What the label lists and what reports show
Zinc sulfate side effects
Zinc sulfate's FDA label lists its adverse reactions in its own words. FAERS holds 2,808 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is diarrhoea (223 reports).
- Generic listed
Check it at the source: the zinc sulfate FDA label on DailyMed (effective October 1, 2020, American Regent, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsNo zinc-related adverse reactions have been reported in clinical studies or post-marketing reports in patients receiving intravenously administered parenteral nutrition solutions containing zinc sulfate within the recommended dosage range. The following were identified in clinical studies or post-marketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Adverse reactions with other components of parenteral nutrition solutions: Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions ( 5.1 )] Vein damage and thrombosis [see Warnings and Precautions ( 5.2 )] Aluminum toxicity [see Warnings and Precautions ( 5.3 )] Adverse reactions with the use of zinc-containing products administered by …
Source: FDA drug label, American Regent, Inc., effective October 1, 2020 (SPL set 4b528c88-07a0-4dce-84c6-ccd32555bbff), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,808 reports list zinc sulfate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 390 are coded as a death and 1,264 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 2 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Zinc sulfate: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions