Pitavastatin

Generic name
pitavastatin
Brand names
Livalo (US, UK, Australia)
Drug class
HMG-CoA Reductase Inhibitor (Statin)
Form
Tablet (1 mg, 2 mg, 4 mg)
Route
Oral
Legal status
Prescription only. Confirmed Authorised in the US, UK, and Australia. Confirmed Never Authorised in Canada. New Zealand status could not be independently verified.

Supply Rules Vary

Trade names by country: United States · United Kingdom · Australia

Australia: Livalo (Abbott Products Australia) (5) · Full directory

What pitavastatin is and how it works

Pitavastatin is a statin (HMG-CoA reductase inhibitor) used, with diet, to lower LDL cholesterol in adults with primary hyperlipidemia and in patients 8 years and older with heterozygous familial hypercholesterolemia. (1)

Unlike some other statins, pitavastatin is only minimally affected by grapefruit and most CYP3A4-based drug interactions. It has one absolute drug interaction (cyclosporine) and two other interactions with specific dose limits (erythromycin, rifampin).

Mechanism of action: how pitavastatin works

Pitavastatin inhibits HMG-CoA reductase. Unlike simvastatin/lovastatin/atorvastatin, it undergoes minimal CYP450 metabolism (slight CYP2C9, essentially none via CYP3A4), instead relying on OATP1B1 hepatic uptake transport — this is why its grapefruit/CYP3A4-inhibitor interaction profile is much milder than those other statins'. Half-life ~12 hours, absolute bioavailability 51%, peak concentration at ~1 hour. (1)

What pitavastatin is used for

Primary hyperlipidemia

Used with diet to reduce LDL cholesterol in adults with primary hyperlipidemia. (1)

Heterozygous familial hypercholesterolemia (HeFH), age 8+

Approved for patients 8 years and older with heterozygous familial hypercholesterolemia specifically — not for familial hypercholesterolemia generally. (1)

Before taking pitavastatin

Do not take / not appropriate for

  • Do not take pitavastatin together with cyclosporine — this combination is contraindicated because it raises pitavastatin exposure about 4.6-fold. (cyclosporine co-administration) (1)
  • Do not take pitavastatin if you have acute liver failure or decompensated cirrhosis, or a known hypersensitivity to it. (liver failure/cirrhosis, hypersensitivity) (1)

Tell your clinician about

  • Every medicine and supplement you take, especially cyclosporine, erythromycin, rifampin, or fibrates.
  • Any liver disease.
  • If you are pregnant, planning pregnancy, or breastfeeding.
(1)

How to take pitavastatin

  • Usual dose range is 1-4 mg once daily, maximum 4 mg/day.
  • Take as directed by your prescriber, typically as long-term therapy.
  • Do not stop taking pitavastatin without consulting your doctor, but also do not continue it if you become pregnant without discussing with your prescriber first (see the Pregnancy section).
(1)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6) (7)

Missed dose

Contact your prescriber or pharmacist for guidance on a missed dose.

Overdose

No specific treatment for pitavastatin overdose is known. Contact Poison Control (in the US: 1-800-222-1222) or seek emergency care immediately for a suspected overdose. (1)

Side effects

Muscle pain, digestive symptoms, and back/limb pain are the most commonly reported side effects.

Muscle pain (myalgia), constipation, diarrhea, back pain, pain in an arm or leg

What to notice: Each occurred in 2% or more of people taking pitavastatin in clinical trials.

What to do: Mention persistent or bothersome symptoms to your clinician. (1)

Possible myopathy or rhabdomyolysis

What to notice: Unexplained muscle pain, tenderness, or weakness, especially with fever or dark urine.

What to do: Contact your clinician promptly; seek emergency care for severe symptoms. (7)

Serious warnings

Cyclosporine interaction — serious

Symptoms: A ~4.6-fold increase in pitavastatin exposure, raising myopathy/rhabdomyolysis risk.

Action: This combination is contraindicated — do not combine. (1)

Myopathy/rhabdomyolysis (class effect) — serious

Symptoms: Unexplained muscle pain, tenderness, or weakness, particularly with fever, dark urine, or feeling generally unwell.

Action: Contact your clinician promptly; seek emergency care for severe symptoms. (7)

Liver problems — serious

Symptoms: Yellowing of the skin or eyes, dark urine, unusual fatigue, or right upper abdominal pain.

Action: Contact your clinician promptly. (1)

Interactions

Medicine or testEffectAction
CyclosporineIncreases pitavastatin exposure about 4.6-fold.Contraindicated — do not combine. (1)
ErythromycinIncreases pitavastatin exposure about 2.8-fold.Do not exceed 1 mg of pitavastatin once daily if combined. (1)
RifampinIncreases pitavastatin peak level about 2-fold.Do not exceed 2 mg of pitavastatin once daily if combined. (1)
FibratesIncreased risk of myopathy and rhabdomyolysis.Your clinician will weigh this risk if combining the two. (1)
Grapefruit and grapefruit juiceUnlike some other statins, pitavastatin's interaction with grapefruit is minor (about 13-14% increase in exposure) — not considered clinically significant.No specific restriction needed based on this finding alone; still mention grapefruit consumption to your clinician. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Hepatic impairment

Mild liver impairment raises pitavastatin's peak level about 30% and total exposure about 60%; moderate impairment raises them about 2.7-fold and 3.8-fold, with half-life extending from about 8 hours (healthy) to 10 hours (mild) to 15 hours (moderate). Pitavastatin is not recommended in severe hepatic impairment, and is contraindicated in acute liver failure or decompensated cirrhosis. (1)

Renal impairment

Dose modification is recommended for moderate (eGFR 30-59) and severe (eGFR 15-29) kidney impairment, and for people on hemodialysis. The effect of mild kidney impairment has not been specifically studied. (1)

Pregnancy — a real, significant update from older guidance

Older sources (and some outdated labeling) described statins as an absolute 'Category X' contraindication in pregnancy. That is no longer the current guidance: in July 2021 the FDA requested this contraindication be removed for the entire statin class, including pitavastatin. The current label describes a mechanism-based caution — pitavastatin may theoretically cause fetal harm, and it's generally recommended to stop it once pregnancy is recognized — but it also explicitly notes that decades of observational data on statins in pregnancy have not identified a drug-associated increase in major birth defects. This is now an individualized decision between you and your prescriber, particularly relevant if you are at very high cardiovascular risk, not a blanket 'never use.' (1) (2)

Breastfeeding — still contraindicated

Unlike the pregnancy guidance above, breastfeeding while taking pitavastatin remains contraindicated per the current label. This distinction — a softened pregnancy stance but an unchanged breastfeeding contraindication — is a real, deliberate difference, not an inconsistency. (1)

Monitoring

Before starting

  • Review liver disease history.
  • Review all current medicines, especially cyclosporine, erythromycin, rifampin, and fibrates.
  • Discuss pregnancy, pregnancy plans, and breastfeeding directly with your prescriber given the real, updated pregnancy guidance above.

During treatment

  • Watch for unexplained muscle pain, tenderness, or weakness.
  • Watch for signs of liver problems (jaundice, dark urine, unusual fatigue).
(1)

Storage

Store at controlled room temperature per the product's specific packaging instructions.

Study the drug class: Statins

Professional information

Clinician-facing context only. Non-US product, brand, and supply information is limited to what is explicitly documented in country-brand-verification.json and country-supply-classification.json.

United States

Indication: Primary hyperlipidemia; HeFH age 8+

Dose summary: 1-4mg once daily, max 4mg/day. Interaction dose caps: 1mg with erythromycin, 2mg with rifampin. Cyclosporine contraindicated.

Renal context: Dose modification for moderate/severe impairment and hemodialysis; mild impairment not studied. (1)

United Kingdom

Indication: Authorised — real UK licence numbers confirmed (PL 32363/0001-8, PL 32363/0011-14).

Dose summary: Not itemized in this pass beyond confirming licensure.

Renal context: Not itemized. (4)

Australia

Indication: Authorised — ARTG Numbers 176640, 176658, 176659 confirmed.

Dose summary: Not itemized in this pass.

Renal context: Not itemized. (5)

Canada

Indication: Never authorised — confirmed absent from the Health Canada Drug Product Database.

Dose summary: Not applicable.

Renal context: Not available. (3)

New Zealand

Indication: Unable to verify.

Dose summary: Not available.

Renal context: Not available. (6)

Mechanism of action

Hepatic guidance

Mild impairment: Cmax +30%/AUC +60%. Moderate: Cmax +2.7x/AUC +3.8x, half-life extends to ~15h. Not recommended in severe impairment; contraindicated in acute liver failure/decompensated cirrhosis.

Overdose note

No specific treatment known; supportive care and poison control guidance. (1)

Frequently asked questions

Is pitavastatin safe during pregnancy?

This is more nuanced than older guidance suggests. The FDA removed the absolute pregnancy contraindication for all statins, including pitavastatin, in 2021. The current label still recommends stopping it once pregnancy is recognized as a precaution, but also notes that decades of statin-class pregnancy data have not shown a clear increase in birth defects. This is now an individualized decision with your prescriber, not an automatic 'never.' (1) (2)

Can I have grapefruit while taking pitavastatin?

Pitavastatin's grapefruit interaction is real but minor (about 13-14% increase in blood levels) and not considered clinically significant — unlike simvastatin or lovastatin, which have much more severe grapefruit interactions. (1)

Can I take pitavastatin with cyclosporine?

No — this combination is contraindicated. Cyclosporine raises pitavastatin exposure about 4.6-fold, increasing the risk of muscle problems. (1)

What is the mechanism of action of pitavastatin?

Pitavastatin inhibits HMG-CoA reductase. Unlike simvastatin/lovastatin/atorvastatin, it undergoes minimal CYP450 metabolism (slight CYP2C9, essentially none via CYP3A4), instead relying on OATP1B1 hepatic uptake transport — this is why its grapefruit/CYP3A4-inhibitor interaction profile is much milder than those other statins'. Half-life ~12 hours, absolute bioavailability 51%, peak concentration at ~1 hour. (1)

What is the generic name of Pitavastatin?

The generic name is pitavastatin. It is sold under brand names including Livalo (US, UK, Australia). (1)

What class of drug is pitavastatin?

Pitavastatin is classed as: HMG-CoA Reductase Inhibitor (Statin). (1)

References

  1. LIVALO (pitavastatin) tablets — prescribing informationDailyMed / FDA (Kowa) · United States · accessed 2026-07-27 · source 1
  2. FDA requests removal of strongest warning against using statins in pregnancy (July 2021)US FDA, Drug Safety Communication · United States (class-wide) · accessed 2026-07-27 · source 2
  3. DPD active-ingredient API query for pitavastatin (zero results)Health Canada Drug Product Database, public API · Canada · accessed 2026-07-27 · source 3
  4. Pitavastatin film-coated tablets, UK Licence Nos PL 32363/0001-8 and PL 32363/0011-14 (Kowa Pharmaceutical Europe)MHRA Products · United Kingdom · accessed 2026-07-27 · source 4
  5. Australian Public Assessment Report for PitavastatinTherapeutic Goods Administration (Australia), AusPAR · Australia · accessed 2026-07-27 · source 5
  6. No dedicated NZ data sheet found for pitavastatin/LivaloMedsafe (absence check) · New Zealand · accessed 2026-07-27 · source 6
  7. HMG-CoA Reductase InhibitorsStatPearls / peer-reviewed literature · class_level_not_country_specific · accessed 2026-07-27 · source 7

Brand names by country

Single-ingredient pitavastatin names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • ZYPITAMAG2 mg, 4 mg · zydus lifesciences limited
  • Livalo1.045 mg, 4.18 mg, 2.09 mg · kowa pharmaceuticals america, inc.

United Kingdom

  • Pitavastatin (Kowa Pharmaceutical Europe) (4)MHRA licensed PL 32363 · 1 mg, 2 mg, 4 mg · Kowa Pharmaceutical Europe Co Ltd

Australia

  • Livalo (Abbott Products Australia) (5)ARTG registered · not specified in fetched source · Abbott Products (Australia) Pty Ltd
View brands in additional countries.

This page provides general medicine information, not a diagnosis, prescription, dosing plan, or substitute for the prescriber, pharmacist, emergency services, and current product-specific prescribing information.

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