Table 3.
Classification of adverse events by the MedDRA coding system (N=41,038)a
| System organ class | Number (%) |
Preferred term (number) |
| Skin and subcutaneous tissue disorders | 26,725 (65.1) |
angioedema (8,067), urticaria (5,426), rash maculo-papular (4,157), rash (3,674), pruritus (2,230), rash erythematous (1,333), fixed eruption (931), Stevens-Johnson syndrome (302), dermatitis bullous (105), erythema multiforme (89), eczema (47), purpura (41), dermatitis exfoliative (36), drug reaction with eosinophilia and systemic symptoms (35), skin exfoliation (28), acute generalized exanthematous pustulosis (26), toxic epidermal necrolysis (26), rash vesicular (23), skin disorder (22), miliaria (21), dermatitis (20), photosensitivity reaction (18), acne (13), hyperhidrosis (11), dermatitis contact (10), henoch-schonlein purpura (4), erythema (3), rash follicular (3), skin necrosis (3), systemic lupus erythematosus rash (3), alopecia (2), cold urticaria (2), erythema nodosum (2), skin discoloration (2), skin reaction (2), skin ulcer (2), butterfly rash (1), chloasma (1), drug eruption (1), dry skin (1), pseudoporphyria (1), psoriasis (1) |
| Eye disorders | 3,790 (9.2) |
periorbital edema (3,709), eye pain (21), lacrimation increased (15), eyelid edema (14), visual impairment (11), corneal edema (7), blepharitis (4), eye disorder (1), eye edema (1), eyelid disorder (1), eyelid retraction (1), macular edema (1), papilledema (1), retinal edema (1), ulcerative keratitis (1), xerophthalmia (1) |
| Immune system disorders | 3,064 (7.5) |
anaphylactic reaction (2,102), anaphylactic shock (898), anaphylactoid reaction (47), eosinophilic, hypersensitivity (16), granulomatosis with polyangiitis (1) |
| General disorders and administration site conditions | 2,725 (6.6) |
face edema (1,237), chest pain (771), edema (338), edema peripheral (197), pyrexia (37), fatigue (33), generalized edema (18), gravitational edema (15), mucosal inflammation (13), pain (11), chills (8), enanthema (8), mucosal ulceration (6), condition aggravated (3), drug ineffective (3), feeling of body temperature change (3), injection site inflammation (3), injection site pain (3), application site reaction (2), asthenia (2), drug tolerance decreased (2), injection site reaction (2), malaise (2), chest discomfort (1), crying (1), drug interaction (1), influenza like illness (1), injection site bruising (1), injection site dermatitis (1), injection site necrosis (1), edema mucosal (1) |
| Gastrointestinal disorders | 2,164 (5.3) |
edema mouth (1,216), mouth ulceration (246), nausea (167), vomiting (142), anesthesia oral (74), gastrointestinal hemorrhage (44), abdominal pain (39), dry mouth (35), dyspepsia (31), stomatitis (31), cheilitis (23), diarrhea (22), tongue edema (18), |
| glossitis (11), flatulence (7), gastritis (7), gingival bleeding (6), melaena (6), gingival hypertrophy (4), mouth cyst (4), tongue ulceration (4), gastric ulcer (3), gastroesophageal reflux disease (3), hematemesis (3), dysphagia (2), tongue disorder (2), abdominal distension (1), anal ulcer (1), aphthous ulcer (1), breath odor (1), duodenal ulcer hemorrhage (1), faces discolored (1), gastrointestinal disorder (1), hypoesthesia oral (1), mouth hemorrhage (1), esophagitis (1), saliva altered (1), salivary hypersecretion (1), tongue discoloration (1), toothache (1) | ||
| Respiratory, thoracic and mediastinal disorders | 1,243 (3.0) |
dyspnea (973), bronchospasm (91), choking (69), asthma (33), throat tightness (11), cough (9), asphyxia (6), dysphonia (5), obstructive airways disorder (5), bradypnea (4), pharyngeal edema (4), respiratory disorder (4), respiratory failure (4), stridor (4), epistaxis (3), pulmonary edema (3), respiratory depression (3), hypoventilation (2), apnea (1), bronchospasm paradoxical (1), hemoptysis (1), hiccups (1), hyperventilation (1), hypoxia (1), laryngeal edema (1), pulmonary congestion (1), respiratory acidosis (1), sputum increased (1) |
| Infections and infestations | 316 (0.8) |
conjunctivitis (206), rhinitis (43), rash pustular (27), pharyngitis (18), cellulitis (5), meningitis (4), eye infection (2), genital infection (2), laryngitis (2), pneumonia (2), abscess (1), gastroenteritis (1), gingivitis (1), infection (1), orchitis (1) |
| Nervous system disorders | 314 (0.8) |
dizziness (147), hypoesthesia (67), dysesthesia (21), headache (20), syncope (16), paranesthesia (10), dystonia (7), tremor (6), tongue paralysis (4), neuropathy peripheral (3), muscle contractions involuntary (2), paralysis (2), apraxia (1), asterixis (1), cerebrovascular disorder (1), coma (1). hyperkinesia (1), migraine (1), parosmia (1), seizure (1), taste disorder (1) |
| Cardiac disorders | 270 (0.7) |
palpitations (222), tachycardia (26), angina pectoris (7), bradycardia (4), cardiac arrest (3), cardiac failure (3), arrhythmia (2), myocardial infarction (2), atrioventricular block (1) |
| Vascular disorders | 138 (0.3) |
flushing (58), hypotension (46), hypertension (18), vasculitis (9), hot flush (3), circulatory collapse (1), hematoma (1), hemorrhage (1), peripheral ischemia (1) |
| Renal and urinary disorders | 62 (0.2) |
acute kidney injury (19), renal impairment (16), hematuria (6), azotemia (5), urinary retention (4), dysuria (3), oliguria (2), tubulointerstitial nephritis (2), chronic kidney disease (1), cystitis hemorrhagic (1), nephritis (1), urethral syndrome (1), urinary incontinence (1) |
| Injury, poisoning and procedural complications | 40 (0.1) |
thermal burn (39), fracture (1) |
| Musculoskeletal and connective tissue disorders | 40 (0.1) |
muscular weakness (11), myalgia (9), back pain (6), arthralgia (5), arthropathy (2), pain in extremity (2), arthritis (1), muscle atrophy (1), muscle spasms (1), systemic lupus erythematosus (1), tendonitis (1) |
| Reproductive system and breast disorders | 34 (0.1) |
genital ulceration (13), edema genital (11), pruritus genital (3), balanoposthitis (2), genital pain (2), genital rash (1), penis disorder (1), perineal pain (1) |
| Psychiatric disorders | 22 (0.1) |
insomnia (7), confusional state (5), agitation (4), anxiety (2), completed suicide (1), eating disorder (1), intentional self-injury (1), nervousness (1) |
| Investigations | 21 (0.1) |
weight increased (14), urine analysis abnormal (3), blood creatine phosphokinase increased (2), international normalized ratio increased (2) |
| Hepatobiliary disorders | 20 (0.0) |
hepatitis (15), hepatocellular injury (3), hepatitis cholestatic (2) |
| Ear and labyrinth disorders | 13 (0.0) |
tinnitus (4), ear pain (3), vertigo (3), hypoacusis (2), ototoxicity (1) |
| Surgical and medical procedures | 12 (0.0) |
local anesthesia (12) |
| Blood and lymphatic system disorders | 11 (0.0) |
agranulocytosis (2), methemoglobinemia (2), thrombocytopenia (2), eosinophilia (1), hemolytic anemia (1), lymphadenopathy (1), thrombocytopenic purpura (1), thrombocytosis (1) |
| Congenital, familial and genetic disorders | 8 (0.0) |
vascular malformation (7), lipidosis (1) |
| Metabolism and nutrition disorders | 4 (0.0) |
hyperkaliemia (2), lactic acidosis (1), lipedema (1) |
| Neoplasms benign, malignant and unspecified (including cysts and polyps) | 2 (0.0) |
angiofibroma (1), angiosarcoma (1) |
MedDRA: Medical Dictionary for Regulatory Activities
a41,038 events from 32,857 cases were included because 15,364 reports had more than one event or drug.