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What the label lists and what reports show

Pindolol side effects

Pindolol's FDA label lists its adverse reactions in its own words. FAERS holds 796 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 urinary tract infection (46 reports).

  • Generic listed
  • A presentation discontinued

Check it at the source: the pindolol FDA label on DailyMed (effective March 17, 2026, Sun Pharmaceutical Industries, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Most adverse reactions have been mild. The incidences listed in the following table are derived from 12-week comparative double-blind, parallel design trials in hypertensive patients given pindolol as monotherapy, given various active control drugs as monotherapy, or given placebo. Data for pindolol and the positive controls were pooled from several trials because no striking differences were seen in the individual studies, with one exception. When considering all adverse reactions reported, the frequency of edema was noticeably higher in positive control trials (16% pindolol vs. 9% positive control) than in placebo controlled trials (6% pindolol vs. 3% placebo). The table includes adverse reactions either volunteered or elicited, and at least possibly drug-related, which were reported in greater than 2% of pindolol patients and other selected important reactions. …

ADVERSE REACTIONS WHICH WERE VOLUNTEERED OR ELICITED (and at least possibly drug-related)

Body System/ Adverse ReactionsPindolol (N = 322) % Central Nervous System
Bizarre or Many Dreams5
Dizziness9
Fatigue8
Hallucinations< 1
Insomnia10
Nervousness7
Weakness4
Paresthesia3
Dyspnea5
Edema6
Heart Failure< 1
Palpitations< 1
Chest Pain3
Joint Pain7
Muscle Cramps3
Muscle Pain10
Abdominal Discomfort4
Nausea5
Pruritus1
Rash< 1
Bizarre or Many Dreams0
Dizziness11
Fatigue4
Hallucinations0
Insomnia3

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

Source: FDA drug label, Sun Pharmaceutical Industries, Inc., effective March 17, 2026 (SPL set b331a73f-bf7b-4442-8901-36d016530279), via openFDA; the full label on DailyMed

What do FAERS reports show?

796 reports list pindolol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 63 are coded as a death and 265 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 21 reactions below, 5 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)52
  • Urinary Tract Infection46
  • Nausea (named in the label)44
  • Fatigue (named in the label)43
  • Dyspnoea (named in the label)42
  • Dizziness (named in the label)41
  • Drug Interaction (a use or a product term, not a reaction)40
  • Diarrhoea (named in the label)31
  • Fall31
  • Sepsis29
  • Rhabdomyolysis28
  • Pain26
  • Headache25
  • Muscular Weakness24
  • Myalgia24
  • Oesophagitis24
  • Depression22
  • Pneumonia21
  • Hypertension (a use or a product term, not a reaction)20
  • Malaise20
  • White Blood Cell Count Abnormal20
  • Arthralgia19
  • Death (an outcome recorded in the report)19
  • Haemoglobin Abnormal19
  • Muscle Spasms19

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

What next?

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