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Nifedical XL Side Effects

Generic Name: nifedipine

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

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

For the Consumer

Applies to nifedipine: oral capsule, oral capsule liquid filled, oral tablet, oral tablet extended release

Along with its needed effects, nifedipine (the active ingredient contained in Nifedical XL) 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 nifedipine:

More common
  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • cough
  • difficult or labored breathing
  • dizziness or lightheadedness
  • fast, irregular, pounding, or racing heartbeat or pulse
  • feeling of warmth
  • headache
  • muscle cramps
  • rapid weight gain
  • shakiness in the legs, arms, hands, or feet
  • shortness of breath
  • tightness in the chest
  • tingling of the hands or feet
  • trembling or shaking of the hands or feet
  • unusual weight gain or loss
  • weakness
  • wheezing
Less common
  • Blue lips and fingernails
  • chest congestion
  • chest pain
  • chills
  • coughing that sometimes produces a pink frothy sputum
  • decreased urine output
  • difficult, fast, or noisy breathing, sometimes with wheezing
  • dilated neck veins
  • extreme fatigue
  • fever
  • increased sweating
  • irregular breathing
  • nausea
  • pain or discomfort in the arms, jaw, back, or neck
  • pale skin
  • severe unusual tiredness or weakness
  • sweating
  • troubled breathing
  • vomiting
Rare
  • Black, tarry stools
  • bleeding gums
  • blood in the eyes
  • blood in the urine or stools
  • bloody stools
  • bluish color
  • blurred vision
  • body aches or pain
  • changes in skin color
  • cold sweats
  • dark urine
  • difficulty with swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • dryness or soreness of throat
  • ear congestion or pain
  • extra heartbeats
  • eye pain
  • feeling unusually cold
  • general tiredness and weakness
  • headache, severe and throbbing
  • hoarseness
  • increased urge to urinate during the night
  • irritation in the mouth
  • itching
  • large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • light-colored stools
  • nasal congestion
  • neck pain
  • nervousness
  • no blood pressure or pulse
  • noisy breathing
  • pain
  • pain in the groin or genitals
  • pain or burning while urinating
  • painful or difficult urination
  • pinpoint red spots on the skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness and swelling of the gums
  • redness in the whites of the eyes
  • runny nose
  • shakiness and unsteady walk
  • sharp back pain just below ribs
  • shivering
  • skin rash
  • small clicking, bubbling, or rattling sounds in the lung when listening with a stethoscope
  • sneezing
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stopping of heart
  • swelling around the eyes
  • swollen glands
  • tenderness
  • tender, swollen glands in the neck
  • troubled breathing with exertion
  • unconsciousness
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • unusual bleeding or bruising
  • upper right abdominal or stomach pain
  • vision changes
  • voice changes
  • vomiting of blood or material that looks like coffee grounds
  • waking to urinate at night
  • yellow eyes and skin

Some side effects of nifedipine 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:

More common
  • Belching
  • feeling of indigestion
  • mood changes
  • pain in the chest below the breastbone
  • redness of the face, neck, arms, and occasionally, upper chest
Less common
  • Abnormal ejaculation
  • bloody nose
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • decreased interest in sexual intercourse
  • decreased sexual performance or desire
  • diarrhea
  • difficulty having a bowel movement (stool)
  • excess air or gas in stomach or intestines
  • feeling of constant movement of self or surroundings
  • full feeling
  • general feeling of discomfort or illness
  • inability to have or keep an erection
  • increased need to urinate
  • joint stiffness
  • leg cramps or pain
  • loss in sexual ability, desire, drive, or performance
  • nervousness
  • passing gas
  • passing urine more often
  • sneezing
  • stuffy nose
  • trouble sleeping
Rare
  • Acid or sour stomach
  • ankle, knee, or great toe joint pain
  • cracks in the skin
  • difficulty with moving
  • discouragement
  • excessive muscle tone
  • fear or nervousness
  • feeling sad or empty
  • hair loss or thinning of the hair
  • heartburn
  • increased sensitivity of the skin to sunlight
  • irritability
  • itching, pain, redness, swelling, tenderness, or warmth on the skin
  • lack of appetite
  • lack or loss of strength
  • loss of heat from the body
  • loss of interest or pleasure
  • loss of strength or energy
  • loss in sexual ability, desire, drive, or performance
  • lower back or side pain
  • muscle pain or weakness
  • muscle stiffness
  • muscle tension or tightness
  • pain or burning in the throat
  • red, swollen skin
  • redness or other discoloration of the skin
  • scaly skin
  • severe sunburn
  • sleepiness or unusual drowsiness
  • sleeplessness
  • stomach discomfort, upset, or pain
  • swelling of the breasts or breast soreness in both females and males
  • tiredness
  • trouble concentrating
  • unable to sleep

For Healthcare Professionals

Applies to nifedipine: compounding powder, oral capsule, oral tablet extended release

General

Recent data suggest that the use of short-acting nifedipine (the active ingredient contained in Nifedical XL) in moderate to high doses in patients with coronary artery disease (particularly in the elderly) has been associated with an increase in total mortality. In addition, in general, approximately 20% of patients have experienced side effects, mostly due to the vasodilatory properties of the drug (headache, flushing, dizziness). These effects have usually been transient and mild in severity, and have been minimized by dose reduction or addition of a beta-blocker (if indicated).

Nervous system

A 59-year-old man with hypertension (BP of 160/110) developed a severe headache, right-sided paresthesia, and complete bilateral loss of vision 30 minutes after receiving his first dose of nifedipine (the active ingredient contained in Nifedical XL) 20 mg orally. A CT scan confirmed the diagnosis of bilateral occipital lobe infarction resulting in cortical blindness with macular sparing. The authors of this case report believe that nifedipine may have caused a local cerebral vascular steal phenomenon or a global reduction in cerebral blood flow, and have located approximately four similar reports.

Nervous system side effects are the most common and have included headache (7% to 35%), weakness (10% to 12%), dizziness/lightheadedness/giddiness (3% to 27%), and tremor (1% or less to 8%). Paresthesia, insomnia, somnolence, and vertigo (3% or less); sleep disturbances and shakiness (2% or less); ataxia, decreased libido, hypertonia, hypesthesia, and migraine (1% or less); and dystonia, dysosmia, and dysgeusia have been reported. Rare cases of stroke associated with nifedipine-induced hypotension have been reported.

Cardiovascular

Nifedipine-induced hypotension may result in retinal, coronary, or cerebral ischemia in some patients, resulting in visual field defects, angina, or stroke. A single case report of profound hypotension and death associated with nifedipine (the active ingredient contained in Nifedical XL) in a 17-year-old woman with primary pulmonary hypertension (PPH) has been reported. The patient had extraordinarily high right atrial pressures and depressed cardiac output, indicating caution when one is testing the efficacy of calcium channel blockers in patients with PPH.

A 34-year-old woman experienced torsades de pointes leading to ventricular fibrillation after a 20 mg sublingual dose of nifedipine was administered to treat a hypertensive emergency.

Atrioventricular block is an unusual side effect of nifedipine therapy.

Rare cases of nifedipine-associated noncardiac pulmonary edema in patients with pulmonary hypertension and left ventricular outflow obstruction syndromes, such as aortic stenosis and hypertrophic cardiomyopathy have been reported.

Although relatively minor, the negative inotropic side effect of nifedipine may be important in patients with a history of congestive heart failure.

Cardiovascular side effects can be significant and have included peripheral edema (7% to 29%), hypotension (less than 1% to 5%), palpitations (less than 1% to 7%), myocardial infarction (4%), congestive heart failure (2%), and noncardiogenic edema (0.6% to 8%). Arrhythmia, increased angina, tachycardia, and syncope (1% or less); substernal chest pain, atrial fibrillation, bradycardia, cardiac arrest, extrasystole, phlebitis, postural hypotension, and cutaneous angiectases (less than 1%); erythromelalgia (0.5%); ventricular arrhythmias and conduction disturbances (less than 0.5%); and atrial and ventricular dysrhythmias have been reported. Patients with hypovolemia and/or concomitant antihypertensive therapy are at increased risk of hypotension associated with nifedipine. Some patients with exertional angina pectoris have reported increased chest pain after taking nifedipine. This may, however, reflect progressive disease rather than drug effect. Ventricular fibrillation has rarely been reported.

Gastrointestinal

Gastrointestinal (GI) side effects are common and have included nausea (2% to 11%); heartburn (11%); constipation (3.3% or less); abdominal pain, diarrhea, dry mouth, dyspepsia, and flatulence (3% or less); abdominal cramps (2% or less); eructation, gastroesophageal reflux, gingival hyperplasia, melena, taste perversion, and vomiting (1% or less); and dysphagia, esophagitis, GI disorder, GI hemorrhage, GI irritation, gum disorder, and gum hemorrhage (less than 1%). Rarely, bezoars have been reported in patients taking extended release nifedipine (the active ingredient contained in Nifedical XL) as Procardia XL(R). Gastrointestinal obstruction resulting in hospitalization and surgery (including the need for bezoar removal) has been reported with Procardia XL(R), even in patients with no known gastrointestinal disease. Tablet adherence to the GI wall with ulceration has been reported with Procardia XL(R); some cases required hospitalization and intervention.

Hepatic

Nifedipine-associated hepatitis is dose-dependent, idiosyncratic, and thought to be due to hypersensitivity because it is often associated with fever, rash, eosinophilia, and arthritis. One case of alcoholic-like liver lesions, consisting of steatosis and Mallory bodies, has been associated with the use of nifedipine (the active ingredient contained in Nifedical XL)

Some studies have shown that nifedipine may increase hepatic portal venous hypertension, which may be important in patients with severe liver disease. Frequent monitoring of liver function tests during nifedipine therapy is recommended in patients with underlying liver disease.

Hepatic side effects have included increased GGT (less than 1%); transient elevations of liver function tests and rare cases of hepatitis (approximately 0.5%); allergic hepatitis (less than 0.5%); and jaundice.

Renal

Rare cases of immune-complex nephritis and nephrotic syndrome associated with nifedipine (the active ingredient contained in Nifedical XL) therapy have been reported. A case of acute, reversible renal failure attributable to nifedipine administration in a patient with congestive heart failure has been reported.

Renal side effects have included kidney calculus (less than 1%) and new or worsened renal insufficiency (less than 0.5%). Patients who are at higher risk include the elderly and patients with preexisting renal or arteriosclerotic vascular disease. Use of nifedipine has also been associated with improved glomerular filtration rate and effective renal plasma flow in hypertensive patients with moderate renal dysfunction, regardless of its antihypertensive effect.

Hypersensitivity

Hypersensitivity side effects have included allergic reaction (less than 1%), angioedema (mostly oropharyngeal edema with difficulty breathing in a few patients; less than 0.5%), and anaphylactic reaction. Cases of urticarial eruptions and erythema multiforme, often associated with other findings of hypersensitivity, have been reported.

Hematologic

Hematologic side effects have included purpura (1% or less); eosinophilia and lymphadenopathy (less than 1%); and thrombocytopenia, anemia, and leukopenia (less than 0.5%).

Dermatologic

Dermatologic side effects have included rash and pruritus (3% or less); dermatitis, urticaria, and sweating (2% or less); alopecia (1% or less); angioedema, petechial rash, and photosensitivity reaction (less than 1%); and exfoliative dermatitis (less than 0.5%). Rare cases of erythromelalgia, pemphigus foliaceus, and pemphigoid nodularis have been reported. Exfoliative or bullous skin reactions (such as erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), photosensitivity reactions, and acute generalized exanthematous pustulosis have been reported during postmarketing experience.

A single case of pemphigus foliaceus associated with nifedipine, resolving after discontinuation of the drug, and recurring upon rechallenge has been reported. Prior to this case, only drugs with an active sulfhydryl group, such as penicillamine and captopril, were implicated in the development of pemphigus foliaceus.

Psychiatric

Psychiatric side effects have included nervousness (2% or less to 7%); mood changes (7%); jitteriness (2% or less); anxiety, depression, and paroniria (1% or less); confusion (less than 1%); paranoid syndrome (less than 0.5%); and agitation and psychosis.

Other

Other side effects have included edema (10% to 30%); flushing/heat sensation (less than 3% to 25%); fatigue (4% to 5.9%); asthenia (less than 1% to 4%); chest pain, leg pain, and pain (3% or less); difficulties in balance, fever, and chills (2% or less); facial edema, hot flashes, malaise, periorbital edema, rigors, and tinnitus (1% or less); and cellulitis, abnormal laboratory test (unspecified), neck pain, and pelvic pain (less than 1%). A single report of falsely elevated laboratory urinary vanillylmandelic acid (VMA) values by spectrophotometry during nifedipine (the active ingredient contained in Nifedical XL) therapy has been reported.

Respiratory

At least one case of acute pulmonary edema during tocolytic therapy with oral nifedipine (the active ingredient contained in Nifedical XL) has been reported. The patient developed pulmonary edema 3 days after starting nifedipine (two doses of 20 mg sublingually 30 minutes apart followed by 40 mg orally every 6 hours). Symptoms included dyspnea, orthopnea, tachypnea, and tachycardia which resolved following discontinuation of nifedipine.

Respiratory side effects have included dyspnea, cough, nasal congestion, sore throat, and wheezing (less than 1% to 6%); epistaxis and rhinitis (3% or less); pulmonary edema (2%); chest congestion (2% or less); and upper respiratory tract infection, respiratory disorder, and sinusitis (1% or less).

Metabolic

Metabolic side effects have included gout and increased weight (1% or less), weight loss (less than 1%), and hyperglycemia.

Musculoskeletal

Musculoskeletal side effects have included muscle cramps (2% or less to 8%); leg cramps and arthralgia (3% or less); inflammation and joint stiffness (2% or less); back pain and myalgia (1% or less); arthritis, joint disorder, and myasthenia (less than 1%), and arthritis with ANA (+) (less than 0.5%).

Genitourinary

Genitourinary side effects have included impotence, polyuria, and urinary frequency (3% or less); sexual difficulties (2% or less); breast pain, dysuria, hematuria, and nocturia (1% or less); and urogenital disorder, erectile dysfunction, and gynecomastia (less than 1%).

Ocular

Ocular side effects have included blurred vision (2% or less); abnormal lacrimation and abnormal vision (1% or less); amblyopia, conjunctivitis, diplopia, eye disorder, and eye hemorrhage (less than 1%); and transient blindness (at the peak of plasma level; less than 0.5%).

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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