pharmacopeia
GET
/api/v1/drug/nifedipine
2D structure
dimethyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
SMILES CC1=C(C(C(=C(N1)C)C(=O)OC)C2=CC=CC=C2[N+](=O)[O-])C(=O)OC
InChIKey HYIMSNHJOBLJNT-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Calcium Channel Antagonists; L-Calcium Channel Receptor Antagonists.

Calcium ChannelL-Calcium Channel Receptor

Indications

Sourced from openFDA
  • & USAGE I. Vasospastic Angina Nifedipine extended-release tablets are indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm.ICD-10: I20.9

Contraindications

Sourced from openFDA
  • Known hypersensitivity reaction to nifedipine.contraindicated

Dosage & administration

Sourced from openFDA

DOSAGE & ADMINISTRATION Dosage must be adjusted according to each patient’s needs. Therapy for either hypertension or angina should be initiated with 30 or 60 mg once daily. Nifedipine Extended-Release Tablets USP should be swallowed whole and should not be bitten or divided. In general, titration should proceed over a 7 to 14 day period so that the physician can fully assess the response to each dose level and monitor blood pressure before proceeding to higher doses. Since steady-state plasma levels are achieved on the second day of dosing, titration may proceed more rapidly, if symptoms so warrant, provided the patient is assessed frequently. Titration to doses above 120 mg are not recommended. Angina patients controlled on nifedipine capsules alone or in combination with other antianginal medications may be safely switched to nifedipine extended-release tablets at the nearest equivalent total daily dose (e.g., 30 mg t.i.d. of nifedipine capsules may be changed to 90 mg once daily of nifedipine extended-release tablets). Subsequent titration to higher or lower doses may be necessary and should be initiated as clinically warranted. Experience with doses greater than 90 mg in patients with angina is limited. Therefore, doses greater than 90 mg should be used with caution and only when clinically warranted. Avoid coadministration of nifedipine with grapefruit juice (see CLINICAL PHARMACOLOGY and PRECAUTIONS: Other Interactions ). No “rebound effect” has been observed upon discontinuation of nifedipine extended-release tablets.

Warnings & precautions

Sourced from openFDA

Excessive Hypotension Although in most angina patients the hypotensive effect of nifedipine is modest and well tolerated, occasional patients have had excessive and poorly tolerated hypotension. These responses have usually occurred during initial titration or at the time of subsequent upward dosage adjustment, and may be more likely in patients on concomitant beta blockers. Severe hypotension and/or increased fluid volume requirements have been reported in patients receiving nifedipine together with a beta-blocking agent who underwent coronary artery bypass surgery using high dose fentanyl anesthesia. The interaction with high dose fentanyl appears to be due to the combination of nifedipine and a beta blocker, but the possibility that it may occur with nifedipine alone, with low doses of fentanyl, in other surgical procedures, or with other narcotic analgesics cannot be ruled out. In nifedipine-treated patients where surgery using high dose fentanyl anesthesia is contemplated, the physician should be aware of these potential problems and, if the patient’s condition permits, sufficient time (at least 36 hours) should be allowed for nifedipine to be washed out of the body prior to surgery.

Adverse reactions

Sourced from openFDA

ADVERSE EXPERIENCES Over 1000 patients from both controlled and open trials with nifedipine extended-release tablets in hypertension and angina were included in the evaluation of adverse experiences. All side effects reported during nifedipine extended-release tablets therapy were tabulated independent of their causal relation to medication. The most common side effect reported with nifedipine extended-release tablets was edema which was dose related and ranged in frequency from approximately 10% to about 30% at the highest dose studied (180 mg). Other common adverse experiences reported in placebo-controlled trials include: Nifedipine Extended-Release Tablets (%) (N=707) Placebo (%) (N=266) Adverse Effect Headache 15.8 9.8 Fatigue 5.9 4.1 Dizziness 4.1 4.5 Constipation 3.3 2.3 Nausea 3.3 1.9 Of these, only edema and headache were more common in nifedipine extended-release tablets patients than placebo patients. The following adverse reactions occurred with an incidence of less than 3.0%. With the exception of leg cramps, the incidence of these side effects was similar to that of placebo alone. Body as a Whole/Systemic: asthenia, flushing, pain Cardiovascular: palpitations Central Nervous System: insomnia, nervousness, paresthesia, somnolence Dermatologic: pruritus, rash Gastrointestinal: abdominal pain, diarrhea, dry mouth, dyspepsia, flatulence Musculoskeletal: arthralgia, leg cramps Respiratory: chest pain (nonspecific), dyspnea Urogenital: impotence, polyuria Other adverse reactions were reported sporadically with an incidence of 1.0% or less.

Overdosage

Sourced from openFDA

Experience with nifedipine overdosage is limited. Generally, overdosage with nifedipine leading to pronounced hypotension calls for active cardiovascular support, including monitoring of cardiovascular and respiratory function, elevation of extremities, judicious use of calcium infusion, pressor agents, and fluids. Clearance of nifedipine would be expected to be prolonged in patients with impaired liver function. Since nifedipine is highly protein-bound, dialysis is not likely to be of any benefit. There has been one reported case of massive overdosage with nifedipine extended-release tablets. The main effects of ingestion of approximately 4800 mg of nifedipine extended-release tablets in a young man attempting suicide as a result of cocaine-induced depression was initial dizziness, palpitations, flushing, and nervousness. Within several hours of ingestion, nausea, vomiting, and generalized edema developed. No significant hypotension was apparent at presentation, 18 hours post-ingestion. Electrolyte abnormalities consisted of a mild, transient elevation of serum creatinine, and modest elevations of LDH and CPK, but normal SGOT.

Approval history

Sourced from openFDA
  • Sep 6, 1989NDANDA019684Pfizer
  • Oct 8, 1991ANDAANDA073250Velzen Pharma Pvt
  • Apr 30, 1992ANDAANDA074045Velzen Pharma Pvt
  • Sep 27, 2000ANDAANDA075289Valeant Pharms North
  • Dec 4, 2000ANDAANDA075269Valeant Pharms North
  • Aug 16, 2002ANDAANDA076070Valeant Pharms North
  • Nov 21, 2005ANDAANDA077127Osmotica Pharm Us
  • Apr 25, 2013ANDAANDA202644Heritage Pharma

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
46,183 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective2,5535.5%
  2. 2Dyspnoea2,4535.3%
  3. 3Fatigue2,3405.1%
  4. 4Diarrhoea2,3025.0%
  5. 5Nausea2,2594.9%
  6. 6Off Label Use2,0824.5%
  7. 7Headache2,0294.4%
  8. 8Dizziness1,7943.9%
  9. 9Hypertension1,7883.9%
  10. 10Pain1,7143.7%
  11. 11Death1,5323.3%
  12. 12Asthenia1,5103.3%
  13. 13Pneumonia1,5043.3%
  14. 14Acute Kidney Injury1,4673.2%
  15. 15Hypotension1,4553.2%

Literature

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Recent PubMed references pinned to Nifedipine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 192 ClinicalTrials.gov registrations naming Nifedipine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Structural analogs

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Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

Frequently asked questions

How does Nifedipine work?
Mechanism-of-action classes: Calcium Channel Antagonists; L-Calcium Channel Receptor Antagonists.
What is Nifedipine used for?
According to FDA labeling, Nifedipine carries indications including: & USAGE I. Vasospastic Angina Nifedipine extended-release tablets are indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Nifedipine?
Nifedipine is classified as Dihydropyridine derivatives, Dihydropyridine Calcium Channel Blocker, Calcium Channel Antagonists, L-Calcium Channel Receptor Antagonists, Coronary Arterial Vasodilation, Decreased Blood Pressure.
What are the brand names for Nifedipine?
Nifedipine is marketed under brand names including Afeditab CR, Procardia.
What are the contraindications for Nifedipine?
Nifedipine labeling lists contraindications including: Known hypersensitivity reaction to nifedipine.. Always consult the full prescribing information and a clinician.
Note. Data for nifedipine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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