Bromfenac


w174



General information:


Withdrawn ID: w174
Canonical SMILES:
Standard InChI:
Standard InChIKey:
ATC class(es): S01BC11
Molecular Formula: C15H12BrNO3
Molweight: 334.165



Withdrawal information:


Withdrawn due to drug safety reasons:Yes
First approved: 1997
First death: 1998
First withdrawn: 1998
Last withdrawn: 1998
Reference: https://www.ncbi.nlm.nih.gov/pubmed/21574210



Side-effects:

Total reported cases (submitted by medical professionals) with Bromfenac as primary suspect: 90


Reported final outcomes:
Hospitalization (initial or prolonged): 8
Disability: 5
Intervention required to prevent permanent impairment/damage: 5
Life-Threatening condition: 4
Death: 2


Reported side-effects:

Side-effect Case number
ULCERATIVE KERATITIS12
Cystoid macular oedema11
Eye irritation9
Eye pain7
CORNEAL PERFORATION6
Product use in unapproved indication5
Off label use5
Intentional product use issue5
Treatment failure4
Swelling of eyelid4
Pruritus4
Product packaging quantity issue4
MENTAL STATUS CHANGES4
JAUNDICE4
Drug ineffective4
Drug dose omission4
Dermatitis allergic4
COAGULOPATHY4
Blepharitis4
ABDOMINAL PAIN4
Visual impairment3
Punctate keratitis3
Ocular discomfort3
NAUSEA3
Macular oedema3
CORNEAL DISORDER3
WOUND SECRETION2
VOMITING2
VISUAL ACUITY REDUCED2
Vision blurred2
TREATMENT NONCOMPLIANCE2
Product quality issue2
Product physical consistency issue2
Product colour issue2
Ocular hyperaemia2
Mydriasis2
Medication residue present2
LIVER TRANSPLANT2
Keratitis2
Halo vision2
FATIGUE2
ENDOPHTHALMITIS2
Drug ineffective for unapproved indication2
Drug hypersensitivity2
Drug administration error2
CORNEAL SCAR2
Corneal opacity2
CORNEAL OEDEMA2
Corneal erosion2
CONDITION AGGRAVATED2
CATARACT2
Visual field defect1
TRANSPLANT1
Toxic epidermal necrolysis1
Toxic anterior segment syndrome1
Tooth discolouration1
Seizure1
SCLERAL THINNING1
SCLERAL GRAFT1
SCLERAL DISORDER1
Scleral discolouration1
Retinal haemorrhage1
Retinal detachment1
Retinal artery occlusion1
Rash1
PYREXIA1
Product supply issue1
Product prescribing error1
Product label issue1
Product dropper issue1
Product dose omission issue1
Product container issue1
Posterior capsule opacification1
Photosensitivity reaction1
Photophobia1
Periorbital swelling1
Pain1
Overdose1
Ocular pemphigoid1
Night blindness1
MOUTH BREATHING1
Migraine1
Metamorphopsia1
MALAISE1
MACULOPATHY1
MACULAR DEGENERATION1
Loss of consciousness1
Lacrimation increased1
Iritis1
Iris adhesions1
Intraocular pressure increased1
Instillation site pain1
Instillation site irritation1
Instillation site haemorrhage1
Instillation site dryness1
Incorrect dose administered1
IMPAIRED HEALING1
IMPAIRED DRIVING ABILITY1
Hyperaemia1
HEADACHE1
GRAFT COMPLICATION1
Face oedema1
Eyelid oedema1
Eye inflammation1
Eye infection1
Eye disorder1
Expired product administered1
Erythema1
Epistaxis1
Ear pain1
DYSPNOEA1
Dry eye1
Drug prescribing error1
Drug interaction1
Diplopia1
DETACHED DESCEMET'S MEMBRANE1
Cytomegalovirus infection1
Corneal transplant1
CORNEAL THINNING1
Corneal operation1
CORNEAL INFECTION1
CORNEAL EPITHELIUM DEFECT1
CONSTIPATION1
Conjunctivitis1
Conjunctival oedema1
CATARACT OPERATION COMPLICATION1
CATARACT OPERATION1
CARDIAC ASTHMA1
CARDIAC ARREST1
Burning sensation1
Blindness1
ASTHMA1
ARTHRALGIA1
Anterior chamber inflammation1
Anterior chamber disorder1
Anterior chamber cell1
ANAPHYLACTIC REACTION1
AMNIOTIC MEMBRANE GRAFT1
Accidental exposure to product1
ABDOMINAL PAIN LOWER1





Filtered ChEMBL targets:

Target UniProtKB ID Activity in nm Target Name Target gene
P23219 8.481 Prostaglandin G/H synthase 1 PGH1_HUMAN



Toxicity information:

Toxicity class: 4
Toxicity type: hepatic
LD50: 311 mg/kg



External links:

ChEBML: CHEMBL1077
DrugBank: DB00963