Procardia XL

Last updated on RxList: 7/12/2021
Procardia XL Side Effects Center

What Is Procardia XL?

Procardia XL (nifedipine) Extended Release Tablets is a calcium channel blocker used to treat high blood pressure and chest pain. It is available in generic form.

What Are Side Effects of Procardia XL?

Common side effects of Procardia XL include:

  • headache,
  • dizziness,
  • drowsiness,
  • tired feeling,
  • nausea,
  • constipation,
  • diarrhea,
  • stomach pain,
  • sleep problems (insomnia),
  • rash,
  • itching,
  • joint pain,
  • leg/muscle cramps,
  • urinating more than usual,
  • sexual problems, or
  • flushing (warmth, redness, or tingly feeling under your skin).

Tell your doctor if you have unlikely but serious side effects of Procardia XL including:

  • swelling of the ankles and feet,
  • shortness of breath, and
  • unusual weakness or tiredness.

Dosage for Procardia XL

The recommended dosage of Procardia XL is 30 or 60 mg once daily.

What Drugs, Substances, or Supplements Interact with Procardia XL?

Acarbose, cimetidine, fentanyl, digoxin, St. John's wort, warfarin, antifungal medication, HIV/AIDS medication, and seizure medications may interact with Procardia XL. Tell your doctor all medications you take. Before taking Procardia XL tell your doctor if you have kidney or liver disease, coronary artery disease, congestive heart failure, or digestive problems. Do not stop taking Procardia XL without first consulting with your doctor.

Procardia XL During Pregnancy or Breastfeeding

If you are pregnant only use Procardia XL if the potential benefit outweighs the potential risk to the fetus. Talk to your doctor before taking Procardia XL if you are breastfeeding.

Additional Information

Our Procardia XL (nifedipine) Extended Release Tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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In the U.S., 1 in every 4 deaths is caused by heart disease. See Answer
Procardia XL Consumer Information

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Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

  • worsening chest pain;
  • pounding heartbeats or fluttering in your chest;
  • a light-headed feeling, like you might pass out;
  • swelling in your hands or lower legs; or
  • upper stomach pain, jaundice (yellowing of the skin or eyes).

You may have more severe or more frequent episodes of angina when you first start taking nifedipine or whenever your dose is changed.

Common side effects may include:

  • swelling;
  • flushing (warmth, redness, or tingly feeling);
  • headache, dizziness;
  • nausea, heartburn; or
  • feeling weak or tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Procardia XL (Nifedipine Extended Release Tablets)

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Procardia XL Professional Information

SIDE EFFECTS

Adverse Experiences

Over 1000 patients from both controlled and open trials with PROCARDIA XL Extended Release Tablets in hypertension and angina were included in the evaluation of adverse experiences. All side effects reported during PROCARDIA XL Extended Release Tablet therapy were tabulated independent of their causal relation to medication. The most common side effect reported with PROCARDIA XL was edema which was dose related and ranged in frequency from approximately 10% to about 30% at the highest dose studied (180 mg). Other common adverse experiences reported in placebo-controlled trials include:

Adverse Effect PROCARDIA XL (%)
(N=707)
Placebo (%)
(N=266)
Headache 15.8 9.8
Fatigue 5.9 4.1
Dizziness 4.1 4.5
Constipation 3.3 2.3
Nausea 3.3 1.9

Of these, only edema and headache were more common in PROCARDIA XL patients than placebo patients.

The following adverse reactions occurred with an incidence of less than 3.0%. With the exception of leg cramps, the incidence of these side effects was similar to that of placebo alone.

Body as a Whole/Systemic: asthenia, flushing, pain Cardiovascular: palpitations

Central Nervous System: insomnia, nervousness, paresthesia, somnolence

Dermatologic: pruritus, rash

Gastrointestinal: abdominal pain, diarrhea, dry mouth, dyspepsia, flatulence

Musculoskeletal: arthralgia, leg cramps

Respiratory: chest pain (nonspecific), dyspnea

Urogenital: impotence, polyuria

Other adverse reactions were reported sporadically with an incidence of 1.0% or less. These include:

Body as a Whole/Systemic: face edema, fever, hot flashes, malaise, periorbital edema, rigors

Cardiovascular: arrhythmia, hypotension, increased angina, tachycardia, syncope

Central Nervous System: anxiety, ataxia, decreased libido, depression, hypertonia, hypoesthesia, migraine, paroniria, tremor, vertigo

Dermatologic: alopecia, increased sweating, urticaria, purpura

Gastrointestinal: eructation, gastroesophageal reflux, gum hyperplasia, melena, vomiting, weight increase

Musculoskeletal: back pain, gout, myalgias

Respiratory: coughing, epistaxis, upper respiratory tract infection, respiratory disorder, sinusitis

Special Senses: abnormal lacrimation, abnormal vision, taste perversion, tinnitus

Urogenital/Reproductive: breast pain, dysuria, hematuria, nocturia

Adverse experiences which occurred in less than 1 in 1000 patients cannot be distinguished from concurrent disease states or medications.

The following adverse experiences, reported in less than 1% of patients, occurred under conditions (e.g., open trials, marketing experience) where a causal relationship is uncertain: gastrointestinal irritation, gastrointestinal bleeding, gynecomastia.

Gastrointestinal obstruction resulting in hospitalization and surgery, including the need for bezoar removal, has occurred in association with PROCARDIA XL, even in patients with no prior history of gastrointestinal disease (see WARNINGS).

Cases of tablet adherence to the gastrointestinal wall with ulceration have been reported, some requiring hospitalization and intervention.

In multiple-dose U.S. and foreign controlled studies with nifedipine capsules in which adverse reactions were reported spontaneously, adverse effects were frequent but generally not serious and rarely required discontinuation of therapy or dosage adjustment. Most were expected consequences of the vasodilator effects of nifedipine.

Adverse Effect PROCARDIA
CAPSULES (%)
(N=226)
Placebo (%)
(N=235)
Dizziness, lightheadedness, giddiness 27 15
Flushing, heat sensation 25 8
Headache 23 20
Weakness 12 10
Nausea, heartburn 11 8
Muscle cramps, tremor 8 3
Peripheral edema 7 1
Nervousness, mood changes 7 4
Palpitations 7 5
Dyspnea, cough, wheezing 6 3
Nasal congestion, sore throat 6 8

There is also a large uncontrolled experience in over 2100 patients in the United States. Most of the patients had vasospastic or resistant angina pectoris, and about half had concomitant treatment with beta-adrenergic blocking agents. The relatively common adverse events were similar in nature to those seen with PROCARDIA XL.

In addition, more serious adverse events were observed, not readily distinguishable from the natural history of the disease in these patients. It remains possible, however, that some or many of these events were drug related. Myocardial infarction occurred in about 4% of patients and congestive heart failure or pulmonary edema in about 2%. Ventricular arrhythmias or conduction disturbances each occurred in fewer than 0.5% of patients.

In a subgroup of over 1000 patients receiving PROCARDIA with concomitant beta blocker therapy, the pattern and incidence of adverse experiences was not different from that of the entire group of PROCARDIA-treated patients (see PRECAUTIONS).

In a subgroup of approximately 250 patients with a diagnosis of congestive heart failure as well as angina, dizziness or lightheadedness, peripheral edema, headache, or flushing each occurred in one in eight patients. Hypotension occurred in about one in 20 patients. Syncope occurred in approximately one patient in 250. Myocardial infarction or symptoms of congestive heart failure each occurred in about one patient in 15. Atrial or ventricular dysrhythmias each occurred in about one patient in 150.

In post-marketing experience, there have been rare reports of exfoliative dermatitis caused by nifedipine. There have been rare reports of exfoliative or bullous skin adverse events (such as erythema multiforme, Stevens-Johnson Syndrome, and toxic epidermal necrolysis) and photosensitivity reactions. Acute generalized exanthematous pustulosis also has been reported.

Read the entire FDA prescribing information for Procardia XL (Nifedipine Extended Release Tablets)

SLIDESHOW

Heart Disease: Symptoms, Signs, and Causes See Slideshow

© Procardia XL Patient Information is supplied by Cerner Multum, Inc. and Procardia XL Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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