Nifedipino

ATC code

C08CA05

Therapeutic class

Calcium channel blocker · Dihydropyridine derivative

Forms

oral tablet, extended release, oral capsule, immediate release

Brand names

Adalat Oros (ES) · Procardia XL (US) · Adalat LP (FR) · Nifediac CC (US)

Overall confidence

medium

Regulatory sources consulted

aemps-cima-ft-59538
CredibleMeds.org
Flockhart Table
ACOG Practice Bulletin No. 171
RxNorm rxcui 7417 ↗

Approved indications

Arterial hypertension.
Chronic stable angina pectoris (effort angina).
Raynaud's phenomenon. · off-label
Tocolysis (acute) for management of preterm labor. · off-label

Contraindications

Absolute

Hypersensitivity to nifedipine or other dihydropyridines.
Cardiovascular shock.
Concomitant use with rifampicin (due to enzyme induction).
Unstable angina or recent acute myocardial infarction (within the first 4 weeks).

Clinical warnings

Major warning · Hypotension: Use with caution in patients with very low blood pressure (severe hypotension with systolic pressure < 90 mmHg). — AEMPS CIMA
Major warning · Heart failure: May precipitate or worsen heart failure, especially in combination with beta-blockers. — AEMPS CIMA
Boxed warning · Immediate-release formulations should not be used for the treatment of hypertension or acute angina due to the risk of profound hypotension, ischemia, and death. — FDA

Drug interactions

HighRifampicinJ04AB02
Mechanism: Potent induction of nifedipine metabolism via CYP3A4, leading to subtherapeutic plasma concentrations and loss of efficacy.
Recommendation: Concomitant use is contraindicated.
AEMPS CIMA
ModerateGrapefruit juice
Mechanism: Inhibition of CYP3A4 in the gut wall, increasing the bioavailability and plasma concentrations of nifedipine, enhancing its hypotensive effect.
Recommendation: Avoid consumption of grapefruit juice during treatment with nifedipine.
AEMPS CIMA

Adverse events

Common (≥1%)

peripheral edema · headache · flushing · dizziness · nausea · constipation

Rare but serious

myocardial infarction (paradoxical) · congestive heart failure · severe hypotension · syncope · hepatotoxicity · exfoliative dermatitis

Pregnancy and lactation

FDA category: C

Contraindicated in the first 20 weeks of pregnancy. Should not be used during pregnancy unless the clinical condition of the woman requires treatment. It is excreted in breast milk; a decision must be made whether to discontinue breast-feeding or therapy.