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.
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
- Myalgia
Myalgia
408 reports
- Diarrhoea
Diarrhoea
335 reports
- Dizziness
Dizziness
285 reports
- Dyspnoea
Dyspnoea
281 reports
- Decreased Appetite
Decreased Appetite
280 reports
- Pyrexia
Pyrexia
278 reports
- Nausea
Nausea
274 reports
- Fatigue
Fatigue
273 reports
- Pruritus
Pruritus
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) 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.
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.
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.
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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
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?
What pregnancy or breastfeeding source fields are listed for pitavastatin?
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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Other drugs grouped near pitavastatin - same-class peers and common alternatives.
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cholestyramine
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Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for pitavastatin: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 3,148.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 17.82%.
- doxepin Δ 0.03 pts · 9,780 reports · Tricyclic Antidepressant (TCA) 17.85%death share
- clozapine Δ 0.14 pts · 121,298 reports · Atypical Antipsychotic 17.68%death share
- fluconazole Δ 0.17 pts · 67,703 reports · Azole Antifungal 17.99%death share
- fondaparinux Δ 0.17 pts · 7,980 reports · Factor Xa Inhibitor (Injectable) 17.99%death share
Medication Guides
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FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: January 16, 2026
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
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 from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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