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Plendil

Last reviewed on RxList: 11/9/2012
Plendil Side Effects Center

Last reviewed on RxList 11/18/2016

Plendil (felodipine) is a calcium channel blocker used to treat hypertension (high blood pressure). Plendil is available in generic form. Common side effects of Plendil include:

  • dizziness,
  • lightheadedness,
  • headache,
  • flushing, or
  • stomach upset as your body adjusts to the medication.

Other side effects of Plendil include:

  • drowsiness,
  • weakness,
  • restlessness,
  • nervousness,
  • nausea,
  • constipation,
  • diarrhea,
  • stomach pain,
  • sleep problems (insomnia),
  • joint pain or muscle cramps,
  • flushing (warmth, redness, or tingly feeling under your skin),
  • rash,
  • urinating more than usual, or
  • cold symptoms such as stuffy nose, sneezing, and sore throat.

Tell your doctor if you have serious side effects of Plendil including:

  • swelling of the hands/ankles/feet (edema), or
  • fast or irregular heartbeat.

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, nonsteroidal 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 breastfeeding.

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.

Plendil Consumer Information

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)

Plendil Professional Information

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)

Related Resources for Plendil

Read the Plendil User Reviews »

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

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