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What the label lists and what reports show

Disopyramide side effects

Disopyramide's FDA label: “The most common adverse reactions, which are dose dependent, are associated with the anticholinergic properties of the drug.” FAERS holds 850 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is atrial fibrillation (48 reports).

  • Generic listed
  • A presentation discontinued
  • Boxed warning

Check it at the source: the disopyramide FDA label on DailyMed (effective August 24, 2026, Pfizer Laboratories Div Pfizer Inc); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The most common adverse reactions, which are dose dependent, are associated with the anticholinergic properties of the drug.

From the label: adverse reactions, continued

The adverse reactions which were reported in Norpace clinical trials encompass observations in 1,500 patients, including 90 patients studied for at least 4 years. The most serious adverse reactions are hypotension and congestive heart failure. The most common adverse reactions, which are dose dependent, are associated with the anticholinergic properties of the drug. These may be transitory, but may be persistent or can be severe. Urinary retention is the most serious anticholinergic effect.

Source: FDA drug label, Pfizer Laboratories Div Pfizer Inc, effective August 24, 2026 (SPL set e2aa1642-d262-4520-bc6a-9fd3ad795677), via openFDA; the full label on DailyMed

What do FAERS reports show?

850 reports list disopyramide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 40 are coded as a death and 216 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. Of the 18 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Drug Ineffective (a use or a product term, not a reaction)140
  • Off Label Use (a use or a product term, not a reaction)60
  • Atrial Fibrillation48
  • Dyspnoea44
  • Malaise (named in the label)43
  • Fatigue (named in the label)42
  • Palpitations32
  • Dizziness (named in the label)31
  • Asthenia27
  • Feeling Abnormal27
  • Drug Ineffective For Unapproved Indication (a use or a product term, not a reaction)23
  • Drug Interaction (a use or a product term, not a reaction)23
  • Product Use Issue (a use or a product term, not a reaction)23
  • Constipation (named in the label)22
  • Loss Of Consciousness21
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)21
  • Chest Pain (named in the label)20
  • Dry Mouth (named in the label)20
  • Nausea (named in the label)20
  • Condition Aggravated (a use or a product term, not a reaction)19
  • Pneumonia18
  • Weight Decreased18
  • Headache (named in the label)17
  • Pain In Extremity17
  • Blood Pressure Increased16

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Disopyramide: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions