Adverse events are generally associated with excessive intake of ergocalciferol leading to the development of hypercalcaemia.
The following convention has been used for the classification of frequency:
Very common (≥ 1/10)
Common (≥ 1/100 to < 1/10)
Uncommon (≥ 1/1,000 to < 1/100)
Rare (≥ 1/10,000 to < 1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated from the available data)
System Organ Class | Adverse event | Frequency |
Metabolism and nutrition disorders | Hypercalcaemia * | Very common |
Hypercholesterolaemia† | Not known |
Muscle weakness§ | Not known |
Muscle pain§ | Not known |
Mild acidosis† | Not known |
Polydipsia† | Not known |
Anorexia† | Not known |
Psychiatric disorders | Overt psychosis† | Rare |
Somnolence§ | Not known |
Nervous system disorders | Headache§ | Not known |
Endocrine disorders | Hypoparathyroidism* pseudohypopathyroidism* | Very common |
Eye disorders | Conjunctivitis (calcific) | Not known |
Photophobia | Not known |
Cardiac disorders | Cardiac arrhythmias | Not known |
Rebal disorders | Elevated serum creatinine levels* | Very common |
Vascular disorders | Generalised vascular calcification† | Not known |
Hypertension† | Not known |
Respiratory, thoracic and mediastinal disorders | Rhinorrhoea† | Not known |
Gastrointestinal disorders | Pancreatitis† | Not known |
Nausea§ | Not known |
Vomiting§ | Not known |
Dry mouth§ | Not known |
Constipation§ | Not known |
Diarrhoea§ | Not known |
Abdominal pain§ | Not known |
Skin and subcutaneous tissue disorders | Pruritus† | Not known |
Musculoskeletal and connective tissue disorders | Bone pain§ | Not known |
Ectopic calcification† | Not known |
Renal and urinary disorders | Polyuria† | Not known |
Nocturia† | Not known |
Nephrocalcinosis† | Not known |
Albuminuria† | Not known |
Reversible azotemia† | Not known |
Reproductive system and breast disorders | Decreased libido† | Not known |
General disorders and administration site conditions | Hyperthermia† | Not known |
Fatigue§ | Not known |
Irritability† | Not known |
Weakness§ | Not known |
Investigations | Elevated AST † | Not known |
Elevated ALT† | Not known |
Elevated BUN† | Not known |
Weight loss† | Not known |
Surgical and medical procedures | Metallic taste§ | Not known |
*In clinical studies on hypoparathyroidism and pseudohypopathyroidism, hypercalcaemia was noted on at least one occasion in about 1 in 3 patients and hypercalciuria in about 1 in 7. Elevated serum creatinine levels were observed in about 1 in 6 patients (approximately one half of whom had normal levels at baseline).
§ Possible early symptoms of hypercalcaemia
†Possible late symptoms of hypercalcaemia
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.