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Sular Side Effects

Generic Name: nisoldipine

Note: This document contains side effect information about nisoldipine. Some of the dosage forms listed on this page may not apply to the brand name Sular.

For the Consumer

Applies to nisoldipine: oral tablet extended release

Along with its needed effects, nisoldipine (the active ingredient contained in Sular) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking nisoldipine:

More common
  • Bloating or swelling of face, arms, hands, lower legs, or feet
  • rapid weight gain
  • tingling of hands or feet
  • unusual weight gain or loss
Less common
  • Chest pain
  • dizziness, lightheadedness, or fainting
  • fast, irregular, pounding, or racing heartbeat or pulse
  • feeling of warmth or heat
  • flushing or redness of skin, especially on face and neck
  • headache
  • rash
  • sweating
Rare
  • Chest tightness
  • shortness of breath
  • swelling of the arms, face, legs, lips, tongue, or throat

Some side effects of nisoldipine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Body aches or pain
  • congestion
  • cough
  • dryness or soreness of throat
  • fever
  • heartbeat sensations
  • hoarseness
  • pain or tenderness around eyes and cheekbones
  • runny nose
  • stuffy nose
  • tender, swollen glands in neck
  • trouble in swallowing
  • voice changes

For Healthcare Professionals

Applies to nisoldipine: oral tablet extended release

General

Nisoldipine is generally well tolerated. In controlled trials of patients with hypertension, 11% of treated patients discontinued therapy due to adverse drug events, compared with 2.9% of placebo patients. The most common side effects are related to the vasodilating properties of nisoldipine (the active ingredient contained in Sular) and are dose-related.[Ref]

Cardiovascular

Some patients, particularly those with severe obstructive coronary artery disease, have developed increased frequency, duration, and/or severity of angina, or acute myocardial infarction, after starting calcium channel blocker therapy or at the time of dosage increase. In controlled studies of nisoldipine (the active ingredient contained in Sular) in patients with angina this was seen in approximately 1.5% of treated patients, compared with 0.9% of patients given placebo.[Ref]

Cardiovascular side effects have included peripheral edema (up to 22%), vasodilation (4%), palpitation (3%), and chest pain (2%). 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), and venous insufficiency have been reported in less than or equal to 1% of patients. Initial therapy with nisoldipine can induce unstable angina pectoris.[Ref]

Nervous system

Nervous system side effects have included headache (up to 22%) and dizziness (5%). Abnormal dreams, abnormal thinking and confusion, amnesia, anxiety, ataxia, cerebral ischemia, decreased libido, depression, hypesthesia, hypertonia, insomnia, nervousness, paresthesia, somnolence, tremor, and vertigo have been reported in less than or equal to 1% of patients.[Ref]

Respiratory

Respiratory side effects have included sinusitis (up to 3%) and pharyngitis (up to 5%). Asthma, dyspnea, end inspiratory wheeze and fine rales, epistaxis, increased cough, laryngitis, pleural effusion, and rhinitis have been reported in less than or equal to 1% of patients.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea (2%) and anorexia, colitis, diarrhea, dry mouth, dyspepsia, dysphagia, flatulence, gastritis, gastrointestinal hemorrhage, gingival hyperplasia, glossitis, increased appetite, melena, mouth ulcerations, and taste disturbance in less than or equal to 1% of patients.[Ref]

Dermatologic

Dermatologic side effects have included rash (2%) and acne, alopecia, dry skin, exfoliative dermatitis, fungal dermatitis, herpes simplex, herpes zoster, maculopapular rash, pruritus, pustular rash, skin discoloration, skin ulcer, sweating, and urticaria in less than or equal to 1% of patients. Photosensitivity has been reported with immediate release nisoldipine (the active ingredient contained in Sular) during postmarketing experience.[Ref]

Genitourinary

Genitourinary side effects have included dysuria, hematuria, impotence, increased BUN and serum creatinine, nocturia, urinary frequency, vaginal hemorrhage, and vaginitis in less than or equal to 1% of patients. Gynecomastia has been reported with the use of calcium channel blockers during postmarketing experience.[Ref]

Metabolic

Metabolic side effects have included gout, hypokalemia, increased serum creatine kinase, increased nonprotein nitrogen, weight gain, and weight loss in less than or equal to 1% of patients.[Ref]

Hematologic

Hematologic side effects have included anemia, ecchymoses, leukopenia, and petechiae in less than or equal to 1% of patients.

Endocrine

Endocrine side effects have included diabetes mellitus and thyroiditis in less than or equal to 1% of patients.

Hepatic

Hepatic side effects have included abnormal liver function tests and hepatomegaly in less than or equal to 1% of patients.

Hypersensitivity

Hypersensitivity side effects have included systemic hypersensitivity reaction (including angioedema, shortness of breath, tachycardia, chest tightness, hypotension, and/or rash) during postmarketing experience.[Ref]

Musculoskeletal

Musculoskeletal side effects have included arthralgia, arthritis, leg cramps, myalgia, myasthenia, myositis, and tenosynovitis in less than or equal to 1% of patients.[Ref]

Ocular

Ocular side effects have included abnormal vision, amblyopia, blepharitis, glaucoma, itchy eyes, keratoconjunctivitis, retinal detachment, watery eyes, temporary unilateral vision loss, and vitreous floater in less than or equal to 1% of patients.

Other

Other side effects have included cellulitis, chills, ear pain, facial edema, fever, flu syndrome, malaise, otitis media, and tinnitus in less than or equal to 1% of patients.

References

1. "Product Information. Sular (nisoldipine)." Zeneca Pharmaceuticals, Wilmington, DE.

2. Friedel HA, Sorkin EM "Nisoldipine. A preliminary review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy in the treatment of angina pectoris, hypertension and related cardiovascular disorders." Drugs 36 (1988): 682-731

3. van Harten J, van Brummelen P, Lodewijks MT, Danhof M, Breimer DD "Pharmacokinetics and hemodynamic effects of nisoldipine and its interaction with cimetidine." Clin Pharmacol Ther 43 (1988): 332-41

4. van Harten J, Burggraaf J, Ligthart GJ, van Brummelen P, Breimer DD "Single- and multiple-dose nisoldipine kinetics and effects in the young, the middle-aged, and the elderly." Clin Pharmacol Ther 45 (1989): 600-7

5. Mitchell J, Frishman W, Heiman M "Nisoldipine: a new dihydropyridine calcium-channel blocker." J Clin Pharmacol 33 (1993): 46-52

6. van Harten J, Burggraaf J, van Brummelen P, Breimer DD "Influence of renal function on the pharmacokinetics and cardiovascular effects of nisoldipine after single and multiple dosing." Clin Pharmacokinet 16 (1989): 55-64

7. Plosker GL, Faulds D "Nisoldipine coat-core: a review of its pharmacology and therapeutic efficacy in hypertension." Drugs 52 (1996): 232-53

8. Murray TS "A study to investigate the comparative efficacy and tolerability of nisoldipine coat-core and atenolol in the treatment of mild to moderate hypertension." Br J Clin Pract 50 (1996): 368-72

Some side effects of Sular may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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