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lovastatin Side Effects

Also known as: Mevacor, Altoprev

Analysis of 25,229 adverse event reports submitted to the FDA from 2001 to 2025.

Total Reports

25,229

Death-Related

2,045

8.1% of reports

Hospitalizations

6,900

27.3% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

DRUG INEFFECTIVE
1,661
FATIGUE
1,518
NAUSEA
1,396
DIARRHOEA
1,251
DYSPNOEA
1,209
DIZZINESS
1,147
PAIN
1,062
HEADACHE
1,002
ASTHENIA
971
FALL
893
ARTHRALGIA
812
OFF LABEL USE
806
DEATH
783
VOMITING
750
CHRONIC KIDNEY DISEASE
747
PAIN IN EXTREMITY
746
WEIGHT DECREASED
693
COUGH
681
MALAISE
679
PNEUMONIA
671

Who Reports Side Effects

Gender Distribution

Female 13,981 (58%)
Male 10,054 (42%)
Unknown 27

Age Distribution

0-17 75 (0%)
18-44 617 (4%)
45-64 5,392 (34%)
65-74 4,835 (30%)
75+ 5,090 (32%)

Reporting Trend by Year

2001 2025

Reactions in Death Reports

Top reactions reported in 2,045 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 779
COMPLETED SUICIDE 146
PNEUMONIA 127
CARDIAC ARREST 108
RENAL FAILURE 108
DYSPNOEA 104
DISEASE PROGRESSION 102
CARDIO-RESPIRATORY ARREST 97
RESPIRATORY FAILURE 89
FATIGUE 87
CARDIAC FAILURE CONGESTIVE 86
ASTHENIA 81
MYOCARDIAL INFARCTION 81
HYPOTENSION 80
NAUSEA 79
FALL 76
CHRONIC KIDNEY DISEASE 71
PAIN 70
SEPSIS 70
TOXICITY TO VARIOUS AGENTS 69

Reactions in Hospitalization Reports

Top reactions in 6,900 reports where hospitalization was an outcome.

Reaction Reports
PNEUMONIA 529
DYSPNOEA 528
FALL 496
NAUSEA 449
ASTHENIA 441
FATIGUE 425
DIARRHOEA 397
VOMITING 356
DIZZINESS 349
PAIN 323
MYOCARDIAL INFARCTION 316
CARDIAC FAILURE CONGESTIVE 293
DEHYDRATION 291
RENAL FAILURE 279
CHEST PAIN 274
ATRIAL FIBRILLATION 267
ANAEMIA 265
URINARY TRACT INFECTION 264
CEREBROVASCULAR ACCIDENT 251
HEADACHE 249

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What the FAERS Data Reveals About lovastatin Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 25,229 voluntary reports linked to lovastatin and its brand equivalents (Mevacor, Altoprev), spanning 2001 through 2025. Of those, 2,045 (8.1%) listed death as an outcome and 6,900 (27.3%) 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, 58% were female and 42% male; age distribution skews toward 45-64, with 5,392 reports in that bracket. The single most reported reaction is drug ineffective with 1,661 submissions, followed by fatigue and nausea.

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.