Pitavastatin: uses, dosing, side effects & brands

Pitavastatin is a hmg-coa reductase inhibitor sold in the U.S. under 4 brand and generic names, for hypercholesterolemia, hyperlipoproteinemias and hypertriglyceridemia. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Drug class: Hmg-Coa Reductase Inhibitor
Treats: Hypercholesterolemia, Hyperlipoproteinemias and Hypertriglyceridemia
Available as: Tablet
Sold as: 4 products — Pitavastatin Calcium, Nikita and Livalo, and others
Prescription?: Prescription only
Generic available?: Yes
Half-life: about 12 hours
What the pharmacy pays: about $38 for a 30-count supply — not your price

How pitavastatin is dosed

From the FDA label for Pitavastatin Calcium (application ANDA206015). Other pitavastatin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

Take orally once daily with or without food at the same time each day. ( 2.1 ) For patients requiring a high-intensity statin or are unable to achieve their LDL-C goal receiving pitavastatin tablets 4 mg daily, prescribe alternative LDL-C-lowering treatment. ( 2.1 ) Assess LDL-C when clinically appropriate, as early as 4 weeks after initiation of pitavastatin tablets, and adjust the dosage if necessary. ( 2.1 ) Recommended dosage is 2 mg to 4 mg once daily. Maximum recommended dosage is 4 mg once daily. ( 2.2 ) Recommended starting dosage for patients with moderate and severe renal impairment and end-stage renal disease on hemodialysis is 1 mg once daily. Maximum recommended dosage is 2 mg once daily. ( 2.3 ) See full prescribing information for pitavastatin tablets dosage modifications due to drug interactions. ( 2.4 ) 2.1 Important Dosage and Administration Information Take pitavastatin tablets orally once daily with or without food at the same time each day. For patients that require a high-intensity statin or are unable to achieve their LDL-C goal receiving pitavastatin tablets 4 mg daily, prescribe alternative LDL-C-lowering treatment. Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating pitavastatin tablets, and adjust the dosage if necessary. 2.2 Recommended Dosage for Adults and Pediatric Patients Aged 8 Years and Older The recommended dosage…

Pitavastatin side effects

The following serious adverse reactions are discussed in other sections of the labeling: Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1) ] Immune-Mediated Necrotizing Myopathy [see Warning and Precautions (5.2) ] Hepatic Dysfunction [see Warning and Precautions (5.3) ] Increases in HbA1c and Fasting Serum Glucose Levels [see Warning and Precautions (5.4) ] . The most frequent adverse reactions (rate ≥ 2%) were myalgia, constipation, diarrhea, back pain, and pain in extremity. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of one drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adverse Reactions in Adults with Primary Hyperlipidemia In 10 controlled clinical studies and 4 subsequent open-label extension studies, 3,291 adult patients with primary hyperlipidemia were administered pitavastatin 1 mg to 4 mg daily. The mean continuous exposure of pitavastatin (1 mg to 4 mg) was 36.7 weeks (median 51.1 weeks). The mean age of the patients was 60.9 years (range; 18 years to 89 years) and 52% were females. Approximately 93% of the…

Who shouldn’t take pitavastatin

Pitavastatin tablets are contraindicated in the following conditions: Concomitant use of cyclosporine [see Drug Interactions (7) ]. Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3) ] . Hypersensitivity to pitavastatin or any excipents in pitavastatin tablets. Hypersensitivity reactions including angioedema, rash, pruritus, and urticaria have been reported with pitavastatin tablets [see Adverse Reactions (6.1) ]. Cyclosporine ( 4 , 7 ) Active liver failure or decompensated cirrhosis ( 4 , 5.3 ) Hypersensitivity to pitavastatin or any excipients in pitavastatin tablets ( 4 )

Pitavastatin drug interactions

Table 2 includes a list of drugs that increase the risk of myopathy and rhabdomyolysis when administered concomitantly with pitavastatin and instructions for preventing or managing drug interactions [see Warnings and Precautions (5.1) , Clinical Pharmacology (12.3) ]. Table 2: Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Pitavastatin Cyclosporine Clinical Impact: Cyclosporine significantly increases pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis. Intervention: Concomitant use of cyclosporine with pitavastatin is contraindicated [see Contraindications (4) ]. Gemfibrozil Clinical Impact: Gemfibrozil may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of gemfibrozil with statins, including pitavastatin. Intervention: Avoid concomitant use of gemfibrozil with pitavastatin. Erythromycin Clinical Impact: Erythromycin significantly increases pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis. Intervention: In patients taking erythromycin, do not exceed pitavastatin 1 mg once daily [see Dosage and Administration (2.4) ]. Rifampin Clinical Impact: Rifampin significantly increases peak pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis. Intervention: In patients taking rifampin, do not exceed pitavastatin 2 mg once daily [see Dosage and Administration (2.4) ]. Fibrates Clinical Impact: Fibrates may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of fibrates with statins, including pitavastatin. Intervention: Consider if the benefit of using fibrates concomitantly with pitavastatin outweighs the increased risk of myopathy and rhabdomyolysis. N i a c in Clinical Impact: The risk of myopathy and rhabdomyolysis may be increased with concomitant use of lipid-modifying doses (≥1 g/day) of niacin with pitavastatin. Intervention: Consider if the benefit of using lipid-modifying doses (≥1 g/day) of niacin concomitantly with pitavastatin outweighs the increased risk of myopathy and rhabdomyolysis. Colchicine Clinical Impact: Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with statins, including pitavastatin. Intervention: Consider the risk/benefit of concomitant use of colchicine with pitavastatin. See full prescribing information for details regarding concomitant use of pitavastatin with other drugs that increase the risk of myopathy and rhabdomyolysis. ( 2.4 , 7 )

Every pitavastatin product we track (4)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Pitavastatin products
#	Drug	Rating	Type	Form	Generic?	Pharmacy pays
1	Pitavastatin Calcium	68/100	Prescription	Tablet	Generic	$38	View →
2	Nikita	64/100	Prescription	Tablet	Generic	$38	View →
3	Livalo	Not yet rated	Prescription	Tablet	Generic	$38	View →
4	Zypitamag	Not yet rated	Prescription	Tablet	No data	—	View →

What pitavastatin pills look like

Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.

Pitavastatin pill imprints
Imprint	Strength	Colour	Shape	Maker
1;KC	1.045 mg	white	round	—
2;KC	2.09 mg	white	round	—
4;KC	4.18 mg	white	round	—
P2	2 mg	white	round	—
P1	1 mg	white	round	—
P4	4 mg	white	round	—
58;OP	2.09 mg	white	round	—
59;OP	4.18 mg	white	round	—
57;OP	1.045 mg	white	round	—
H1;P	1 mg	white	round	—
H2;P	2 mg	white	round	—
H4;P	4 mg	white	round	—

Pitavastatin recalls

From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.

How long pitavastatin keeps

No pitavastatin label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.

Does pitavastatin expire? The in-use limits and storage rules from its labels

Pitavastatin and breastfeeding

From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.

No published information exists on the use of pitavastatin during breastfeeding. It is 99% bound to plasma proteins, so amounts in milk are likely low. Because of a concern with disruption of infant lipid metabolism, the consensus is that pitavastatin should not be used during breastfeeding. However, others have argued that children homozygous for familial hypercholesterolemia are treated with statins beginning at 1 year of age, that statins have low oral bioavailability, and risks to the breastfed infant are low, especially with rosuvastatin and pravastatin. Until more data become available, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Full LactMed record for pitavastatin: levels in milk, effects in breastfed infants, and the drugs it would consider instead

National Institute of Child Health and Human Development, record revised July 15, 2026. LactMed states its information is not a substitute for professional judgement.

What people report to the FDA about pitavastatin

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1,816 reports naming pitavastatin, and the FDA flagged 93% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

diarrhoea112 reports
nausea100 reports
pyrexia89 reports
decreased appetite81 reports
dizziness81 reports
malaise81 reports
dyspnoea79 reports
fall76 reports

Read these as a signal, not a rate. A report does not mean pitavastatin caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.

Source: openFDA drug/event (FAERS), retrieved July 27, 2026.

How long pitavastatin stays in your system

The elimination half-life of pitavastatin is about 12 hours. This is the mean plasma elimination (terminal) half-life the label reports in §12.3 for typical adults; the label gives no separate distribution-phase figure. Pitavastatin is not a prodrug. Its main metabolite is pitavastatin lactone (formed by UGT glucuronidation, with only minimal CYP450 involvement); the label does not describe the lactone as an active moiety and gives no half-life for it, so there is no known active metabolite that outlasts the parent. Liver impairment lengthens it: in the hepatic-impairment study, mean half-life was 15 hours with moderate impairment and 10 hours with mild impairment, versus 8 hours in the healthy volunteers of that same study (a lower figure than the ~12-hour overall mean, so treat these as within-study comparisons rather than absolute values). For kidney impairment the label reports higher exposure (AUC roughly 102% higher in moderate impairment, 86% higher in hemodialysis patients, 36% higher in severe impairment) but does not state a changed half-life. In adults 65 and older, Cmax and AUC were about 10% and 30% higher; again no half-life change is stated. This is not a drug-test detection window and not dosing guidance.

DailyMed — PITAVASTATIN CALCIUM (pitavastatin) tablet, film coated — FDA label, §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.

Related calculators

How long it stays in your system →

Frequently asked questions

What is pitavastatin?

Pitavastatin Calcium is a HMG-CoA reductase inhibitor used to treat Hypercholesterolemia, Hyperlipoproteinemias, Hypertriglyceridemia.

What kind of drug is pitavastatin?

The FDA classifies pitavastatin as a hmg-coa reductase inhibitor. Statins block HMG-CoA reductase, the key enzyme the liver uses to make cholesterol. With less cholesterol being produced, the liver pulls more LDL ("bad") cholesterol out of the blood, lowering overall blood cholesterol levels. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.

How long does pitavastatin stay in your system?

The elimination half-life of pitavastatin is about 12 hours — that is how long the body takes to clear half of a dose. This is the mean plasma elimination (terminal) half-life the label reports in §12.3 for typical adults; the label gives no separate distribution-phase figure. Pitavastatin is not a prodrug. Its main metabolite is pitavastatin lactone (formed by UGT glucuronidation, with only minimal CYP450 involvement); the label does not describe the lactone as an active moiety and gives no half-life for it, so there is no known active metabolite that outlasts the parent. Liver impairment lengthens it: in the hepatic-impairment study, mean half-life was 15 hours with moderate impairment and 10 hours with mild impairment, versus 8 hours in the healthy volunteers of that same study (a lower figure than the ~12-hour overall mean, so treat these as within-study comparisons rather than absolute values). For kidney impairment the label reports higher exposure (AUC roughly 102% higher in moderate impairment, 86% higher in hemodialysis patients, 36% higher in severe impairment) but does not state a changed half-life. In adults 65 and older, Cmax and AUC were about 10% and 30% higher; again no half-life change is stated. This is not a drug-test detection window and not dosing guidance. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.

Can you take pitavastatin with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run pitavastatin against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What brand names is pitavastatin sold under?

We track 4 pitavastatin-containing products in the U.S.: Pitavastatin Calcium, Nikita, Livalo and Zypitamag. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.

What forms does pitavastatin come in?

Across the brands we track, pitavastatin is currently marketed as tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic pitavastatin?

Yes. Our catalog lists 1 generic pitavastatin product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.

Has pitavastatin been recalled?

The FDA's Enforcement database lists at least 5 recall records whose product description mentions pitavastatin. The most recent: Pitavastatin Tablets (Feb 3, 2026). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.

Cite this page

APA: pharmaranks. (2026, July 24). Pitavastatin: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/pitavastatin
MLA: “Pitavastatin: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/pitavastatin.

We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.

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.

Read the full FDA label for pitavastatin on DailyMed (NIH) ↗.