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Procardia

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Procardia

Procardia Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Procardia (nifedipine) is used to treat hypertension (high blood pressure) and to treat angina (chest pain). It is a calcium channel blocker. This medication is available in generic form. Common side effects include dizziness, flushing, weakness, swelling ankles/feet, and headache.

The usual starting dose of Procardia is one 10 mg capsule, 3 times/day. The usual effective dose range is 10-20 mg three times daily. Procardia may interact with other heart medications to treat the same or another condition, cimetidine, erythromycin, itraconazole or ketoconazole, carbamazepine, phenytoin, rifampin, or rifabutin. Tell your doctor all medications you use. During pregnancy, Procardia should be used only when prescribed. This medication passes into breast milk. Consult your doctor before breast-feeding.

Our Procardia (nifedipine) 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 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 (Nifedipine) »

What is Patient Information Overview?

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

Procardia Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness, flushing, weakness, swelling ankles/feet, constipation, and headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

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: fast/irregular/pounding heartbeat, fainting.

Tell your doctor immediately if any of these rare but very serious side effects occur: vision changes.

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 (Nifedipine)»

What is Prescribing information?

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

Procardia FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

In multiple-dose United States and foreign controlled studies 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 PROCARDIA.

Adverse Effect PROCARDIA
(%)
(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
Palpitation 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 most common adverse events were:

Incidence Approximately 10%

Cardiovascular: peripheral edema
Central Nervous System:
dizziness or lightheadedness
Gastrointestinal:
nausea
Systemic:
headache and flushing, weakness
Incidence Approximately 5%
Cardiovascular:
transient hypotension

Incidence 2% or Less

Cardiovascular: palpitation
Respiratory:
nasal and chest congestion, shortness of breath
Gastrointestinal:
diarrhea, constipation, cramps, flatulence
Musculoskeletal:
inflammation, joint stiffness, muscle cramps
Central Nervous System:
shakiness, nervousness, jitteriness, sleep disturbances, blurred vision, difficulties in balance
Other:
dermatitis, pruritus, urticaria, fever, sweating, chills, sexual difficulties

Incidence Approximately 0.5%

Cardiovascular: syncope (mostly with initial dosing and/or an increase in dose), erythromelalgia

Incidence Less Than 0.5%

Hematologic: thrombocytopenia, anemia, leukopenia, purpura
Gastrointestinal:
allergic hepatitis
Face and Throat:
angioedema (mostly oropharyngeal edema with breathing difficulty in a few patients), gingival hyperplasia
CNS:
depression, paranoid syndrome
Special Senses:
transient blindness at the peak of plasma level, tinnitus
Urogenital:
nocturia, polyuria
Other:
arthritis with ANA (+), exfoliative dermatitis, gynecomastia
Musculoskeletal:
myalgia

Several of these side effects appear to be dose related. Peripheral edema occurred in about one in 25 patients at doses less than 60 mg per day and in about one patient in eight at 120 mg per day or more. Transient hypotension, generally of mild to moderate severity and seldom requiring discontinuation of therapy, occurred in one of 50 patients at less than 60 mg per day and in one of 20 patients at 120 mg per day or more.

Very rarely, introduction of PROCARDIA therapy was associated with an increase in anginal pain, possibly due to associated hypotension. Transient unilateral loss of vision has also occurred.

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 were not different from that of the entire group of PROCARDIA (nifedipine) treated patients. (See PRECAUTIONS.)

In a subgroup of approximately 250 patients with a diagnosis of congestive heart failure as well as angina pectoris (about 10% of the total patient population), 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 (Nifedipine) »

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Procardia - User Reviews

Procardia User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Procardia 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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