Amlodipine (amlodipine besylate tablets)

Generic name: Amlodipine besylate tablets, USP, 2.5 mg, 5 mg and 10 mg · Brand names: Norvasc, Amvaz, Katerzia, Norliqva (other amlodipine products, not tablets of this record)

Quick facts

Drug class
Amlodipine is a calcium channel blocker.
Source text (exact source wording)
Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. (11 DESCRIPTION, Lupin label)
Rx or otc
Rx (prescription): the label is a prescription drug label
Controlled schedule
NOT a controlled substance per label text read (no schedule statement found)
Forms and strengths
  • Tablets: 2.5 mg white, hexagon, flat-faced, beveled edged tablets, engraved with “2.5 mg” on one side
  • Tablets: 5 mg white, octagonal, flat-faced, beveled edged tablets, engraved with “5 mg” on one side
  • Tablets: 10 mg white, round, flat-faced, beveled edged tablets, engraved with “10 mg” on one side (3 DOSAGE FORMS AND STRENGTHS, China Resources Lupin label)
  • Oral liquid amlodipine brands (Katerzia, Norliqva) and combination products (for example Azor, Caduet, Exforge per MedlinePlus) are separate products not covered here
Generic available
Value
yes
Source
DailyMed lists many ANDA amlodipine besylate tablets (Saike ANDA090752, Lupin ANDA078043, Epic ANDA078552) and an NDA authorized generic (Mylan/Greenstone)
Common use one line
Used to treat high blood pressure and certain types of chest pain (angina).

What it is used for

Amlodipine is used to lower high blood pressure, which lowers the risk of strokes and heart attacks. It is also used for chronic stable angina and vasospastic angina, and in people with coronary artery disease shown on angiography who do not have heart failure or an ejection fraction below 40%, to reduce the risk of hospitalization for angina and of a coronary revascularization procedure. It may be used alone or with other medicines, and many patients need more than one drug to reach blood pressure goals.
Source text (exact source wording)
1.1 Hypertension: Amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine besylate. Amlodipine besylate tablets may be used alone or in combination with other antihypertensive agents. 1.2 Coronary Artery Disease (CAD): Chronic Stable Angina: Amlodipine besylate tablets are indicated for the symptomatic treatment of chronic stable angina. Amlodipine besylate tablets may be used alone or in combination with other antianginal agents. Vasospastic Angina (Prinzmetal's or Variant Angina): Amlodipine besylate tablets are indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine besylate tablets may be used as monotherapy or in combination with other antianginal agents. Angiographically Documented CAD: In patients with recently documented CAD by angiography and without heart failure or an ejection fraction <40%, amlodipine besylate tablets are indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure. (Lupin label, verbatim)

How it works

Amlodipine blocks calcium from entering the muscle cells of blood vessels and the heart, with a greater effect on blood vessel muscle. It relaxes the blood vessels so blood pressure goes down. Blood calcium levels are not affected.
Source text (exact source wording)
Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Serum calcium concentration is not affected by amlodipine. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure. (12.1 Mechanism of Action; sentences in label order, some omitted)

Dosage: adults

For high blood pressure the usual starting dose is 5 mg once daily and the maximum is 10 mg once daily. Small, fragile or elderly patients, or those with liver problems, may start at 2.5 mg once daily. Doses are adjusted to blood pressure goals, generally waiting 7 to 14 days between steps. For angina the dose is 5 to 10 mg, and for coronary artery disease 5 to 10 mg once daily. Take it once a day, with or without food.
Source text (exact source wording)
2.1 Adults: The usual initial antihypertensive oral dose of amlodipine besylate tablet is 5 mg once daily and the maximum dose is 10 mg once daily. Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding amlodipine besylate tablet to other antihypertensive therapy. Adjust dosage according to blood pressure goals. In general, wait 7 to 14 days between titration steps. Titrate more rapidly, however, if clinically warranted, provided the patient is assessed frequently. Angina: The recommended dose for chronic stable or vasospastic angina is 5 to 10 mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patients will require 10 mg for adequate effect. Coronary artery disease: The recommended dose range for patients with coronary artery disease is 5 to 10 mg once daily. In clinical studies, the majority of patients required 10 mg. (Lupin label, verbatim)

Dosage: children

For high blood pressure in children ages 6 to 17 years the effective dose is 2.5 mg to 5 mg once daily. Doses above 5 mg a day have not been studied in children. The effect on blood pressure under 6 years of age is not known.
Source text (exact source wording)
2.2 Children: The effective antihypertensive oral dose in pediatric patients ages 6 to 17 years is 2.5 mg to 5 mg once daily. Doses in excess of 5 mg daily have not been studied in pediatric patients. 8.4 Pediatric Use: Effect of Amlodipine besylate on blood pressure in patients less than 6 years of age is not known.

Dosage adjustments

Drug interaction caps
With moderate or strong CYP3A inhibitors, amlodipine levels go up and the dose may need to be lowered; watch for low blood pressure and swelling. The simvastatin dose should be limited to 20 mg daily in people taking amlodipine.
Source text (exact source wording)
Co-administration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction. Monitor for symptoms of hypotension and edema when amlodipine is co-administered with CYP3A inhibitors to determine the need for dose adjustment. (7.1) Limit the dose of simvastatin in patients on amlodipine to 20 mg daily. (7.2)
Kidney
The label says kidney impairment does not significantly change how amlodipine is processed, so patients with kidney failure may receive the usual initial dose.
Source text (exact source wording)
The pharmacokinetics of amlodipine are not significantly influenced by renal impairment. Patients with renal failure may therefore receive the usual initial dose. (12.3 Pharmacokinetics, Lupin label)
Liver
People with liver problems may start at 2.5 mg once daily. The half-life is 56 hours in impaired liver function, so the dose should be raised slowly in severe liver impairment.
Source text (exact source wording)
Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily (2.1). Because amlodipine besylate is extensively metabolized by the liver and the plasma elimination half-life (t1/2) is 56 hours in patients with impaired hepatic function, titrate slowly when administering amlodipine besylate to patients with severe hepatic impairment. (5.3)
Elderly
For older patients the dose should be chosen cautiously, usually at the low end of the range. Older patients clear amlodipine more slowly, and may be started on 2.5 mg once daily.
Source text (exact source wording)
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Elderly patients have decreased clearance of amlodipine with a resulting increase of AUC of approximately 40 to 60%, and a lower initial dose may be required. (8.5 Geriatric Use)

Missed dose

If you miss a dose, take it as soon as you remember. If it has been more than 12 hours since the missed dose, wait and take the next dose at your regular time. Do not take a double dose.
Source text (exact source wording)
If you miss a dose, take it as soon as you remember. Do not takeamlodipine besylate tablets if it has been more than 12 hours since you missed your last dose. Wait and take the next dose at your regular time. (Patient leaflet, Lupin label; 'Do not takeamlodipine' spacing as printed)

Overdose

An overdose is expected to cause very low blood pressure from widened blood vessels and possibly a fast heartbeat. Treatment is heart and breathing monitoring and supportive care. The leaflet says to call your doctor or Poison Control Center, or go to the nearest emergency room.
Source text (exact source wording)
Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. In humans, experience with intentional overdosage of amlodipine is limited. If massive overdose should occur, initiate active cardiac and respiratory monitoring. Frequent blood pressure measurements are essential. Should hypotension occur, provide cardiovascular support including elevation of the extremities and the judicious administration of fluids. If hypotension remains unresponsive to these conservative measures, consider administration of vasopressors (such as phenylephrine) with attention to circulating volume and urine output. As amlodipine is highly protein bound, hemodialysis is not likely to be of benefit. (10 OVERDOSAGE) Patient leaflet: If you took too muchamlodipine besylate tablets, call your doctor or Poison Control Center, or go to the nearest hospital emergency room right away.

Storage

Store at 20° to 25°C (68° to 77°F), away from light and moisture, not in the bathroom, and away from children.
Source text (exact source wording)
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] and dispense in tight, light-resistant containers (USP). (16 Storage) Patient leaflet: Keep amlodipine besylate tablets away from children. Store amlodipine besylate tablets at 20° to 25°C (68° to 77°F). Keep amlodipine besylate tablets out of the light. Do not store in the bathroom. Keep amlodipine besylate tablets in a dry place.

Boxed warning

This medicine does not have a boxed warning.
Source text (exact source wording)
NONE (no boxed warning section in the Lupin label)

Contraindications

Do not use if you are known to be sensitive or allergic to amlodipine.
Source text (exact source wording)
Amlodipine besylate tablets are contraindicated in patients with known sensitivity to amlodipine. (4)

Warnings and precautions

Low blood pressure with symptoms is possible, especially in people with severe aortic stenosis. Sudden low blood pressure is unlikely because it works gradually.
Heading
5.1 Hypotension
Source text (exact source wording)
Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely.
Chest pain can get worse and a heart attack can happen after starting or raising the dose, especially in people with severe blocked heart arteries.
Heading
5.2 Increased Angina or Myocardial Infarction
Source text (exact source wording)
Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine, particularly in patients with severe obstructive coronary artery disease.
In severe liver impairment the dose should be raised slowly because amlodipine is cleared by the liver and the half-life is 56 hours.
Heading
5.3 Patients with Hepatic Failure
Source text (exact source wording)
Because amlodipine besylate is extensively metabolized by the liver and the plasma elimination half-life (t1/2) is 56 hours in patients with impaired hepatic function, titrate slowly when administering amlodipine besylate to patients with severe hepatic impairment.

Pregnancy and breastfeeding

Limited data from reports after the drug was marketed are not enough to tell whether amlodipine carries a risk of major birth defects or miscarriage. Pregnant women with high blood pressure should be carefully monitored. Amlodipine is present in breast milk at an estimated median relative infant dose of 4.2%, and no adverse effects on breastfed infants have been observed.
Source text (exact source wording)
8.1 Pregnancy, Risk Summary: The limited available data based on post-marketing reports with amlodipine use in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy. In animal reproduction studies, there was no evidence of adverse developmental effects when pregnant rats and rabbits were treated orally with amlodipine maleate during organogenesis at doses approximately 10 and 20-times the maximum recommended human dose (MRHD), respectively. However for rats, litter size was significantly decreased (by about 50%) and the number of intrauterine deaths was significantly increased (about 5-fold). Amlodipine has been shown to prolong both the gestation period and the duration of labor in rats at this dose. Clinical Considerations: Pregnant women with hypertension should be carefully monitored and managed accordingly. 8.2 Lactation, Risk Summary: Limited available data from a published clinical lactation study reports that amlodipine is present in human milk at an estimated median relative infant dose of 4.2%. No adverse effects of amlodipine on the breastfed infant have been observed. There is no available information on the effects of amlodipine on milk production.

Side effects

Common
The label's most common reaction is swelling (edema), which is dose related: 1.8% at 2.5 mg, 3.0% at 5 mg and 10.8% at 10 mg, compared with 0.6% on placebo. Dizziness, flushing and palpitation also occurred in a dose-related way. Fatigue (4.5% vs 2.8%), nausea (2.9% vs 1.9%), abdominal pain (1.6% vs 0.3%) and somnolence (1.4% vs 0.6%) were reported in more than 1% but not clearly dose related.
Threshold
Label Highlights: 'Most common adverse reaction to amlodipine is edema which occurred in a dose related manner. Other adverse experiences not dose related but reported with an incidence >1.0% are fatigue, nausea, abdominal pain, and somnolence. (6)'
Source text (exact source wording)
Highlights: Most common adverse reaction to amlodipine is edema which occurred in a dose related manner. Other adverse experiences not dose related but reported with an incidence >1.0% are fatigue, nausea, abdominal pain, and somnolence. (6) 6.1: The most commonly reported side effects more frequent than placebo are reflected in the table below. The incidence (%) of side effects that occurred in a dose related manner are as follows. Columns Amlodipine 2.5 mg (N=275) | 5 mg (N=296) | 10 mg (N=268) | Placebo (N=520): Edema 1.8 | 3.0 | 10.8 | 0.6. Dizziness 1.1 | 3.4 | 3.4 | 1.5. Flushing 0.7 | 1.4 | 2.6 | 0.0. Palpitation 0.7 | 1.4 | 4.5 | 0.6. Other adverse reactions not clearly dose related with incidence greater than 1.0%: Amlodipine % (N=1730) | Placebo % (N=1250): Fatigue 4.5 | 2.8. Nausea 2.9 | 1.9. Abdominal Pain 1.6 | 0.3. Somnolence 1.4 | 0.6.
Less common
Events seen in fewer than 1% but more than 0.1% of patients, where a link to the drug is uncertain, include irregular heartbeat, slow or fast heartbeat, fainting, tremor, vertigo, constipation, diarrhea, muscle cramps, sexual dysfunction, trouble sleeping, rash, vision changes and ringing in the ears.
Source text (exact source wording)
The following events occurred in <1% but >0.1% of patients in controlled clinical trials or under conditions of open trials or marketing experience where a causal relationship is uncertain; they are listed to alert the physician to a possible relationship: Cardiovascular: arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, peripheral ischemia, syncope, tachycardia, vasculitis. Central and Peripheral Nervous System: hypoesthesia, neuropathy peripheral, paresthesia, tremor, vertigo. Gastrointestinal: anorexia, constipation, dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia. General: allergic reaction, asthenia, back pain, hot flushes, malaise, pain, rigors, weight gain, weight decrease. Musculoskeletal System: arthralgia, arthrosis, muscle cramps, myalgia. Psychiatric: sexual dysfunction (male and female), insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization. Respiratory System: dyspnea, epistaxis. Skin and Appendages: angioedema, erythema multiforme, pruritus, rash, rash erythematous, rash maculopapular. Special Senses: abnormal vision, conjunctivitis, diplopia, eye pain, tinnitus. Urinary System: micturition frequency, micturition disorder, nocturia. Autonomic Nervous System: dry mouth, sweating increased. Metabolic and Nutritional: hyperglycemia, thirst. Hemopoietic: leukopenia, purpura, thrombocytopenia. (6.1; footnote markers dropped in transcription)
Serious
The label warns of symptomatic low blood pressure and of worse chest pain or a heart attack after starting or raising the dose. After approval there were reports of jaundice and liver enzyme increases, some needing hospitalization. MedlinePlus says to call a doctor right away or get emergency care for more frequent or more severe chest pain, a rapid, pounding or irregular heartbeat, or fainting.
Source text (exact source wording)
LABEL: Warnings 5.1 to 5.3 (symptomatic hypotension; worsening angina and acute myocardial infarction; slow titration in severe hepatic impairment). Postmarketing (6.2): The following postmarketing event has been reported infrequently where a causal relationship is uncertain: gynecomastia. In postmarketing experience, jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis), in some cases severe enough to require hospitalization, have been reported in association with use of amlodipine. Postmarketing reporting has also revealed a possible association between extrapyramidal disorder and amlodipine. || PATIENT LEAFLET (label): when you first start taking amlodipine or increase your dose, you may have a heart attack or your angina may get worse; call your doctor right away or go to an emergency room. || MEDLINEPLUS a692044 (call your doctor immediately or get emergency medical treatment): more frequent or more severe chest pain; rapid, pounding, or irregular heartbeat; fainting.
Led to discontinuation
In controlled trials, about 1.5% of amlodipine patients had to stop because of side effects, not significantly different from about 1% on placebo.
Source text (exact source wording)
In controlled clinical trials directly comparing amlodipine (N=1730) at doses up to 10 mg to placebo (N=1250), discontinuation of amlodipine because of adverse reactions was required in only about 1.5% of patients and was not significantly different from placebo (about 1%). (6.1)

Interactions

Drugs
Raises amlodipine levels and may require a lower dose. Watch for low blood pressure and swelling.
Name
CYP3A inhibitors (moderate and strong)
Section
7.1
Source text (exact source wording)
Co-administration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction. Monitor for symptoms of hypotension and edema when amlodipine is co-administered with CYP3A inhibitors to determine the need for dose adjustment. (7.1)
No information is available on how much inducers change amlodipine, so blood pressure should be closely monitored.
Name
CYP3A inducers
Section
7.1
Source text (exact source wording)
No information is available on the quantitative effects of CYP3A inducers on amlodipine. Blood pressure should be closely monitored when amlodipine is co-administered with CYP3A inducers. (7.1)
Watch for low blood pressure when sildenafil is taken with amlodipine.
Name
Sildenafil
Section
7.1
Source text (exact source wording)
Monitor for hypotension when sildenafil is co-administered with amlodipine. (7.1)
Amlodipine raises simvastatin levels. Limit simvastatin to 20 mg daily.
Name
Simvastatin
Section
7.2
Source text (exact source wording)
Co-administration of simvastatin with amlodipine increases the systemic exposure of simvastatin. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily. (7.2)
Amlodipine may raise cyclosporine or tacrolimus levels, so blood levels should be monitored often.
Name
Cyclosporine and tacrolimus
Section
7.2
Source text (exact source wording)
Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered. Frequent monitoring of trough blood levels of cyclosporine and tacrolimus is recommended and adjust the dose when appropriate. (7.2)
Food and alcohol
Take it with or without food.
Name
Food
Section
Patient leaflet; MedlinePlus a692044
Source text (exact source wording)
Take amlodipine besylate tablet once a day, with or without food. (Patient leaflet, Lupin label; printed 'Takeamlodipine')
Name
Grapefruit
Name
Alcohol
If your doctor prescribes a low-salt diet, follow it carefully.
Name
Low-salt diet
Section
MedlinePlus a692044
Source text (exact source wording)
If your doctor prescribes a low-salt or low-sodium diet, follow these directions carefully.

Patient tips

Label patient leaflet
Take it once a day with or without food. Tell your doctor about all your medicines and whether you have had heart or liver problems. Possible side effects include leg or ankle swelling, tiredness, dizziness, flushing and irregular or very fast heartbeat. When you first start or raise the dose, you may have a heart attack or your angina may get worse; call your doctor right away or go to an emergency room.
Source text (exact source wording)
Amlodipine besylate tablet is a type of medicine known as a calcium channel blocker (CCB). It is used to treat high blood pressure (hypertension) and a type of chest pain called angina. Do not use amlodipine besylate tablets if you are allergic to amlodipine (the active ingredient in amlodipine besylate tablets), or to the inactive ingredients. Tell your doctor if you: ever had heart disease; ever had liver problems; are pregnant, or plan to become pregnant; are breast-feeding. Take amlodipine besylate tablet once a day, with or without food. Other medicines: You can use nitroglycerin and amlodipine besylate tablets together. Amlodipine besylate tablets may cause the following side effects. Most side effects are mild or moderate: swelling of your legs or ankles; tiredness, extreme sleepiness; stomach pain, nausea; dizziness; flushing (hot or warm feeling in your face); arrhythmia (irregular heartbeat); heart palpitations (very fast heartbeat); muscle rigidity, tremor and/or abnormal muscle movement. It is rare, but when you first start taking amlodipine besylate tablets or increase your dose, you may have a heart attack or your angina may get worse. If that happens, call your doctor right away or go directly to a hospital emergency room. (Patient leaflet, Lupin label, verbatim excerpts in label order)
Medlineplus
Keep taking it even if you feel well. Follow any low-salt diet your doctor prescribes. Tell your doctor if you have heart failure or heart or liver disease.
Source text (exact source wording)
Take once a day with or without food. Continue to take amlodipine even if you feel well. If your doctor prescribes a low-salt or low-sodium diet, follow these directions carefully. Tell your doctor or pharmacist if you are allergic to this medication. Tell your doctor if you have or have ever had heart failure or heart or liver disease.

Alternatives

Class source
Label 12.1: dihydropyridine calcium antagonist; MedlinePlus a692044: calcium channel blockers. openFDA and Drugs@FDA not searched for class.
Indication source
Label Section 1 (hypertension, angina, CAD).
Candidates
Name
nifedipine
Name
felodipine
Name
verapamil

Frequently asked questions

Question
What is amlodipine used for?
Answer
It is used to treat high blood pressure and certain types of chest pain (angina). It can also be used in people with coronary artery disease shown on angiography to reduce the risk of hospitalization for angina and of a coronary revascularization procedure.
Source section
1 INDICATIONS AND USAGE; MedlinePlus
Source
Lupin label, set ID 003dd1ec-16f8-4f96-b6a8-c4689d35892a; MedlinePlus a692044
Question
Can I take amlodipine with food?
Answer
Yes. Take it once a day, with or without food.
Source section
Patient leaflet
Source
Lupin label; MedlinePlus a692044
Question
What if I miss a dose?
Answer
Take it as soon as you remember. If it has been more than 12 hours since you missed your last dose, wait and take the next dose at your regular time. Do not take a double dose.
Source section
Patient leaflet; MedlinePlus
Source
Lupin label; MedlinePlus a692044
Question
What are the common side effects?
Answer
In trials the most commonly reported side effects more frequent than placebo were swelling (edema), dizziness, flushing and palpitation. Swelling was reported in 10.8% at 10 mg compared with 0.6% on placebo.
Source section
6.1 Clinical Trials Experience
Source
Lupin label
Question
Should I stop taking it when my blood pressure is normal or I feel well?
Answer
MedlinePlus says to continue to take amlodipine even if you feel well.
Source section
MedlinePlus: How should this medicine be used
Source
MedlinePlus a692044
Question
What should I not combine with amlodipine?
Answer
The label says to limit simvastatin to 20 mg daily, to monitor for low blood pressure and swelling with CYP3A inhibitors, to monitor for low blood pressure with sildenafil, and to monitor cyclosporine or tacrolimus levels often.
Source section
7 DRUG INTERACTIONS
Source
Lupin label
Question
Is amlodipine safe in pregnancy or while breastfeeding?
Answer
Limited data from reports after the drug was marketed are not enough to inform a risk for major birth defects and miscarriage. Amlodipine is present in breast milk at an estimated median relative infant dose of 4.2%, and no adverse effects on breastfed infants have been observed.
Source section
8.1; 8.2
Source
Lupin label
Question
When should I call a doctor?
Answer
Call right away or get emergency care for more frequent or more severe chest pain, a rapid, pounding or irregular heartbeat, or fainting. The leaflet says a heart attack or worse angina may happen when you first start or raise the dose.
Source section
Patient leaflet; MedlinePlus
Source
Lupin label; MedlinePlus a692044

Sources

  • DailyMed generic label (CHOSEN): Amlodipine besylate tablet, Lupin Pharmaceuticals, Inc.
    Set id: 003dd1ec-16f8-4f96-b6a8-c4689d35892a · Label effective or revised date: Revised: 4/2026 (How Supplied and patient leaflet: Revised: December 2024) · Dailymed version date: not recorded for this label · Fetched at: 2026-11-03 · Sections used: Highlights, 1, 2, 3, 4, 5, 6.1, 6.2, 7, 8.1, 8.2, 8.4, 8.5, 10, 11, 12.1-12.4, 16, patient leaflet; captured via Chrome printer-friendly page
  • DailyMed brand label: Norvasc, Viatris Specialty LLC
    Set id: 7367289c-b0b0-466a-83e2-558e2985c29f · Label effective or revised date: Revised: 2/2023 · Dailymed version date: DailyMed list published_date Dec 10, 2025 · Fetched at: 2026-11-02 · Sections used: first 100,000 characters only: 2.1, 2.2, storage, strengths
  • MedlinePlus: Amlodipine
    Set id: n/a · Label effective or revised date: Last Revised - 09/15/2025 · Fetched at: 2026-11-02 · Sections used: why prescribed, how used, missed dose, side effects, overdose, storage, precautions, brand names
  • openFDA / Drugs@FDA
    Set id: n/a · Label effective or revised date: NOT FOUND (not searched) · Fetched at: 2026-11-02 · Sections used: none

Information is taken from the cited sources and is for general reference only. It is not medical advice. Report side effects to FDA MedWatch at 1-800-FDA-1088. For a poison emergency call 1-800-222-1222. See prices for this drug