Amlodipine is a calcium channel blocker sold in the U.S. under 5 brand and generic names, for variant angina pectoris, coronary artery disease and hypertension. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Amlodipine Besylate (application ANDA206367). Other amlodipine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Adult recommended starting dose: 5 mg once daily with maximum dose 10 mg once daily. ( 2.1 ) Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily. ( 2.1 ) Pediatric starting dose: 2.5 mg to 5 mg once daily. ( 2.2 ) Important Limitation: Doses in excess of 5 mg daily have not been studied in pediatric patients. ( 2.2 ) 2.1 Adults The usual initial antihypertensive oral dose of amlodipine besylate tablets 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 tablets 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 to10 mg once daily. In clinical studies, the majority of patients required 10 mg [see Clinical Studies ( 14.4 )]. 2.2…
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 ) To report SUSPECTED ADVERSE REACTIONS, contact Exelan Pharmaceuticals, Inc. at 1-866-604-3268 or www.exelanpharma.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Amlodipine besylate tablets have been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. In general, treatment with amlodipine besylate tablets was well-tolerated at doses up to 10 mg daily. Most adverse reactions reported during therapy with amlodipine besylate tablets were of mild or moderate severity. In controlled clinical trials directly comparing amlodipine besylate tablets (N=1730) at doses up to 10 mg to placebo (N=1250), discontinuation of amlodipine besylate tablets because of adverse reactions was required in only about 1.5% of patients and was not significantly different from placebo (about 1%). The most commonly reported side effects more frequent…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
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| 1 | 70/100 | Prescription | Tablet | Generic | $0 | View → | |
| 2 | 68/100 | Prescription | Tablet | Generic |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| CDT;051 | 5 mg | white | oval | — |
| CDT;052 | 5 mg | white | oval | — |
| CDT;054 | 5 mg | white | oval | — |
| CDT;058 | 5 mg | white | oval | — |
| CDT;101 | 10 mg | blue | oval | — |
| CDT;102 | 10 mg | blue |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Amlodipine and Olmesartan Medoxomil Tablets
Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Ascend Laboratories, LLC · May 5, 2026
Amlodipine and Olmesartan Medoxomil Tablets
Failed Dissolution Specifications: low dissolution results
Ascend Laboratories, LLC · Jul 21, 2025
Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg
Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Lupin Pharmaceuticals Inc. · Jul 2, 2025
The elimination half-life of amlodipine is about 30 to 50 hours. This is the parent drug's terminal elimination half-life in adults with normal liver function; it is longer (about 56 hours) in people with impaired liver function, and elderly patients and those with liver problems or heart failure clear the drug more slowly (roughly 40 to 60% higher blood levels). Amlodipine's metabolites are inactive, so no active-metabolite caveat applies.
NORVASC (amlodipine besylate) tablets — FDA prescribing information, DailyMed ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Amlodipine besylate tablets are contraindicated in patients with known sensitivity to amlodipine. Known sensitivity to amlodipine ( 4 )
Do not exceed doses greater than 20 mg daily of simvastatin. ( 7.2 ) 7.1 Impact of Other Drugs on Amlodipine CYP3A Inhibitors 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 [see Clinical Pharmacology ( 12.3 )] . CYP3A Inducers 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. Sildenafil Monitor for hypotension when sildenafil is co-administered with amlodipine [see Clinical Pharmacology ( 12.2 )] . 7.2 Impact of Amlodipine on Other Drugs Simvastatin 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 [see Clinical Pharmacology ( 12.3 )]. Immunosuppressants 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 [see Clinical Pharmacology ( 12.3 )].
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| 3 | Not yet rated | Prescription | Tablet | Generic | $0 | View → |
| 4 | Not yet rated | Prescription | Solution | Generic | $0 | View → |
| 5 | Not yet rated | Prescription | Solution | Generic | $0 | View → |
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| CDT;104 | 10 mg | blue | oval | — |
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| CDT;108 | 10 mg | blue | oval | — |
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| Pfizer;CDT;058 | 5 mg / 80 mg | white | oval | — |
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| Pfizer;CDT;101 | 10 mg / 10 mg | blue | oval | — |
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| Pfizer;CDT;102 | 10 mg / 20 mg | blue | oval | — |
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| Pfizer;CDT;108 | 10 mg / 80 mg | blue | oval | — |
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