Prescription medication · HMG-CoA Reductase Inhibitor (Statin)
pitavastatin
Also sold as Livalo. Pitavastatin is used to lower LDL-C (bad cholesterol) in adults.
Data updated 2026-05-15
- 3,148
- FDA reportsLightly reported
- 9
- InteractionsFew interactions
- 84% less
- Generic vs brandHuge savings
- 3
- Recall records
What the data shows
pitavastatin (Livalo) is a prescription HMG-CoA Reductase Inhibitor (Statin), among the least-reported drugs the FDA tracks (3,148 FDA reports), whose generic runs roughly half the brand price or less (84% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
pitavastatin (Livalo) is a prescription HMG-CoA Reductase Inhibitor (Statin). Pitavastatin is used to lower LDL-C (bad cholesterol) in adults.
Pitavastatin (Livalo) is a drug that helps lower bad cholesterol (LDL-C) in your blood. It is used along with a healthy diet.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$10.23/unit
Generic Price
$1.65/unit
Generic Savings
84%
Generic Available
Yes (7 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Pitavastatin is used to lower LDL-C (bad cholesterol) in adults.
Common side effects
Muscle pain, Constipation, Back pain
Key warnings
Pitavastatin can cause muscle problems, including myopathy and rhabdomyolysis.
The sections below are summarized in plain English from pitavastatin's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Pitavastatin belongs to a class of drugs called statins. It works by blocking a substance your body needs to make cholesterol. This helps to lower the amount of cholesterol in your blood.
How to Take It
Take pitavastatin once a day, with or without food. Try to take it at the same time each day. The usual dose is between 2 mg and 4 mg daily. Your doctor may adjust your dose based on your cholesterol levels.
This is a plain-language summary of pitavastatin's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Do not take pitavastatin if you are pregnant. It can harm your unborn baby. Breastfeeding is also not recommended while taking this medicine.
This is a plain-language summary of pitavastatin's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
This is a plain-language summary of pitavastatin's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store pitavastatin at room temperature, away from light.
Side Effects (from patient reports)
Based on 3,148 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for pitavastatin, by number of reports
- Muscle pain
Muscle pain
408 reports
- Diarrhea
Diarrhea
335 reports
- Feeling dizzy
Feeling dizzy
285 reports
- Difficulty breathing
Difficulty breathing
281 reports
- Loss of appetite
Loss of appetite
280 reports
- Fever
Fever
278 reports
- Feeling sick to your stomach
Feeling sick to your stomach
274 reports
- Feeling tired
Feeling tired
273 reports
- Itching
Itching
272 reports
- Headache
Headache
269 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for pitavastatin each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where pitavastatin sits
pitavastatin has more FDA adverse-event reports than 18% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is pitavastatin; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 3,148 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
3,148
Reports Mentioning Death
561
17.8% of reports — not proof of cause
Hospitalization Reports
1,405
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | MYALGIA | 408 |
| 2 | DIARRHOEA | 335 |
| 3 | DIZZINESS | 285 |
| 4 | DYSPNOEA | 281 |
| 5 | DECREASED APPETITE | 280 |
| 6 | PYREXIA | 278 |
| 7 | NAUSEA | 274 |
| 8 | FATIGUE | 273 |
| 9 | PRURITUS | 272 |
| 10 | HEADACHE | 269 |
| 11 | MALAISE | 265 |
| 12 | FALL | 264 |
| 13 | ARTHRALGIA | 261 |
| 14 | ASTHENIA | 255 |
| 15 | ALTERED STATE OF CONSCIOUSNESS | 250 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Pitavastatin can cause muscle problems, including myopathy and rhabdomyolysis. Tell your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have a fever or feel sick. Pitavastatin can also cause liver problems. Your doctor may do blood tests to check your liver before and during treatment.
Known Drug Interactions
Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with pitavastatin tablets Cyclosporine Clinical Impact: Cyclosporine significantly increases pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis. Intervention: Concomitant use of cyclosporine with pitavastatin tablets is contraindicated [see Contraindications ( 4 )].
Mechanism: Cyclosporine stops the body from clearing pitavastatin, causing the medicine to build up to unsafe levels in the blood. This significantly increases the risk of serious muscle damage and kidney problems.
What to do: Do not take these two medications together. This combination is contraindicated because it is considered too dangerous.
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 tablets 1 mg once daily [see Dosage and Administration ( 2.4 )].
Mechanism: Erythromycin slows down how the body processes pitavastatin, which leads to higher amounts of the drug in your system. Having too much pitavastatin in the blood can cause severe muscle breakdown.
What to do: If you must take both drugs, your doctor should limit your pitavastatin dose to no more than 1 mg once daily.
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 tablets 2 mg once daily [see Dosage and Administration ( 2.4 )].
Mechanism: Rifampin causes the levels of pitavastatin in the blood to spike higher than they should. These high levels increase the chance of experiencing dangerous muscle injury.
What to do: If you are taking rifampin, your daily dose of pitavastatin should not exceed 2 mg.
Colchicine Clinical Impact: Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with statins, including pitavastatin tablets. Intervention: Consider the risk/benefit of concomitant use of colchicine with pitavastatin tablets.
Mechanism: Taking these two drugs together can increase the risk of serious muscle damage.
What to do: Your doctor should carefully consider if the benefits of taking both drugs are worth the risks.
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 tablets. Intervention: Avoid concomitant use of gemfibrozil with pitavastatin tablets.
Mechanism: Gemfibrozil can cause muscle problems on its own, and the risk becomes even higher when it is mixed with a statin.
What to do: You should not take these two medications together.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I take pitavastatin with other medications?
How long will I need to take pitavastatin?
Will I still need to follow a diet while taking pitavastatin?
What should I do if I experience muscle pain?
Can pitavastatin affect my liver?
Are there any foods I should avoid while taking pitavastatin?
What is the maximum dose of pitavastatin?
What should I do if I have kidney problems?
Can I drink alcohol while taking pitavastatin?
What are the symptoms of an allergic reaction to pitavastatin?
What are the common side effects of pitavastatin?
Does pitavastatin interact with other medications?
What drug class is pitavastatin?
Is there a generic version of pitavastatin?
Is pitavastatin safe during pregnancy?
Has pitavastatin been recalled?
Active Recalls
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Annora Pharma Private Limited
Failed Impurity/Degradation Specifications
AvKARE
Failed Impurities/Degradation Specifications.
Orient Pharma Co., Ltd. Yunlin Plant
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Medication Guides
Understanding Drug Interactions
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Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for pitavastatin
The FDA label for pitavastatin (sold under brand names such as Livalo) classifies it as a prescription-only medication in the HMG-CoA Reductase Inhibitor (Statin) class. Pitavastatin is used to lower LDL-C (bad cholesterol) in adults. Official labeling lists 5 commonly reported side effects, including Muscle pain, Constipation, Back pain.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 3,148 voluntary reports. The database also lists 9 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $1.65 versus $10.23 for the brand - a 84% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 3 recall records on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: January 16, 2026
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages