NIFEDICAL XL (Nifedipine) Tablet, Film Coated, Extended Release [Cardinal Health]

Over 1000 patients from both controlled and open trials with nifedipine extended-release tablets in hypertension and angina were incorporated within the look at adverse encounters. All negative effects reported during nifedipine extended-release tablet therapy were tabulated in addition to the causal regards to medication. The most typical side-effect reported with nifedipine extended-release tablet was edema that was dose related and ranged in frequency from roughly 10% to around 30% in the greatest dose studied (180 mg). Other common adverse encounters reported in placebo-controlled trials include:

Of those, only edema and headache were more prevalent in patients given nifedipine extended-release tablets than placebo patients.

The next side effects happened by having an incidence of under 3.%. Except for leg cramps, the incidence of those negative effects looked like those of placebo alone.

Body in generalOrWide spread: asthenia, flushing, discomfort
Cardiovascular: palpitations
Nervous System: insomnia, nervousness, paresthesia, somnolence
Dermatologic: pruritus, rash
Gastrointestinal: abdominal discomfort, diarrhea, xerostomia, dyspepsia, wind
Musculoskeletal: arthralgia, leg cramps
Respiratory system: chest discomfort (nonspecific), dyspnea
Urogenital: impotence, polyuria

Other side effects were reported sporadically by having an incidence of just one.% or fewer. Included in this are:

Body in generalOrWide spread: face edema, fever, menopausal flashes, malaise, periorbital edema, rigors
Cardiovascular: arrhythmia, hypotension, elevated angina, tachycardia, syncope
Nervous System: anxiety, ataxia, decreased libido, depression, hypertonia, hypoesthesia, migraine, paroniria, tremor, vertigo
Dermatologic: alopecia, elevated sweating, hives, purpura
Gastrointestinal: eructation, gastroesophageal reflux, gum hyperplasia, melena, vomiting, weight increase
Musculoskeletal: back discomfort, gout, myalgias
Respiratory system: coughing, epistaxis, upper respiratory system infection, respiratory system disorder, sinus problems
Special Senses: abnormal lacrimation, abnormal vision, taste perversion, tinnitus
Urogenital/Reproductive: breast discomfort, dysuria, hematuria, nocturia

Adverse encounters which happened in under one in 1000 patients can’t be distinguished from concurrent disease states or medications.

The next adverse encounters, reported in under 1% of patients, happened under conditions (e.g., open trials, marketing encounters) in which a causal relationship is uncertain: gastrointestinal irritation, gastrointestinal bleeding, gynecomastia.

Gastrointestinal obstruction leading to hospitalization and surgery, including the requirement for bezoar removal, has happened in colaboration with nifedipine extended-release tablets, even just in patients without any prior good reputation for gastrointestinal disease.

In multiple-dose U.S. and foreign controlled studies with nifedipine capsules by which side effects were reported spontaneously, negative effects were frequent but generally not serious and barely needed stopping of therapy or dosage adjustment. Most were expected effects from the vasodilator results of nifedipine.

There’s additionally a large out of control experience of over 2100 patients within the U . s . States. The majority of the patients had vasospastic or resistant angina pectoris, contributing to half had concomitant treatment with beta-adrenergic blocking agents. The relatively common adverse occasions were similar anyway to individuals seen with nifedipine extended-release tablets.

Additionally, more severe adverse occasions were observed, not readily distinguishable in the natural good reputation for the condition during these patients. It remains possible, however, that some or a number of these occasions were drug related. Myocardial infarction happened within 4% of patients and congestive heart failure or lung edema within 2%. Ventricular arrhythmias or conduction disturbances each happened in less than .5% of patients.

Inside a subgroup well over 1000 patients receiving nifedipine with concomitant beta-blocker therapy, the pattern and incidence of adverse encounters wasn’t not the same as those of the whole number of nifedipine treated patients (see Safeguards).

Inside a subgroup of roughly 250 patients having a proper diagnosis of congestive heart failure in addition to angina, dizziness or lightheadedness, peripheral edema, headache or flushing each happened in a single in eight patients. Hypotension happened within one out of 20 patients. Syncope happened in roughly one patient in 250. Myocardial infarction or signs and symptoms of congestive heart failure each happened within one patient in 15. Atrial or ventricular dysrhythmias each happened within one patient in 150.

In publish-marketing experience, there has been rare reports of exfoliative eczema brought on by nifedipine. There has been rare reports of exfoliative or bullous skin adverse occasions (for example erythema multiforme, Stevens-Manley syndrome, and toxic epidermal necrolysis) and photosensitivity reactions.


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