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Nisoldipine

Nisoldipine is an extended-release calcium channel blocker used to treat high blood pressure (hypertension), alone or with other blood pressure medicines.

Brand name Sular
Drug class Dihydropyridine Calcium Channel Blocker
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 3 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Nisoldipine at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Nisoldipine (Sular) is a once-daily calcium channel blocker for high blood pressure that keeps calcium out of the muscle in small artery walls so they relax and widen; it is a less commonly prescribed relative of amlodipine, on the market since the mid-1990s and available as a generic. Most people handle it well, and the side effects they notice are usually ankle or foot swelling, headache, flushing or dizziness. Report chest pain (angina) right away if it is new, comes more often or lasts longer after starting it or a dose increase, since people with severely blocked heart arteries have rarely had worse angina or even a heart attack at these times.

Clinical pearls

  • Take it on an empty stomach, one hour before or two hours after eating, because high-fat meals change how much gets absorbed.
  • Avoid grapefruit and grapefruit juice before and after your dose, since they can push nisoldipine levels much higher.
  • Swallow the extended-release tablet whole, because biting, splitting or crushing it destroys the slow, all-day release.
  • Phenytoin, a seizure medicine, can drop nisoldipine to undetectable levels, so the two should not be combined.
How you get itPrescription only
Comes asExtended-release tablet
Earliest FDA record1995
Companies listing it with the FDA3
FDA label last updatedMar 12, 2026
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Nisoldipine, written from its FDA label.

What Nisoldipine is used for

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Nisoldipine is used for one condition across the supported products.

  • Sular (oral extended-release tablet): treatment of hypertension (high blood pressure), alone or with other blood pressure medicines.
  • Nisoldipine extended-release tablets (oral): treatment of hypertension, alone or with other blood pressure medicines.

How Nisoldipine works

▾

Nisoldipine belongs to the dihydropyridine class of calcium channel blockers. It blocks calcium from entering muscle cells in blood vessel walls. This relaxes and widens the small arteries and lowers resistance to blood flow.

It acts more strongly on blood vessels than on the heart muscle. Most of its blood pressure effect comes from lowering that resistance. It also has a mild diuretic (water-losing) effect.

Nisoldipine dosage

▾

Nisoldipine extended-release tablets, including Sular, are taken by mouth once a day. Your prescriber starts you low and raises the dose gradually to control your blood pressure.

  • Take it on an empty stomach, 1 hour before or 2 hours after a meal.
  • Swallow the tablet whole. Do not bite, divide or crush it.
  • Avoid grapefruit products before and after your dose.
  • It has been used safely with diuretics, ACE inhibitors and beta-blockers.

Follow your prescriber and pharmacy label for your exact dose and what to do about a missed dose.

Dosing details from the FDA-approved label

From the Nisoldipine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Hypertension (general adult dosing)
    • Initiate with 17 mg orally once daily, then increase by 8.5 mg per week or longer intervals to attain adequate control of blood pressure
    • Usual maintenance dosage is 17 to 34 mg once daily
    • Maximum: Doses beyond 34 mg once daily are not recommended
    • Take on an empty stomach (1 hour before or 2 hours after a meal); avoid grapefruit products before and after dosing; swallow whole, not bitten, divided or crushed
  • Patients over age 65 or with impaired liver function
    • Starting dose not exceeding 8.5 mg daily
    • Maximum: Doses beyond 34 mg once daily are not recommended
    • Expected to develop higher plasma concentrations of nisoldipine; monitor blood pressure closely during any dosage adjustment
Read the label’s full dosing text

DOSAGE AND ADMINISTRATION The dosage of nisoldipine extended-release tablets must be adjusted to each patient’s needs. Therapy usually should be initiated with 17 mg orally once daily, then increased by 8.5 mg per week or longer intervals, to attain adequate control of blood pressure. Usual maintenance dosage is 17 to 34 mg once daily. Blood pressure response increases over the 8.5 to 34 mg daily dose range but adverse event rates also increase. Doses beyond 34 mg once daily are not recommended. Nisoldipine extended-release tablets have been used safely with diuretics, ACE inhibitors, and beta-blocking agents. Patients over age 65, or patients with impaired liver function, are expected to develop higher plasma concentrations of nisoldipine. Their blood pressure should be monitored closely during any dosage adjustment. A starting dose not exceeding 8.5 mg daily is recommended in these patient groups. Nisoldipine extended-release tablets should be administered orally once daily. Nisoldipine extended-release tablets should be taken on an empty stomach (1 hour before or 2 hours after a meal). Grapefruit products should be avoided before and after dosing. Nisoldipine extended-release tablets are an extended release dosage form and tablets should be swallowed whole, not bitten, divided or crushed.

Read the full Dosage and Administration section on DailyMed →

Nisoldipine side effects

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Most side effects are related to the way nisoldipine widens blood vessels, and they are usually mild.

Common side effects

  • Swelling in the legs, ankles or feet (peripheral edema)
  • Headache
  • Dizziness
  • Sore throat (pharyngitis)
  • Flushing or vasodilation (widened blood vessels)
  • Sinus irritation (sinusitis)
  • Palpitations (feeling your heartbeat)
  • Nausea

When to get medical help

  • Call your doctor if chest pain (angina) starts, gets worse or happens more often, especially after starting nisoldipine or a dose increase.
  • Get emergency help for signs of a heart attack.
  • Get emergency help for signs of a serious allergic reaction, such as swelling of the face or throat, trouble breathing, chest tightness or a widespread rash.
  • Tell your doctor if you notice worsening heart failure symptoms, fainting or a very fast or irregular heartbeat.

About 10.9% of people in U.S. trials stopped nisoldipine because of side effects, compared with 2.9% on placebo. Get help right away for worsening chest pain, signs of a heart attack, or an allergic reaction with swelling, trouble breathing or a rash.

Nisoldipine warnings and precautions

▾

Worsening angina or heart attack: Rarely, people with severe coronary artery disease have had more angina or a heart attack when starting a calcium channel blocker or raising the dose. Report new or worsening chest pain promptly.

  • Use calcium channel blockers with caution if you have heart failure.
  • Older adults and people with liver problems have higher drug levels and need closer blood pressure monitoring.
  • Rare allergic reactions, including angioedema (swelling), have been reported.

Nisoldipine interactions

▾

Several foods and drugs change how much nisoldipine gets into your blood.

  • Grapefruit juice: can raise levels roughly 3-fold or more, so avoid it.
  • Phenytoin: can drop nisoldipine to undetectable levels, so another blood pressure medicine should be considered.
  • CYP3A4 inhibitors and inducers: change how the body breaks down nisoldipine, so they should generally be avoided.
  • Cimetidine: raises nisoldipine levels by about 30 to 45%.
  • Atenolol: blood pressure effect tended to be greater.
  • Quinidine: lowers nisoldipine exposure by about 26%.
  • No significant interactions were found with warfarin or digoxin.

Interactions listed in the FDA-approved label

From the Nisoldipine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Cimetidine: A 30 to 45% increase in AUC and Cmax of nisoldipine was observed with cimetidine 400 mg twice daily.
  • Ranitidine: Ranitidine 150 mg twice daily did not interact significantly with nisoldipine (AUC was decreased by 15 to 20%); no pharmacodynamic effects of either histamine H2 receptor antagonist were observed.
  • CYP3A4 inhibitors and inducers: Nisoldipine is a substrate of CYP3A4. Coadministration with any known inducer or inhibitor of CYP3A4 should be avoided in general.
  • Phenytoin: Coadministration with a dose bioequivalent to 34 mg nisoldipine extended-release tablets in epileptic patients lowered nisoldipine plasma concentrations to undetectable levels. Avoid coadministration and consider alternative antihypertensive therapy.
  • Beta-blockers (atenolol, propranolol): Pharmacokinetic interactions were variable and not significant; propranolol attenuated the heart rate increase following immediate release nisoldipine, and the blood pressure effect of nisoldipine tended to be greater in patients on atenolol than in patients on no other antihypertensive therapy.
  • Quinidine: Quinidine at 648 mg bid decreased the bioavailability (AUC) of nisoldipine by 26%, but not the peak concentration; immediate release nisoldipine increased plasma quinidine concentrations by about 20% without ECG changes, and clinical significance is not known.
  • Warfarin: No significant interactions were found between nisoldipine and warfarin.
  • Digoxin: No significant interactions were found between nisoldipine and digoxin.
Read the label’s full interactions text

Drug Interactions A 30 to 45% increase in AUC and C max of nisoldipine was observed with concomitant administration of cimetidine 400 mg twice daily. Ranitidine 150 mg twice daily did not interact significantly with nisoldipine (AUC was decreased by 15 to 20%). No pharmacodynamic effects of either histamine H2 receptor antagonist were observed. CYP3A4 inhibitors and inducers Nisoldipine is substrate of CYP3A4 and coadministration of nisoldipine extended-release tablets with any known inducer or inhibitor of CYP3A4 should be avoided in general. Coadministration of phenytoin with a dose bioequivalent to 34 mg nisoldipine extended-release tablets in epileptic patients lowered the nisoldipine plasma concentrations to undetectable levels. Coadministration of nisoldipine extended-release tablets with phenytoin should be avoided and alternative antihypertensive therapy should be considered. Pharmacokinetic interactions between nisoldipine and beta-blockers (atenolol, propranolol) were variable and not significant. Propranolol attenuated the heart rate increase following administration of immediate release nisoldipine. The blood pressure effect of nisoldipine extended-release tablets tended to be greater in patients on atenolol than in patients on no other antihypertensive therapy. Quinidine at 648 mg bid decreased the bioavailability (AUC) of nisoldipine by 26%, but not the peak concentration. Immediate release nisoldipine increased plasma quinidine concentrations by about 20%. This interaction was not accompanied by ECG changes and its clinical significance is not known. No significant interactions were found between nisoldipine and warfarin or digoxin.

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Nisoldipine

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  • Do not take it if you are allergic to dihydropyridine calcium channel blockers.
  • Tell your prescriber about coronary artery disease, angina or heart failure.
  • Adults over 65 usually start at a lower dose and get closer monitoring.
  • If you have liver disease or cirrhosis, you will be given lower starting and maintenance doses.
  • Mild to moderate kidney impairment generally doesn't require a dose adjustment.
  • Tell your prescriber about all your medicines, especially phenytoin.

Nisoldipine overdose

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There is no experience with nisoldipine overdose. With similar drugs, the main concern is very low blood pressure, which needs active heart and breathing support in a medical setting. Dialysis is unlikely to help, but plasmapheresis may. Seek emergency help or call poison control if you take too much.

What Nisoldipine does in the body

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A dose of nisoldipine lowers vascular resistance and blood pressure, with a brief rise in heart rate. That rise is greater with immediate-release forms. With ongoing use, the lower resistance is sustained. The blood pressure effect is dose-related and is bigger when blood pressure starts out higher.

It doesn't appear to weaken the heart's pumping in a significant way. It also has no clinically important effect on heart rate.

How your body processes Nisoldipine

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Nisoldipine is well absorbed, but only about 5% reaches the bloodstream unchanged because much of it is broken down in the gut wall. A high-fat meal raises peak levels by up to 245%, which is why it's taken on an empty stomach. Peak levels come about 9 hours after a dose, and the half-life is roughly 14 hours.

The liver heavily metabolizes it, likely through CYP enzymes. It is then cleared mostly in urine as metabolites, with only traces of unchanged drug.

How to store Nisoldipine

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Protect from light and moisture. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) . Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

232

Supplements & herbs that interact with Nisoldipine

232 supplements and herbal products have documented interactions with Nisoldipine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 7
  • Moderate · 183
  • Minor · 42
Every supplement checked against Nisoldipine — ranked by severity The full interaction hub: 7 major · 183 moderate · 42 minor · every one linked to its full report. Check Nisoldipine against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

2

Nutrient depletion considerations

Nisoldipine has been associated with lower levels of 2 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

See the full Nisoldipine nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Nisoldipine: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Nisoldipine — the kind of thing our pharmacy team would talk through with you at the counter.

What is nisoldipine for?

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It treats high blood pressure. Your doctor may prescribe it alone or with other blood pressure medicines. It works by relaxing and widening your small arteries.

How should I take it?

▾
Take one tablet by mouth once a day on an empty stomach, either 1 hour before or 2 hours after a meal. Swallow it whole. Don't crush, split or chew it, because it's built to release slowly. Follow your prescriber's directions for your dose.

Can I have grapefruit juice with it?

▾
No, please avoid grapefruit products before and after your dose. Grapefruit can raise the amount of nisoldipine in your blood a lot. That can make side effects such as low blood pressure more likely.

What side effects should I expect?

▾
The most common ones are swelling in the legs or feet, headache, dizziness, a sore throat and flushing. Swelling is more likely at higher doses. Tell me or your doctor if they bother you or don't settle down.

When should I call my doctor right away?

▾
Call if you have new or worsening chest pain, especially after starting it or increasing the dose. Get emergency help for signs of a heart attack, or for facial swelling, trouble breathing or chest tightness. Those could signal a serious allergic reaction.

Do my other medicines matter?

▾
Yes. Phenytoin can make nisoldipine stop working, and drugs that affect the CYP3A4 enzyme should generally be avoided. Cimetidine can raise nisoldipine levels. Always tell your pharmacist about everything you take.

Is Nisoldipine available over the counter?

▾
No. Nisoldipine is a prescription medicine: every Nisoldipine product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Nisoldipine first available?

▾
The earliest FDA record we hold for Nisoldipine is from 1995: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Nisoldipine was first used.

Who makes Nisoldipine?

▾
3 companies currently list Nisoldipine products in the FDA's NDC Directory, including Covis Pharma US, Inc, Prasco Laboratories, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Nisoldipine on HelloPharmacist

Detailed data & references for Nisoldipine Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Nisoldipine forms and strengths (how it comes)

Nisoldipine is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Extended-release tablet

By mouth
Brands Sular
How this form is used
What it may be used for
  • Sular is indicated for hypertension, alone or with other blood pressure medicines.
  • Nisoldipine extended-release tablets are indicated for hypertension, alone or with other blood pressure medicines.
Important instructions
  • Sular is taken by mouth once daily on an empty stomach, 1 hour before or 2 hours after a meal.
  • Sular tablets should be swallowed whole, not bitten, divided or crushed.
  • Nisoldipine extended-release tablets are taken by mouth once daily on an empty stomach.
  • Nisoldipine extended-release tablets should be swallowed whole, and grapefruit products should be avoided.
Available strengths 3 strengths
20 FDA-listed product records ⓘ

Nisoldipine on the U.S. market: products, makers and brands

How Nisoldipine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

3 companies list 8 Nisoldipine product records with the FDA, mostly as extended-release tablet; the earliest marketing or approval year on record is 1995. Brand names on the directory include Sular; the rest are generics.

1
Dose forms ⓘ
3
Labelers (makers, repackagers, distributors)
2
Brand names
8
FDA-listed product records ⓘ
1995
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (2) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Covis Pharma US, Inc38%
Prasco Laboratories38%
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.25%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Compare Nisoldipine products

A representative set of FDA-listed product records for Nisoldipine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Extended-release tablet
8.5 mg Oral Covis Pharma US, Inc NDA View NDC →
17 mg Oral Covis Pharma US, Inc NDA View NDC →
34 mg Oral Covis Pharma US, Inc NDA View NDC →
8.5 mg Oral Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. ANDA View NDC →
17 mg Oral Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. ANDA View NDC →
8.5 mg Oral Prasco Laboratories NDA AUTHORIZED GENERIC View NDC →
17 mg Oral Prasco Laboratories NDA AUTHORIZED GENERIC View NDC →
34 mg Oral Prasco Laboratories NDA AUTHORIZED GENERIC View NDC →

Showing 8 of 8 products — FDA National Drug Code Directory. See every product, package size and price: browse all 8 Nisoldipine NDCs →

Nisoldipine recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Nisoldipine recalls since July 2021.

✅No Nisoldipine recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Nisoldipine RxCUI 7435 1 dose form · 8 strengths
  1. Dose form (SCDF) Extended Release Oral Tablet RxCUI 373094 In current FDA listings
    Clinical drug / strength (SCD) 24 HR nisoldipine 10 MG RxCUI 311983 24 HR nisoldipine 17 MG RxCUI 763519 24 HR nisoldipine 20 MG RxCUI 311984 24 HR nisoldipine 25.5 MG RxCUI 763574 24 HR nisoldipine 30 MG RxCUI 311985 24 HR nisoldipine 34 MG RxCUI 763589 24 HR nisoldipine 40 MG RxCUI 360344 24 HR nisoldipine 8.5 MG RxCUI 790489

Look up RxCUI 7435 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Nisoldipine costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet, Film Coated, Extended Release · Oral 8.5 mg $3.56 per tablet NDC details & price history
Tablet, Film Coated, Extended Release · Oral 17 mg $4.66 per tablet NDC details & price history
Tablet, Film Coated, Extended Release · Oral 34 mg $5.24 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Nisoldipine brand names

Nisoldipine is sold under one brand name in the FDA directory — Sular. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Sular

Who makes Nisoldipine: manufacturers and labelers

3 companies list Nisoldipine products with the FDA. By number of product records, the largest are Covis Pharma US, Inc, Prasco Laboratories, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Covis Pharma US, Inc 3 Prasco Laboratories 3 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 2

Nisoldipine drug class (RxNorm)

Nisoldipine belongs to the Dihydropyridine Calcium Channel Blocker class.

Pharmacologic class Dihydropyridine Calcium Channel Blocker
Drug family (ATC) Dihydropyridine derivatives
How it works Calcium Channel Antagonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Nisoldipine page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Mar 12, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Nisoldipine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Nisoldipine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
3
Finished products in the current FDA directory
8
Companies listing them (makers, repackagers, distributors)
3
FDA labeler codes behind them ⓘ
3
Linked representative label ⓘ
Covis Pharma US, Inc
Linked label effective
Mar 12, 2026
Composite sections available
19
Linked SPL Set ID
589157fa-d129-4de3-be3d-e0e1c22c5873
Linked SPL Document ID
daa4568e-f725-4df3-85eb-ff0ede789c78
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Covis Pharma US, Inc is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →