What the label lists and what reports show
Nicardipine side effects
Nicardipine's FDA label: “Most common adverse reactions are headache (13%), hypotension (5%), tachycardia (4%) and nausea/vomiting (4%).” FAERS holds 4,340 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 acute kidney injury (243 reports).
- Generic listed
Check it at the source: the nicardipine FDA label on DailyMed (effective August 24, 2024, Hikma Pharmaceuticals USA Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions are headache (13%), hypotension (5%), tachycardia (4%) and nausea/vomiting (4%).
From the label: adverse reactions, continuedMost common adverse reactions are headache (13%), hypotension (5%), tachycardia (4%) and nausea/vomiting (4%). To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Adverse Reactions Observed in Clinical Trials 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. Two hundred forty-four patients participated in two multicenter, double-blind, placebo-controlled trials of nicardipine. Adverse experiences were generally not serious and most were expected consequences of vasodilation. Adverse reactions occasionally required dosage adjustment. Therapy was discontinued in approximately 12% of patients, mainly due to hypotension, headache, and tachycardia. Adverse reactions that occurred more often on nicardipine than on placebo by at least 2% were headache (13%) and nausea/vomiting (4%). The following adverse reactions have been reported in clinical trials or in the literature during the use of intravenously administered nicardipine.
Source: FDA drug label, Hikma Pharmaceuticals USA Inc., effective August 24, 2024 (SPL set 18fb1c2b-0c1e-436c-a5b6-d4840b5da228), via openFDA; the full label on DailyMed
What do FAERS reports show?
4,340 reports list nicardipine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 582 are coded as a death and 2,314 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 17 reactions below, 2 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Nicardipine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions