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What the label lists and what reports show

Rocuronium side effects

Rocuronium's FDA label: “In clinical trials, the most common adverse reactions (2%) are transient hypotension and hypertension.” FAERS holds 11,713 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 anaphylactic reaction (1,279 reports).

  • Generic listed
  • In shortage

Check it at the source: the rocuronium FDA label on DailyMed (effective July 16, 2025, Fresenius Kabi USA, LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

In clinical trials, the most common adverse reactions (2%) are transient hypotension and hypertension.

From the label: adverse reactions, continued

In clinical trials, the most common adverse reactions (2%) are transient hypotension and hypertension. The following adverse reactions are described, or described in greater detail, in other sections: Anaphylaxis [see Warnings and Precautions ( 5.2 )] Residual paralysis [see Warnings and Precautions ( 5.5 )] Myopathy [see Warnings and Precautions ( 5.6 )] Increased pulmonary vascular resistance [see Warnings and Precautions ( 5.12 )] Most common adverse reactions (2%) are transient hypotension and hypertension. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical studies of another rocuronium bromide injection product in the U.S. (n=1137) and Europe (n=1394) totaled 2531 patients.

Source: FDA drug label, Fresenius Kabi USA, LLC, effective July 16, 2025 (SPL set 9a622308-7bda-4ca0-9de5-d6b3b4be3384), via openFDA; the full label on DailyMed

What do FAERS reports show?

11,713 reports list rocuronium among the medicines taken, each a report of something that happened, not proof the medicine caused it; 938 are coded as a death and 4,263 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 20 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

  • Anaphylactic Reaction (named in the label)1,279
  • Hypotension (named in the label)1,124
  • Drug Ineffective (a use or a product term, not a reaction)1,112
  • Anaphylactic Shock1,004
  • Cardiac Arrest662
  • Drug Interaction (a use or a product term, not a reaction)466
  • Tachycardia (named in the label)428
  • Off Label Use (a use or a product term, not a reaction)413
  • Bradycardia397
  • Bronchospasm (named in the label)377
  • Rash (named in the label)292
  • Urticaria278
  • Anaesthetic Complication Neurological270
  • Oxygen Saturation Decreased265
  • Hypoxia263
  • Respiratory Failure256
  • Serotonin Syndrome225
  • Circulatory Collapse215
  • Hyperthermia Malignant198
  • Blood Pressure Decreased197
  • Condition Aggravated (a use or a product term, not a reaction)190
  • Erythema187
  • Dyspnoea186
  • Foetal Exposure During Pregnancy (a use or a product term, not a reaction)186
  • Acute Kidney Injury165

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

What next?

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