cleviprex
Pharmaranks rates Cleviprex 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Cleviprex (Clevidipine) is a dihydropyridine calcium channel blocker used to treat Hypertension.
Clevidipine · by Chiesi
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Clevidipine
- Drug class
- Dihydropyridine Calcium Channel Blocker
- Form
- Emulsion
- Strength
- Clevidipine 125MG/250ML (0.5MG/ML) · Clevidipine 25MG/50ML (0.5MG/ML) · Clevidipine 50MG/100ML (0.5MG/ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- hypertension
- Manufacturer
- Chiesi
- FDA application
- NDA022156
What is Cleviprex?
From the FDA label:Cleviprex is a sterile, milky-white emulsion containing 0.5 mg/mL of clevidipine suitable for intravenous administration. Clevidipine is a dihydropyridine calcium channel blocker. Chemically, the active substance, clevidipine, is butyroxymethyl methyl 4-(2´,3´-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate. It is a racemic mixture with a molecular weight of 456.3 g/mol. Each enantiomer has equipotent antihypertensive activity. The structure and formula are: Clevidipine is practically insoluble in water and is formulated in an oil-in-water emulsion. In addition to the active ingredient, clevidipine, Cleviprex contains soybean oil (200 mg/mL), glycerin (22.5 mg/mL), purified egg yolk phospholipids (12 mg/mL),oleic acid (0.3 mg/mL), disodium edetate (0.05 mg/mL), and sodium hydroxide to adjust pH. Cleviprex has a pH of 6.0 – 8.0 and is a ready-to-use emulsion. Clevidipine Structure and Formula
How to use
For intravenous use : Cleviprex is intended for intravenous use. Titrate Cleviprex to achieve the desired blood pressure reduction. Individualize dosage depending on the blood pressure response of the patient and the goal blood pressure. (2.2) Monitoring : Monitor blood pressure and heart rate during infusion, and until vital signs stabilize. (2.1) Initial dose : Initiate intravenous infusion of Cleviprex at 1- 2 mg/hour. (2.2) Dose titration : Double the dose at short (90 second) intervals initially. As the blood pressure approaches goal, increase the dose by less than doubling and lengthen the time between dose adjustments to every 5-10 minutes. An approximately 1-2 mg/hour increase will generally produce an additional 2-4 mmHg decrease in systolic pressure. (2.2) Maintenance dose : Most patients will achieve the desired therapeutic response at approximately 4-6 mg/hour. Severe hypertension is likely to require higher doses. (2.2) Maximum dose : Most patients have received maximum doses of 16 mg/hour or less. There is limited experience with short-term dosing as high as 32 mg/hour. Because of lipid load restrictions, no more than 1000 mL or an average of 21 mg/hour of Cleviprex infusion is recommended per 24 hour period. There is little experience beyond 72 hours at any dose. (2.2) 2.1 Monitoring Monitor blood pressure and heart rate continually during infusion, and then…
Side effects
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 The Medicines Company at 1-888-977-MDCO (6326) 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. Perioperative Hypertension The placebo-controlled experience with Cleviprex in the perioperative setting was both small and brief…
Warnings
Important safety information
Maintain aseptic technique. Discard unused portion 12 hours after stopper puncture. (5.1) Hypotension and reflex tachycardia are potential consequences of rapid upward titration of Cleviprex. (5.2) Dihydropyridine calcium channel blockers can produce negative inotropic effects and exacerbate heart failure. Monitor heart failure patients carefully. (5.4) Cleviprex gives no protection against the effects of abrupt beta-blocker withdrawal. (5.5) Patients who receive prolonged Cleviprex infusions and are not transitioned to other antihypertensive therapies should be monitored for the possibility of rebound hypertension for at least 8 hours after the infusion is stopped. (5.6) 5.1 Need for Aseptic Technique Use aseptic technique and discard any unused product within 12 hours of stopper puncture [see Dosage and Administration (2.3)] . 5.2 Hypotension and Reflex Tachycardia Cleviprex may produce systemic hypotension and reflex tachycardia. If either occurs, decrease the dose of Cleviprex. There is limited experience with short-duration therapy with beta-blockers as a treatment for Cleviprex-induced tachycardia. Beta-blocker use for this purpose is not recommended. 5.3 Lipid Intake Cleviprex contains approximately 0.2 g of lipid per mL (2.0 kcal). Lipid intake restrictions may be necessary for patients with significant disorders of lipid metabolism. For these patients, a reduction in the quantity of concurrently administered lipids may be necessary to compensate for the amount of lipid infused as part of the Cleviprex formulation. 5.4 Negative Inotropy Dihydropyridine calcium channel blockers can produce negative inotropic effects and exacerbate heart failure. Monitor heart failure patients carefully. 5.5 Beta-Blocker Withdrawal Cleviprex is not a beta-blocker, does not reduce heart rate, and gives no protection against the effects of abrupt beta-blocker withdrawal. Beta-blockers should be withdrawn only after a gradual reduction in dose. 5.6 Rebound Hypertension Patients who receive prolonged Cleviprex infusions and are not transitioned to other antihypertensive therapies should be monitored for the possibility of rebound hypertension for at least 8 hours after the infusion is stopped. 5.7 Pheochromocytoma There is no information to guide use of Cleviprex in treating hypertension associated with pheochromocytoma.
Who should not take Cleviprex
Cleviprex is contraindicated in patients with: Allergy to soy or eggs (4.1) Defective lipid metabolism (4.2) Severe aortic stenosis (4.3) 4.1 Known Allergy Cleviprex is contraindicated in patients with allergies to soybeans, soy products, eggs, or egg products. 4.2 Defective Lipid Metabolism Cleviprex is contraindicated in patients with defective lipid metabolism such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia. 4.3 Severe Aortic Stenosis Cleviprex is contraindicated in patients with severe aortic stenosis because afterload reduction can be expected to reduce myocardial oxygen delivery.
Overdose — what happens if you take too much
There has been no experience of overdosage in human clinical trials. In clinical trials, doses of Cleviprex up to 106 mg/hour or 1153 mg maximum total dose were administered. The expected major effects of overdose would be hypotension and reflex tachycardia. Discontinuation of Cleviprex leads to a reduction in antihypertensive effects within 5 to 15 minutes [see Clinical Pharmacology (12.2)] . In case of suspected overdosage, Cleviprex should be discontinued immediately and the patient’s blood pressure should be supported.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
No clinical drug interaction studies were conducted. Clevidipine and its major dihydropyridine metabolite do not have the potential for blocking or inducing any CYP enzyme. At clinically relevant concentrations, clevidipine and its metabolites do not inhibit or induce any CYP450 enzymes. The potential of clevidipine to interact with other drugs is low. (7)
Storing Cleviprex, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “Once the stopper is punctured, use within 12 hours and discard any unused portion.”
Drug class
How this class works, per Calcium Channel Blockers - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Cleviprex ranks — best-rated dihydropyridine calcium channel blocker for:
Dosage forms
Emulsion
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Cleviprex treat?
- Cleviprex (Clevidipine) may be used to treat hypertension, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Cleviprex work?
- Cleviprex is a dihydropyridine calcium channel blocker. Dihydropyridine calcium channel blockers stop calcium from entering the muscle cells in your blood vessel walls. With less calcium, those muscles relax and the vessels widen, which lowers blood pressure and eases the heart's workload.
- How is Cleviprex rated?
- pharmaranks gives Cleviprex a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Cleviprex?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Cleviprex. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Cleviprex?
- Cleviprex is marketed by Chiesi. You can see Chiesi's full profile, rating, and other products on pharmaranks.
- Is Cleviprex a brand-name or generic drug?
- Cleviprex is a brand-name product with the active ingredient Clevidipine.
- Is Cleviprex available over the counter?
- No. Cleviprex is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Cleviprex come in?
- Cleviprex is currently marketed as emulsion, per the FDA's National Drug Code Directory.
- What class of drug is Cleviprex?
- Cleviprex is classified as dihydropyridine calcium channel blocker, per the FDA's Established Pharmacologic Class.
- Is Cleviprex FDA-registered?
- Cleviprex is on record with the U.S. FDA under application number NDA022156. You can verify this on its official FDA label.
- Has Cleviprex been recalled by the FDA?
- Yes. Cleviprex has 1 recorded FDA recall event in the openFDA enforcement database. A recall removes specific lots from the market — usually for manufacturing, contamination, potency, or labeling issues — and does not mean the drug is unsafe to take; your specific lot was almost certainly never affected. This recall history is factored into its safety score above. Always check the FDA recall database or your pharmacist for current alerts.
- Is Cleviprex safe?
- There's no single safe-or-not verdict. pharmaranks gives Cleviprex a recall-safety score of 72/100, based on its FDA recall history (1 recorded recall event) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Cleviprex?
- Cleviprex's side effects are taken directly from its FDA label. From the label: 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,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
What people report to the FDA about CLEVIDIPINE
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 84 reports naming CLEVIDIPINE — the active ingredient in Cleviprex, and the FDA flagged 88% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- hypotension7 reports
- hypertensive crisis5 reports
- hypoxia5 reports
- respiratory failure5 reports
- treatment failure5 reports
- anti-neutrophil cytoplasmic antibody positive vasculitis4 reports
- blood triglycerides increased4 reports
- acute kidney injury3 reports
Read these as a signal, not a rate. A report does not mean CLEVIDIPINE caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label.
Source: openFDA drug/event (FAERS), retrieved September 25, 2026.
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cleviprex
72/100