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ivermectin Side Effects

Also known as: Stromectol

Analysis of 5,936 adverse event reports submitted to the FDA from 2004 to 2025.

Total Reports

5,936

Death-Related

540

9.1% of reports

Hospitalizations

2,144

36.1% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

DRUG INEFFECTIVE
728
HEADACHE
634
ASTHENIA
588
PYREXIA
484
OFF LABEL USE
463
PRODUCT USE IN UNAPPROVED INDICATION
445
PRURITUS
374
DIARRHOEA
286
OCULAR HYPERAEMIA
255
COMA
246
CONJUNCTIVAL HAEMORRHAGE
238
ERYTHEMA
237
BACK PAIN
225
VERTIGO
217
ARTHRALGIA
203
VOMITING
197
RASH
194
FATIGUE
169
GAIT DISTURBANCE
165
NAUSEA
158

Who Reports Side Effects

Gender Distribution

Female 2,666 (52%)
Male 2,392 (47%)
Unknown 31

Age Distribution

0-17 303 (7%)
18-44 1,300 (32%)
45-64 1,362 (34%)
65-74 579 (14%)
75+ 521 (13%)

Reporting Trend by Year

2004 2025

Reactions in Death Reports

Top reactions reported in 540 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 99
DRUG INEFFECTIVE 81
STRONGYLOIDIASIS 61
COMA 55
PYREXIA 50
SEPTIC SHOCK 48
ASTHENIA 45
MULTIPLE ORGAN DYSFUNCTION SYNDROME 42
OFF LABEL USE 37
SEPSIS 37
RESPIRATORY FAILURE 32
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS 31
PNEUMONIA 30
DIARRHOEA 24
CONDITION AGGRAVATED 23
HEADACHE 23
ACUTE KIDNEY INJURY 22
HYPOTENSION 21
HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS 20
CARDIAC ARREST 19

Reactions in Hospitalization Reports

Top reactions in 2,144 reports where hospitalization was an outcome.

Reaction Reports
ASTHENIA 538
HEADACHE 493
PYREXIA 426
OCULAR HYPERAEMIA 240
CONJUNCTIVAL HAEMORRHAGE 238
COMA 229
BACK PAIN 202
DIARRHOEA 202
VERTIGO 200
ARTHRALGIA 147
GAIT DISTURBANCE 144
VOMITING 143
URINARY INCONTINENCE 130
ENCEPHALOPATHY 124
OFF LABEL USE 111
PRURITUS 110
MYALGIA 105
DRUG INEFFECTIVE 102
HYPOTENSION 101
DEPRESSED LEVEL OF CONSCIOUSNESS 100

Nearby — Related Medications

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What the FAERS Data Reveals About ivermectin Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 5,936 voluntary reports linked to ivermectin and its brand equivalents (Stromectol), spanning 2004 through 2025. Of those, 540 (9.1%) listed death as an outcome and 2,144 (36.1%) 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, 52% were female and 47% male; age distribution skews toward 45-64, with 1,362 reports in that bracket. The single most reported reaction is drug ineffective with 728 submissions, followed by headache and asthenia.

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.