Felodipine
Regulatory sources consulted
- aemps-cima-ft-64832
- RxNorm rxcui 4316 ↗
Approved indications
- Arterial hypertension.
- Stable angina pectoris.
Contraindications
Absolute
- Pregnancy.
- Unstable heart failure.
- Acute myocardial infarction.
- Unstable angina pectoris.
- Haemodynamically significant cardiac valve obstruction.
Clinical warnings
- Major warning · May cause significant hypotension with reflex tachycardia, which in susceptible patients may lead to myocardial ischemia. — AEMPS CIMA
- Mild gingival hyperplasia has been reported in patients with pronounced gingivitis/periodontitis. The swelling can be avoided or reversed by careful dental hygiene. — AEMPS CIMA
Drug interactions
- HighGrapefruit juice
Mechanism: Inhibition of intestinal CYP3A4, leading to increased bioavailability and plasma concentrations of felodipine.
Recommendation: Avoid concomitant intake of grapefruit juice.
AEMPS CIMA
- HighItraconazoleJ02AC02
Mechanism: Potent CYP3A4 inhibitor, which significantly increases felodipine plasma concentrations.
Recommendation: Concomitant use is contraindicated or should be avoided.
AEMPS CIMA
- HighCarbamazepineN03AF01
Mechanism: Potent CYP3A4 inducer, which drastically reduces felodipine plasma concentrations and may lead to a lack of efficacy.
Recommendation: Avoid concomitant use. If necessary, consider an alternative antihypertensive agent.
AEMPS CIMA
Adverse events
Common (≥1%)
peripheral oedema · headache · flushing
Rare but serious
syncope · myocardial infarction · hepatitis · angioedema
Pregnancy and lactation
FDA category: X
Contraindicated during pregnancy. It is excreted in breast milk and is not recommended for use during lactation.