Gatifloxacin


w163



General information:


Withdrawn ID: w163
Canonical SMILES:
Standard InChI:
Standard InChIKey:
ATC class(es): J01MA16
S01AE06
Molecular Formula: C19H22FN3O4
Molweight: 375.394



Withdrawal information:


Withdrawn due to drug safety reasons:Yes
First approved: 1999
First withdrawn: 2006
Last withdrawn: 2006
Reference: https://www.ncbi.nlm.nih.gov/pubmed/20068268



Side-effects:

Total reported cases (submitted by medical professionals) with Gatifloxacin as primary suspect: 1371


Reported final outcomes:
Hospitalization (initial or prolonged): 514
Intervention required to prevent permanent impairment/damage: 156
Life-Threatening condition: 118
Death: 48
Disability: 36
Congenital anomaly: 2


Reported side-effects:

Side-effect Case number
HYPOGLYCAEMIA362
HYPERGLYCAEMIA249
BLOOD GLUCOSE INCREASED83
DIZZINESS57
BLOOD GLUCOSE DECREASED54
DIARRHOEA39
NAUSEA38
CONVULSION37
CONFUSIONAL STATE34
LOSS OF CONSCIOUSNESS33
DRUG INEFFECTIVE33
RASH32
ENDOPHTHALMITIS30
ASTHENIA29
HYPERHIDROSIS28
DIABETES MELLITUS28
DYSPNOEA25
PRURITUS24
CLOSTRIDIUM COLITIS23
VOMITING22
COMA22
TREMOR20
HYPOTENSION19
DRUG INTERACTION19
DEPRESSED LEVEL OF CONSCIOUSNESS18
RENAL FAILURE ACUTE17
MENTAL STATUS CHANGES17
HALLUCINATION17
ELECTROCARDIOGRAM QT PROLONGED17
BLOOD CREATININE INCREASED17
URTICARIA16
DRUG PRESCRIBING ERROR16
POLYDIPSIA15
VISION BLURRED14
MALAISE14
INTERNATIONAL NORMALISED RATIO INCREASED14
TORSADE DE POINTES13
RENAL FAILURE13
POLYURIA13
HEADACHE13
FATIGUE13
ERYTHEMA13
CHEST PAIN13
DEHYDRATION12
SYNCOPE11
HYPOGLYCAEMIC COMA11
EYE PAIN11
DISORIENTATION11
DIABETIC KETOACIDOSIS11
ANAPHYLACTIC REACTION11
AGITATION11
TOXIC ANTERIOR SEGMENT SYNDROME10
SWELLING FACE10
INJECTION SITE REACTION10
HYPERSENSITIVITY10
FEELING ABNORMAL10
DIABETIC HYPEROSMOLAR COMA10
DEATH10
ANOREXIA10
ANAPHYLACTIC SHOCK10
PYREXIA9
PNEUMONIA9
LIVER FUNCTION TEST ABNORMAL9
HYPONATRAEMIA9
DECREASED APPETITE9
BLOOD GLUCOSE FLUCTUATION9
BLOOD CREATININE9
STEVENS-JOHNSON SYNDROME8
SOMNOLENCE8
PALPITATIONS8
Off label use8
INSOMNIA8
ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED8
DIABETES MELLITUS INADEQUATE CONTROL8
ARTHRALGIA8
ANXIETY8
TACHYCARDIA7
RHABDOMYOLYSIS7
HYPOAESTHESIA7
HYPEROSMOLAR STATE7
HEPATIC FUNCTION ABNORMAL7
GLYCOSYLATED HAEMOGLOBIN INCREASED7
EYE IRRITATION7
DYSGEUSIA7
COUGH7
CONDITION AGGRAVATED7
CARDIAC FAILURE CONGESTIVE7
CARDIAC FAILURE7
CARDIAC ARREST7
ARRHYTHMIA7
VISUAL ACUITY REDUCED6
THIRST6
MUSCULAR WEAKNESS6
METABOLIC ACIDOSIS6
MEDICATION ERROR6
LETHARGY6
INFUSION RELATED REACTION6
HYPERKALAEMIA6
DRUG HYPERSENSITIVITY6
DEMENTIA6
DELIRIUM6
CORNEAL PERFORATION6
CHILLS6
BRADYCARDIA6
BLOOD PRESSURE INCREASED6
BLOOD PRESSURE DECREASED6
BLOOD POTASSIUM INCREASED6
BLINDNESS6
ANGIONEUROTIC OEDEMA6
ABDOMINAL PAIN6
ABDOMINAL DISCOMFORT6
VERTIGO5
VENTRICULAR FIBRILLATION5
TENDONITIS5
TACHYPNOEA5
RESPIRATORY FAILURE5
RENAL IMPAIRMENT5
INTRAOCULAR PRESSURE INCREASED5
HEART RATE INCREASED5
GRAND MAL CONVULSION5
DYSPHAGIA5
DIABETES MELLITUS NON-INSULIN-DEPENDENT5
CORNEAL OPACITY5
CORNEAL OEDEMA5
CLOSTRIDIAL INFECTION5
CEREBROVASCULAR ACCIDENT5
CARDIO-RESPIRATORY ARREST5
ATRIAL FIBRILLATION5
ASPARTATE AMINOTRANSFERASE INCREASED5
ALANINE AMINOTRANSFERASE INCREASED5
AGGRESSION5
ABDOMINAL PAIN UPPER5
WEIGHT DECREASED4
VISUAL DISTURBANCE4
URINARY TRACT INFECTION4
THROMBOCYTOPENIA4
SWOLLEN TONGUE4
SEPSIS4
RASH ERYTHEMATOUS4
PSYCHOTIC DISORDER4
PHARYNGEAL OEDEMA4
PAIN4
ORAL INTAKE REDUCED4
NEUROPATHY PERIPHERAL4
NERVOUSNESS4
INFECTION4
HYPERTENSION4
HALLUCINATION, VISUAL4
HAEMOGLOBIN DECREASED4
EYELID OEDEMA4
DRY MOUTH4
DIABETIC COMA4
DIABETES MELLITUS INSULIN-DEPENDENT4
DELUSION4
COLD SWEAT4
CHEST DISCOMFORT4
BLOOD UREA INCREASED4
BLOOD GLUCOSE ABNORMAL4
AMNESIA4
AGEUSIA4
ULCERATIVE KERATITIS3
TONGUE DRY3
TINNITUS3
THROAT IRRITATION3
TENDON DISORDER3
SUPRAVENTRICULAR TACHYCARDIA3
STAPHYLOCOCCAL INFECTION3
RECTAL HAEMORRHAGE3
RASH GENERALISED3
PROTHROMBIN TIME PROLONGED3
PROTHROMBIN TIME3
PREGNANCY3
PARANOIA3
PARAESTHESIA3
PANCYTOPENIA3
PAIN IN EXTREMITY3
OEDEMA PERIPHERAL3
OCULAR HYPERAEMIA3
NOCTURIA3
JOINT SWELLING3
JAUNDICE3
HYPERGLYCAEMIC HYPEROSMOLAR NONKETOTIC SYNDROME3
HEPATITIS3
GLUCOSE TOLERANCE IMPAIRED3
FLUSHING3
EYE DISORDER3
EXTRAVASATION3
ENCEPHALOPATHY3
DYSPNOEA EXERTIONAL3
DRUG ERUPTION3
DIALYSIS3
DEPRESSION3
DEEP VEIN THROMBOSIS3
CORNEAL EROSION3
CORNEAL EPITHELIUM DEFECT3
CORNEAL DISORDER3
CONJUNCTIVITIS3
CONJUNCTIVAL HYPERAEMIA3
CEREBRAL HAEMORRHAGE3
BLOOD POTASSIUM3
BLOOD CREATINE PHOSPHOKINASE INCREASED3
BLINDNESS UNILATERAL3
BLINDNESS TRANSIENT3
AGRANULOCYTOSIS3
ADVERSE EVENT3
ABDOMINAL PAIN LOWER3
ABDOMINAL DISTENSION3
WOUND INFECTION2
WHITE BLOOD CELL COUNT INCREASED2
WHITE BLOOD CELL COUNT DECREASED2
WEIGHT INCREASED2
VITREOUS OPACITIES2
VENTRICULAR ARRHYTHMIA2
UVEITIS2
URINE OUTPUT DECREASED2
URINE ABNORMALITY2
TONGUE DISORDER2
THROAT TIGHTNESS2
THERAPEUTIC RESPONSE DECREASED2
TENDON RUPTURE2
STOMACH DISCOMFORT2
SPEECH DISORDER2
SHOCK2
POST PROCEDURAL COMPLICATION2
PNEUMOTHORAX2
PLATELET COUNT DECREASED2
PHARMACEUTICAL PRODUCT COMPLAINT2
PANCREATITIS ACUTE2
PALLOR2
ORTHOSTATIC HYPOTENSION2
Oropharyngeal pain2
ORAL PAIN2
ORAL CANDIDIASIS2
NEUROPATHY2
NEPHROLITHIASIS2
NEPHRITIS INTERSTITIAL2
NECK PAIN2
MYOCLONUS2
MYOCARDIAL INFARCTION2
MYDRIASIS2
MYALGIA2
MULTI-ORGAN FAILURE2
MARKEDLY REDUCED DIETARY INTAKE2
LIVER DISORDER2
LEUKOPENIA2
LACTIC ACIDOSIS2
KETOACIDOSIS2
Instillation site pain2
INJECTION SITE PRURITUS2
INJECTION SITE ERYTHEMA2
INFUSION SITE REACTION2
INFLAMMATION2
HYPOXIA2
HYPOVOLAEMIA2
HYPOAESTHESIA ORAL2
HYPERNATRAEMIA2
HUNGER2
HEPATOTOXICITY2
HEPATIC FAILURE2
HEPATIC ENZYME INCREASED2
HAEMORRHAGE2
GASTROOESOPHAGEAL REFLUX DISEASE2
GAMMA-GLUTAMYLTRANSFERASE INCREASED2
GAIT DISTURBANCE2
FREQUENT BOWEL MOVEMENTS2
FALL2
FACE OEDEMA2
EYE INFLAMMATION2
EOSINOPHILIA2
EMPYEMA2
ELECTROENCEPHALOGRAM ABNORMAL2
DYSURIA2
DYSARTHRIA2
DRY SKIN2
DRY EYE2
Drug-induced liver injury2
DRUG DISPENSING ERROR2
DIFFICULTY IN WALKING2
DIABETIC HYPERGLYCAEMIC COMA2
DEAFNESS2
DACRYOCYSTITIS INFECTIVE2
CREATININE RENAL CLEARANCE2
CONJUNCTIVITIS ALLERGIC2
CIRCULATORY COLLAPSE2
CARDIAC DISORDER2
CANDIDIASIS2
C-REACTIVE PROTEIN INCREASED2
BLOOD TRIGLYCERIDES INCREASED2
BLOOD PRESSURE SYSTOLIC INCREASED2
BLOOD OSMOLARITY2
BLOOD LACTATE DEHYDROGENASE INCREASED2
BLOOD ALKALINE PHOSPHATASE INCREASED2
BLISTER2
BILIARY TRACT DISORDER2
BALANCE DISORDER2
BACK PAIN2
ATRIOVENTRICULAR BLOCK COMPLETE2
ASCITES2
ARTHRITIS2
APLASTIC ANAEMIA2
ANION GAP ABNORMAL2
ANGINA UNSTABLE2
ADVERSE DRUG REACTION2
ACUTE RESPIRATORY DISTRESS SYNDROME2
ACIDOSIS2
ABNORMAL BEHAVIOUR2
VITRITIS1
VITREOUS FLOATERS1
Visual impairment1
Visual field defect1
VIRAL INFECTION1
VESTIBULAR DISORDER1
VENTRICULAR TACHYCARDIA1
VENTRICULAR EXTRASYSTOLES1
VEIN DISCOLOURATION1
VAGINAL MYCOSIS1
VAGINAL ERYTHEMA1
VAGINAL CANDIDIASIS1
URTICARIA GENERALISED1
URTICARIA CHRONIC1
URINE AMPHETAMINE POSITIVE1
URINARY INCONTINENCE1
UNEVALUABLE EVENT1
TYPE 2 DIABETES MELLITUS1
TUBULOINTERSTITIAL NEPHRITIS1
TROPONIN INCREASED1
TREATMENT NONCOMPLIANCE1
TRANSIENT ISCHAEMIC ATTACK1
TOXIC EPIDERMAL NECROLYSIS1
TOOTHACHE1
TONIC CLONIC MOVEMENTS1
TONGUE DISCOLOURATION1
TONGUE BLACK HAIRY1
TIC1
THROMBOTIC THROMBOCYTOPENIC PURPURA1
THERAPY NON-RESPONDER1
TESTICULAR SWELLING1
TENDON PAIN1
SWELLING1
SUPRAVENTRICULAR EXTRASYSTOLES1
Superficial injury of eye1
SUICIDAL IDEATION1
SUBDURAL HAEMATOMA1
STREPTOCOCCAL INFECTION1
STOMATITIS1
STAPHYLOCOCCAL BACTERAEMIA1
Sneezing1
SLEEP DISORDER1
SLEEP APNOEA SYNDROME1
SKIN ULCER1
SKIN LESION1
SKIN GRAFT1
SKIN EXFOLIATION1
SINUSITIS1
SINUS TACHYCARDIA1
SINUS DISORDER1
SIMPLE PARTIAL SEIZURES1
SHOULDER PAIN1
SHOCK HYPOGLYCAEMIC1
SERUM SICKNESS1
SEPTIC SHOCK1
SENSATION OF PRESSURE IN EAR1
Seizure1
Secretion discharge1
SCROTAL DISORDER1
SCOTOMA1
Scleromalacia1
SCLERAL HYPERAEMIA1
RESTLESSNESS1
RESTLESS LEGS SYNDROME1
Respiratory tract congestion1
RESPIRATORY RATE INCREASED1
RESPIRATORY DISORDER1
RESPIRATORY ARREST1
RESPIRATORY ALKALOSIS1
RESPIRATORY ACIDOSIS1
RENAL FUNCTION TEST ABNORMAL1
RENAL FUNCTION TEST1
RENAL FAILURE CHRONIC1
RENAL CYST1
Rectal tenesmus1
RASH PRURITIC1
PYOTHORAX1
PURPLE GLOVE SYNDROME1
PUPILLARY REFLEX IMPAIRED1
PUPILLARY DISORDER1
PUNCTATE KERATITIS1
PULSE PRESSURE DECREASED1
PSORIASIS1
PRURITUS GENERALISED1
PROTHROMBIN LEVEL DECREASED1
PROTEIN TOTAL INCREASED1
PROTEIN TOTAL DECREASED1
PROTEIN TOTAL1
PRODUCTIVE COUGH1
Product substitution issue1
Product delivery mechanism issue1
Product container seal issue1
PROCTITIS1
PROCEDURAL COMPLICATION1
PREMATURE SEPARATION OF PLACENTA1
POSTURING1
POSTOPERATIVE INFECTION1
POSTERIOR CAPSULE OPACIFICATION1
Poor quality product administered1
POLYNEUROPATHY1
POLLAKIURIA1
PNEUMONIA ASPIRATION1
PLEURITIC PAIN1
PLEURISY1
PLEURAL EFFUSION1
PHOTOSENSITIVITY REACTION1
PHOTOPHOBIA1
PHOTODERMATOSIS1
Pharyngeal erythema1
PETECHIAE1
PERICARDITIS1
PENILE HAEMORRHAGE1
PARALYSIS1
PANCREATITIS1
PANCREATIC INJURY1
PAIN OF SKIN1
PAIN IN JAW1
OVERDOSE1
OTORRHOEA1
OROPHARYNGEAL SWELLING1
ORGAN FAILURE1
Optic neuritis1
OPHTHALMOLOGICAL EXAMINATION ABNORMAL1
Ophthalmic herpes simplex1
Open fracture1
OLIGURIA1
OESOPHAGEAL ULCER1
OESOPHAGEAL SPASM1
OEDEMA MOUTH1
OEDEMA1
OCULAR ICTERUS1
OCULAR DISCOMFORT1
OCCULT BLOOD POSITIVE1
NORMAL NEWBORN1
NODAL ARRHYTHMIA1
NEUTROPHILIA1
NEUTROPENIA1
NEUROPATHIC PAIN1
NEURALGIA1
NERVOUS SYSTEM DISORDER1
NERVE INJURY1
NEPHROPATHY TOXIC1
NEPHROPATHY1
Nasopharyngitis1
Nasal congestion1
MYOPIA1
MYOCARDITIS1
MYELOPATHY1
Mycotic endophthalmitis1
MUSCULOSKELETAL DISCOMFORT1
MUSCLE TWITCHING1
MUSCLE TIGHTNESS1
MUSCLE CRAMP1
MUCOUS MEMBRANE DISORDER1
MOVEMENT DISORDER1
MOUTH HAEMORRHAGE1
MOTION SICKNESS1
MOOD SWINGS1
MOANING1
METABOLIC DISORDER1
MEMORY IMPAIRMENT1
MEGACOLON1
MACULOPATHY1
Macular oedema1
LUNG NEOPLASM MALIGNANT1
LUNG INFILTRATION1
LUNG DISORDER1
LONG QT SYNDROME1
LIVER INJURY1
LEUKOCYTOSIS1
LACRIMATION INCREASED1
KERATOPATHY1
KERATOCONJUNCTIVITIS SICCA1
Keratitis fungal1
KERATITIS1
Joint dislocation1
JAUNDICE CHOLESTATIC1
ISCHAEMIC STROKE1
ISCHAEMIA1
INTESTINAL PERFORATION1
INTESTINAL FUNCTIONAL DISORDER1
INTERNATIONAL NORMALISED RATIO DECREASED1
INSULIN-REQUIRING TYPE II DIABETES MELLITUS1
INJURY1
INJECTION SITE RASH1
INFUSION SITE PRURITUS1
INFUSION SITE ERYTHEMA1
INFLUENZA1
INFERTILITY1
INFECTION MASKED1
INCORRECT DOSE ADMINISTERED1
INADEQUATE DIET1
IMPAIRED WORK ABILITY1
IMPAIRED INSULIN SECRETION1
Impaired healing1
IMPAIRED GASTRIC EMPTYING1
Hypoxic-ischaemic encephalopathy1
HYPOPYON1
HYPOKINESIA1
HYPOKALAEMIA1
HYPOGLYCAEMIC SEIZURE1
HYPOGLYCAEMIC ENCEPHALOPATHY1
HYPOCOAGULABLE STATE1
HYPOACUSIS1
HYPERPHAGIA1
HYPERMETROPIA1
HYPERCALCAEMIA1
HOT FLUSH1
HICCUPS1
HERPES ZOSTER1
HEPATOCELLULAR DAMAGE1
HEPATITIS CHOLESTATIC1
HEPATITIS ACUTE1
HEPATIC STEATOSIS1
HEPATIC FIBROSIS1
HEPATIC CIRRHOSIS1
HEART RATE DECREASED1
HAEMORRHOIDS1
HAEMORRHAGE INTRACRANIAL1
HAEMOPTYSIS1
HAEMOLYTIC URAEMIC SYNDROME1
HAEMOLYTIC ANAEMIA1
HAEMODYNAMIC INSTABILITY1
HAEMATURIA1
HAEMATOCHEZIA1
HAEMATEMESIS1
GLOSSITIS1
GLOBULINS INCREASED1
GLARE1
GINGIVAL BLEEDING1
GENERALISED ERYTHEMA1
GASTROINTESTINAL MOTILITY DISORDER1
GASTROINTESTINAL HAEMORRHAGE1
GASTROINTESTINAL DISORDER1
GASTRIC DISORDER1
Foreign body sensation in eyes1
FOETAL DISTRESS SYNDROME1
FLUID RETENTION1
FEELING JITTERY1
FEELING HOT1
FEELING COLD1
FAECES DISCOLOURED1
FAECAL OCCULT BLOOD POSITIVE1
FAECAL INCONTINENCE1
EYELIDS PRURITUS1
EYELID PTOSIS1
Eye swelling1
EYE INFECTION BACTERIAL1
EYE HAEMORRHAGE1
EYE DISCHARGE1
ERUCTATION1
ENTEROCOLITIS1
EMOTIONAL DISORDER1
ELECTROLYTE IMBALANCE1
ELECTROCARDIOGRAM T WAVE INVERSION1
ELECTROCARDIOGRAM ST SEGMENT ABNORMAL1
ECZEMA1
Eating disorder1
DYSTONIA1
DYSSTASIA1
DYSPHONIA1
DRUG SCREEN POSITIVE1
DRUG INTERACTION POTENTIATION1
DRUG EXPOSURE DURING PREGNANCY1
DRUG EFFECT DECREASED1
DRUG ADMINISTRATION ERROR1
DISTURBANCE IN ATTENTION1
DISSEMINATED INTRAVASCULAR COAGULATION1
DISEASE RECURRENCE1
DISEASE PROGRESSION1
DIPLOPIA1
Diarrhoea infectious1
DERMATITIS1
DEPRESSED MOOD1
DECUBITUS ULCER1
DECREASED INTEREST1
DACRYOSTENOSIS CONGENITAL1
CYANOSIS1
CULTURE POSITIVE1
CREPITATIONS1
CREATININE RENAL CLEARANCE DECREASED1
CORNEAL ULCER1
Corneal thinning1
CORNEAL SCAR1
CORNEAL INFILTRATES1
CORNEAL DEPOSITS1
CORNEAL ABRASION1
COORDINATION ABNORMAL1
COOMBS DIRECT TEST POSITIVE1
CONDUCTION DISORDER1
COMPARTMENT SYNDROME1
COMMUNICATION DISORDER1
COLITIS1
COAGULATION TIME PROLONGED1
CLOSTRIDIUM DIFFICILE TOXIN TEST POSITIVE1
Clostridium difficile colitis1
CHRONIC OBSTRUCTIVE PULMONARY DISEASE1
CHRONIC OBSTRUCTIVE AIRWAYS DISEASE EXACERBATED1
CHOREA1
CHOLESTASIS1
CHOKING1
CEPHALO-PELVIC DISPROPORTION1
CELLULITIS1
CATHETER RELATED INFECTION1
Cataract operation1
Cataract1
CARDIOMEGALY1
CARDIAC FAILURE ACUTE1
CAESAREAN SECTION1
BURNING SENSATION1
BUNDLE BRANCH BLOCK1
BRONCHOSPASM1
BRONCHITIS ACUTE1
BRONCHITIS1
BRAIN DEATH1
BODY TEMPERATURE1
BLOOD URINE PRESENT1
BLOOD UREA DECREASED1
BLOOD UREA1
BLOOD TEST ABNORMAL1
BLOOD SODIUM DECREASED1
BLOOD SODIUM ABNORMAL1
BLOOD SODIUM1
BLOOD PRESSURE SYSTOLIC DECREASED1
BLOOD PRESSURE ORTHOSTATIC1
BLOOD PRESSURE DIASTOLIC INCREASED1
BLOOD PRESSURE DIASTOLIC DECREASED1
BLOOD POTASSIUM DECREASED1
BLOOD MAGNESIUM ABNORMAL1
BLOOD CREATININE ABNORMAL1
BLEPHARITIS1
BETA HAEMOLYTIC STREPTOCOCCAL INFECTION1
BACTERAEMIA1
AURA1
ATELECTASIS1
ASTIGMATISM1
ASPIRATION1
APPENDIX DISORDER1
APNOEA1
APHASIA1
APALLIC SYNDROME1
ANOSMIA1
ANORECTAL DISORDER1
ANAPHYLACTOID REACTION1
ANAEMIA1
ALVEOLITIS ALLERGIC1
Allergy to chemicals1
ADAMS-STOKES SYNDROME1
ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS1
ACTIVITIES OF DAILY LIVING IMPAIRED1
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED1
ACCIDENTAL OVERDOSE1
ACCIDENTAL EXPOSURE1
ABSCESS1
ABNORMAL SENSATION IN EYE1
ABNORMAL LABOUR1
ABNORMAL FAECES1
ABNORMAL DREAMS1





Toxicity information:

Toxicity class: 5
Toxicity type: cardiovascular
LD50: 3266 mg/kg



External links:

ChEBML: CHEMBL31
DrugBank: DB01044