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Nisoldipine Side Effects

In Summary

Commonly reported side effects of nisoldipine include: headache and peripheral edema. Other side effects include: dizziness. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to nisoldipine: oral tablet extended release

As well as its needed effects, nisoldipine may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking nisoldipine, check with your doctor immediately:

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

Minor Side Effects

Some nisoldipine side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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 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 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 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

It is possible that some side effects of nisoldipine may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

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