Sular
- Generic Name: nisoldipine
- Brand Name: Sular
Sular (Nisoldipine) side effects drug center
Sular Side Effects Center
Sular (nisoldipine) is a calcium channel blocker used to treat high blood pressure (hypertension). Sular is available in generic form. Common side effects of Sular include:
- dizziness,
- swelling ankles/feet,
- flushing (warmth, redness, or tingly feeling under your skin),
- headache,
- nausea,
- stuffy nose,
- sore throat, or
- skin rash.
Tell your doctor if you have serious side effects of Sular including:
- fast or pounding heartbeats or
- feeling like you might pass out.
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.
Sular Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- a light-headed feeling, like you might pass out;
- chest pain or pressure, pain spreading to your jaw or shoulder;
- swelling in your hands or feet;
- flushing (sudden warmth, redness, or tingly feeling);
- fast heartbeats; or
- sudden numbness or weakness, problems with vision or speech.
You may have new or worsening chest pain when you first start taking nisoldipine or whenever your dose is changed.
Common side effects may include:
- swelling;
- headache;
- dizziness; or
- flushing.
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.
Read the entire detailed patient monograph for Sular (Nisoldipine)
Sular Professional Information
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) |
| 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, dose bioequivalent to: | ||||
| Placebo | 8.5mg | 17mg | 25.5mg | 34mg | |
| (Rates in %) | N=280 | N=30 | N=170 | N=105 | N=139 |
| Peripheral Edema | 10 | 7 | 15 | 20 | 27 |
| Dizziness | 4 | 7 | 3 | 3 | 4 |
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 to these events cannot be established, they are listed to alert the physician to a possible relationship with SULAR 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: 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 has not been established. An unusual event observed with immediate release nisoldipine but not observed with SULAR 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)
&Copy; Sular Patient Information is supplied by Cerner Multum, Inc. and Sular Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.