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Procardia XL

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Procardia XL

Procardia XL Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

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. Common side effects of Procardia XL include headache, dizziness, drowsiness, tired feeling, nausea, constipation, diarrhea, stomach pain, sleep problems, rash, itching, joint pain, and leg cramps.

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

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Procardia XL in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • worsening angina;
  • severe constipation and cramps, severe stomach pain or heartburn, coughing up blood;
  • feeling like you might pass out;
  • feeling short of breath, swelling in your hands or feet;
  • fast or pounding heartbeats;
  • numbness or tingly feeling;
  • jaundice (yellowing of the skin or eyes); or
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

Less serious side effects may include:

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

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Procardia XL Overview - Patient Information: Side Effects

SIDE EFFECTS: Headache, dizziness, nausea, flushing, constipation, leg/muscle cramps, or sexual problems may occur. To reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

An empty tablet shell may appear in your stool. This is harmless since your body has already absorbed the medication.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: swelling of the ankles/feet, shortness of breath, unusual weakness/tiredness.

Tell your doctor immediately if any of these rare but very serious side effects occur: fast/slow/irregular heartbeat, fainting, mental/mood changes, swollen/tender gums, vision changes, severe constipation, severe stomach/abdominal pain, black stools.

Although this medication is effective in preventing chest pain (angina), some people who already have severe heart disease may rarely develop worsening chest pain or a heart attack after starting this medication or increasing the dose. Get medical help right away if you experience: worsening chest pain, symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Procardia XL (Nifedipine Extended Release Tablets)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Procardia XL FDA Prescribing Information: Side Effects
(Adverse Reactions)

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) »

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Procardia XL - User Reviews

Procardia XL User Reviews

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Here is a collection of user reviews for the medication Procardia XL sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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