Plendil Side Effects

Generic Name: felodipine

Note: This page contains side effects data for the generic drug felodipine. It is possible that some of the dosage forms included below may not apply to the brand name Plendil.

It is possible that some side effects of Plendil may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to felodipine: oral tablet extended release

As well as its needed effects, felodipine (the active ingredient contained in Plendil) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking felodipine, check with your doctor immediately:

More common
  • Bloating or swelling of face, arms, hands, lower legs, or feet
  • rapid weight gain
  • tingling of hands or feet
  • unusual weight gain or loss
Less common
  • 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
Incidence not known
  • 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

If any of the following symptoms of overdose occur while taking felodipine, get emergency help immediately:

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

Some felodipine side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common
  • 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
Rare
  • Bleeding gums
  • irritation in mouth
  • redness and swelling of gums
Incidence not known
  • 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.

References

1. Yedinak KC, Lopez LM "Felodipine: a new dihydropyridine calcium-channel antagonist." DICP 25 (1991): 1193-206

2. "Felodipine--another calcium-channel blocker for hypertension." Med Lett Drugs Ther 33 (1991): 115-6

3. Todd PA, Faulds D "Felodipine: a review of the pharmacology and therapeutic use of the extended release formulation in cardiovascular disorders." Drugs 44 (1992): 251-77

4. "Product Information. Plendil (felodipine)." Merck & Co, Inc, West Point, PA.

5. Schaefer RM, Aldons PM, Burgess ED, Tilvis R, Singh GP, Rehn L, Morgan TO "Improved tolerability of felodipine compared with amlodipine in elderly hypertensives: A randomised, double-blind study in 535 patients, focusing on vasodilatory adverse events." Int J Clin Pract 52 (1998): 381

6. Weber MA, Goldberg AI, Faison EP, Lipschutz K, Shapiro DA, Nelson EB, Irvin JD "Extended-release felodipine in patients with mild to moderate hypertension." Clin Pharmacol Ther 55 (1994): 346-52

7. Carruthers SG, Vintreed C "Antihypertensive effect and tolerability of felodipine extended release (er) tablets in comparison with felodipine plain tablets (pt) and placebo in hypertensives on a diuretic." Clin Invest Med 16 (1993): 386-94

8. Wiklund I, Dimenas E, Partridge S "Effects of felodipine extended release on quality of life - an analysis of four clinical trials." Curr Ther Res Clin Exp 56 (1995): 81-94

9. Cambell LM, Ross JR, Goves JR, Lees CT, McCullagh A, Barnes P, Timerick SJ, Richardson PD "A dose-finding, placebo-controlled study on extended-release felodipine once daily in treatment of hypertension." J Cardiovasc Pharmacol 14 (1989): 869-73

10. Cutler SA, Hammond JJ "A multicenter comparison of isradipine and felodipine in the treatment of mild-to-moderate hypertension. The Physician's Study Group." Am J Hypertens 6 (1993): s44-8

11. Achilli F, Buono G, Difraia S, Dolara A, Raffo M, Montereggi A, Ravera E, Valagussa F "Acute and chronic effects of felodipine extended release and amlodipine in patients with exertional angina: a double-masked, clinical comparison." Curr Ther Res Clin Exp 57 (1996): 523-36

12. Fagan TC, Haggert BE, Liss C "Efficacy and tolerability of extended-release felodipine and extended-release nifedipine in patients with mild-to-moderate essential hypertension." Clin Ther 16 (1994): 634-46

13. Goudie AW, Gupta OP, Gray PL, Ross JRM, Goves JR, Mckenna BJ, Blomfield IA, Bramley KW, Sharp RW, Jones DF, Hadley RJ "A comparison of felodipine and nifedipine as monotherapy in patients with mild-to-moderate hypertension." Curr Ther Res Clin Exp 55 (1994): 625-31

14. Walton T, Symes LR "Felodipine and isradipine: new calcium-channel-blocking agents for the treatment of hypertension." Clin Pharm 12 (1993): 261-75

15. Vanderkrogt KP, Brand R, Dawson EC "Amlodipine versus extended-release felodipine in general practice: a randomized, parallel-group study in patients with mild-to-moderate hypertension." Curr Ther Res Clin Exp 57 (1996): 145-58

16. Welin L, Elvelin L, Niklasson A, Olsson G, Elmfeldt D "Overview of the safety of felodipine based on clinical trials in patients with hypertension." Am J Cardiol 79 (1997): 996

17. Al-Niaimi F, Lyon C "Felodipine-induced eruptive telangiectasia following mastectomy and radiotherapy." Br J Dermatol (2009):

18. Hasselgren B, Edgar B, Johnsson G, Ronn O "The acute haemodynamic and renal effects of oral felodipine and ramipril in healthy subjects." Eur J Clin Pharmacol 45 (1993): 327-32

19. Silvestre JF, Albares MP, Carnero L, Botella R "Photodistributed felodipine-induced facial telangiectasia." J Am Acad Dermatol 45 (2001): 323-4

20. Lorimer AR, Pringle SD "The safety of felodipine." J Cardiovasc Pharmacol 15 (1990): s85-9

21. Young PC, Turiansky GW, Sau P, Liebman MD, Benson PM "Felodipine-induced gingival hyperplasia." Cutis 62 (1998): 41-3

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