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What the label lists and what reports show

Clevidipine side effects

Clevidipine's FDA label: “Most common adverse reactions (>2%) are headache, nausea, and vomiting.” FAERS holds 362 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 (30 reports).

  • No generic listed

Check it at the source: the clevidipine FDA label on DailyMed (effective November 6, 2025, Chiesi USA, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Most common adverse reactions (>2%) are headache, nausea, and vomiting.

From the label: adverse reactions, continued

The following risk is discussed elsewhere in the labeling: Hypotension and Reflex Tachycardia [see Warnings and Precautions (5.2)] Most common adverse reactions (>2%) are headache, nausea, and vomiting. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Chiesi USA, Inc. at 1-888-661-9260 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Cleviprex clinical development included 19 studies, with 99 healthy subjects and 1307 hypertensive patients who received at least one dose of clevidipine (1406 total exposures). Clevidipine was evaluated in 15 studies in hypertensive patients: 1099 patients with perioperative hypertension, 126 with severe hypertension and 82 patients with essential hypertension. The desired therapeutic response was achieved at doses of 4-6 mg/hour. Cleviprex was infused for <24 hours in the majority of patients (n=1199); it was infused as a continuous infusion in an additional 93 patients for durations between 24 and 72 hours. 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. …

Source: FDA drug label, Chiesi USA, Inc., effective November 6, 2025 (SPL set f9290625-b723-4eda-bab8-a97bef6041f6), via openFDA; the full label on DailyMed

What do FAERS reports show?

362 reports list clevidipine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 22 are coded as a death and 52 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, 4 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.

The 25 most reported reactions

  • Drug Ineffective (a use or a product term, not a reaction)35
  • Hypotension (named in the label)30
  • Hypoxia26
  • Ventilation Perfusion Mismatch25
  • Oxygen Saturation Decreased18
  • Tachycardia (named in the label)17
  • Atrial Fibrillation (named in the label)15
  • Bradycardia13
  • Extravasation13
  • Blood Pressure Inadequately Controlled11
  • Off Label Use (a use or a product term, not a reaction)11
  • Infusion Site Extravasation10
  • Blood Triglycerides Increased9
  • Drug Administration Error9
  • No Adverse Event (a use or a product term, not a reaction)8
  • Acute Kidney Injury7
  • Hypertriglyceridaemia7
  • Pyrexia7
  • Blood Pressure Increased6
  • Cerebral Haemorrhage6
  • Hypertensive Crisis6
  • Ileus (named in the label)6
  • Mental Status Changes6
  • Blood Pressure Decreased5
  • Heart Rate Increased5

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

What next?

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