacemaker activity. Together, these effects help steady the heartbeat.
Procainamide dosage
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Procainamide injection is given by a healthcare professional into a vein or a muscle.
- Intravenous: gives the fastest control of serious arrhythmias. It should be done with close observation, such as in a hospital or emergency facility.
- Intramuscular: works more slowly and gives less of a temporary spike in blood levels. It may be used if you are nauseated or vomiting, cannot take anything by mouth before surgery, or have trouble absorbing oral medicine.
- Pills or capsules are preferred for less urgent arrhythmias and long-term maintenance after the injection.
Your doctor sets the dose and schedule. Because it is given in a medical setting, missed doses are managed by your care team.
Dosing details from the FDA-approved label
From the Procainamide prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Intramuscular administration (alternative to oral route for less threatening arrhythmias in patients who are nauseated or vomiting, NPO preoperatively, or who may have malabsorptive problems)
- An initial daily dose of 50 mg per kg body weight may be estimated, divided into fractional doses of one-eighth to one-quarter to be injected intramuscularly every three to six hours until oral therapy is possible
- If more than three injections are given, assess age, renal function, clinical response and, if available, blood levels of PA and NAPA in adjusting further doses
- Arrhythmias associated with anesthesia or surgical operation
- 100 to 500 mg by intramuscular injection
- Intravenous direct injection for initial arrhythmia control
- Doses of 100 mg may be administered every 5 minutes at a rate not to exceed 50 mg per minute until the arrhythmia is suppressed or until 500 mg has been administered, then wait 10 minutes or longer before resuming
- Maximum: The maximum advisable dosage by repeated bolus injections or loading infusion is 1 gram
- Dilute the 100 mg per mL or 500 mg per mL concentrations prior to intravenous injection to facilitate control of dosage rate; under ECG monitoring
- Intravenous initial loading infusion
- 20 mg per mL (1 g diluted to 50 mL with 5% Dextrose Injection, USP) at a constant rate of 1 mL per minute for 25 to 30 minutes to deliver 500 to 600 mg of PA
- Maximum: The maximum advisable dosage by repeated bolus injections or loading infusion is 1 gram
- It is unusual to require more than 600 mg to achieve satisfactory antiarrhythmic effects
- Intravenous maintenance infusion
- 2 mg per mL (1,000 mg in 500 mL of 5% Dextrose Injection, USP) at 1 to 3 mL/minute
- Or 4 mg per mL (1 g in 250 mL) at 0.5 to 1.5 mL/minute, delivering an equivalent 2 to 6 mg per minute
- The 4 mg per mL concentration is for when fluid intake must be limited; the rate depends on weight, age, renal elimination, hepatic acetylation rate and cardiac status; reduced renal excretion lowers the dose rate needed
Read the label’s full dosing text
DOSAGE AND ADMINISTRATION Procainamide Hydrochloride Injection is useful for arrhythmias which require immediate suppression and for maintenance of arrhythmia control. Intravenous therapy allows most rapid control of serious arrhythmias, including those following myocardial infarction; it should be carried out in circumstances where close observation and monitoring of the patient are possible, such as in hospital or emergency facilities. Intramuscular administration is less apt to produce temporary high plasma levels but therapeutic plasma levels are not obtained as rapidly as with intravenous administration. Oral procainamide dosage forms are preferable for less urgent arrhythmias as well as for long-term maintenance after initial parenteral PA therapy. Intramuscular administration may be used as an alternative to the oral route for patients with less threatening arrhythmias but who are nauseated or vomiting, who are ordered to receive nothing by mouth preoperatively, or who may have malabsorptive problems. An initial daily dose of 50 mg per kg body weight may be estimated. This amount should be divided into fractional doses of one-eighth to one-quarter to be injected intramuscularly every three to six hours until oral therapy is possible. If more than three injections are given, the physician may wish to assess patient factors such as age and renal function (see below), clinical response and, if available, blood levels of PA and NAPA in adjusting further doses for that individual. For treatment of arrhythmias associated with anesthesia or surgical operation, the suggested dose is 100 to 500 mg by intramuscular injection. Intravenous administration of Procainamide Hydrochloride Injection should be done cautiously to avoid a possible hypotensive response (see PRECAUTIONS and OVERDOSAGE ). Initial arrhythmia control, under ECG monitoring, may usually be accomplished safely within a half-hour by either of the two methods which follows: Direct injection into a vein or into tubing of an established infusion line should be done slowly at a rate not to exceed 50 mg per minute. It is advisable to dilute either the 100 mg per mL or the 500 mg per mL concentrations of procainamide hydrochloride prior to intravenous injection to facilitate control of dosage rate.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Procainamide side effects
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Side effects can include the following.
Common side effects
- Low blood pressure, more often with intravenous use
- Nausea, vomiting or loss of appetite
- Abdominal pain or diarrhea
- Bitter taste
- Dizziness or giddiness
- Weakness
- Skin reactions such as rash, hives, itching or flushing
When to get medical help
- Fever, chills, sore throat or mouth sores, which can be signs of a serious drop in blood cells
- Unusual bruising or bleeding
- Joint pain, chest or belly pain, fever or muscle aches, which can signal a lupus-like reaction
- Swelling of the face or lips, trouble breathing, wheezing or other allergic symptoms
- Severe low blood pressure or a dangerous heart rhythm change
- Mood changes, depression, or hallucinations
- Signs of liver problems, such as feeling unwell or pain in the upper right belly
- Tremor, extreme drowsiness or slowed breathing, which can signal too much medicine
Procainamide warnings and precautions
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- Rhythm and survival risk: Procainamide can cause new heart rhythm problems. Antiarrhythmic drugs have not been shown to improve survival, so it is reserved for life-threatening ventricular arrhythmias.
- Blood problems: Serious drops in blood cells can occur, mostly in the first 12 weeks. Blood counts are checked regularly.
- Lupus-like illness: Long-term use may cause a positive ANA test and symptoms like joint pain, fever and chest pain.
- Heart conduction: It can worsen heart block. Caution is needed with first-degree block, atrial flutter or fibrillation, and heart failure.
- Kidneys: Poor kidney function can cause the drug to build up.
- Sulfites: The injection contains sodium metabisulfite, which can trigger allergic reactions in sensitive people.
- Myasthenia gravis: Symptoms may worsen.
Procainamide interactions
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Tell your care team about every medicine you take. Key ones to be careful with:
- Other antiarrhythmics (quinidine, disopyramide): effects on the heart can add up, and a lower dose may be needed.
- Anticholinergic drugs: they may add to effects on conduction between the upper and lower heart chambers.
- Succinylcholine and similar muscle relaxants: lower doses of those drugs may be needed.
- Digitalis: used with caution when the rhythm problem is caused by digitalis toxicity.
Interactions listed in the FDA-approved label
From the Procainamide prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Other antiarrhythmic drugs: Additive effects on the heart may occur with PA administration. Dosage reduction may be necessary.
- Anticholinergic drugs: Concurrent use with PA may produce additive antivagal effects on A-V nodal conduction, although this is not as well documented for PA as for quinidine.
- Neuromuscular blocking agents such as succinylcholine: Patients taking PA may require less than usual doses of the neuromuscular blocker, due to PA effects on reducing acetylcholine release.
Read the label’s full interactions text
Drug Interactions If other antiarrhythmic drugs are being used, additive effects on the heart may occur with PA administration, and dosage reduction may be necessary (see WARNINGS ). Anticholinergic drugs administered concurrently with PA may produce additive antivagal effects on A-V nodal conduction, although this is not as well documented for PA as for quinidine. Patients taking PA who require neuromuscular blocking agents such as succinylcholine may require less than usual doses of the latter, due to PA effects on reducing acetylcholine release.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Procainamide
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- Do not use with complete heart block.
- Avoid or stop with second-degree block or hemiblock unless a pacemaker controls the heart rate.
- Do not use with established systemic lupus erythematosus.
- Do not use with torsades de pointes.
- Tell your doctor about allergies to procaine, similar local anesthetics or sulfites.
- Tell your doctor about heart failure, kidney problems, myasthenia gravis or low blood counts.
- Older age and reduced kidney function slow how fast the body clears procainamide.
Procainamide overdose
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Too much procainamide can cause low blood pressure, widened and abnormal heart tracings, more heart block, extra beats, or dangerous rhythms. It can also cause drowsiness, tremor and slowed breathing. Treatment is supportive care with close monitoring, and possibly blood pressure medicines and breathing or heart support. There is no specific antidote, but hemodialysis can remove it.
What Procainamide does in the body
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Procainamide lengthens the recovery time of heart tissue and slows electrical conduction. On an ECG it can widen the QRS complex and sometimes lengthen the Q-T and P-R intervals. It usually does not affect the pumping strength of a healthy heart, though output may drop in a damaged heart. High levels can cause heart block or tremors.
How your body processes Procainamide
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Given intravenously, procainamide reaches therapeutic levels within minutes. Given into a muscle, blood levels peak in about 15 to 60 minutes. The body clears it with a half-life of about three to four hours when kidneys are normal. Some is changed in the liver to NAPA, which also treats arrhythmias. Much of it leaves through the kidneys. Age and poor kidney function slow clearance.
How to store Procainamide
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Store at 20° to 25°C (68° to 77°F).
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Procainamide
59 supplements and herbal products have documented interactions with Procainamide in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 9
- Moderate · 39
- Minor · 11
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Procainamide: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Procainamide — the kind of thing our pharmacy team would talk through with you at the counter.
What is procainamide injection for?
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Why do I have to be in the hospital for this?
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What side effects should I expect?
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What symptoms should I report right away?
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Will I need blood tests?
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Can I take other heart medicines with it?
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Is Procainamide available over the counter?
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When was Procainamide first available?
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Who makes Procainamide?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Procainamide on HelloPharmacist
Procainamide forms and strengths (how it comes)
Procainamide is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Procainamide Hydrochloride injection treats documented life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia.
- Procainamide Hci injection treats documented life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia.
- Procainamide Hydrochloride injection given intravenously allows the fastest control of serious arrhythmias and requires close monitoring, such as in a hospital or emergency facility.
- Procainamide Hydrochloride injection given into a muscle works more slowly than the intravenous route.
- Procainamide Hci injection starts treatment in the hospital for life-threatening arrhythmias.
Procainamide on the U.S. market: products, makers and brands
How Procainamide appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
10 companies list 16 Procainamide product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 1950. Brand names on the directory include Procan, Procanbid, Procapan and 2 more; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (4) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Compare Procainamide products
A representative set of FDA-listed product records for Procainamide — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 100 mg/mL | Intramuscular, Intravenous | Caplin Steriles Limited | ANDA | View NDC → |
| 500 mg/mL | Intramuscular, Intravenous | Caplin Steriles Limited | ANDA | View NDC → |
| 100 mg/mL | Intramuscular, Intravenous | Gland Pharma Limited | ANDA | View NDC → |
| 500 mg/mL | Intramuscular, Intravenous | Gland Pharma Limited | ANDA | View NDC → |
| 100 mg/mL | Intramuscular, Intravenous | HF Acquisition Co LLC, DBA HealthFirst × 2 listings | ANDA | View NDC → |
| 100 mg/mL | Intramuscular, Intravenous | Hospira, Inc. | ANDA | View NDC → |
| 100 mg/mL | Intramuscular, Intravenous | International Medication Systems, Limited | ANDA | View NDC → |
| 100 mg/mL | Intramuscular, Intravenous | Medical Purchasing Solutions, LLC | ANDA | View NDC → |
| 100 mg/mL | Intramuscular, Intravenous | Medical Purchasing Solutions, LLC. | ANDA | View NDC → |
| 100 mg/mL | Intramuscular, Intravenous | Nexus Pharmaceuticals LLC | ANDA | View NDC → |
| 500 mg/mL | Intramuscular, Intravenous | Nexus Pharmaceuticals LLC | ANDA | View NDC → |
| 100 mg/mL | Intramuscular, Intravenous | ProPharma Distribution | ANDA | View NDC → |
| 100 mg/mL | Intramuscular, Intravenous | Remedyrepack Inc. | ANDA | View NDC → |
| 100 mg/mL | Intramuscular, Intravenous | Sagent Pharmaceuticals | ANDA | View NDC → |
| 500 mg/mL | Intramuscular, Intravenous | Sagent Pharmaceuticals | ANDA | View NDC → |
Showing 16 of 16 products — FDA National Drug Code Directory. See every product, package size and price: browse all 16 Procainamide NDCs →
Procainamide side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Procainamide — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Procainamide in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Procainamide FDA approval history
How Procainamide went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Procainamide recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Procainamide recalls since July 2021.
✅No Procainamide recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 8700 5 dose forms · 11 strengths
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Dose form (SCDF) Extended Release Oral Tablet RxCUI 373599No current FDA listingClinical drug / strength (SCD) 12 HR procainamide hydrochloride 1000 MGRxCUI 85786812 HR procainamide hydrochloride 500 MGRxCUI 857879 -
Dose form (SCDF) Injectable Solution RxCUI 373597In current FDA listingsClinical drug / strength (SCD) hydrochloride 100 MG/MLRxCUI 857886hydrochloride 500 MG/MLRxCUI 857962 -
Dose form (SCDF) Oral Capsule RxCUI 373596No current FDA listingClinical drug / strength (SCD) hydrochloride 250 MGRxCUI 858109hydrochloride 375 MGRxCUI 857896hydrochloride 500 MGRxCUI 858111 -
Dose form (SCDF) Oral Tablet RxCUI 373598No current FDA listingClinical drug / strength (SCD) hydrochloride 250 MGRxCUI 857892hydrochloride 375 MGRxCUI 857901hydrochloride 500 MGRxCUI 858113 -
Dose form (SCDF) Prefilled Syringe RxCUI 1862219No current FDA listingClinical drug / strength (SCD) 10 ML procainamide hydrochloride 100 MG/MLRxCUI 1862220
Look up RxCUI 8700 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Procainamide supply and shortage status
Whether Procainamide is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Procainamide brand names
Procainamide is sold under 5 brand names in the FDA directory — Procan, Procanbid, Procapan, Pronestyl and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Procainamide: manufacturers and labelers
10 companies list Procainamide products with the FDA. By number of product records, the largest are Caplin Steriles Limited, Gland Pharma Limited, HF Acquisition Co LLC, DBA HealthFirst. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Procainamide drug class (RxNorm)
Procainamide belongs to the Antiarrhythmic class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Procainamide page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Sagent Pharmaceuticals is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →