Plendil Side Effects

Generic Name: felodipine

Note: This document contains side effect information about felodipine. Some of the dosage forms listed on this page may not apply to the brand name Plendil.

For the Consumer

Applies to felodipine: oral tablet extended release

Along with its needed effects, felodipine (the active ingredient contained in Plendil) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking felodipine:

• Bloating or swelling of face, arms, hands, lower legs, or feet
• rapid weight gain
• tingling of hands or feet
• unusual weight gain or loss

• Body aches or pain
• chills
• cough
• difficulty in breathing
• ear congestion
• fever
• headache
• loss of voice
• nasal congestion
• runny nose
• sneezing
• sore throat
• unusual tiredness or weakness

• Blurred vision
• chest pain, tightness, or heaviness
• confusion
• congestion
• cough producing mucus
• diarrhea
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• fast, slow, or irregular heartbeat
• general feeling of discomfort or illness
• hoarseness
• joint pain
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• muscle aches and pains
• nausea
• pain or discomfort in arms, jaw, back, or neck
• pale skin
• shivering
• shortness of breath
• sweating
• swelling or puffiness of face
• tender or swollen glands in neck
• trouble in swallowing
• trouble sleeping
• troubled breathing with exertion
• unusual bleeding or bruising
• voice changes
• wheezing

Get emergency help immediately if any of the following symptoms of overdose occur while taking felodipine:

• Feeling of warmth
• redness of the face, neck, arms and occasionally, upper chest

Some side effects of felodipine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• belching
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• constipation
• heartburn
• indigestion
• lack or loss of strength
• skin rash
• stomach discomfort, upset, or pain

• Bleeding gums
• irritation in mouth
• redness and swelling of gums

• Bloated or full feeling
• bloody nose
• burning while urinating
• decreased interest in sexual intercourse
• difficult or painful urination
• difficulty in moving
• discouragement
• disturbed color perception
• double vision
• dry mouth
• excess air or gas in stomach or intestines
• feeling sad or empty
• fear or nervousness
• frequent strong or increased urge to urinate
• halos around lights
• hives or welts
• inability to have or keep an erection
• increased need to urinate
• increased volume of pale or dilute urine
• irritability
• itching
• loss in sexual ability, desire, drive, or performance
• loss of interest or pleasure
• muscle cramps or stiffness
• night blindness
• overbright appearance of lights
• pain or tenderness around eyes and cheekbones
• passing gas
• passing urine more often
• redness of skin
• sleepiness or unusual drowsiness
• sleeplessness
• sores, welting, or blisters
• swelling of the breasts or breast soreness in both females and males
• swollen joints
• tiredness
• trouble concentrating
• tunnel vision
• unable to sleep

For Healthcare Professionals

Applies to felodipine: oral tablet extended release

General

Side effects of felodipine (the active ingredient contained in Plendil) were generally mild and transient. The most common side effects reported with felodipine given at 2.5 to 10 mg per day were peripheral edema and headache. Therapy was discontinued due to adverse drug events in about 6% of patients, primarily for peripheral edema, headache or flushing.

A dose of 20 mg per day has been evaluated in some clinical trials. Although 20 mg per day increased the antihypertensive effect of felodipine, a disproportionate increase in side effects, especially those associated with vasodilatory effects, was reported.^[Ref]

Other

Peripheral edema was generally mild, but it was age and dose related. It resulted in treatment discontinuation in about 3% of patients.

Other side effects have included peripheral edema (up to 17.4%), flushing (up to 6.9%), asthenia (up to 3.9%), warm sensation (up to 1.5%), chest pain, facial edema, and influenza-like illness.

Nervous system

Nervous system side effects have included headache (up to 14.7%), dizziness (up to 3.7%), paresthesia (up to 1.6%), syncope, insomnia, and somnolence.^[Ref]

Cardiovascular

Cardiovascular side effects have included palpitation (up to 2.5%), myocardial infarction, hypotension, angina pectoris, arrhythmia, tachycardia, premature beats, and leukocytoclastic vasculitis. A few rare cases of felodipine-induced telangiectasia have been reported.^[Ref]

Gastrointestinal

Gingival hyperplasia has been avoided or has regressed with good dental hygiene.^[Ref]

Gastrointestinal side effects have included dyspepsia (up to 3.9%), nausea (up to 1.7%), constipation (1.5%), abdominal pain, diarrhea, vomiting, dry mouth, flatulence, and acid regurgitation. Gingival hyperplasia, usually mild, has been reported in less than 0.5% of patients.^[Ref]

Respiratory

Respiratory side effects have included upper respiratory infection (up to 3.9%), cough (up to 1.7%), rhinorrhea (up to 1.6%), sneezing (up to 1.6%), dyspnea, pharyngitis, bronchitis, influenza, sinusitis, epistaxis, and respiratory infection.

Dermatologic

Dermatologic side effects have included rash (up to 2%), angioedema, contusion, erythema, and urticaria.

Hematologic

Hematologic side effects have included anemia.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, back pain, leg pain, foot pain, muscle cramps, myalgia, arm pain, knee pain, and hip pain.^[Ref]

Hepatic

Hepatic side effects have included elevated ALT (SGPT) and unspecified serum transaminases.

In clinical studies, one of two episodes of elevated serum transaminases decreased following drug discontinuation; no follow-up was available for the second patient.

Psychiatric

Psychiatric system side effects have included depression, anxiety disorders, irritability, nervousness, and decreased libido.

Genitourinary

Genitourinary side effects have included gynecomastia, impotence, urinary frequency, urinary urgency, dysuria, and polyuria.

Ocular

Ocular system side effects have included visual disturbances.

Some side effects of Plendil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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