Prescription medicine
Rosuvastatin Brand names: Crestor
Rosuvastatin (Crestor) is a prescription medicine with an FDA approval on record since 2003. FDA's NDC Directory lists it from 45 generic labelers, and pharmacies paid $0.0692 per rosuvastatin calcium 40 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the rosuvastatin FDA label on DailyMed (effective September 4, 2026, ScieGen Pharmaceuticals, Inc.); the NDA 21366 record on Drugs@FDA; every rosuvastatin label on DailyMed.
Highlights of the record
FDA label of September 4, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageRosuvastatin tablets are indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events.
Forms and strengths
- 5 mg
- 10 mg
- 20 mg
- 40 mg
Film-coated tablet; tablet; coated tablet.
On the market
- Earliest approval on file
- August 12, 2003 Crestor, Astrazeneca; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 29 first April 29, 2016; 19 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 46 of which 45 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- February 12, 2036 Ezallor Sprinkle capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0692 per tablet Rosuvastatin calcium 40 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 13 since 2013 0 Class I among all firms' recalls; latest December 31, 2025
- FAERS reports
- 110,043 through July 30, 2026
What is rosuvastatin used for?
From the label: indications and usageRosuvastatin tablets are indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events. As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C): in adults with hypercholesterolemia. and slow the progression of atherosclerosis in adults. in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). […]
Conditions named in the indications of rosuvastatin's FDA labels, with every medicine labeled for each:
From other rosuvastatin labelsHigh triglycerides: Hypertriglyceridemia.
Stroke prevention: • reduce the risk of stroke
FDA pharmacologic class: HMG-CoA Reductase Inhibitor.
Source: FDA drug label (Rosuvastatin), ScieGen Pharmaceuticals, Inc., effective September 4, 2026 (SPL set ee4933c5-0d97-494d-ac0f-2083e0100836), via openFDA; the full label on DailyMed
Is there a generic for rosuvastatin (Crestor)?
The FDA approved the first generic rosuvastatin on April 29, 2016. 29 generic applications are approved; 19 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists rosuvastatin from 45 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Crestor tablets; a patent listed only for Ezallor Sprinkle capsules runs to February 12, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2003 earliest approval on file
- 2016 first generic approved
- 2036 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for rosuvastatin (Crestor)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0692 per Rosuvastatin calcium 40 mg tablet, down 7% from $0.0742 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. 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.
- Rosuvastatin calcium 40 mg tablet (generic)
- Crestor 20 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Rosuvastatin calcium 10 mg tablet | Generic | $0.036 per tablet | $1.08 | -10% |
| Rosuvastatin calcium 20 mg tablet | Generic | $0.0454 per tablet | $1.36 | -17% |
| Rosuvastatin calcium 40 mg tablet | Generic | $0.0692 per tablet | $2.08 | -7% |
| Rosuvastatin calcium 5 mg tablet | Generic | $0.0321 per tablet | $0.964 | -16% |
| Crestor 10 mg tablet | Brand | $8.81 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $264.33 | -0.2% |
| Crestor 20 mg tablet | Brand | $8.81 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $264.19 | -0.3% |
| Crestor 40 mg tablet | Brand | $8.81 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $264.20 | -0.2% |
| Crestor 5 mg tablet | Brand | $8.81 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $264.43 | -0.3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has rosuvastatin been recalled?
The FDA's Enforcement Report lists 13 recalls naming rosuvastatin since 2013: 0 Class I (the most serious), 13 Class II, 0 Class III; 4 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 31, 2025 | Class II | AvKARE | Out of specification for dissolution. |
| March 13, 2025 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations |
| March 23, 2023 | Class II | Preferred Pharmaceuticals, Inc. | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. |
| March 20, 2023 | Class II | RemedyRepack Inc. | cGMP Deviations |
| February 7, 2023 | Class II | Accord Healthcare, Inc. | CGMP Deviations: recalling drug products following an FDA inspection. |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup: ROSUVASTATIN CALCIUM, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: IBUPROFEN, Tablet, 400 mg, NDC … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the rosuvastatin label say about other medicines?
The rosuvastatin label names 27 other medicines in its interaction, contraindication or warning sections. The labels of 47 other medicines name rosuvastatin. 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 |
|---|---|---|
| Atazanavir | drug interactions | Prevention or Management:; Simeprevir Dasabuvir/ombitasvir/paritaprevir/ritonavir Elbasvir/grazoprevir Sofosbuvir/velpatasvir Glecaprevir/pibrentasvir Atazanavir/ritonavir Lopinavir/ritonavir; Initiate with rosuvastatin 5 mg once daily, and do not exceed a dosage of rosuvastatin 10 mg once daily. |
| Belumosudil | drug interactions | Mechanism and Clinical Effect (s): Belumosudil increased rosuvastatin exposure more than 4.6-fold. |
| Capmatinib | drug interactions | Mechanism and Clinical Effect (s): Capmatinib increased rosuvastatin exposure more than 2.1-fold. |
| Colchicine | drug interactions | Colchicine Prevention or Management: Consider if the benefit of using colchicine concomitantly with rosuvastatin outweighs the increased risk of myopathy and rhabdomyolysis. |
| Cyclosporine | drug interactions | Mechanism and Clinical Effect (s): Cyclosporine increased rosuvastatin exposure 7-fold. |
| Darolutamide | drug interactions | Mechanism and Clinical Effect (s): Darolutamide increased rosuvastatin exposure more than 5-fold. |
| Elbasvir and grazoprevir | drug interactions | Additional Anti-Viral Medications Prevention or Management: Simeprevir Dasabuvir/ombitasvir/paritaprevir/ritonavir Elbasvir/grazoprevir Sofosbuvir/velpatasvir Glecaprevir/pibrentasvir Atazanavir/ritonavir Lopinavir/ritonavir Initiate with rosuvastatin 5 mg once daily, and do not exceed a dosage of rosuvastatin 10 mg … |
| Enasidenib | drug interactions | Mechanism and Clinical Effect (s): Enasidenib increased rosuvastatin exposure more than 3.4-fold. |
| Febuxostat | drug interactions | Mechanism and Clinical Effect (s): Febuxostat increased rosuvastatin exposure more than 1.9-fold. |
| Fenofibrate | drug interactions | Fenofibrates (e.g., fenofibrate and fenofibric acid) Prevention or Management: Consider if the benefit of using fibrates concomitantly with rosuvastatin outweighs the increased risk of myopathy and rhabdomyolysis. |
| Fenofibric acid | drug interactions | Fenofibrates (e.g., fenofibrate and fenofibric acid) Prevention or Management: Consider if the benefit of using fibrates concomitantly with rosuvastatin outweighs the increased risk of myopathy and rhabdomyolysis. |
| Fostamatinib | drug interactions | Mechanism and Clinical Effect (s): Fostamatinib increased rosuvastatin exposure more than 2.0-fold. |
| Gemfibrozil | drug interactions | Gemfibrozil Prevention or Management: Avoid concomitant use of gemfibrozil with rosuvastatin. |
| Glecaprevir and pibrentasvir | drug interactions | Additional Anti-Viral Medications Prevention or Management: Simeprevir Dasabuvir/ombitasvir/paritaprevir/ritonavir Elbasvir/grazoprevir Sofosbuvir/velpatasvir Glecaprevir/pibrentasvir Atazanavir/ritonavir Lopinavir/ritonavir Initiate with rosuvastatin 5 mg once daily, and do not exceed a dosage of rosuvastatin 10 mg … |
Every other medicine the rosuvastatin label names
| Medicine named | Section | What the label says |
|---|---|---|
| Ledipasvir and sofosbuvir | drug interactions | Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Rosuvastatin Tablets Sofosbuvir/velpatasvir/voxilaprevir or Ledipasvir/sofosbuvir Prevention or Management: |
| Lopinavir and ritonavir | drug interactions | Additional Anti-Viral Medications Prevention or Management: Simeprevir Dasabuvir/ombitasvir/paritaprevir/ritonavir Elbasvir/grazoprevir Sofosbuvir/velpatasvir Glecaprevir/pibrentasvir … |
| Magnesium hydroxide | drug interactions | Mechanism and Clinical Effect (s):; Concomitant aluminum and magnesium hydroxide combination antacid administration decreased the mean exposure of rosuvastatin 50% [see ]. |
| Momelotinib | drug interactions | Mechanism and Clinical Effect (s): Momelotinib increased rosuvastatin exposure by 2.7-fold. |
| Niacin | drug interactions | Prevention or Management:; Consider if the benefit of using lipid-modifying dosages (≥1 g/day) of niacin concomitantly with rosuvastatin outweighs the increased risk of myopathy and rhabdomyolysis. … |
| Regorafenib | drug interactions | Mechanism and Clinical Effect (s): Regorafenib increased rosuvastatin exposure and may increase the risk of myopathy and rhabdomyolysis. |
| Ritonavir | drug interactions | Prevention or Management:; Simeprevir Dasabuvir/ombitasvir/paritaprevir/ritonavir Elbasvir/grazoprevir Sofosbuvir/velpatasvir Glecaprevir/pibrentasvir Atazanavir/ritonavir Lopinavir/ritonavir; … |
| Sofosbuvir and velpatasvir | drug interactions | Additional Anti-Viral Medications Prevention or Management: Simeprevir Dasabuvir/ombitasvir/paritaprevir/ritonavir Elbasvir/grazoprevir Sofosbuvir/velpatasvir Glecaprevir/pibrentasvir … |
| Sofosbuvir and velpatasvir and voxilaprevir | drug interactions | Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Rosuvastatin Tablets Sofosbuvir/velpatasvir/voxilaprevir or Ledipasvir/sofosbuvir Prevention or Management: |
| Tafamidis | drug interactions | Tafamidis Prevention or Management: Avoid concomitant use of tafamidis with rosuvastatin. |
| Teriflunomide | drug interactions | Mechanism and Clinical Effect (s): Teriflunomide increased rosuvastatin exposure more than 2.5-fold. |
| Ticagrelor | drug interactions | Mechanism and Clinical Effect (s): Ticagrelor increased rosuvastatin exposure by 2.3-fold. |
| Warfarin | drug interactions | Prevention or Management:; In patients taking warfarin, obtain an INR before starting rosuvastatin and frequently enough after initiation, dosage titration or discontinuation to ensure that no … |
Other labels that name rosuvastatin
- Asciminib
- Cobicistat
- Danicopan
- Darunavir
- Elagolix
- Eltrombopag
- Eluxadoline
- Ethinyl estradiol and ferrous bisglycinate and levonorgestrel
- Ethinyl estradiol and ferrous fumarate and levonorgestrel
- Ethinyl estradiol and levonorgestrel
- Ethinyl estradiol and norelgestromin
- Ethinyl estradiol and norgestimate
- Ethinyl estradiol and segesterone
- Fostemsavir
- Leflunomide
- Letermovir
- Maribavir
- Nelfinavir
- Oteseconazole
- Pacritinib
- Pretomanid
- Resmetirom
- Rolapitant
- Tedizolid
- Voclosporin
Source: FDA drug label (Rosuvastatin), ScieGen Pharmaceuticals, Inc., effective September 4, 2026 (SPL set ee4933c5-0d97-494d-ac0f-2083e0100836), via openFDA; the full label on DailyMed
What do FAERS reports show for rosuvastatin?
The FDA Adverse Event Reporting System holds 110,043 reports that list rosuvastatin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6,970 are coded as a death and 38,707 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 rosuvastatin?
13 other medicines are given the same way (oral) and in the same FDA class as rosuvastatin or labeled mainly for the same use (heart attack and coronary artery disease), the same class first. Heart attack and coronary artery disease lists all 38 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 |
|---|---|---|---|---|
| Atorvastatin | Heart attack and coronary artery disease, High cholesterol, High triglycerides | 61 labelers | $0.0228 per tablet 10 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 |
| Amlodipine and atorvastatin | Heart attack and coronary artery disease, High cholesterol, High triglycerides, Stroke prevention | 6 labelers | $1.34 per unit 10-40 mg | No current entry |
| Lovastatin | Heart attack and coronary artery disease, High cholesterol | 19 labelers | $0.0436 per tablet 20 mg tablet | No current entry |
| Pitavastatin | High cholesterol | 12 labelers | $0.954 per tablet 2 mg tablet | No current entry |
| Ezetimibe and simvastatin | Heart attack and coronary artery disease, High cholesterol | 7 labelers | $0.285 per unit 10-80 mg | No current entry |
| Fluvastatin | High cholesterol | 4 labelers | $2.88 per tablet 80 mg tablet | A presentation being discontinued |
Every medicine labeled for the same conditions as rosuvastatin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does rosuvastatin compare with medicines for the same use?
13 side-by-side pages set rosuvastatin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to rosuvastatin
- 13 medicines for the same use
- Other statins
- the pharmacologic class, with prices and generics
- Rosuvastatin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other