pitavastatin Side Effects
Also known as: Livalo
Analysis of 3,148 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
3,148
Death-Related
561
17.8% of reports
Hospitalizations
1,405
44.6% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 561 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| HAEMORRHAGIC STROKE | 233 |
| CARDIO-RESPIRATORY ARREST | 229 |
| TACHYCARDIA | 229 |
| DIARRHOEA | 227 |
| ALTERED STATE OF CONSCIOUSNESS | 223 |
| DYSPNOEA | 221 |
| SEPSIS | 221 |
| FALL | 219 |
| OCULAR DISCOMFORT | 217 |
| PRURITUS | 216 |
| AMAUROSIS FUGAX | 215 |
| HAEMATEMESIS | 215 |
| ASCITES | 214 |
| EYE PAIN | 214 |
| DIZZINESS | 213 |
| HEAD DISCOMFORT | 213 |
| ARTHRALGIA | 212 |
| BLINDNESS | 212 |
| CHILLS | 212 |
| COMA | 211 |
Reactions in Hospitalization Reports
Top reactions in 1,405 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| PYREXIA | 92 |
| PNEUMONIA | 73 |
| DIARRHOEA | 67 |
| INTERSTITIAL LUNG DISEASE | 59 |
| DECREASED APPETITE | 58 |
| MALAISE | 55 |
| ANAEMIA | 54 |
| HEPATIC FUNCTION ABNORMAL | 53 |
| OFF LABEL USE | 51 |
| NAUSEA | 44 |
| CARDIAC FAILURE | 43 |
| DYSPNOEA | 42 |
| ACUTE KIDNEY INJURY | 41 |
| DIZZINESS | 40 |
| CONDITION AGGRAVATED | 39 |
| DEHYDRATION | 39 |
| FALL | 39 |
| CEREBRAL INFARCTION | 36 |
| RENAL IMPAIRMENT | 35 |
| FEBRILE NEUTROPENIA | 33 |
Nearby — Related Medications
What the FAERS Data Reveals About pitavastatin Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 3,148 voluntary reports linked to pitavastatin and its brand equivalents (Livalo), spanning 2004 through 2025. Of those, 561 (17.8%) listed death as an outcome and 1,405 (44.6%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 48% were female and 52% male; age distribution skews toward 65-74, with 772 reports in that bracket. The single most reported reaction is myalgia with 408 submissions, followed by diarrhoea and dizziness.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.