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Procainamide Side Effects

The most commonly reported side effects of procainamide include off label use, drug hypersensitivity, and atrial fibrillation, based on 509 FDA adverse event reports from 2004 to 2025. 23.2% of reports found the drug to be ineffective.

Procainamide side effects

Percentages show how often each reaction appears relative to total reports for procainamide.

1
Drug Ineffective23.2%118
2
Off Label Use7.3%37
3
Drug Hypersensitivity6.7%34
4
Atrial Fibrillation5.7%29
5
Ventricular Tachycardia4.5%23
6
Drug Ineffective For Unapproved Indication4.5%23
7
Nausea4.3%22
8
Systemic Lupus Erythematosus4.3%22
9
Electrocardiogram Qt Prolonged4.1%21
10
Arthralgia4.1%21
11
Fatigue4.1%21
12
Atrial Fibrillation3.9%20
13
Pain3.9%20
14
Pain3.9%20
15
Pleural Effusion3.9%20

These are voluntary reports and do not establish that procainamide caused these reactions.

Report severity

85.1%Serious433 reports
45.6%Hospitalizations232 reports
14.5%Fatal74 reports

Seriousness is determined by the reporter, not by OpenClaim.

Procainamide drug interactions

Other drugs that appear in adverse event reports alongside procainamide. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Amiodarone-hydrochloride34.2%174
2
Lidocaine18.3%93
3
Quinidine7.7%39
4
Esmolol-hydrochloride6.5%33
5
Propranolol-hydrochloride6.3%32
6
Mexiletine-hydrochloride5.3%27
7
Digoxin5.1%26
8
Sotalol-hydrochloride5.1%26
9
Adenosine4.9%25
10
Hydralazine-hydrochloride4.5%23
11
Adalimumab3.9%20
12
Chlorpromazine3.5%18
13
Voriconazole3.5%18
14
Propofol3.3%17
15
Terbinafine3.3%17

Taken alongside

1
Furosemide13.2%67
2
Aspirin11.2%57
3
Amiodarone-hydrochloride11.2%57
4
Lidocaine10.6%54
5
Acetaminophen9.0%46
6
Metoprolol9.0%46
7
Heparin7.3%37
8
Digoxin7.1%36
9
Fentanyl7.1%36
10
Nitroglycerin6.5%33
11
Epinephrine5.7%29
12
Warfarin5.5%28
13
Vancomycin5.5%28
14
Propofol5.1%26
15
Potassium-chloride4.5%23

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports procainamide side effects

37.1% of procainamide adverse event reports involve female patients and 51.9% involve male patients. The largest age group is adult at 56%. These figures reflect who reports side effects, not underlying risk.

Sex

Female37.1%
Male51.9%
Unknown11.0%

Age group

< 28.5%
2–111.2%
12–171.7%
18–6455.6%
65+32.9%

What is procainamide used for

Conditions and purposes for which patients were taking procainamide when the adverse event was reported.

Angina PectorisArrhythmiaArrhythmia ProphylaxisAsthmaAtrial FibrillationAtrial FlutterAtrial TachycardiaArrhythmiaArrhythmic StormAtrial FibrillationAtrial FlutterAtrial TachycardiaCardiac DisorderCardiac FailureCardiac Fibrillation

Showing 15 of 68 indications

Procainamide brand names and reporting trend

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking procainamide with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.