Prescription medicine
Amlodipine and atorvastatin Brand names: Caduet
Amlodipine and atorvastatin (Caduet) is a prescription medicine with an FDA approval on record since 2004. FDA's NDC Directory lists it from 6 generic labelers, and pharmacies paid $1.34 per unit (Amlodipine-atorvast 10-40 mg) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the amlodipine and atorvastatin FDA label on DailyMed (effective May 23, 2025, Alembic Pharmaceuticals Limited); the NDA 21540 record on Drugs@FDA; every amlodipine and atorvastatin label on DailyMed.
Highlights of the record
FDA label of May 23, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageAmlodipine and atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate.
Forms and strengths
- 2.5 mg / 20 mg
- 2.5 mg / 40 mg
- 2.5 mg / 10 mg
- 5 mg / 20 mg
- 5 mg / 40 mg
- 5 mg / 10 mg
- 5 mg / 80 mg
- 10 mg / 10 mg
- 10 mg / 40 mg
- 10 mg / 20 mg
- 10 mg / 80 mg
Film-coated tablet; coated tablet.
On the market
- Earliest approval on file
- January 30, 2004 Caduet, Pharmacia; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 5 first November 29, 2013; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 9 of which 6 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $1.34 per unit Amlodipine-atorvast 10-40 mg
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 13 since 2015 0 Class I among all firms' recalls; latest February 5, 2020
- FAERS reports
- 4,158 through July 30, 2026
What is amlodipine and atorvastatin used for?
From the label: indications and usageAmlodipine and atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine Hypertension Amlodipine is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal 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. […]
Conditions named in the indications of amlodipine and atorvastatin's FDA labels, with every medicine labeled for each:
- High blood pressure
- Angina
- High cholesterol
- Heart attack and coronary artery disease
- High triglycerides
- Stroke prevention
From other amlodipine and atorvastatin labelsAngina: Coronary Artery Disease (CAD) Chronic Stable Angina Amlodipine is indicated for the symptomatic treatment of chronic stable angina.
High cholesterol: As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
Heart attack and coronary artery disease: Amlodipine is indicated for the treatment of Coronary Artery Disease ( 1 ).
High triglycerides: Hypertriglyceridemia.
Stroke prevention: Reduce the risk of myocardial infarction Reduce the risk of stroke In adult patients with clinically evident coronary heart disease, atorvastatin is indicated to:
FDA pharmacologic class: Calcium Channel Blocker, Dihydropyridine Calcium Channel Blocker and HMG-CoA Reductase Inhibitor.
Source: FDA drug label (Amlodipine and Atorvastatin), Alembic Pharmaceuticals Limited, effective May 23, 2025 (SPL set ecab983e-6ed8-4440-b7b4-7ac4bf39b26c), via openFDA; the full label on DailyMed
What does the patient leaflet for amlodipine and atorvastatin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking amlodipine and atorvastatin tablets?Avoid drinking more than 1.2 liters of grapefruit juice each day.
Source: FDA drug label (Amlodipine and Atorvastatin), Alembic Pharmaceuticals Limited, effective May 23, 2025 (SPL set ecab983e-6ed8-4440-b7b4-7ac4bf39b26c), via openFDA; the full label on DailyMed
Is there a generic for amlodipine and atorvastatin (Caduet)?
The FDA approved the first generic amlodipine and atorvastatin on November 29, 2013. 5 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists amlodipine and atorvastatin from 6 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2004 earliest approval on file
- 2013 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for amlodipine and atorvastatin (Caduet)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.34 per unit (Amlodipine-atorvast 10-40 mg), down 6% from $1.42 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Amlodipine-atorvast 10-40 mg (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Amlodipine-atorvast 10-10 mg | Generic | $0.979 per unit | n/a | -34% |
| Amlodipine-atorvast 10-20 mg | Generic | $0.797 per unit | n/a | -34% |
| Amlodipine-atorvast 10-40 mg | Generic | $1.34 per unit | n/a | -6% |
| Amlodipine-atorvast 10-80 mg | Generic | $1.57 per unit | n/a | -28% |
| Amlodipine-atorvast 2.5-10 mg | Generic | $3.08 per unit | n/a | -12% |
| Amlodipine-atorvast 2.5-20 mg | Generic | $4.50 per unit | n/a | n/a |
| Amlodipine-atorvast 2.5-40 mg | Generic | $5.04 per unit | n/a | +16% |
| Amlodipine-atorvast 5-10 mg | Generic | $1.08 per unit | n/a | -22% |
| Amlodipine-atorvast 5-20 mg | Generic | $0.881 per unit | n/a | +9% |
| Amlodipine-atorvast 5-40 mg | Generic | $1.19 per unit | n/a | -42% |
| Amlodipine-atorvast 5-80 mg | Generic | $1.56 per unit | n/a | -38% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has amlodipine and atorvastatin been recalled?
The FDA's Enforcement Report lists 13 recalls naming amlodipine and atorvastatin since 2015: 0 Class I (the most serious), 2 Class II, 11 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 5, 2020 | Class II | Pfizer Inc. | Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting … |
| August 13, 2015 | Class III | Dr. Reddy's Laboratories, Inc. | Subpotent Drug: Subpotent atorvastatin. |
| May 6, 2015 | Class III | Dr. Reddy's Laboratories, Inc. | Subpotent drug |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the amlodipine and atorvastatin label say about other medicines?
The amlodipine and atorvastatin label names 21 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Clarithromycin | drug interactions | Select Azole Antifungals or Macrolide Antibiotics Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of atorvastatin with select azole antifungals or macrolide antibiotics, due to inhibition of CYP3A4 and/or transporters. Intervention: In patients taking clarithromycin or itraconazole, do not exceed atorvastatin 20 mg [see Dosage and Administration (2)]. … |
| Colchicine | drug interactions | Clinical Impact: Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with atorvastatin. Intervention: Consider the risk/benefit of concomitant use of colchicine with atorvastatin. If concomitant use is decided, monitor patients for signs and symptoms of myopathy particularly during initiation of therapy … |
| Cyclosporine | drug interactions | Amlodipine on Other Drugs Immunosuppressants Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered. |
| Darunavir | drug interactions | In patients taking saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir or letermovir do not exceed atorvastatin 20 mg. |
| Digoxin | drug interactions | May increase digoxin plasma levels; monitor patients appropriately ( 7.5 ). |
| Erythromycin | drug interactions | Select Azole Antifungals or Macrolide Antibiotics Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of atorvastatin with select azole antifungals or macrolide antibiotics, due to inhibition of CYP3A4 and/or transporters. … initiation of therapy and during upward dose titration of either drug. Examples: Erythromycin, clarithromycin, itraconazole, ketoconazole, posaconazole, and voriconazole. |
| Fosamprenavir | drug interactions | In patients taking saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir or letermovir do not exceed atorvastatin 20 mg. |
| Gemfibrozil | drug interactions | Drug Interactions that may Increase the Risk of Myopathy and Rhabdomyolysis with Atorvastatin Cyclosporine or Gemfibrozil |
| Itraconazole | drug interactions | Select Azole Antifungals or Macrolide Antibiotics Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of atorvastatin with select azole antifungals or macrolide antibiotics, due to inhibition of CYP3A4 and/or transporters. Intervention: In patients taking clarithromycin or itraconazole, do not exceed atorvastatin 20 mg [see Dosage and Administration (2)]. … |
| Ketoconazole | drug interactions | Select Azole Antifungals or Macrolide Antibiotics Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of atorvastatin with select azole antifungals or macrolide antibiotics, due to inhibition of CYP3A4 and/or transporters. … titration of either drug. Examples: Erythromycin, clarithromycin, itraconazole, ketoconazole, posaconazole, and voriconazole. |
| Letermovir | drug interactions | In patients taking saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir or letermovir do not exceed atorvastatin 20 mg. |
| Nelfinavir | drug interactions | In patients taking nelfinavir, do not exceed atorvastatin 40 mg [see Dosage and Administration (2)]. |
| Niacin | drug interactions | Niacin Clinical Impact: Cases of myopathy and rhabdomyolysis have been observed with concomitant use of lipid modifying dosages of niacin (≥ 1 gram/day niacin) with atorvastatin. Intervention: Consider if the benefit of using lipid modifying dosages of niacin concomitantly with atorvastatin outweighs the increased risk of myopathy and rhabdomyolysis. … |
| Norethindrone | drug interactions | Oral Contraceptives: May increase plasma levels of norethindrone and ethinyl estradiol; consider this effect when selecting an oral contraceptive ( 7.5 ). |
Every other medicine the amlodipine and atorvastatin label names
| Medicine named | Section | What the label says |
|---|---|---|
| Posaconazole | drug interactions | Select Azole Antifungals or Macrolide Antibiotics Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of atorvastatin with select azole antifungals or macrolide antibiotics, due to inhibition of CYP3A4 and/or transporters. … drug. Examples: Erythromycin, clarithromycin, itraconazole, ketoconazole, posaconazole, and voriconazole. |
| Rifampin | drug interactions | Drug Interactions that may Decrease Exposure to Atorvastatin Rifampin |
| Ritonavir | drug interactions | Anti-Viral Medications Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of atorvastatin with many anti-viral medications, which are inhibitors of CYP3A4 and/or transporters (…). … Intervention: • Concomitant use of tipranavir plus ritonavir or glecaprevir plus pibrentasvir with atorvastatin is not recommended. • In patients taking lopinavir plus ritonavir, or simeprevir, consider the risk/benefit … |
| Sildenafil | drug interactions | Sildenafil Monitor for hypotension when sildenafil is co-administered with amlodipine [see Clinical Pharmacology (12.2)]. |
| Sofosbuvir | drug interactions | Anti-Viral Medications Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of atorvastatin with many anti-viral medications, which are inhibitors of CYP3A4 and/or transporters (…). … Administration (2)]. • Consider the risk/benefit of concomitant use of ledipasvir plus sofosbuvir with atorvastatin. • Monitor all patients for signs and symptoms of myopathy particularly during initiation of therapy … |
| Tacrolimus | drug interactions | Amlodipine on Other Drugs Immunosuppressants Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered. |
| Voriconazole | drug interactions | Select Azole Antifungals or Macrolide Antibiotics Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of atorvastatin with select azole antifungals or macrolide antibiotics, due to inhibition of CYP3A4 and/or transporters. … Erythromycin, clarithromycin, itraconazole, ketoconazole, posaconazole, and voriconazole. |
Source: FDA drug label (Amlodipine and Atorvastatin), Alembic Pharmaceuticals Limited, effective May 23, 2025 (SPL set ecab983e-6ed8-4440-b7b4-7ac4bf39b26c), via openFDA; the full label on DailyMed
What do FAERS reports show for amlodipine and atorvastatin?
The FDA Adverse Event Reporting System holds 4,158 reports that list amlodipine and atorvastatin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 386 are coded as a death and 1,100 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as amlodipine and atorvastatin?
72 other medicines are given the same way (oral) and in the same FDA class as amlodipine and atorvastatin or labeled mainly for the same use (high blood pressure), the same class first. High blood pressure lists all 88 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Diltiazem | High blood pressure, Angina | 42 labelers | $0.144 per capsule 24h ER(cd) 120 mg capsule | A presentation being discontinued |
| Rosuvastatin | Heart attack and coronary artery disease, High cholesterol, High triglycerides, Stroke prevention | 46 labelers | $0.0692 per tablet 40 mg tablet | No current entry |
| Pravastatin | Heart attack and coronary artery disease, High cholesterol, High triglycerides | 37 labelers | $0.058 per tablet 20 mg tablet | No current entry |
| Simvastatin | Heart attack and coronary artery disease, High cholesterol, High triglycerides | 27 labelers | $0.0321 per tablet 20 mg tablet | No current entry |
| Nifedipine | High blood pressure, Angina | 32 labelers | $0.130 per tablet 30 mg tablet | No current entry |
| Verapamil | High blood pressure, Angina | 24 labelers | $0.191 per tablet 180 mg tablet | A presentation being discontinued |
| Lovastatin | Heart attack and coronary artery disease, High cholesterol | 19 labelers | $0.0436 per tablet 20 mg tablet | No current entry |
| Felodipine | High blood pressure | 14 labelers | $0.123 per tablet 5 mg tablet | No current entry |
Every medicine labeled for the same conditions as amlodipine and atorvastatin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to amlodipine and atorvastatin
- 72 medicines for the same use
- Other calcium channel blockers
- the pharmacologic class, with prices and generics
- Amlodipine and atorvastatin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other