Side Effects of Sular (nisoldipine)

Calcium channel blockers prevent calcium from entering muscle cells. CCBs relax muscle cells by inhibiting contractions.

Sular selectively relaxes small arteries, dilating them and reducing blood pressure. It has little to no effect on veins or the heart.

Common side effects of Sular:

• swollen ankles and feet
• headache
• dizziness
• nausea
• palpitations
• hypersensitivity reactions

Serious side effects of Sular:

• worsening chest pain
• low blood pressure
• heart attacks

Drug interactions of Sular include cimetidine, ketoconazole, itraconazole, erythromycin, or any drug that reduces liver enzyme activity that breaks down Sular. These drugs can increase blood levels of Sular and may cause more side effects.

The effects of Sular on pregnancy and breastfeeding are unknown. Consult your doctor before breastfeeding.

What are the important side effects of Sular (nisoldipine)?

The most common side effects of nisoldipine:

• Peripheral edema (swollen ankles and feet)
• headache
• dizziness
• nausea
• palpitations
• Hypersensitivity reactions
• worsening of chest pain
• low blood pressure
• heart attacks

Sular (nisoldipine) side effects list for healthcare professionals

Over 6000 patients in clinical trials for hypertension received nisoldipine.

Of 1500 patients who received Sular in hypertension studies, over 55% were exposed for at least 2 months and about one third were exposed for over 6 months, mostly at doses equivalent to 17 mg and above.

Sular is generally well-tolerated. In U.S. clinical trials, 10.9% of 921 Sular patients discontinued treatment due to adverse events compared with 2.9% of 280 placebo patients. Discontinuations due to adverse experiences were related to dose, with a 5.4% and 10.9% rate at the lowest and highest daily dose, respectively.

The most frequently occurring adverse experiences with Sular are related to its vasodilator properties; these are generally mild and rarely lead to patient withdrawal.

The table below lists adverse events from U.S. trials using doses across the clinical dosage range in hypertensive patients. Listed are adverse events with an overall incidence on Sular >1% and higher than with placebo.

The common adverse events occurred at similar rates in men and women, and in patients over age 65 as in those under that age, except that headache was 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 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

Hemic and Lymphatic: anemia, ecchymoses, leukopenia, petechiae

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

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
• 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.

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.

Summary

Sular (nisoldipine) is a calcium channel blocker used to treat high blood pressure. 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.