sular
Pharmaranks rates Sular 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Sular (Nisoldipine) is a dihydropyridine calcium channel blocker used to treat Variant Angina Pectoris, Hypertension.
Nisoldipine · by Azurity
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
- Nisoldipine
- Drug class
- Dihydropyridine Calcium Channel Blocker
- Form
- Tablet, extended release
- Strength
- Nisoldipine 10MG **Federal Register Determination That Product was not Discontinued or Withdrawn for Safety or Effectiveness reasons** · Nisoldipine 17MG · Nisoldipine 20MG **Federal Register Determination That Product was not Discontinued or Withdrawn for Safety or Effectiveness reasons** · Nisoldipine 25.5MG **Federal Register Determination That Product was not Discontinued or Withdrawn for Safety or Effectiveness reasons** · Nisoldipine 30MG **Federal Register Determination That Product was not Discontinued or Withdrawn for Safety or Effectiveness reasons** · Nisoldipine 34MG · Nisoldipine 40MG **Federal Register Determination That Product was not Discontinued or Withdrawn for Safety or Effectiveness reasons** · Nisoldipine 8.5MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- variant angina pectoris, hypertension
- Manufacturer
- Azurity
- What the pharmacy pays
- ~$139.77 for 30 — not your price
- FDA application
- NDA020356
What is Sular?
From the FDA label:SULAR ® (nisoldipine) is an extended release tablet dosage form of the dihydropyridine calcium channel blocker nisoldipine. Nisoldipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, methyl 2-methylpropyl ester, C 20 H 24 N 2 O 6 , and has the structural formula: Nisoldipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 388.4. SULAR tablets comprise three layers: a top barrier layer, a middle layer containing nisoldipine, and a bottom barrier layer. The erodible barrier layers and the hydrogel middle layer provide for the controlled release of the drug. SULAR tablets contain either 8.5, 17, or 34 mg of nisoldipine for once-a-day oral administration. Inactive ingredients in the formulation include: Hypromellose, hypromellose phthalate, lactose, glyceryl behenate, povidone, magnesium stearate, silicon dioxide, methacrylic acid copolymer, and sodium lauryl sulfate. Inactive ingredients in the film coating include: polydextrose, titanium dioxide, hypromellose, polyethylene glycol, iron oxide, and carnauba wax. Additionally, the 17 mg formulation contains FD&C Yellow #5. structure
How to use
The dosage of SULAR 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 - 34 mg daily dose range but adverse event rates also increase. Doses beyond 34 mg once daily are not recommended. SULAR has 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. SULAR tablets should be administered orally once daily. SULAR 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. SULAR is an extended release dosage form and tablets should be swallowed whole, not bitten, divided or crushed.
Side effects
More than 6000 patients world-wide have received nisoldipine in clinical trials for the treatment of hypertension, either as the immediate release or the SULAR extended release formulation. Of about 1,500 patients who received SULAR in hypertension studies, about 55% were exposed for at least 2 months and about one third were exposed for over 6 months, the great majority at doses equivalent to 17 mg and above. SULAR is generally well-tolerated. In the U.S. clinical trials of SULAR in hypertension, 10.9% of the 921 SULAR patients discontinued treatment due to adverse events compared with 2.9% of 280 placebo patients. The frequency of discontinuations due to adverse experiences was related to dose, with a 5.4% and 10.9% discontinuation rate at the lowest and highest daily dose, respectively. The most frequently occurring adverse experiences with SULAR are those related to its vasodilator properties; these are generally mild and only occasionally lead to patient withdrawal from treatment. The table below, from U.S. placebo-controlled parallel dose response trials of SULAR using doses across the clinical dosage range in patients with hypertension, lists all of the adverse events, regardless of the causal relationship to SULAR, for which the overall incidence on SULAR was both >1% and greater with SULAR than with placebo. Adverse Event Nisoldipine (%) (n=663) Placebo (%) (n=280)…
Warnings
Important safety information
Increased angina and/or myocardial infarction in patients with coronary artery disease: Rarely, patients, particularly those with severe obstructive coronary artery disease, have developed increased frequency, duration and/or severity of angina, or acute myocardial infarction on starting calcium channel blocker therapy or at the time of dosage increase. The mechanism of this effect has not been established. In controlled studies of SULAR in patients with angina this was seen about 1.5% of the time in patients given nisoldipine, compared with 0.9% in patients given placebo.
Who should not take Sular
SULAR is contraindicated in patients with known hypersensitivity to dihydropyridine calcium channel blockers.
Overdose — what happens if you take too much
There is no experience with nisoldipine overdosage. Generally, overdosage with other dihydropyridines leading to pronounced hypotension calls for active cardiovascular support including monitoring of cardiovascular and respiratory function, elevation of extremities, judicious use of calcium infusion, pressor agents and fluids. Clearance of nisoldipine would be expected to be slowed in patients with impaired liver function. Since nisoldipine is highly protein bound, dialysis is not likely to be of any benefit; however, plasmapheresis may be beneficial.
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
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 - 20%). No pharmacodynamic effects of either histamine H 2 receptor antagonist were observed. CYP3A4 inhibitors and inducers : SULAR is substrate of CYP3A4 and coadministration of SULAR with any known inducer or inhibitor of CYP3A4 should be avoided in general. Coadministration of phenytoin with a dose bioequivalent to 34 mg SULAR tablets in epileptic patients lowered the nisoldipine plasma concentrations to undetectable levels. Coadministration of SULAR 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 SULAR 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.
Foods & drinks to be careful with
Well-established interactions for this medicine’s drug class, summarized from public health authorities. General information, not medical advice — always confirm with your pharmacist or the label.
Grapefruit & grapefruit juice
Watch out for: grapefruit and grapefruit juice (and, for some drugs, Seville oranges).
Grapefruit blocks a gut enzyme (CYP3A4) that normally breaks this medicine down, so more of it can enter your blood — raising the risk of side effects.
What to do: Avoid grapefruit and grapefruit juice with this medicine unless your pharmacist or the label says it's fine — check, because not every drug in a class is affected the same way.
Source: Grapefruit Juice and Some Drugs Don't Mix — U.S. FDA
Drug class
How this class works, per Calcium Channel Blockers - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Sular ranks — best-rated dihydropyridine calcium channel blocker for:
Dosage forms
Tablet, extended release
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Sular treat?
- Sular (Nisoldipine) may be used to treat variant angina pectoris, 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 Sular work?
- Sular 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 Sular rated?
- pharmaranks gives Sular 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.
- How much does Sular cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $139.77 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Cardene — about $40.98 on the same basis.
- Is there a coupon or discount for Sular?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Sular. 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 Sular?
- Sular is marketed by Azurity. You can see Azurity's full profile, rating, and other products on pharmaranks.
- Is Sular a brand-name or generic drug?
- Sular is a brand-name product with the active ingredient Nisoldipine.
- Is Sular available over the counter?
- No. Sular 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 Sular come in?
- Sular is currently marketed as tablet, extended release, per the FDA's National Drug Code Directory.
- What class of drug is Sular?
- Sular is classified as dihydropyridine calcium channel blocker, per the FDA's Established Pharmacologic Class.
- Is Sular FDA-registered?
- Sular is on record with the U.S. FDA under application number NDA020356. You can verify this on its official FDA label.
- Has Sular been recalled by the FDA?
- Yes. Sular 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 Sular safe?
- There's no single safe-or-not verdict. pharmaranks gives Sular 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 Sular?
- Sular's side effects are taken directly from its FDA label. From the label: More than 6000 patients world-wide have received nisoldipine in clinical trials for the treatment of hypertension, either as the immediate release or the SULAR extended release formulation. Of about 1,500 patients who received SULAR in hypertension studies,… 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 NISOLDIPINE
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 494 reports naming NISOLDIPINE — the active ingredient in Sular, and the FDA flagged 66% 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:
- fatigue33 reports
- nausea26 reports
- dyspnoea25 reports
- diarrhoea23 reports
- asthenia22 reports
- headache22 reports
- dizziness21 reports
- rash19 reports
Read these as a signal, not a rate. A report does not mean NISOLDIPINE 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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sular
72/100