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Felodipine

Felodipin Hexal, Plendil Retard · ATC code C08CA02

Also known as: Felodipin · Brand names: Felodipin Hexal, Plendil Retard, Felocor, Modip, Plendil, Felopdipine

Key facts
Active substance
Felodipine
ATC code
C08CA02
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Key facts

Felodipine is, per the US prescribing information, a dihydropyridine calcium channel blocker used to treat hypertension, alone or with other antihypertensive agents.

What it is used for

  • Treatment of hypertension to lower blood pressure, which lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions.

Dosing

  • Starting dose 5 mg once a day; depending on response, decrease to 2.5 mg or increase to 10 mg once a day, generally at intervals of not less than 2 weeks; recommended range 2.5-10 mg once daily.
  • Doses above 10 mg daily caused a large increase in peripheral edema and other vasodilatory adverse events.
  • Take without food or with a light meal; swallow whole, do not crush or chew.
  • Patients over 65 years and impaired liver function: higher plasma levels possible, start cautiously (2.5 mg daily) with close blood pressure monitoring; dose modification is usually not required in renal impairment.

Contraindications

  • Hypersensitivity to the product.

Important warnings

  • Hypotension: may occasionally cause significant hypotension and rarely syncope; reflex tachycardia may precipitate angina in susceptible people.
  • Heart failure: safety not established; use caution in heart failure or compromised ventricular function, particularly with beta-blockers.
  • Peripheral edema was the most common adverse event, dose and age dependent, generally within 2-3 weeks of starting.
  • Mild gingival hyperplasia (gum swelling) has been reported; good dental hygiene reduces it.

Side effects

  • Most common: peripheral edema and headache; edema led to discontinuation in about 3% of patients.
  • Peripheral edema ranged from about 10% (under 50 years, 5 mg daily) to about 30% (over 60 years, 20 mg daily).
  • Others: flushing, dizziness, palpitation, nausea, asthenia.

Interactions

  • CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, erythromycin, grapefruit juice, cimetidine) may raise felodipine levels several-fold; use caution.
  • Anticonvulsants such as phenytoin, carbamazepine or phenobarbital considerably lower felodipine levels.
  • Felodipine may increase tacrolimus blood concentrations; monitor tacrolimus levels.
  • Metoprolol levels increased with coadministration.

Pregnancy and breastfeeding

  • Digital anomalies of the terminal phalanges occurred in rabbit fetuses; see the full text for details.
  • It is not known whether felodipine is secreted in human milk; decide between stopping nursing or stopping the drug.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Austria

  • Felodipin HexalHexal Pharma Gmbh · 1 register entry
  • Plendil RetardGlenwood Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • FelocorHexal Ag · 1 register entry
  • Felodipin1 A Pharma Gmbh, Heumann Pharma Gmbh & Co. Generica Kg, Ratiopharm Gmbh, Stadapharm Gmbh, Juta Pharma Gmbh, Abz-Pharma Gmbh, Aliud Pharma Gmbh · 9 register entries
  • ModipGlenwood Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • PlendilASTRAZENECA İLAÇ SAN. VE TİC. LTD. ŞTİ. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

USA

  • Felopdipine1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29

Brand names in 24 more European countries
Belgium
Felodipine Eg, Felodipine Retard Eg, Felodipine Sandoz
Bulgaria
Ауронал, Пресид, Фелохексал
Cyprus
Plendil
Czechia
Presid
Denmark
Felodin, Felodipin "hexal", Felodipin Teva, Felodipine Holsten
Estonia
Felodipin Hexal, Presid
Finland
Felodipin Hexal, Felodipin Ratiopharm, Plendil
France
Felodipine L.P. Sandoz, Felodipine L.P. Zentiva, Flodil
Greece
Plendil
Hungary
Felodipin Ratiopharm
Iceland
Felodipine Alvogen
Ireland
Plendil
Italy
Felodipina Mylan Generics, Felodipina Ratiopharm, Felodipina Sandoz, Felodipina Zentiva, Plendil, Prevex
Latvia
Presid
Lithuania
Felodipin Hexal, Presid
Luxembourg
Felodipin Ratiopharm, Felodipine Eg
Netherlands
Felodipine Ratiopharm, Felodipine Retard Cf, Felodipine Sandoz, Plendil
Norway
Felodipin Hexal, Plendil
Poland
Plendil
Portugal
Felodipina Aurovitas, Felodipina Mylan
Romania
Auronal, Plendil, Sistar
Slovakia
Felodipin Ratiopharm, Plendil
Spain
Felodipino Sandoz, Plendil
Sweden
Felodipin Hexal, Felodipin Holsten, Felodipin Omet Pharma, Felodipin Stada, Felodipin Teva, Plendil

EMA – Article 57 product data (EU/EEA), 2026-10-29

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Sources

  1. U.S. Food and Drug Administration. Felodipine (Glenmark Pharmaceuticals Inc., USA) – Prescribing Information, 2026-01-23. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2e4298cf-02e9-49c7-9803-887161e1989a
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.