Does Sular (nisoldipine) cause side effects?
Calcium channel blockers prevent calcium from entering certain types of muscle cells. Since muscle cells need calcium to contract, CCBs prevent the cells from contracting, that is, they cause the muscle cells to relax.
Common side effects of Sular include
Serious side effects of Sular include
Drug interactions of Sular include cimetidine, ketoconazole, itraconazole, erythromycin, or any drug that reduces the activity of liver enzymes that break down Sular, because they can increase blood levels of Sular possibly causing more side effects.
Sular (nisoldipine) side effects list for healthcare professionals
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 (%)|
|Only peripheral edema and possibly dizziness appear to be dose related.|
|Adverse Event||Sular, dose bioequivalent to:|
|(Rates in %)||N=280||N=30||N=170||N=105||N=139|
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.
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
Nervous: abnormal dreams, abnormal thinking and confusion, amnesia, anxiety, ataxia, cerebral ischemia, decreased libido, depression, hypesthesia, hypertonia, insomnia, nervousness, paresthesia, somnolence, tremor, vertigo
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
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;
- shortness of breath,
- chest tightness,
- hypotension, and
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.
What drugs interact with Sular (nisoldipine)?
A 30 to 45% increase in AUC and Cmax 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 H2 receptor antagonist were observed.
Sular (nisoldipine) is a calcium channel blocker (CCB) used to treat high blood pressure (hypertension). Common side effects of Sular include swollen ankles and feet, headache, dizziness, nausea, palpitations, and hypersensitivity reactions. Serious side effects of Sular include worsening chest pain, low blood pressure, and heart attacks. The effects of Sular in pregnancy are unknown. It is unknown if Sular appears in breast milk. Consult your doctor before breastfeeding.
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High blood pressure (hypertension) is a disease in which pressure within the arteries of the body is elevated. About 75 million people in the US have hypertension (1 in 3 adults), and only half of them are able to manage it. Many people do not know that they have high blood pressure because it often has no has no warning signs or symptoms. Systolic and diastolic are the two readings in which blood pressure is measured. The American College of Cardiology released new guidelines for high blood pressure in 2017. The guidelines now state that blood normal blood pressure is 120/80 mmHg. If either one of those numbers is higher, you have high blood pressure. The American Academy of Cardiology defines high blood pressure slightly differently. The AAC considers 130/80 mm Hg. or greater (either number) stage 1 hypertension. Stage 2 hypertension is considered 140/90 mm Hg. or greater. If you have high blood pressure you are at risk of developing life threatening diseases like stroke and heart attack.REFERENCE: CDC. High Blood Pressure. Updated: Nov 13, 2017.
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High blood pressure (hypertension) means high pressure (tension) in the arteries. Treatment for high blood pressure include lifestyle modifications (alcohol, smoking, coffee, salt, diet, exercise), drugs and medications such as ACE inhibitors, angiotensin receptor blockers, beta blockers, diuretics, calcium channel blockers (CCBs), alpha blockers, clonidine, minoxidil, and Exforge.
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Medications & Supplements
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.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.