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What the label lists and what reports show

Cisatracurium side effects

Cisatracurium's FDA label: “The most common adverse reactions (0.1% to 0.4%) were bradycardia, hypotension, flushing, bronchospasm, and rash.” FAERS holds 2,195 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 hypotension (150 reports).

  • Generic listed
  • A presentation discontinued

Check it at the source: the cisatracurium FDA label on DailyMed (effective April 4, 2025, Gland Pharma Limited); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The most common adverse reactions (0.1% to 0.4%) were bradycardia, hypotension, flushing, bronchospasm, and rash.

A table the label prints in its adverse reactions section without a title; its column headings name the groups compared

Adverse ReactionIncidence
Bradycardia0.4%
Hypotension0.2%
Flushing0.2%
Bronchospasm0.2%
Rash0.1%

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.

From the label: adverse reactions, continued

The most common adverse reactions (0.1% to 0.4%) were bradycardia, hypotension, flushing, bronchospasm, and rash. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma at 866-770-7144 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adverse Reactions in Clinical Trials of Cisatracurium Besylate Injection in Surgical Patients The data presented below are based on studies involving 945 surgical patients who received cisatracurium besylate injection in conjunction with other drugs in US and European clinical studies in a variety of procedures [see Clinical Studies (14.1)]. Table 3 displays adverse reactions that occurred at a rate of less than 1%. Table 3. …

Source: FDA drug label, Gland Pharma Limited, effective April 4, 2025 (SPL set 0bacc37a-5e7f-4f05-9206-56fc8041c1ad), via openFDA; the full label on DailyMed

What do FAERS reports show?

2,195 reports list cisatracurium among the medicines taken, each a report of something that happened, not proof the medicine caused it; 369 are coded as a death and 901 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 22 reactions below, 3 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

  • Off Label Use (a use or a product term, not a reaction)161
  • Hypotension (named in the label)150
  • Anaphylactic Shock126
  • Drug Ineffective (a use or a product term, not a reaction)119
  • Anaphylactic Reaction (named in the label)117
  • Drug Interaction (a use or a product term, not a reaction)117
  • Anaesthetic Complication Neurological115
  • Rhabdomyolysis84
  • Cardiac Arrest83
  • Acute Kidney Injury74
  • Drug Reaction With Eosinophilia And Systemic Symptoms72
  • Hypoxia70
  • Tachycardia68
  • Bradycardia (named in the label)67
  • Respiratory Failure61
  • Hyperthermia Malignant59
  • Metabolic Acidosis57
  • Serotonin Syndrome55
  • Multiple Organ Dysfunction Syndrome54
  • Pyrexia54
  • Septic Shock47
  • Dyspnoea45
  • Hypertension43
  • Pneumonia41
  • Acute Respiratory Distress Syndrome38

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

What next?

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