Important Medical Event (IME) list
Important Medical Event (IME) list
Important Medical Event (IME) list
In the Pharmacovigilance process, to facilitate the seriousness assessment of a reported event, the safety team should consider the Eudravigilance list of Important Medical Events (IME), based on MedDRA and which is regularly updated in line with the latest MedDRA version.
The EudraVigilance Expert Working Group coordinated the development of a list of Important Medical Event (IME) list and criteria to facilitate their maintenance.
The Important Medical Event (IME) list is intended to facilitate the classification of suspected adverse reactions as well as the analysis of aggregated data and the evaluation of cases for the daily pharmacovigilance activities of stakeholders in the EU.
The Important Medical Event (IME) list is purely for information.
On 24 March 2021, the EudraVigilance Expert Working Group updated the IME list. Here we have presented the added and deleted PTs from the existing IME list.
Table of Contents
Added PTs in Important Medical Event (IME) list as per MedDRA version 24.0
| PT Name | SOC Name |
| Erythropoietin deficiency anaemia | Blood and lymphatic system disorders |
| Factor IX inhibition | Blood and lymphatic system disorders |
| Factor VIII inhibition | Blood and lymphatic system disorders |
| Nephrogenic anaemia | Blood and lymphatic system disorders |
| Familial hypocalciuric hypercalcaemia | Congenital, familial and genetic disorders |
| Hepatic cytolysis | Hepatobiliary disorders |
| Atypical pneumonia | Infections and infestations |
| Bacterial colitis | Infections and infestations |
| Bacterial parotitis | Infections and infestations |
| Hypopyon | Infections and infestations |
| Anti factor IX antibody increased | Investigations |
| Anti factor IX antibody positive | Investigations |
| Anti factor VIII antibody positive | Investigations |
| Muscular sarcoidosis | Musculoskeletal and connective tissue disorders |
| Bell’s palsy | Nervous system disorders |
| Alcoholism | Psychiatric disorders |
| Eosinophilic pneumonia | Respiratory, thoracic and mediastinal disorders |
| Eosinophilic pneumonia chronic | Respiratory, thoracic and mediastinal disorders |
| Idiopathic pneumonia syndrome | Respiratory, thoracic and mediastinal disorders |
| Pulmonary sarcoidosis | Respiratory, thoracic and mediastinal disorders |
| Cutaneous vasculitis | Skin and subcutaneous tissue disorders |
| Paranasal mucopyocoele | Infections and infestations |
| Chronic coronary syndrome | Cardiac disorders |
| Lupus anticoagulant hypoprothrombinaemia syndrome | Blood and lymphatic system disorders |
| Acquired left ventricle outflow tract obstruction | Cardiac disorders |
| Haemorrhagic occlusive retinal vasculitis | Eye disorders |
| Loss of CAR T-cell persistence | Injury, poisoning and procedural complications |
| Acute aseptic arthritis | Musculoskeletal and connective tissue disorders |
| Renal-limited thrombotic microangiopathy | Renal and urinary disorders |
| Anti-LRP2 nephropathy | Renal and urinary disorders |
| Post-depletion B-cell recovery | Injury, poisoning and procedural complications |
| Bacterial myositis | Infections and infestations |
| Breakthrough haemolysis | Blood and lymphatic system disorders |
| Immune-mediated oesophagitis | Gastrointestinal disorders |
| Immune-mediated cystitis | Renal and urinary disorders |
| Delayed haematopoietic reconstitution | Injury, poisoning and procedural complications |
| Precerebral artery embolism | Nervous system disorders |
| Psychogenic blindness | Psychiatric disorders |
| Colo-urethral fistula | Gastrointestinal disorders |
| Vaccine associated enhanced disease | Immune system disorders |
| Penile gangrene | Infections and infestations |
| Generalised bullous fixed drug eruption | Skin and subcutaneous tissue disorders |
| Hemiconvulsion-hemiplegia-epilepsy syndrome | Nervous system disorders |
| Jugular vein haemorrhage | Nervous system disorders |
| Paraneoplastic erythromelalgia | Vascular disorders |
| Incisional hernia perforation | Injury, poisoning and procedural complications |
| Cancer cells urine present | Investigations |
| Metapneumovirus bronchiolitis | Infections and infestations |
| Parainfluenzae viral bronchitis | Infections and infestations |
| Paravalvular regurgitation | General disorders and administration site conditions |
| Lumbosacral radiculoplexus neuropathy | Nervous system disorders |
| Follicular lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| Prosthetic cardiac valve calcification | General disorders and administration site conditions |
| Prosthetic cardiac valve fibrosis | General disorders and administration site conditions |
| Bone cement implantation syndrome | Injury, poisoning and procedural complications |
| Omental haemorrhage | Gastrointestinal disorders |
| Haemorrhagic gastroenteritis | Gastrointestinal disorders |
| Infected large intestinal ulcer | Infections and infestations |
| Papilla of Vater sclerosis | Gastrointestinal disorders |
| Self-destructive behaviour | Psychiatric disorders |
| Agonal respiration | Respiratory, thoracic and mediastinal disorders |
| Malignant spinal cord compression | Nervous system disorders |
| Stenotrophomonas bacteraemia | Infections and infestations |
| Streptococcal bronchitis | Infections and infestations |
| Vaccine derived SARS-CoV-2 infection | Infections and infestations |
| Metapneumovirus pneumonia | Infections and infestations |
| Retinal occlusive vasculitis | Eye disorders |
| Neurogenic fracture | Musculoskeletal and connective tissue disorders |
| Perivascular epithelioid cell tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| Cardiac lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| Necrotic lymphadenopathy | Blood and lymphatic system disorders |
| Cardiac polyp | Cardiac disorders |
| Cone-rod dystrophy | Congenital, familial and genetic disorders |
| Lacrimo-auriculo-dento-digital syndrome | Congenital, familial and genetic disorders |
| Stiff skin syndrome | Congenital, familial and genetic disorders |
| Pseudohypopyon | Eye disorders |
| Recurrent subareolar breast abscess | Infections and infestations |
| Immune-mediated neurological disorder | Nervous system disorders |
| Urethroscrotal fistula | Renal and urinary disorders |
| Ejaculatory duct cyst | Reproductive system and breast disorders |
| Rheumatoid arthritis-associated interstitial lung disease | Respiratory, thoracic and mediastinal disorders |
| Tracheal compression | Respiratory, thoracic and mediastinal disorders |
| Cancer with a high tumour mutational burden | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| Cutaneous B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| Follicular lymphoma stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| Follicular lymphoma stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| Follicular lymphoma stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| Follicular lymphoma stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| HER2 positive salivary gland cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| Hormone receptor negative HER2 positive breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| Hormone receptor positive HER2 negative breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| Lineage switch leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| Appendix cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| Benedikt’s syndrome | Nervous system disorders |
| Claude’s syndrome | Nervous system disorders |
| Weber’s syndrome | Nervous system disorders |
| Juvenile absence epilepsy | Nervous system disorders |
| Parietal lobe epilepsy | Nervous system disorders |
| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders |
| Pulmonary venous hypertension | Respiratory, thoracic and mediastinal disorders |
| Pulmonary artery compression | Respiratory, thoracic and mediastinal disorders |
| Immune-mediated hypophysitis | Endocrine disorders |
| Acquired hypocalciuric hypercalcaemia | Endocrine disorders |
| Immune-mediated adrenal insuficiency | Endocrine disorders |
| Spleen ischaemia | Blood and lymphatic system disorders |
| Bacterial endophthalmitis | Infections and infestations |
| Herpes simplex bronchitis | Infections and infestations |
| Vaccine associated enhanced respiratory disease | Immune system disorders |
| Cerebral mass effect | Nervous system disorders |
| Chronic myelomonocytic leukaemia with N-ras gene mutation | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| Philadelphia positive acute lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| Philadelphia positive chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| Recurrent N-ras mutation-positive colorectal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| HER2 mutant non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| Homologous recombination deficiency positive advanced ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| Loefgren syndrome | Immune system disorders |
Deleted PTs from Important Medical Event (IME) list as per MedDRA version 24.0
| Term | SOC |
| Acardia | Congenital, familial and genetic disorders |
| Acetylcholinesterase deficiency | Congenital, familial and genetic disorders |
| Alagille syndrome | Congenital, familial and genetic disorders |
| Amegakaryocytic thrombocytopenia | Congenital, familial and genetic disorders |
| Aminoaciduria | Congenital, familial and genetic disorders |
| Ash leaf macule | Congenital, familial and genetic disorders |
| Barakat syndrome | Congenital, familial and genetic disorders |
| Bartter’s syndrome | Congenital, familial and genetic disorders |
| Blood incompatibility haemolytic anaemia of newborn | Congenital, familial and genetic disorders |
| Brachydactyly | Congenital, familial and genetic disorders |
| Branchio-oto-renal syndrome | Congenital, familial and genetic disorders |
| Campomelic syndrome | Congenital, familial and genetic disorders |
| CLOVES syndrome | Congenital, familial and genetic disorders |
| Congenital lacrimal passage anomaly | Congenital, familial and genetic disorders |
| Congenital thrombocyte disorder | Congenital, familial and genetic disorders |
| Congenital tongue anomaly | Congenital, familial and genetic disorders |
| COPA syndrome | Congenital, familial and genetic disorders |
| Dysplastic naevus syndrome | Congenital, familial and genetic disorders |
| Factor V Leiden mutation | Congenital, familial and genetic disorders |
| Filippi syndrome | Congenital, familial and genetic disorders |
| Greig’s syndrome | Congenital, familial and genetic disorders |
| Hand-foot-genital syndrome | Congenital, familial and genetic disorders |
| Hydroxyprolinaemia | Congenital, familial and genetic disorders |
| Hypermethioniuria | Congenital, familial and genetic disorders |
| Microglossia | Congenital, familial and genetic disorders |
| Omenn syndrome | Congenital, familial and genetic disorders |
| Peutz-Jeghers syndrome | Congenital, familial and genetic disorders |
| Phimosis | Congenital, familial and genetic disorders |
| Rhesus haemolytic disease of newborn | Congenital, familial and genetic disorders |
| Supernumerary vertebra | Congenital, familial and genetic disorders |
| Type II hyperlipidaemia | Congenital, familial and genetic disorders |
| Type IIa hyperlipidaemia | Congenital, familial and genetic disorders |
| Type IIb hyperlipidaemia | Congenital, familial and genetic disorders |
| Type III hyperlipidaemia | Congenital, familial and genetic disorders |
| Type V hyperlipidaemia | Congenital, familial and genetic disorders |
| Orbital oedema | Eye disorders |
| Scleral haemorrhage | Eye disorders |
| Pancreatic necrosis | Gastrointestinal disorders |
| Paravalvular aortic regurgitation | General disorders and administration site conditions |
| Therapeutic product cross-reactivity | Immune system disorders |
| Breast abscess | Infections and infestations |
| Kaposi’s varicelliform eruption | Infections and infestations |
| Oral bacterial infection | Infections and infestations |
| Pulmonary mycosis | Infections and infestations |
| Urinary tract infection bacterial | Infections and infestations |
| Arterial bypass occlusion | Injury, poisoning and procedural complications |
| Arterial bypass stenosis | Injury, poisoning and procedural complications |
| Arterial bypass thrombosis | Injury, poisoning and procedural complications |
| Inadequate haemodialysis | Injury, poisoning and procedural complications |
| Brain midline shift | Nervous system disorders |
| Minimal hepatic encephalopathy | Nervous system disorders |
| Structural valve deterioration | Product issues |
| Bladder neck sclerosis | Renal and urinary disorders |
| Immune-mediated pneumonitis | Respiratory, thoracic and mediastinal disorders |
Find the full list of Important Medical Event (IME) list (MedDRA) – version 24.0
Inclusion and exclusion criteria for the important medical events list (MedDRA)
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