Atorvastatin is a hmg-coa reductase inhibitor sold in the U.S. under 2 brand and generic names, for coronary artery disease, hypercholesterolemia and hyperlipoproteinemias. 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 Atorvaliq (application NDA213260). Other atorvastatin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Take orally once daily, only on an empty stomach ( 2.1 ). • Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating ATORVALIQ, and adjust dosage if necessary ( 2.1 ). • Adults ( 2.2 ): o Recommended starting dosage is 10 or 20 mg once daily; dosage range is 10 mg to 80 mg once daily. o Patients requiring LDL-C reduction >45% may start at 40 mg once daily. • Pediatric Patients Aged 10 Years of Age and Older with HeFH: Recommended starting dosage is 10 mg once daily; dosage range is 10 to 20 mg once daily ( 2.3 ). • Pediatric Patients Aged 10 Years of Age and Older with HoFH: Recommended starting dosage is 10 to 20 mg once daily; dosage range is 10 to 80 mg once daily ( 2.4 ). • See full prescribing information for ATORVALIQ dosage modifications due to drug interactions ( 2.5 ). 2.1 Important Dosage and Administration Information • Measure the ATORVALIQ dose using a calibrated oral syringe or other oral dosing device scored using metric units of measurements (i.e., mL). • Take ATORVALIQ orally once daily at any time of day, only on an empty stomach (1 hour before or 2 hours after a meal). • Advise patients to take a missed dose as soon as possible. If the dose was missed by more than 12 hours, patients should not take the missed dose and resume with the next scheduled dose. • Assess LDL-C when clinically appropriate, as early…
The following important adverse reactions are described below and elsewhere in the labeling: • Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1) ] • Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions (5.2) ] • Hepatic Dysfunction [see Warnings and Precautions (5.3) ] • Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions (5.4) ] Most common adverse reactions (incidence ≥5%) are nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact CMP Pharma, Inc. at 1-844-321-1443, 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, the 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. The safety of ATORVALIQ has been established in adequate and well-controlled trials of atorvastatin calcium tablets, referenced below as “atorvastatin” [see Clinical Studies (14) ]. In the atorvastatin placebo-controlled clinical trial database of 16,066 patients (8,755 atorvastatin vs. 7,311 placebo; age range 10-93 years, 39% women, 91% White, 3% Black, 2% Asian, 4% other) with a median treatment duration of 53 weeks, the most…
Grapefruit & grapefruit juice
Avoid grapefruit and grapefruit juice with this medicine unless your pharmacist or the label says it's fine — check, because not every drug in a class is affected the same way.
Grapefruit Juice and Some Drugs Don't Mix — U.S. FDA ↗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 | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Suspension | Generic | $1 | View → | |
| 2 | Not yet rated | Prescription | Tablet | Generic | $1 | View → |
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.
Atorvastatin Calcium Tablets USP
Failed Dissolution Specifications
Ascend Laboratories, LLC · Sep 19, 2025
Atorvastatin Calcium Tablets USP
Failed Dissolution Specifications
Ascend Laboratories, LLC · Sep 19, 2025
Atorvastatin Calcium Tablets USP
Failed Dissolution Specifications
Ascend Laboratories, LLC · Sep 19, 2025
Atorvastatin Calcium Tablets USP
Failed Dissolution Specifications
Ascend Laboratories, LLC · Sep 19, 2025
Atorvastatin Calcium Tablets USP 40 mg
Failed dissolution specifications: lower than specifications
BIOCON PHARMA INC · Mar 17, 2025
The elimination half-life of atorvastatin is about 14 hours. This is the parent drug's plasma elimination half-life; because atorvastatin has active metabolites, its cholesterol-lowering (HMG-CoA reductase-inhibiting) activity lasts materially longer, about 20 to 30 hours.
LIPITOR (atorvastatin calcium) tablet, film coated — DailyMed FDA label, Section 12.3 Pharmacokinetics ↗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.
ATORVALIQ is contraindicated in patients with: • Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3) ] • Hypersensitivity to atorvastatin or any excipients in ATORVALIQ. Hypersensitivity reactions, including anaphylaxis, angioneurotic edema, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported [see Adverse Reactions (6.2) ] . • Acute liver failure or decompensated cirrhosis ( 4 ). • Hypersensitivity to atorvastatin or any excipient in ATORVALIQ ( 4 ).
See full prescribing information for details regarding concomitant use of ATORVALIQ with other drugs or grapefruit juice that increase the risk of myopathy and rhabdomyolysis ( 2.5 , 7.1 ). • Rifampin: May reduce atorvastatin plasma concentrations. Administer simultaneously with ATORVALIQ ( 7.2 ). • Oral Contraceptives: May increase plasma levels of norethindrone and ethinyl estradiol; consider this effect when selecting an oral contraceptive ( 7.3 ). • Digoxin: May increase digoxin plasma levels; monitor patients appropriately ( 7.3 ). 7.1 Drug Interactions that may Increase the Risk of Myopathy and Rhabdomyolysis with ATORVALIQ Atorvastatin is a substrate of CYP3A4 and transporters (e.g., OATP1B1/1B3, P-gp, or BCRP). Atorvastatin plasma levels can be significantly increased with concomitant administration of inhibitors of CYP3A4 and transporters. Table 2 includes a list of drugs that may increase exposure to atorvastatin and may increase the risk of myopathy and rhabdomyolysis when used concomitantly and instructions for preventing or managing them [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ] . Table 2: Drug Interactions that may Increase the Risk of Myopathy and Rhabdomyolysis with ATORVALIQ Cyclosporine or Gemfibrozil Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of…
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| CDT;104 | 10 mg | blue | oval | — |
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| CDT;108 | 10 mg | blue | oval | — |
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| TV;5059 | 20 mg | white | oval | — |
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| TV;5058 | 40 mg | white | oval | — |
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| TV;5057 | 80 mg | white | oval | — |
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| TV;AT1 | 10 mg | white | oval | — |
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