Sular Side Effects

Generic Name: nisoldipine

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

Side Effects of Sular - for the Consumer

Sular Extended-Release Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Sular Extended-Release Tablets:

Dizziness; flushing; headache; lightheadedness; mild swelling of the arms, legs, feet, or hands.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; loss of vision or other vision changes; mood or mental changes; severe or persistent dizziness or headache; severe or persistent swelling of the arms, legs, feet, or hands; shortness of breath; sudden unusual weight gain; tender, bleeding, or swollen gums; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

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 and are dose-related.

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 in patients with angina this was seen in approximately 1.5% of treated patients, compared with 0.9% of patients given placebo.

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.

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.

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.

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.

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 during postmarketing experience.

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.

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.

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.

Musculoskeletal

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

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.

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