What the label lists and what reports show

Ergocalciferol side effects

Ergocalciferol's FDA label lists its adverse reactions in its own words. FAERS holds 382,573 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 fatigue (37,944 reports).

Generic listed

Check it at the source: the ergocalciferol FDA label on DailyMed (effective September 4, 2026, Torrent Pharmaceuticals Limited); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions
Hypervitaminosis D is characterized by effects on the following organ system: Renal: Impairment of renal function with polyuria, nocturia, polydipsia, hypercalciuria, reversible azotemia, hypertension, nephrocalcinosis, generalized vascular calcification, or irreversible renal insufficiency which may result in death. CNS: Mental retardation. Soft Tissues: Widespread calcification of the soft tissues, including the heart, blood vessels, renal tubules, and lungs. Skeletal: Bone demineralization (osteoporosis) in adults occurs concomitantly. Decline in the average rate of linear growth and increased mineralization of bones in infants and children (dwarfism) vague aches, stiffness, and weakness. Gastrointestinal: Nausea, anorexia, constipation. Metabolic: Mild acidosis, anemia, weight loss. To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc. …

Source: FDA drug label, Torrent Pharmaceuticals Limited, effective September 4, 2026 (SPL set 4ae38744-020d-4c37-a6f1-88f55c2f1047), via openFDA; the full label on DailyMed

What do FAERS reports show?

382,573 reports list ergocalciferol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 22,811 are coded as a death and 102,586 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, 1 is 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

Fatigue37,944
Nausea (named in the label)28,193
Diarrhoea27,098
Headache25,984
Drug Ineffective (a use or a product term, not a reaction)25,677
Pain24,231
Off Label Use (a use or a product term, not a reaction)23,141
Dyspnoea20,509
Arthralgia20,180
Dizziness19,629
Asthenia17,233
Fall17,040
Vomiting15,863
Pain In Extremity14,933
Malaise14,767
Rash14,204
Pneumonia13,629
Pruritus13,492
Weight Decreased12,632
Cough12,613
Insomnia11,764
Back Pain11,599
Condition Aggravated (a use or a product term, not a reaction)11,503
Pyrexia11,259
Anxiety10,724

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Ergocalciferol: 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