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zinc sulfate Side Effects

Also known as: Zinc, Orazinc

Analysis of 2,699 adverse event reports submitted to the FDA from 2004 to 2025.

Total Reports

2,699

Death-Related

383

14.2% of reports

Hospitalizations

1,216

45.1% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

DIARRHOEA
215
FATIGUE
172
NAUSEA
166
DEATH
153
OFF LABEL USE
147
PAIN
146
DYSPNOEA
136
VOMITING
136
PYREXIA
127
HEADACHE
99
ASTHENIA
98
ANAEMIA
95
PNEUMONIA
93
BACK PAIN
90
FALL
89
DRUG INEFFECTIVE
88
DIZZINESS
86
MALAISE
84
NEUTROPENIA
84
HYPOTENSION
83

Who Reports Side Effects

Gender Distribution

Female 1,303 (52%)
Male 1,199 (48%)
Unknown 1

Age Distribution

0-17 117 (6%)
18-44 314 (16%)
45-64 686 (36%)
65-74 468 (24%)
75+ 341 (18%)

Reporting Trend by Year

2004 2025

Reactions in Death Reports

Top reactions reported in 383 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 151
ANAEMIA 36
PULMONARY EMBOLISM 33
COVID-19 31
THROMBOCYTOPENIA 29
RENAL FAILURE 27
ACUTE KIDNEY INJURY 26
CARDIAC ARREST 26
RESPIRATORY FAILURE 26
PLATELET COUNT DECREASED 25
RESPIRATORY TRACT INFECTION 25
RESPIRATORY TRACT INFECTION VIRAL 25
PNEUMONIA 24
RESPIRATORY TRACT INFECTION BACTERIAL 24
HYPOTENSION 23
SEPSIS 21
DIARRHOEA 19
NAUSEA 18
CARDIO-RESPIRATORY ARREST 17
HYPOXIA 17

Reactions in Hospitalization Reports

Top reactions in 1,216 reports where hospitalization was an outcome.

Reaction Reports
DIARRHOEA 118
PAIN 102
PYREXIA 102
VOMITING 93
DYSPNOEA 83
PNEUMONIA 77
NAUSEA 76
NEUTROPENIA 69
ANAEMIA 68
ASTHENIA 67
FALL 65
MALAISE 65
URINARY TRACT INFECTION 64
BACK PAIN 61
CHILLS 60
FATIGUE 60
HYPOTENSION 59
ABDOMINAL PAIN 57
CROHN^S DISEASE 51
ACUTE KIDNEY INJURY 50

Nearby — Related Medications

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What the FAERS Data Reveals About zinc sulfate Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 2,699 voluntary reports linked to zinc sulfate and its brand equivalents (Zinc, Orazinc), spanning 2004 through 2025. Of those, 383 (14.2%) listed death as an outcome and 1,216 (45.1%) 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 48% male; age distribution skews toward 45-64, with 686 reports in that bracket. The single most reported reaction is diarrhoea with 215 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.