Procardia
- Generic Name: nifedipine
- Brand Name: Procardia
Procardia (Nifedipine) side effects drug center
Procardia Side Effects Center
What Is Procardia?
Procardia (nifedipine) is a calcium channel blocker used to treat hypertension (high blood pressure) and to treat angina (chest pain). Procardia is available in generic form.
What Are Side Effects of Procardia?
Common side effects of Procardia include:
- dizziness,
- weakness,
- swelling ankles/feet,
- joint pain,
- leg cramps,
- headache,
- drowsiness,
- tired feeling,
- nausea,
- diarrhea,
- constipation,
- stomach pain,
- sleep problems (insomnia),
- rash or itching,
- urinating more than usual, or
- flushing (warmth/redness/tingly feeling under your skin).
Tell your doctor if you experience unlikely but serious side effects of Procardia including:
- fast/irregular/pounding heartbeat, or
- fainting.
Dosage for Procardia
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.
What Drugs, Substances, or Supplements Interact with Procardia?
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.
Procardia During Pregnancy and Breastfeeding
During pregnancy, Procardia should be used only when prescribed. This medication passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Procardia (nifedipine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Procardia Consumer Information
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 (Nifedipine)
Procardia Professional Information
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 betaadrenergic 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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&Copy; Procardia Patient Information is supplied by Cerner Multum, Inc. and Procardia Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.