Summary by ADR
Our ref no: Data source: Date: Search parameters: Substance: Reactions: Countries: Date interval:
Number of reports Adverse reaction
PR55-2006 Vigibase May 29, 2007
Drug X All All All 4446
Number of adverse events
ABDOMEN ENLARGED ABDOMINAL PAIN ABDOMINAL RIGIDITY ABNORMAL PALMAR/PLANTAR CREASES ABORTION ABORTION MISSED ABSCESS ACIDOSIS ACNE ADRENAL INSUFFICIENCY AGGRESSIVE REACTION AGITATION AGRANULOCYTOSIS ALBUMINURIA ALKALOSIS ALLERGIC REACTION ALLERGY AGGRAVATED ALOPECIA ALVEOLITIS AMENORRHOEA AMNESIA AMNIOCENTESIS ABNORMAL ANAEMIA ANAEMIA B TWELVE DEFICIENCY ANAEMIA HAEMOLYTIC ANAEMIA HAEMOLYTIC DCP ANAEMIA HYPOCHROMIC ANAEMIA MACROCYTIC ANAESTHESIA LOCAL ANAPHYLACTIC SHOCK ANAPHYLACTOID REACTION ANENCEPHALY ANGINA PECTORIS ANGINA PECTORIS AGGRAVATED ANGIOEDEMA ANOREXIA ANTIDIURETIC HORMONE DISORDER ANTINUCLEAR FACTOR TEST POSITIVE ANURIA ANXIETY
14 687 1 2 209 3 3 6 1 1 5 2 6 3 2 19 1 8 1 3 13 2 89 1 2 2 13 1 1 11 3 1 10 3 17 16 7 1 1 15
AORTIC STENOSIS APATHY APGAR SCORE LOW APHASIA APLASIA BONE MARROW APNOEA APPENDICITIS APPETITE INCREASED APPLICATION SITE REACTION APRAXIA ARRHYTHMIA ARRHYTHMIA ATRIAL ARTERIOSCLEROSIS ARTHRALGIA ARTHRITIS ARTHRITIS AGGRAVATED ARTHRITIS RHEUMATOID AGGRAVATED ARTHROSIS ASCITES ASPHYXIA ASPHYXIA NEONATAL ASPIRATION ASTHENIA ASTHMA ATAXIA AV BLOCK BACK PAIN BILIRUBINAEMIA BIRTH POSTMATURE BIRTH PREMATURE BLEEDING TIME INCREASED BLINDNESS BLINDNESS TEMPORARY BONE DISORDER BRADYCARDIA BRAIN HYPOXIA BREAST ENLARGEMENT BREAST PAIN BREAST PAIN FEMALE BRONCHITIS BRONCHOSPASM BRONCHOSPASM AGGRAVATED BULLOUS ERUPTION BUN INCREASED BUNDLE BRANCH BLOCK CAESAREAN SECTION CARCINOMA CARDIAC ARREST CARDIAC ARREST NEONATAL CARDIAC FAILURE CARDIAC FAILURE LEFT CARDIAC FAILURE RIGHT CARDIOMYOPATHY CARTILAGE DAMAGE CEREBRAL HAEMORRHAGE CEREBRAL HAEMORRHAGE NEONATAL
2 1 11 2 1 2 1 9 2 1 6 1 2 14 8 2 2 2 3 1 1 1 18 2 6 1 13 4 2 7 1 2 1 2 10 1 3 4 2 4 14 2 7 6 2 25 1 17 3 9 2 8 1 1 2 1
CEREBROVASCULAR DISORDER CERVICITIS CERVIX LESION CHEILITIS CHEST PAIN CHOLELITHIASIS CHROMATOPSIA CIRCULATORY FAILURE CLEFT PALATE CLOSTRIDIAL INFECTION CLUBFOOT COAGULATION DISORDER COLITIS COLITIS HAEMORRHAGIC COLITIS PSEUDOMEMBRANOUS COLITIS ULCERATIVE COMA CONCENTRATION IMPAIRED CONDITION AGGRAVATED CONFUSION CONGENITAL ANOMALY NOS CONJUNCTIVITIS CONSTIPATION CONVULSIONS CONVULSIONS GRAND MAL CONVULSIONS NEONATAL COORDINATION ABNORMAL CORONARY ARTERY DISORDER COUGHING CRAMPS LEGS CREATINE PHOSPHOKINASE INCREASED CREATININE CLEARANCE DECREASED CRYPTORCHISM CYANOSIS CYSTITIS CYSTITIS HAEMORRHAGIC DEAFNESS DEATH DEATH FOETAL DEATH NEONATAL DEHYDRATION DELIRIUM DEPERSONALIZATION DEPRESSION DEPRESSION PSYCHOTIC DERMATITIS DERMATITIS EXFOLIATIVE DEVELOPMENTAL DELAY DIABETES MELLITUS REACTIVATED DIARRHOEA DIARRHOEA BLOODY DIPLOPIA DISSEM. INTRAVASC. COAGULATION DIVERTICULITIS DIZZINESS DREAMING ABNORMAL
6 1 2 1 40 1 1 13 3 1 3 3 6 1 1 3 25 2 50 31 4 10 31 9 3 4 4 1 4 8 5 1 2 3 2 2 12 53 12 1 6 3 9 14 1 6 1 6 1 1001 3 5 7 1 152 1
DRUG ABUSE DRUG DEPENDENCE DRUG EXPOSURE IN PREGNANCY DRUG LEVEL DECREASED DRUG LEVEL INCREASED DUODENAL ULCER DUODENAL ULCER HAEMORRHAGIC DUODENAL ULCER PERFORATED DUODENITIS DYSAESTHESIA DYSKINESIA DYSMENORRHOEA DYSPEPSIA DYSPHAGIA DYSPHONIA DYSPNOEA DYSTONIA DYSURIA EAR ACHE EAR MALFORMATION ECG ABNORMAL SPECIFIC ECHOCARDIOGRAM ABNORMAL ECZEMA ELECTIVE ABORTION ELECTROLYTE ABNORMALITY EMBOLISM - BLOOD CLOT EMBOLISM PULMONARY EMBOLUS AMNIOTIC FLUID EMOTIONAL LABILITY EMPHYSEMA ENANTHEMA ENDOCRINE DISORDER NOS ENDOMETRIAL DISORDER ENDOMETRIAL NEOPLASM MALIGNANT ENDOMETRITIS ENDOMETRITIS DECIDUAL ENTERITIS ENZYME ABNORMALITY EOSINOPHILIA EPIDERMAL NECROLYSIS EPISTAXIS ERUCTATION ERYTHEMA MULTIFORME ERYTHEMA NODOSUM ERYTHROCYTES ABNORMAL ESR INCREASED EUPHORIA EXTRAPYRAMIDAL DISORDER EYE ABNORMALITY EYE PAIN FACE MALFORMATION FACE OEDEMA FAECAL INCONTINENCE FAECES DISCOLOURED FALL FALLOPIAN TUBE DISORDER
4 1 35 6 2 10 6 4 1 2 4 20 162 5 1 49 2 9 2 3 1 1 3 2 1 1 11 9 5 1 1 2 1 1 24 2 3 2 5 6 6 12 7 2 1 2 3 2 4 1 5 22 3 2 1 3
FATIGUE FERTILITY DECREASED FEMALE FEVER FIBRILLATION ATRIAL FIBRILLATION VENTRICULAR FINGER MALFORMATION FIXED ERUPTION FLATULENCE FLUSHING FOETAL DISTRESS FOETAL HEART RATE ABNORMAL FOETAL MATURATION IMPAIRED FONTANELLE CLOSURE DELAYED FRACTURE PATHOLOGICAL GAIT ABNORMAL GALLBLADDER DISORDER GAMMA-GT INCREASED GANGRENE GASTRIC CARCINOMA GASTRIC ULCER GASTRIC ULCER HAEMORRHAGIC GASTRIC ULCER PERFORATED GASTRITIS GASTRITIS HAEMORRHAGIC GASTROENTERITIS GASTROESOPHAGEAL REFLUX GASTRO-INTESTINAL DISORDER NOS GENITAL INFECTION GENITAL MALFORMATION GI HAEMORRHAGE GI MALFORMATION GINGIVITIS GLAUCOMA GLOSSITIS GLYCOSURIA GONADOTROPINS INCREASED GOUT GRANULOCYTOPENIA GROWTH RETARDED GUM HYPERPLASIA GYNAECOMASTIA HAEMANGIOMA ACQUIRED HAEMATEMESIS HAEMATOMA HAEMATURIA HAEMOPERITONEUM HAEMOPTYSIS HAEMORRHAGE IN PREGNANCY HAEMORRHAGE INTRAABDOMINAL HAEMORRHAGE NOS HAEMORRHAGE RECTUM HAEMORRHOIDS HAIR DISCOLOURATION HALITOSIS HALLUCINATION HEADACHE
33 1 97 4 5 3 2 154 16 13 15 6 3 2 15 1 4 1 2 19 7 5 21 8 1 4 23 1 1 77 1 2 2 3 1 4 4 7 4 2 10 1 10 4 10 2 1 4 2 294 7 1 1 4 10 84
HEART DISORDER HEART MALFORMATION HEPATIC ENZYMES INCREASED HEPATIC FAILURE HEPATIC FUNCTION ABNORMAL HEPATIC NEOPLASM MALIGNANT HEPATITIS HEPATITIS CHOLESTATIC HEPATOCELLULAR DAMAGE HERNIA CONGENITAL HERNIA NOS HERPES SIMPLEX HERPES ZOSTER HICCUP HIGH DENSITY LIPOPROTEIN DECREASE HYDROCEPHALY COMMUNICATIVE HYPERACUSIS HYPERAESTHESIA HYPERCALCAEMIA HYPERCHOLESTEROLAEMIA HYPERGLYCAEMIA HYPERHAEMOGLOBINAEMIA HYPERKALAEMIA HYPERKINESIA HYPERLIPAEMIA HYPERPROLACTINAEMIA HYPERPYREXIA HYPERTENSION HYPERTENSION INTRACRANIAL HYPERTENSION PULMONARY HYPERTONIA HYPERTRICHOSIS HYPERVENTILATION HYPOAESTHESIA HYPOGLYCAEMIA HYPOKALAEMIA HYPOMAGNESAEMIA HYPONATRAEMIA HYPOREFLEXIA HYPOSPADIAS HYPOTENSION HYPOTENSION POSTURAL HYPOTHERMIA HYPOTHYROIDISM HYPOTONIA HYPOTONIA NEONATAL HYPOTRICHOSIS HYPOVENTILATION HYSTERIA ILEITIS ILEUS IMPOTENCE INCORRECT DOSE ADMINISTERED INFECTION INFECTION BACTERIAL INFERTILITY FEMALE
4 1 1 3 16 1 21 11 1 1 1 1 3 4 1 1 1 1 3 5 4 1 2 6 1 2 2 11 2 3 8 1 1 4 3 10 1 7 1 1 34 4 1 1 1 2 11 2 1 1 2 7 1 10 4 1
INFLUENZA-LIKE SYMPTOMS INJECTION SITE INFLAMMATION INSOMNIA INTERMENSTRUAL BLEEDING INTESTINAL GANGRENE INTESTINAL NECROSIS INTESTINAL OBSTRUCTION INTESTINAL PERFORATION INTESTINAL ULCERATION JAUNDICE JAW MALFORMATION JOINT MALFORMATION KERATITIS KERATOCONJUNCTIVITIS KETOSIS LABOUR ABNORMAL LABOUR PREMATURE LACERATION LACRIMAL GLAND DISORDER LACRIMATION ABNORMAL LACTATION NONPUERPERAL LACTATION PUERPERAL DECREASED LACTOSE INTOLERANCE LARYNGISMUS LARYNGITIS LARYNX OEDEMA LDH INCREASED LE SYNDROME LEG PAIN LEUCOPENIA LEUKOCYTOSIS LEUKORRHOEA LIBIDO DECREASED LIMB MALFORMATION LYMPHADENOPATHY CERVICAL LYMPHOPENIA MACULA LUTEA DEGENERATION MALAISE MALFORMATION FOOT MALFORMATION HAND MALFORMATION RIB MALFORMATION SKULL MALFORMATIONS MULTIPLE MANIC REACTION MASTITIS MASTITIS MALE MECONIUM INCREASED MEDICATION ERROR MEDICINE INEFFECTIVE MELAENA MELANOMA MALIGNANT MENORRHAGIA MENSTRUAL DISORDER MICROCEPHALY MICTURITION DISORDER MICTURITION FREQUENCY
4 7 15 41 1 1 2 2 2 1 4 2 1 1 1 8 3 2 1 1 1 1 1 3 1 2 1 3 2 16 21 6 4 5 1 2 1 60 1 1 1 2 6 2 1 1 1 12 16 21 1 125 41 3 4 6
MIGRAINE MIOSIS MONILIASIS GENITAL MOTION SICKNESS MOUTH DRY MUSCLE ATROPHY MUSCLE CONTRACTIONS INVOLUNTARY MUSCLE WEAKNESS MYALGIA MYASTHENIA GRAVIS-LIKE SYNDROME MYOCARDIAL INFARCTION MYOCARDIAL ISCHAEMIA MYOCARDITIS MYOPATHY MYOSITIS NAIL DISORDER NAUSEA NEONATAL DISORDER NEOPLASM NOS NEPHRITIS NEPHROSIS NERVOUSNESS NEURITIS NEUROLOGIC DISORDER NOS NEUROPATHY PERIPHERAL NEUROSIS NIPPLE ULCERATION NON-HODGKIN'S LYMPHOMA NPN INCREASED NYSTAGMUS OCULAR HAEMORRHAGE OCULOGYRIC CRISIS OCULOMOTOR NERVE PARALYSIS OEDEMA OEDEMA CEREBRAL OEDEMA DEPENDENT OEDEMA GENERALISED OEDEMA GENITAL OEDEMA MOUTH OEDEMA PERIORBITAL OEDEMA PERIPHERAL OESOPHAGEAL ULCERATION OESOPHAGITIS OESOPHAGOSPASM OLIGOHYDRAMNIOS OLIGURIA OSTEOPOROSIS OVARIAN DISORDER PAIN PALLOR PALPITATION PANCREATITIS PANCYTOPENIA PAPILLOEDEMA PARAESTHESIA PARALYSIS
5 2 2 1 15 1 23 3 47 1 12 3 1 3 5 4 394 9 3 4 1 15 3 3 1 1 1 1 4 2 2 1 1 13 2 6 2 2 2 5 19 2 13 2 3 3 1 3 83 1 22 6 4 1 23 3
PARALYSIS FLACCID CONGENITAL PARANOID REACTION PARONIRIA PAROSMIA PELVIC INFLAMMATION PEMPHIGOID REACTION PEPTIC ULCER PEPTIC ULCER HAEMORRHAGIC PEPTIC ULCER HAEMPER PEPTIC ULCER PERFORATED PERICARDIAL EFFUSION PERICARDITIS PERINEAL PAIN FEMALE PERINEAL PAIN MALE PERIPHERAL ISCHAEMIA PERITONITIS PERSONALITY DISORDER PHARYNGITIS PHLEBITIS PHOSPHATASE ACID INCREASED PHOSPHATASE ALKALINE INCREASED PHOTOPHOBIA PHOTOSENSITIVITY ALLERGIC REACT PHOTOSENSITIVITY REACTION PITUITARY INSUFFICIENCY PITUITARY NEOPLASM NOS PLACENTAL DISORDER PLATELETS ABNORMAL PNEUMONIA PNEUMONIA LOBAR POLYCYTHAEMIA POLYDACTYLY POLYURIA PORPHYRIA POST-MENOPAUSAL BLEEDING POST-OPERATIVE COMPLICATIONS NOS PRE-ECLAMPSIA PREGNANCY ECTOPIC PREGNANCY UNINTENDED PROCTITIS PROSTATIC DISORDER PROTHROMBIN DECREASED PRURITUS PRURITUS GENITAL PSORIASIS PSORIASIS AGGRAVATED PSYCHOSIS PTERYGIUM PTOSIS PULMONARY CARCINOMA PULMONARY FIBROSIS PULMONARY INFILTRATION PULMONARY MALFORMATION PULMONARY OEDEMA PULSE WEAK PURPURA
1 1 3 2 1 1 6 2 2 3 1 1 2 1 3 4 1 8 2 1 11 2 1 11 1 1 10 3 7 1 2 1 5 1 2 1 1 24 353 1 2 4 58 3 1 3 4 2 2 1 2 3 1 7 2 21
PURULENT DISCHARGE PYELONEPHRITIS QT PROLONGED RASH RASH ERYTHEMATOUS RASH FOLLICULAR RASH MACULO-PAPULAR RASH PSORIAFORM RASH PURPURIC RASH PUSTULAR RASH VESICULAR RECTAL DISORDER RENAL CALCULUS RENAL FAILURE ACUTE RENAL FUNCTION ABNORMAL RENAL PAIN RESPIRATORY DEPRESSION RESPIRATORY DEPRESSION NEONATAL RESPIRATORY DISORDER RESPIRATORY DISORDER NEONATAL RESPIRATORY DISTRESS SYNDROME RESPIRATORY INSUFFICIENCY RESPIRATORY TRACT MALFORMATION RHABDOMYOLYSIS RHINITIS RIGORS SALIVA INCREASED SALIVARY GLAND ENLARGEMENT SALPINGITIS SENSORY DISTURBANCE SEPSIS SEPSIS NEONATAL SERUM SICKNESS SGOT INCREASED SGPT INCREASED SIADH SIALOADENITIS SINUSITIS SKELETAL MALFORMATION SKIN DISCOLOURATION SKIN DISORDER SKIN DRY SKIN EXFOLIATION SKIN ODOR ABNORMAL SKIN ULCERATION SMALL FOR GESTATIONAL AGE SOMNOLENCE SPEECH DISORDER SPINA BIFIDA SPLENOMEGALY SPUTUM INCREASED STEVENS JOHNSON SYNDROME STILLBIRTH STOMACH PERFORATION STOMATITIS STOMATITIS APHTHOUS
1 2 1 84 30 1 37 3 4 1 1 4 1 11 7 1 3 2 7 1 3 6 1 3 4 38 6 1 9 1 13 1 2 11 10 1 1 1 2 4 2 2 2 3 3 1 34 2 1 2 1 9 6 1 8 1
STOMATITIS ULCERATIVE STRIDOR STUPOR SUDDEN DEATH SUICIDE ATTEMPT SURGICAL INTERVENTION SWEATING INCREASED SYNCOPE SYNDACTYLY SYNOVITIS TACHYCARDIA TACHYCARDIA SUPRAVENTRICULAR TASTE LOSS TASTE PERVERSION TEMPERATURE CHANGED SENSATION TENDERNESS NOS TENDINITIS TENDON RUPTURE TENESMUS TERM NOT ACCEPTED IN WHO-ART TERM UNDER ASSESSMENT FOR WHO-ART TESTIS DISORDER TETANY THERAPEUTIC RESPONSE DECREASED THERAPEUTIC RESPONSE INCREASED THINKING ABNORMAL THIRST THROAT TIGHTNESS THROMBOCYTHAEMIA THROMBOCYTOPENIA THROMBOEMBOLISM THROMBOPHLEBITIS THROMBOPHLEBITIS DEEP THROMBOSIS THROMBOSIS CORONARY THYROID DISORDER TINNITUS TOLERANCE DECREASED TONGUE DISORDER TONGUE OEDEMA TOOTH CARIES TOOTH DISORDER TOXIC SHOCK SYNDROME TREMOR TREMOR NEONATAL TSH DECREASED UMBILICAL CORD ABNORMALITY UNEXPECTED THERAPEUTIC EFFECT URAEMIA URETHRAL DISORDER URINARY INCONTINENCE URINARY RETENTION URINARY TRACT INFECTION URINE ABNORMAL URTICARIA URTICARIA ACUTE
9 1 3 1 2 10 31 48 4 1 23 1 5 17 6 1 1 1 1 82 97 2 1 51 4 2 3 1 1 38 2 1 2 6 3 2 6 3 3 1 2 3 2 29 1 1 1 5 2 1 5 13 5 4 43 1
UTERINE ATONY UTERINE CONTRACTIONS UTERINE DISORDER NOS UTERINE FIBROID UTERINE HAEMORRHAGE UTERINE NEOPLASM UTERINE PERFORATION UTERINE RUPTURE UTERINE SPASM UTEROVAGINAL PROLAPSE VAGINAL DISCOMFORT VAGINAL HAEMORRHAGE VAGINITIS VASCULAR DISORDER VASCULAR MALFORMATION PERIPHERAL VASCULITIS VASODILATATION WBC ABNORMAL NOS WEIGHT DECREASE WEIGHT INCREASE VEIN PAIN VENTRICULAR SEPTAL DEFECT VERTIGO VISION ABNORMAL WITHDRAWAL SYNDROME VOMITING XEROPHTHALMIA YAWNING
2 7 11 2 50 1 4 38 12 2 1 103 5 2 2 4 7 1 8 6 1 2 16 27 2 209 1 1
8159