Adverse Drug Reactions in Summaries of Product Characteristics and Patient Information Leaflets

Recommendations about the mentioning of adverse reactions according to their frequency (CIOMS III) and classification of adverse reactions according to their organ systems (MedDRA) in the Summary of Product Characteristics and Package Leaflet (revision 1)

Categories of adverse reactions frequency

According to the Guidelines for Preparing Core Clinical Safety information on Drugs) of the CIOMS III Working Group, whenever possible, the calculation of adverse reaction frequency should be expressed according of the categories of adverse reactions frequency.

CIOMS III Working group recommended following categories for description of adverse reaction frequency
Very common ≥ 1/10 (≥ 10 %)
Common, Frequent ≥ 1/100 and < 1/10 (≥ 1% and < 10%)
Uncommon, Infrequent ≥ 1/1000 and < 1/100 (≥ 0,1% and < 1%)
Rare ≥ 1/10000 and < 1/1000 (≥ 0,01% and < 0,1%)
Very rare < 1/10000 (< 0,01 %)

The recommendation of the Agency for Medicinal Products and Medical Devices is that the frequency of adverse reactions be mentioned in the Package Leaflet in a descriptive form, so that the information is understandable for patients (i.e. the adverse reaction occurs in 1 out of 100 patients taking the medicine).

Classification of organic systems according to MedDRA
I. I. Blood and lymphatic system disorders
II. Cardiac disorders
III. Congenital, familial and genetic disorders
IV. Ear and labyrinth disorders
V. Endocrine disorders
VI. Eye disorders
VII. Gastrointestinal disorders
VIII. General disorders and administration site conditions
IX. Hepatobiliary disorders
X. Immune system disorders
XI. Infections and infestations
XII. Investigations
XIII. Injury, poisoning and procedural complications
XIV. Metabolism and nutrition disorders
XV. Musculoskeletal system and connective tissue disorders
XVI. Neoplasms benign, malignant and unspecified (incl. cysts and polyps)
XVII. Nervous system disorders
XVIII. Pregnancy, puerperium and perinatal conditions
XIX. Psychiatric disorders
XX. Renal and urinary disorders
XXI. Reproductive system and breast disorders
XXII. Respiratory, thoracic and mediastinal disorders
XXIII. Skin and subcutaneous tissue disorders
XXIV. Social circumstances
XXV. Surgical and medical procedures
XXVI. Vascular disorders