Nicardipine

What Nicardipine is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

I. Stable Angina Nicardipine hydrochloride capsules are indicated for the management of patients with chronic stable angina (effort-associated angina). Nicardipine hydrochloride capsules may be used alone or in combination with beta-blockers. II. Hypertension Nicardipine hydrochloride capsules are indicated for the treatment of hypertension. …

— FDA label: Nicardipine Hydrochloride, Amerisyn LLC, effective July 24, 2026. Read the full label on DailyMed →

Label quoted: the one for the most common form (capsule, oral), Nicardipine Hydrochloride, Amerisyn LLC; it covers 2 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

The FDA has 33 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Related medical specialties

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 33 FDA labels for this medicine have a boxed warning.

Nicardipine side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

In multiple-dose U.S. and foreign controlled short-term (up to 3 months) studies 1910 patients received nicardipine hydrochloride capsules alone or in combination with other drugs. In these studies adverse events were reported spontaneously; adverse experiences were generally not serious but occasionally required dosage adjustment and about 10% of patients left the studies prematurely because of them.

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Peak responses were not observed to be associated with adverse effects during clinical trials, but physicians should be aware that adverse effects associated with decreases in blood pressure (tachycardia, hypotension, etc.) could occur around the time of the peak effect. Most adverse effects were expected consequences of the vasodilator effects of nicardipine hydrochloride capsules. Angina The incidence rates of adverse effects in anginal patients were derived from multicenter, controlled clinical trials. Following are the rates of adverse effects for nicardipine hydrochloride capsules (n=520) and placebo (n=310), respectively, that occurred in 0.4% of patients or more. These represent events considered probably drug-related by the investigator (except for certain cardiovascular events that were recorded in a different category). Where the frequency of adverse effects for nicardipine hydrochloride capsules and placebo is similar, causal relationship is uncertain. The only dose-related effects were pedal edema and increased angina. Table 2 Percent of Patients With Adverse Effects in Controlled Studies (Incidence of Discontinuations Shown in Parentheses) ADVERSE EXPERIENCE NICARDIPINE HYDROCHLORIDE CAPSULES (n= 520) PLACEBO (n= 310) Pedal Edema 7.1 (0) 0.3 (0) Dizziness 6.9 (1.2) 0.6 (0) Headache 6.4 (0.6) 2.6 (0) Asthenia 5.8 (0.4) 2.6 (0) Flushing 5.6 (0.4) 1.0 (0) Increased Angina 5.6 (3.5) 4.2 (1.9) Palpitations 3.3 (0.4) 0.0 (0) Nausea 1.9 (0) 0.3 (0) Dyspepsia 1.5 (0.6) 0.6 (0.3) Dry Mouth 1.4 (0) 0.3 (0) Somnolence 1.4 (0) 1.0 (0) Rash 1.2 (0.2) 0.3 (0) Tachycardia 1.2 (0.2) 0.6 (0) Myalgia 1.0 (0) 0.0 (0) Other Edema 1.0 (0) 0.0 (0) Paresthesia 1.0 (0.2) 0.3 (0) Sustained Tachycardia 0.8 (0.6) 0.0 (0) Syncope 0.8 (0.2) 0.0 (0) Constipation 0.6 (0.2) 0.6 (0) Dyspnea 0.6 (0) 0.0 (0) Abnormal ECG 0.6 (0.6) 0.0 (0) Malaise 0.6 (0) 0.0 (0) Nervousness 0.6 (0) 0.3 (0) Tremor 0.6 (0) 0.0 (0) In addition, adverse events were observed that are not readily distinguishable from the natural history of the atherosclerotic vascular disease in these patients. Adverse events in this category each occurred in <0.4% of patients receiving nicardipine hydrochloride capsules and included myocardial infarction, atrial fibrillation, exertional hypotension, pericarditis, heart block, cerebral ischemia, and ventricular tachycardia. It is possible that some of these events were drug-related. Hypertension The incidence rates of adverse effects in hypertensive patients were derived from multicenter, controlled clinical trials. Following are the rates of adverse effects for nicardipine hydrochloride capsules (n= 1390) and placebo (n= 211), respectively, that occurred in 0.4% of patients or more. These represent events considered probably drug-related by the investigator.

— FDA label: Nicardipine Hydrochloride, Amerisyn LLC, effective July 24, 2026. This is part of the section. Read the full label on DailyMed →

Nicardipine drug interactions

Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.

Beta Blockers In controlled clinical studies, adrenergic beta-receptor blockers have been frequently administered concomitantly with nicardipine hydrochloride capsules. The combination is well tolerated. Cimetidine Cimetidine increases nicardipine hydrochloride capsules plasma levels. Patients receiving the two drugs concomitantly should be carefully monitored. Digoxin Some calcium blockers may increase the concentration of digitalis preparations in the blood.

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Nicardipine hydrochloride capsules usually do not alter the plasma levels of digoxin; however, serum digoxin levels should be evaluated after concomitant therapy with nicardipine hydrochloride capsules are initiated. Maalox® Coadministration of Maalox TC had no effect on nicardipine hydrochloride capsules absorption. Fentanyl Anesthesia Severe hypotension has been reported during fentanyl anesthesia with concomitant use of a beta-blocker and a calcium channel blocker. Even though such interactions were not seen during clinical studies with nicardipine hydrochloride capsules, an increased volume of circulating fluids might be required if such an interaction were to occur. Cyclosporine Concomitant administration of oral or intravenous nicardipine and cyclosporine results in elevated plasma cyclosporine levels through nicardipine inhibition of hepatic microsomal enzymes, including CYP3A4. Plasma concentrations of cyclosporine should therefore be closely monitored, and its dosage reduced accordingly, in patients treated with nicardipine. Tacrolimus: Concomitant administration of oral or intravenous nicardipine and tacrolimus may result in elevated plasma tacrolimus levels through nicardipine inhibition of hepatic microsomal enzymes, including CYP3A4. Closely monitor plasma concentrations of tacrolimus during nicardipine administration, and adjust the dose of tacrolimus accordingly. When therapeutic concentrations of furosemide, propranolol, dipyridamole, warfarin, quinidine or naproxen were added to human plasma (in vitro), the plasma protein binding of nicardipine hydrochloride capsules were not altered. Carcinogenesis, Mutagenesis, Impairment of Fertility Rats treated with nicardipine in the diet (at concentrations calculated to provide daily dosage levels of 5, 15 or 45 mg/kg/day) for 2 years showed a dose-dependent increase in thyroid hyperplasia and neoplasia (follicular adenoma/carcinoma). One- and 3 month studies in the rat have suggested that these results are linked to a nicardipine-induced reduction in plasma thyroxine (T4) levels with a consequent increase in plasma levels of thyroid stimulating hormone (TSH). Chronic elevation of TSH is known to cause hyperstimulation of the thyroid. In rats on an iodine deficient diet, nicardipine administration for 1 month was associated with thyroid hyperplasia that was prevented by T4 supplementation. Mice treated with nicardipine in the diet (at concentrations calculated to provide daily dosage levels of up to 100 mg/kg/day) for up to 18 months showed no evidence of neoplasia of any tissue and no evidence of thyroid changes.

— FDA label: Nicardipine Hydrochloride, Amerisyn LLC, effective July 24, 2026. This is part of the section. Read the full label on DailyMed →

Nicardipine dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

Angina The dose should be individually titrated for each patient beginning with 20 mg three times daily. Doses in the range of 20 to 40 mg three times a day have been shown to be effective. At least 3 days should be allowed before increasing the nicardipine hydrochloride capsules dose to ensure achievement of steady-state plasma drug concentrations.

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Concomitant Use With Other Antianginal Agents Sublingual NTG may be taken as required to abort acute anginal attacks during nicardipine hydrochloride capsules therapy. Prophylactic Nitrate Therapy: nicardipine hydrochloride capsules may be safely co-administered with short- and long-acting nitrates. Beta-blockers: Nicardipine hydrochloride capsules may be safely co-administered with beta- blockers (see Drug Interactions). Hypertension The dose of nicardipine hydrochloride capsules should be individually adjusted according to the blood pressure response beginning with 20 mg three times daily. The effective doses in clinical trials have ranged from 20 mg to 40 mg three times daily. The maximum blood pressure lowering effect occurs approximately 1 to 2 hours after dosing. To assess the adequacy of blood pressure response, the blood pressure should be measured at trough (8 hours after dosing). Because of the prominent peak effects of nicardipine, blood pressure should be measured 1 to 2 hours after dosing, particularly during initiation of therapy (see PRECAUTIONS: Blood Pressure, INDICATIONS AND USAGE, CLINICAL PHARMACOLOGY, Effects in Hypertension). At least 3 days should be allowed before increasing the nicardipine hydrochloride capsules dose to ensure achievement of steady-state plasma drug concentrations. Concomitant Use With Other Antihypertensive Agents Diuretics: nicardipine hydrochloride capsules may be safety co-administered with thiazide diuretics. Beta-blockers: nicardipine hydrochloride capsules may be safely co-administered with beta-blocker (see PRECAUTIONS, Drug Interactions) Special Patient Population Renal Insufficiency Although there is no evidence that nicardipine hydrochloride capsules impair renal function, careful dose titration beginning with 20 mg tid is advised (see PRECAUTIONS). Hepatic Insufficiency Nicardipine hydrochloride capsules should be administered cautiously in patients with severely impaired hepatic function. A suggested starting dose of 20 mg twice a day is advised with individual titration based on clinical findings maintaining the twice a day schedule (see PRECAUTIONS). Congestive Heart Failure Caution is advised when titrating nicardipine hydrochloride capsules dosage in patients with congestive heart failure (see WARNINGS).

— FDA label: Nicardipine Hydrochloride, Amerisyn LLC, effective July 24, 2026. Read the full label on DailyMed →

When Nicardipine should not be used

Quoted from the “Contraindications” section of the FDA-approved label.

Nicardipine hydrochloride capsules are contraindicated in patients with hypersensitivity to the drug. Because part of the effect of nicardipine hydrochloride capsules are secondary to reduced afterload, the drug is also contraindicated in patients with advanced aortic stenosis. Reduction of diastolic pressure in these patients may worsen rather than improve myocardial oxygen balance.

— FDA label: Nicardipine Hydrochloride, Amerisyn LLC, effective July 24, 2026. Read the full label on DailyMed →

Nicardipine overdose

Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).

Overdosage with a 600-mg single dose (15 to 30 times normal clinical dose) has been reported. Marked hypotension (blood pressure unobtainable) and bradycardia (heart rate 20 bpm in normal sinus rhythm) occurred, along with drowsiness, confusion and slurred speech. Supportive treatment with a vasopressor resulted in gradual improvement with normal vital signs approximately 9 hours posttreatment.

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Based on results obtained in laboratory animals, overdosage may cause systemic hypotension, bradycardia (following initial tachycardia) and progressive atrioventricular conduction block. Reversible hepatic function abnormalities and sporadic focal hepatic necrosis were noted in some animal species receiving very large doses of nicardipine. For treatment of overdose standard measures (for example, evacuation of gastric contents, elevation of extremities, attention to circulating fluid volume, and urine output) including monitoring of cardiac and respiratory functions should be implemented. The patient should be positioned so as to avoid cerebral anoxia. Frequent blood pressure determinations are essential. Vasopressors are clinically indicated for patients exhibiting profound hypotension. Intravenous calcium gluconate may help reverse the effects of calcium entry blockade.

— FDA label: Nicardipine Hydrochloride, Amerisyn LLC, effective July 24, 2026. Read the full label on DailyMed →

Forms and how it is given

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

• Baxter Healthcare Corporation7 products
• Hikma Pharmaceuticals USA Inc.4 products
• Fresenius Kabi USA, LLC3 products
• Epic Pharma, LLC2 products
• Eugia US LLC2 products
• ANI Pharmaceuticals, Inc.2 products
• Amneal Pharmaceuticals NY LLC2 products
• Caplin Steriles Limited2 products
• Somerset Therapeutics, LLC2 products
• Amerisyn LLC2 products
• Puracap Laboratories LLC dba Blu Pharmaceuticals2 products
• Burel Pharmaceuticals, LLC2 products
• Glenmark Pharmaceuticals Inc., USA2 products
• Bionpharma Inc.2 products
• WG Critical Care, LLC2 products
• Amici Pharma, Inc.2 products
• Cipla USA Inc.2 products
• American Regent, Inc.1 product
• Archis Pharma LLC1 product
• Civica, Inc.1 product
• Chengdu Shuode Pharmaceutical Co., Ltd1 product
• Meitheal Pharmaceuticals Inc.1 product
• Qilu Pharmaceutical Co., Ltd.1 product
• Sagent Pharmaceuticals1 product
• Armas Pharmaceuticals Inc.1 product
• West-Ward Pharmaceuticals Corp1 product
• Micro Labs Limited1 product
• HF Acquisition Co LLC, DBA HealthFirst1 product
• Lifestar Pharma LLC1 product

FDA approval history

• NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
• ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (18)

• ANDA074670Ani Pharms · October 28, 1996
• ANDA074928Epic Pharma LLC · March 19, 1998
• ANDA090534Am Regent · November 17, 2009
• ANDA090664Somerset Theraps LLC · November 17, 2009
• ANDA090671Mankind Pharma · November 17, 2009
• ANDA211121Eugia Pharma · April 8, 2021
• ANDA216357Glenmark Pharms Ltd · December 16, 2022
• ANDA217555Bionpharma · May 3, 2023
• ANDA216420Micro Labs · July 7, 2023
• ANDA215377Pharmazone · July 17, 2023
• ANDA218202Amneal · April 10, 2024
• ANDA203978Inforlife · April 17, 2024
• ANDA217548Chengdu Shuode · September 6, 2024
• ANDA215592Cipla · September 24, 2024
• ANDA216819Nanjing King Friend · August 20, 2025
• ANDA220243Caplin · October 22, 2025
• ANDA219608Qilu Pharm Hainan · October 28, 2025
• ANDA219334Fresenius Kabi USA · August 4, 2026

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

1. August 6, 2026 · Class II · Ongoing · D-0813-2026

   CGMP Deviations

   CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Manufactured and Marketed by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA — Baxter Healthcare Corporation

2. July 24, 2026 · Class II · Ongoing · D-0802-2026

   Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

   niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL Single Dose Vial (NDC 72572-470-01) and b) 10x10 mL Single Dose Vials (NDC 72572-470-10), Rx Only, Mfd for: Civica, Inc., Lehi, UT, M — American Regent, Inc.

3. April 18, 2025 · Class II · Ongoing · D-0398-2025

   Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.

   niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc., Lehi, UT 84043,Mfd by: American Regent, Inc., New Albany, OH 43064. NDC Carton: 72572-470-10/ NDC — American Regent, Inc.

4. April 18, 2025 · Class II · Ongoing · D-0399-2025

   Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.

   niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial: 0517-0735-01] — American Regent, Inc.

5. May 14, 2024 · Class II · Terminated · D-0503-2024

   Lack of Assurance of Sterility.

   niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenous Use Only, Mfd for: Civica, Inc., Lehi, UT 84043; Mfd by: American Regent, Inc., New Albany, OH 430 — American Regent, Inc.

6. February 20, 2024 · Class II · Ongoing · D-0390-2024

   Failed Impurities/Degradation Specifications: Out of specification for organic impurities

   Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 NDC 55150-183-10 — Eugia US LLC

7. February 20, 2024 · Class II · Ongoing · D-0391-2024

   Failed Impurities/Degradation Specifications: Out of specification for organic impurities

   Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, NDC 55150-183-11 — Eugia US LLC

8. May 13, 2013 · Class III · Terminated · D-691-2013

   Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)

   Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx Only, Mfd. by Exela Pharma Sciences, LLC, Lenoir, NC, Dist. by: West-ward Pharmaceutical Corp., Eatontown, NJ --- NDC 0143-9689-10 — West-ward Pharmaceutical Corp.

Official identifiers

Next steps

• Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
• Latest FDA drug recallsAll medicines, newest first
• Cardene IVBrand page: products, maker and price
• High blood pressureCondition named on the label: hospitals that treat it
• Baxter Healthcare CorporationMaker or distributor
• Hikma Pharmaceuticals USA Inc.Maker or distributor
• Fresenius Kabi USA, LLCMaker or distributor
• All prescription drugs A to ZSearch by generic, brand or Spanish name

Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Nicardipine Hydrochloride, Amerisyn LLC, effective July 24, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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