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Plendil

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Plendil

Plendil Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Plendil (felodipine) is used to treat hypertension (high blood pressure). Plendil is in a class of drugs called calcium channel blockers. Plendil is available in generic form. Common side effects include dizziness, lightheadedness, headache, flushing, or stomach upset as your body adjusts to the medication.

The recommended starting dose of Plendil is 5 mg once/day, which may be decreased to 2.5 mg or increased to 10 mg once/day, depending on the patient response. Plendil may adversely interact with other medications for high blood pressure, intravenous (IV) calcium, azole antifungals, anti-seizure medications, cimetidine, macrolide antibiotics, or tacrolimus. Check labels on all medicines (e.g., cough-and-cold products, diet aids, non-steroidal anti-inflammatory drugs or NSAIDs for pain/fever reduction) as they may contain ingredients that could increase your blood pressure. Ask your doctor about the safe use of these products. Plendil should be used only when prescribed during pregnancy. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Our Plendil 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.

Plendil 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:

  • feeling like you might pass out;
  • feeling short of breath, swelling in your hands or feet;
  • fast or pounding heartbeats;
  • numbness or tingly feeling; 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, weakness;
  • feeling restless or nervous;
  • nausea, upset stomach, constipation, diarrhea, stomach pain;
  • sleep problems (insomnia);
  • joint pain or muscle cramps;
  • warmth, redness, or tingly feeling under your skin;
  • mild rash;
  • urinating more than usual; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

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 Plendil (Felodipine) »

What is Patient Information Overview?

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

Plendil Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness, lightheadedness, headache, flushing, or stomach upset may occur as your body adjusts to the medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

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 serious side effects occur: swelling of the hands/ankles/feet (edema).

Tell your doctor immediately if any of these unlikely but serious side effects occur: fast/irregular heartbeat.

Although unlikely, felodipine may cause mild swelling of the gums. Massage your gums and brush and floss your teeth regularly to minimize this problem. See your dentist regularly.

Tell your doctor immediately if this rare but very serious side effect occurs: fainting.

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 Plendil (Felodipine)»

What is Prescribing information?

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

Plendil FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

In controlled studies in the United States and overseas, approximately 3000 patients were treated with felodipine as either the extended-release or the immediate-release formulation.

The most common clinical adverse events reported with PLENDIL administered as monotherapy at the recommended dosage range of 2.5 mg to 10 mg once a day were peripheral edema and headache. Peripheral edema was generally mild, but it was age and dose related and resulted in discontinuation of therapy in about 3% of the enrolled patients. Discontinuation of therapy due to any clinical adverse event occurred in about 6% of the patients receiving PLENDIL, principally for peripheral edema, headache, or flushing.

Adverse events that occurred with an incidence of 1.5% or greater at any of the recommended doses of 2.5 mg to 10 mg once a day (PLENDIL, N = 861; Placebo, N = 334), without regard to causality, are compared to placebo and are listed by dose in the table below. These events are reported from controlled clinical trials with patients who were randomized to a fixed dose of PLENDIL or titrated from an initial dose of 2.5 mg or 5 mg once a day. A dose of 20 mg once a day has been evaluated in some clinical studies. Although the antihypertensive effect of PLENDIL is increased at 20 mg once a day, there is a disproportionate increase in adverse events, especially those associated with vasodilatory effects (see DOSAGE AND ADMINISTRATION).

Percent of Patients with Adverse Events in Controlled Trials* of PLENDIL (N=861) as Monotherapy without Regard to Causality (Incidence of discontinuations shown in parentheses)

Body System Adverse Events Placebo
N=334
2.5 mg
N=255
5 mg
N=581
10 mg
N=408
Body as a Whole
  Peripheral Edema 3.3 (0.0) 2.0 (0.0) 8.8 (2.2) 17.4 (2.5)
  Asthenia 3.3 (0.0) 3.9 (0.0) 3.3 (0.0) 2.2 (0.0)
  Warm Sensation 0.0 (0.0) 0.0 (0.0) 0.9 (0.2) 1.5 (0.0)
Cardiovascular
  Palpitation 2.4 (0.0) 0.4 (0.0) 1.4 (0.3) 2.5 (0.5)
Digestive
  Nausea 1.5 (0.9) 1.2 (0.0) 1.7 (0.3) 1.0 (0.7)
  Dyspepsia 1.2 (0.0) 3.9 (0.0) 0.7 (0.0) 0.5 (0.0)
  Constipation 0.9 (0.0) 1.2 (0.0) 0.3 (0.0) 1.5 (0.2)
Nervous
  Headache 10.2 (0.9) 10.6 (0.4) 11.0 (1.7) 14.7 (2.0)
  Dizziness 2.7 (0.3) 2.7 (0.0) 3.6 (0.5) 3.7 (0.5)
  Paresthesia 1.5 (0.3) 1.6 (0.0) 1.2 (0.0) 1.2 (0.2)
Respiratory
Upper Respiratory Infection
  Cough 0.3 (0.0) 0.8 (0.0) 1.2 (0.0) 1.7 (0.0)
  Rhinorrhea 0.0 (0.0) 1.6 (0.0) 0.2 (0.0) 0.2 (0.0)
  Sneezing 0.0 (0.0) 1.6 (0.0) 0.0 (0.0) 0.0 (0.0)
Skin
  Rash 0.9 (0.0) 2.0 (0.0) 0.2 (0.0) 0.2 (0.0)
  Flushing 0.9 (0.3) 3.9 (0.0) 5.3 (0.7) 6.9 (1.2)
*Patients in titration studies may have been exposed to more than one dose level of PLENDIL.

Adverse events that occurred in 0.5 up to 1.5% of patients who received PLENDIL in all controlled clinical trials at the recommended dosage range of 2.5 mg to 10 mg once a day, and serious adverse events that occurred at a lower rate, or events reported during marketing experience (those lower rate events are in italics) are listed below. These events are listed in order of decreasing severity within each category, and the relationship of these events to administration of PLENDIL is uncertain: Body as a Whole: Chest pain, facial edema, flu-like illness; Cardiovascular: Myocardial infarction, hypotension, syncope, angina pectoris, arrhythmia, tachycardia, premature beats; Digestive: Abdominal pain, diarrhea, vomiting, dry mouth, flatulence, acid regurgitation; Endocrine: Gynecomastia; Hematologic: Anemia; Metabolic: ALT (SGPT) increased; Musculoskeletal: Arthralgia, back pain, leg pain, foot pain, muscle cramps, myalgia, arm pain, knee pain, hip pain; Nervous/Psychiatric: Insomnia, depression, anxiety disorders, irritability, nervousness, somnolence, decreased libido; Respiratory: Dyspnea, pharyngitis, bronchitis, influenza, sinusitis, epistaxis, respiratory infection; Skin: Angioedema, contusion, erythema, urticaria, leukocytoclastic vasculitis; Special Senses: Visual disturbances; Urogenital: Impotence, urinary frequency, urinary urgency, dysuria, polyuria.

Gingival Hyperplasia

Gingival hyperplasia, usually mild, occurred in < 0.5% of patients in controlled studies. This condition may be avoided or may regress with improved dental hygiene. (See PATIENT INFORMATION.)

Clinical Laboratory Test Findings

Serum Electrolytes

No significant effects on serum electrolytes were observed during short- and long-term therapy (see CLINICAL PHARMACOLOGY, Renal/Endocrine Effects).

Serum Glucose

No significant effects on fasting serum glucose were observed in patients treated with PLENDIL in the U.S. controlled study.

Liver Enzymes

1 of 2 episodes of elevated serum transaminases decreased once drug was discontinued in clinical studies; no follow-up was available for the other patient.

Read the entire FDA prescribing information for Plendil (Felodipine) »

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Plendil - User Reviews

Plendil User Reviews

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Here is a collection of user reviews for the medication Plendil 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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