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Sular

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Sular

Sular

Sular Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Sular (nisoldipine) is used to treat high blood pressure (hypertension). It is a calcium channel blocker. This medication is available in generic form. Common side effects include dizziness, swelling ankles/feet, flushing, or headache.

The initial dosage of Sular is 20 mg orally once daily, then increased by 10 mg per week or longer intervals, to attain adequate control of blood pressure. Usual maintenance dosage is 20 to 40 mg once daily. Sular may interact with other blood pressure medications, armodafanil, modafanil, cimetidine, conivaptan, dexamethasone, antibiotics, antifungals, rifabutin, rifampin, rifapentine, St. John's wort, antidepressants, barbiturates, HIV medications, or seizure medications. Tell your doctor all medications and supplements you use. During pregnancy, Sular should be used only when prescribed. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Our Sular (nisoldipine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Sular in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • swelling in your legs or ankles;
  • chest pain;
  • fast or pounding heartbeats; or
  • feeling like you might pass out.

Less serious side effects may include:

  • dizziness;
  • warmth, redness, or tingly feeling under your skin;
  • headache;
  • nausea;
  • stuffy nose, sore throat; or
  • mild skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Sular (Nisoldipine) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Sular Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness, swelling ankles/feet, flushing, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

An empty tablet shell may appear in your stool. This effect is harmless because your body has already absorbed the medication.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fast/irregular/pounding heartbeat, fainting.

Tell your doctor immediately if any of these rare but very serious side effects occur: vision changes.

Some people who already have severe heart disease may rarely develop worsening chest pain or a heart attack after starting this medication or increasing the dose. Get medical help right away if you experience: worsening chest pain, symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Sular (Nisoldipine)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Sular FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 (nisoldipine) extended release formulation. Of about 1,500 patients who received SULAR (nisoldipine) 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 of 20 to 60 mg daily.

SULAR (nisoldipine) is generally well-tolerated. In the U.S. clinical trials of SULAR (nisoldipine) in hypertension, 10.9% of the 921 SULAR (nisoldipine) 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% discontinuation rate at 10 mg daily and a 10.9% discontinuation rate at 60 mg daily.

The most frequently occurring adverse experiences with SULAR (nisoldipine) 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 (nisoldipine) using doses from 10 - 60 mg once daily in patients with hypertension, lists all of the adverse events, regardless of the causal relationship to SULAR (nisoldipine) , for which the overall incidence on SULAR (nisoldipine) was both > 1% and greater with SULAR (nisoldipine) than with placebo.

Adverse Event Nisoldipine (%)
(n=663)
Placebo (%)
(n=280)
Peripheral Edema 22 10
Headache 22 15
Dizziness 5 4
Pharyngitis 5 4
Vasodilation 4 2
Sinusitis 3 2
Palpitation 3 1
Chest Pain 2 1
Nausea 2 1
Rash 2 1

Only peripheral edema and possibly dizziness appear to be dose related.

Adverse Event SULAR
Placebo 10mg 20mg 30mg 40mg 60mg
(Rates in %) N=280 N=30 N=170 N=105 N=139 N=137
Peripheral Edema 10 7 15 20 27 29
Dizziness 4 7 3 3 4 10

The common adverse events occurred at about the same rate in men as in women, and at a similar rate in patients over age 65 as in those under that age, except that headache was much less common in older patients. Except for peripheral edema and vasodilation, which were more common in whites, adverse event rates were similar in blacks and whites.

The following adverse events occurred in ≤ 1% of all patients treated for hypertension in U.S. and foreign clinical trials, or with unspecified incidence in other studies. Although a causal relationship of SULAR (nisoldipine) to these events cannot be established, they are listed to alert the physician to a possible relationship with SULAR (nisoldipine) treatment.

Body As A Whole: cellulitis, chills, facial edema, fever, flu syndrome, malaise

Cardiovascular: atrial fibrillation, cerebrovascular accident, congestive heart failure, first degree AV block, hypertension, hypotension, jugular venous distension, migraine, myocardial infarction, postural hypotension, ventricular extrasystoles, supraventricular tachycardia, syncope, systolic ejection murmur, T wave abnormalities on ECG (flattening, inversion, nonspecific changes), venous insufficiency

Digestive: abnormal liver function tests, anorexia, colitis, diarrhea, dry mouth, dyspepsia, dysphagia, flatulence, gastritis, gastrointestinal hemorrhage, gingival hyperplasia, glossitis, hepatomegaly, increased appetite, melena, mouth ulceration

Endocrine: diabetes mellitus, thyroiditis

Hemic and Lymphatic: anemia, ecchymoses, leukopenia, petechiae

Metabolic and Nutritional: gout, hypokalemia, increased serum creatine kinase, increased nonprotein nitrogen, weight gain, weight loss

Musculoskeletal: arthralgia, arthritis, leg cramps, myalgia, myasthenia, myositis, tenosynovitis

Nervous: abnormal dreams, abnormal thinking and confusion, amnesia, anxiety, ataxia, cerebral ischemia, decreased libido, depression, hypesthesia, hypertonia, insomnia, nervousness, paresthesia, somnolence, tremor, vertigo

Respiratory: asthma, dyspnea, end inspiratory wheeze and fine rales, epistaxis, increased cough, laryngitis, pharyngitis, pleural effusion, rhinitis, sinusitis

Skin and Appendages: acne, alopecia, dry skin, exfoliative dermatitis, fungal dermatitis, herpes simplex, herpes zoster, maculopapular rash, pruritus, pustular rash, skin discoloration, skin ulcer, sweating, urticaria

Special Senses: abnormal vision, amblyopia, blepharitis, conjunctivitis, ear pain, glaucoma, itchy eyes, keratoconjunctivitis, otitis media, retinal detachment, tinnitus, watery eyes, taste disturbance, temporary unilateral loss of vision, vitreous floater

Urogenital: dysuria, hematuria, impotence, nocturia, urinary frequency, increased BUN and serum creatinine, vaginal hemorrhage, vaginitis.

The following postmarketing event has been reported very rarely in patients receiving SULAR (nisoldipine) : systemic hypersensitivity reaction which may include one or more of the following; angioedema, shortness of breath, tachycardia, chest tightness, hypotension, and rash. A definite causal relationship with SULAR (nisoldipine) has not been established. An unusual event observed with immediate release nisoldipine but not observed with SULAR (nisoldipine) was one case of photosensitivity. Gynecomastia has been associated with the use of calcium channel blockers.

Read the entire FDA prescribing information for Sular (Nisoldipine) »

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Sular - User Reviews

Sular User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Sular sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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