Amlodipine 4mg/5ml oral solution
Requires a prescription from a doctor or prescriber
Amlodipine, initially approved by the FDA in 1987, is a popular antihypertensive drug belonging to the group of drugs called <em>dihydropyridine calcium channel blockers</em>.
Genetic variations that may affect drug response
1 known genetic variation may influence how your body responds to Amlodipine 4mg/5ml oral solution.Gene involved: NPPA
These are known genetic variations. They don't mean the medicine won't work for you — speak to your doctor or a pharmacogenomics specialist for personalised advice. Source: DrugBank (CC BY-NC 4.0).
Safety information for pregnancy and breastfeeding
Pregnancy
The safety of amlodipine in human pregnancy or lactation has not been proven.
Breastfeeding
The safety of amlodipine in human pregnancy or lactation has not been proven.
Discontinue when administering amlodipine [FDA label].
Always consult your doctor or midwife before taking any medicine during pregnancy or while breastfeeding. Source: DrugBank (CC BY-NC 4.0).
Official documents, adverse reaction reporting, and safety monitoring
Report a side effect
Submit a Yellow Card report to the MHRA
Official medicine documents
Safety monitoring data
Yellow Card reports
The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.
View Drug Analysis Profile
Suspected adverse reactions reported for Amlodipine
Browse all iDAP reports
Interactive Drug Analysis Profiles for all medicines
Report a side effect
Submit a Yellow Card report to the MHRA
Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
EudraVigilance
The European Medicines Agency (EMA) collects suspected adverse reaction reports from across the EU/EEA through the EudraVigilance system. Search for safety data on this medicine.
View EudraVigilance report
Suspected adverse reactions reported for Amlodipine
About EudraVigilance
Learn about EU pharmacovigilance and safety monitoring
EudraVigilance data is published by the European Medicines Agency (EMA). A suspected adverse reaction is not necessarily caused by the medicine.
1 branded products available
WHO defined daily dose (DDD)
5 mg
Not a recommended dose. The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults. It is a statistical measure used for research and comparison purposes only.
Source: WHO Collaborating Centre for Drug Statistics Methodology, distributed via NHS dm+d BNF mapping files. Contains public sector information licensed under the Open Government Licence v3.0.
Therapeutically similar medicines
Similarity based on WHO Anatomical Therapeutic Chemical (ATC) classification and NHS BNF section grouping. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
NHS prescribing volume and spending trends
Clinical guidelines and formulary information
British National Formulary
Amlodipine
Source: British National Formulary, NICE. Joint Formulary Committee. Contains public sector information licensed under the Open Government Licence v3.0.
NICE clinical guidance(4)
Stable angina: management (CG126)
Stable angina (QS21)
Hypertension in pregnancy: diagnosis and management (NG133)
Acute coronary syndromes (NG185)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
Check stock at pharmacies and supply information
Pharmacy stock checkers
Search for this medicine at major UK pharmacy chains. These links open the retailer's own website — results depend on their current online catalogue.
Supply & product information
Official product databases and supply status monitoring
Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. emc (electronic medicines compendium) is operated by Datapharm Ltd. Shortage information sourced from NHS Specialist Pharmacy Service (SPS), sps.nhs.uk.
Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
Browse tools
SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. BNF codes from NHS Business Services Authority (NHSBSA). ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
30 found
Half-life
30–50 hours
Mechanism
Mechanism of action on blood pressure Amlodipine is considered a peripheral a…
Food interactions
3 warnings
Human targets
9 targets
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
6-12 hours
Half-life
30–50 hours
Plasma…
Protein binding
98%
[A175327], [A175336]
Volume of distribution
21 L/kg
[A175327], [A175336]
Metabolism
90%
Elimination
30–50 hours
Clearance
1.3 ml/min/kg
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
Amlodipine is commonly used in the treatment of high blood pressure and angina. Amlodipine has antioxidant properties and an ability to enhance the production of nitric oxide (NO), an important vasodilator that decreases blood pressure [A175321]. The option for single daily dosing of amlodipine is an attractive feature of this drug [FDA label].
• Hypertension
• Coronary artery disease
• Chronic stable angina
• Vasospastic angina (Prinzmetal’s or Variant angina)
• Angiographically documented coronary artery disease in patients without heart failure or an ejection fraction < 40%
Known interactions with other medications. Always consult a healthcare professional.
Showing 50 of 1374 interactions
Overdose
An overdose of amlodipine could result in a high degree of peripheral vasodilatation with a possibility of reflex tachycardia. Significant and prolonged hypotension leading to shock and fatal outcomes have been reported [FDA label].
Carcinogenesis, mutagenesis, impairment of fertility
Rats and mice treated with amlodipine maleate in the diet on a long-term basis for up to 2 years demonstrated no evidence of a carcinogenic effect of the drug. For the mouse, the highest dose was comparable to the maximum recommended human dose of 10 mg amlodipine per day. For the rat, the highest dose was measured to be about twice the maximum recommended human dose [FDA label].
Mutagenicity studies using amlodipine maleate showed no drug-related gene or chromosomal effects [FDA label].
There was no impact on the fertility of rats given oral amlodipine maleate (males for 64 days and females for 14 days before mating) at doses up to 10 mg amlodipine/kg/day (8 times the maximum recommended human dose) [FDA label].
Use in pregnancy
The safety of amlodipine in human pregnancy or lactation has not been proven.
Amlodipine is therefore considered a pregnancy category C drug F3757.
Use amlodipine only if the potential benefit justifies the potential risk [FDA label].
Use in nursing
Discontinue when administering amlodipine [FDA label].
Amlodipine is considered a peripheral arterial vasodilator that exerts its action directly on vascular smooth muscle to lead to a reduction in peripheral vascular resistance, causing a decrease in blood pressure. Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker) that inhibits the influx of calcium ions into both vascular smooth muscle and cardiac muscle. Experimental studies imply that amlodipine binds to both dihydropyridine and nondihydropyridine binding sites, located on cell membranes. The contraction of cardiac muscle and vascular smooth muscle are dependent on the movement of extracellular calcium ions into these cells by specific ion channels. Amlodipine blocks calcium ion influx across cell membranes with selectivity. A stronger effect of amlodipine is exerted on vascular smooth muscle cells than on cardiac muscle cells [FDA label]. Direct actions of amlodipine on vascular smooth muscle result in reduced blood pressure F3757.
Mechanism of action in angina
The exact mechanism by which amlodipine relieves the symptoms of angina have not been fully elucidated to this date, however, the mechanism of action is likely twofold:
Amlodipine has a dilating effect on peripheral arterioles, reducing the total peripheral resistance (afterload) against which the cardiac muscle functions. Since the heart rate remains stable during amlodipine administration, the reduced work of the heart reduces both myocardial energy use and oxygen requirements F3757.
Dilatation of the main coronary arteries and coronary arterioles, both in healthy and ischemic areas, is another possible mechanism of amlodipine reduction of blood pressure. The dilatation causes an increase in myocardial oxygen delivery in patients experiencing coronary artery spasm (Prinzmetal's or variant angina) and reduces coronary vasoconstriction caused by smoking F3757.
Amlodipine has a strong affinity for cell membranes, modulating calcium influx by inhibiting selected membrane calcium channels. This drug's unique binding properties allow for its long-acting action and less frequent dosing regimen [A573], [FDA label].
Hemodynamic effects
After the administration of therapeutic doses of amlodipine to patients diagnosed with hypertension, amlodipine causes vasodilation, which results in a reduction of supine and standing blood pressure. During these blood pressure reductions, there are no clinically significant changes in heart rate or plasma catecholamine levels with long-term use. Acute intravenous administration of amlodipine reduces arterial blood pressure and increases heart rate in patients with chronic stable angina, however, chronic oral administration of amlodipine in clinical studies did not cause clinically significant alterations in heart rate or blood pressures in patients diagnosed with angina and normal blood pressure. With long-term, once daily oral administration, antihypertensive effectiveness is maintained for at least 24 hours [FDA label].
Electrophysiologic effects
Amlodipine does not change sinoatrial (SA) nodal function or atrioventricular (AV) conduction in animals or humans. In patients who were diagnosed with chronic stable angina, the intravenous administration of 10 mg of amlodipine did not cause clinically significant alterations A-H and H-V conduction and sinus node recovery time after cardiac pacing. Patients administered amlodipine with concomitant beta-blockers produced similar results. In clinical trials in which amlodipine was given in combination with beta-blockers to patients diagnosed with hypertension or angina, no adverse effects on electrocardiographic parameters were noted. In clinical studies comprised of angina patients alone, amlodipine did not change electrocardiographic intervals or produce high degrees of AV block [FDA label].
Effects on angina
Amlodipine relieves the symptoms of chest pain associated with angina. In patients diagnosed with angina, daily administration of a single amlodipine dose increases total exercise time, the time to angina onset, and the time to 1 mm ST-segment depression on ECG studies, decreases anginal attack frequency, and decreases the requirement for nitroglycerin tablets F3757.
How the body processes this drug — absorption, distribution, metabolism, and elimination
Steady-state plasma amlodipine levels are achieved after 7-8 days of consecutive daily dosing. Absorption is not affected by food [FDA label].
Plasma elimination half-life is 56 hours in patients with impaired hepatic function, titrate slowly when administering this drug to patients with severe hepatic impairment [FDA label].
[A175327], [A175336]
[A175327], [A175336]
[A574]
[A175327], [A175336]
Elderly patients show a reduced clearance of amlodipine with an AUC (area under the curve) increase of about 40–60%, and a lower initial dose may be required [FDA label].
Proteins and enzymes this drug interacts with in the body
PMID:12181424 PMID:15454078 PMID:15863612 PMID:16299511 PMID:17224476 PMID:20953164 PMID:23677916 PMID:24728418 PMID:26253506 PMID:27218670 PMID:29078335 PMID:29742403 PMID:30023270 PMID:30172029 PMID:34163037 PMID:8099908
Mediates influx of calcium ions into the cytoplasm, and thereby triggers calcium release from the sarcoplasm (By similarity). Plays an important role in excitation-contraction coupling in the heart. Required for normal heart development and normal regulation of heart rhythm .
PMID:15454078 PMID:15863612 PMID:17224476 PMID:24728418 PMID:26253506
Required for normal contraction of smooth muscle cells in blood vessels and in the intestine.
Essential for normal blood pressure regulation via its role in the contraction of arterial smooth muscle cells .
PMID:28119464
Long-lasting (L-type) calcium channels belong to the 'high-voltage activated' (HVA) group (Probable)
A particularity of this type of channels is an opening at quite negative potentials, and a voltage-dependent inactivation. T-type channels serve pacemaking functions in both central neurons and cardiac nodal cells and support calcium signaling in secretory cells and vascular smooth muscle. They may also be involved in the modulation of firing patterns of neurons which is important for information processing as well as in cell growth processes.
Gates in voltage ranges similar to, but higher than alpha 1G or alpha 1H
PMID:35293990
Plays an important role in excitation-contraction coupling (By similarity)
They are involved in pain signaling .
PMID:25296916
Calcium channels containing alpha-1B subunit may play a role in directed migration of immature neurons. Mediates Ca(2+) release probability at hippocampal neuronal soma and synaptic terminals (By similarity)
PMID:1309651 PMID:15615847 PMID:8107964
Regulates the activity of L-type calcium channels that contain CACNA1A as pore-forming subunit (By similarity). Regulates the activity of L-type calcium channels that contain CACNA1C as pore-forming subunit and increases the presence of the channel complex at the cell membrane .
PMID:15615847
Required for functional expression L-type calcium channels that contain CACNA1D as pore-forming subunit .
PMID:1309651
Regulates the activity of L-type calcium channels that contain CACNA1B as pore-forming subunit PMID:8107964
Enzymes involved in drug metabolism — important for understanding drug interactions
Proteins that transport this drug across cell membranes
PMID:2897240 PMID:35970996 PMID:8898203 PMID:9038218 PMID:35507548
Catalyzes the flop of phospholipids from the cytoplasmic to the exoplasmic leaflet of the apical membrane. Participates mainly to the flop of phosphatidylcholine, phosphatidylethanolamine, beta-D-glucosylceramides and sphingomyelins .
PMID:8898203
Energy-dependent efflux pump responsible for decreased drug accumulation in multidrug-resistant cells PMID:2897240 PMID:35970996 PMID:9038218
ATC C09BB13
ATC C09BB04
ATC C10BX18
ATC C07FB12
ATC C09DB05
ATC C09XA53
ATC C10BX03
ATC C09BX04
ATC C09DB07
ATC C09DX06
ATC C09BX01
ATC C10BX11
ATC C09DB02
ATC C10BX09
ATC C09DX01
ATC C10BX19
ATC C09DB01
ATC C09XA54
ATC C10BX07
ATC C09BB03
ATC C07FB07
ATC C09DB06
ATC C07FB13
ATC C09DX08
ATC C08CA01
ATC C09BX06
ATC C09BX03
ATC C09DB04
ATC C09DX03
ATC C08GA02
ATC C08CA51
ATC C09DB09
ATC C10BX14
ATC C09BB07
ATC C09DX07
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Amlodipine
Additional database identifiers
Drugs Product Database (DPD)
11344
Drugs Product Database (DPD)
1223
ChemSpider
2077
BindingDB
50088383
HUGO Gene Nomenclature Committee (HGNC)
HGNC:1390
GenAtlas
CACNA1C
GeneCards
CACNA1C
GenBank Gene Database
M92270
Guide to Pharmacology
529
UniProt Accession
CAC1C_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:1396
GenAtlas
CACNA1I
GeneCards
CACNA1I
GenBank Gene Database
AF129133
GenBank Protein Database
5565888
Guide to Pharmacology
537
UniProt Accession
CAC1I_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:1399
GenAtlas
CACNA2D1
GeneCards
CACNA2D1
GenBank Gene Database
M76559
GenBank Protein Database
179762
UniProt Accession
CA2D1_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:1389
GenAtlas
CACNA1B
GeneCards
CACNA1B
GenBank Gene Database
M94172
GenBank Protein Database
179758
Guide to Pharmacology
533
UniProt Accession
CAC1B_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:1401
GenAtlas
CACNB1
GeneCards
CACNB1
GenBank Gene Database
M92303
GenBank Protein Database
179806
UniProt Accession
CACB1_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:15460
GeneCards
CACNA2D3
GenBank Gene Database
AJ272268
GenBank Protein Database
7105926
UniProt Accession
CA2D3_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:1368
GenAtlas
CA1
GeneCards
CA1
GenBank Gene Database
X05014
GenBank Protein Database
29600
Guide to Pharmacology
2597
UniProt Accession
CAH1_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:11120
GenAtlas
SMPD1
GeneCards
SMPD1
GenBank Gene Database
M59916
GenBank Protein Database
179095
Guide to Pharmacology
2514
UniProt Accession
ASM_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:1399
GenAtlas
CACNA2D1
GeneCards
CACNA2D1
GenBank Gene Database
M76559
GenBank Protein Database
179762
UniProt Accession
CA2D1_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:1400
GenAtlas
CACNA2D2
GeneCards
CACNA2D2
GenBank Gene Database
AJ251368
UniProt Accession
CA2D2_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:1389
GenAtlas
CACNA1B
GeneCards
CACNA1B
GenBank Gene Database
M94172
GenBank Protein Database
179758
Guide to Pharmacology
533
UniProt Accession
CAC1B_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2637
GenAtlas
CYP3A4
GeneCards
CYP3A4
GenBank Gene Database
M18907
Guide to Pharmacology
1337
UniProt Accession
CP3A4_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2595
GeneCards
CYP1A1
GenBank Gene Database
K03191
GenBank Protein Database
181276
Guide to Pharmacology
1318
UniProt Accession
CP1A1_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2615
GeneCards
CYP2B6
GenBank Gene Database
M29874
GenBank Protein Database
181296
Guide to Pharmacology
1324
UniProt Accession
CP2B6_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2638
GenAtlas
CYP3A5
GeneCards
CYP3A5
GenBank Gene Database
J04813
GenBank Protein Database
181346
Guide to Pharmacology
1338
UniProt Accession
CP3A5_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2622
GenAtlas
CYP2C8
GeneCards
CYP2C8
GenBank Gene Database
M17397
Guide to Pharmacology
1325
UniProt Accession
CP2C8_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2625
GenAtlas
CYP2D6
GeneCards
CYP2D6
GenBank Gene Database
M20403
GenBank Protein Database
181350
Guide to Pharmacology
1329
UniProt Accession
CP2D6_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2621
GeneCards
CYP2C19
GenBank Gene Database
M61854
GenBank Protein Database
181344
Guide to Pharmacology
1328
UniProt Accession
CP2CJ_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2623
GenAtlas
CYP2C9
GeneCards
CYP2C9
GenBank Gene Database
AY341248
Guide to Pharmacology
1326
UniProt Accession
CP2C9_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:40
GenAtlas
ABCB1
GeneCards
ABCB1
GenBank Gene Database
M14758
GenBank Protein Database
307180
Guide to Pharmacology
768
UniProt Accession
MDR1_HUMAN
International reference pricing
Reference pricing from DrugBank. Prices are indicative and may not reflect current UK costs.
Source: DrugBank. Used under CC BY-NC 4.0 academic licence for non-commercial purposes.
Patent information
28 active patents, 14 expired
Source: DrugBank · CC BY-NC 4.0. Patent data sourced from national patent offices. Expiry dates may not reflect extensions, regulatory exclusivity periods, or legal challenges.
DrugBank citations
If you use DrugBank data in your research, please cite the following publications: