Phenazopyridine


326



General information:


Withdrawn ID: 326
Canonical SMILES:
Standard InChI:
Standard InChIKey:
ATC class(es): G04BX06
Molecular Formula: C11H11N5
Molweight: 213.238



Withdrawal information:


Withdrawn due to drug safety reasons:No
First approved: 1987
First withdrawn: 2009
Last withdrawn: 2009



Side-effects:

Total reported cases (submitted by medical professionals) with Phenazopyridine as primary suspect: 48


Reported final outcomes:
Hospitalization (initial or prolonged): 26
Intervention required to prevent permanent impairment/damage: 8
Life-Threatening condition: 5
Death: 2


Reported side-effects:

Side-effect Case number
METHAEMOGLOBINAEMIA14
RENAL FAILURE ACUTE7
HAEMOLYTIC ANAEMIA7
Acute kidney injury5
SKIN DISCOLOURATION4
PYREXIA4
OXYGEN SATURATION DECREASED4
OVERDOSE4
JAUNDICE4
HAEMOLYSIS4
FATIGUE4
DYSPNOEA4
DIZZINESS4
DIARRHOEA4
CYANOSIS4
ANAEMIA4
YELLOW SKIN3
VOMITING3
SULPHAEMOGLOBINAEMIA3
PRURITUS3
NAUSEA3
MALAISE3
Hypoxia3
DYSPNOEA EXERTIONAL3
DRUG HYPERSENSITIVITY3
Chromaturia3
Toxicity to various agents2
RASH MACULAR2
RASH2
MYOCARDIAL INFARCTION2
Incorrect product administration duration2
HYPONATRAEMIA2
HYPERSENSITIVITY2
HAEMOGLOBIN DECREASED2
HAEMATOCRIT DECREASED2
EPIGASTRIC DISCOMFORT2
DYSPEPSIA2
DEPRESSED LEVEL OF CONSCIOUSNESS2
Confusional state2
CHEST DISCOMFORT2
BLOOD PRESSURE DECREASED2
ACCIDENTAL OVERDOSE2
Wrong product administered1
WEIGHT DECREASED1
VERTIGO1
URTICARIA1
UROSEPSIS1
UROBILIN URINE PRESENT1
URINE COLOUR ABNORMAL1
URINARY TRACT INFECTION1
TREMOR1
Transcription medication error1
THROAT TIGHTNESS1
THIRST1
Tachycardia1
Syncope1
SWELLING1
Suprapubic pain1
SUDDEN DEATH1
SOMNOLENCE1
Skin lesion1
SINUS TACHYCARDIA1
SEPSIS1
Seizure1
SEDATION1
SCLERAL DISCOLOURATION1
Retinal haemorrhage1
RETCHING1
RESPIRATORY RATE INCREASED1
Respiratory distress1
RENAL TUBULAR NECROSIS1
Renal impairment1
RED BLOOD CELL SEDIMENTATION RATE INCREASED1
REACTION TO AZO-DYES1
RASH PAPULAR1
RASH GENERALISED1
RASH ERYTHEMATOUS1
PUPILLARY REFLEX IMPAIRED1
PULMONARY EMBOLISM1
PROTHROMBIN LEVEL INCREASED1
PROTEIN TOTAL INCREASED1
Product use in unapproved indication1
Product packaging issue1
Product packaging confusion1
Product name confusion1
Product label issue1
Product label confusion1
Product dispensing error1
Product communication issue1
Product barcode issue1
PRESYNCOPE1
POLYCHROMASIA1
PO2 DECREASED1
PLATELET COUNT INCREASED1
PANCYTOPENIA1
PANCREATITIS1
OLIGURIA1
NEPHROSCLEROSIS1
NEPHROLITHIASIS1
Myeloid leukaemia1
MYDRIASIS1
MUCOSAL DRYNESS1
Micturition urgency1
MICROCYTOSIS1
METABOLIC ACIDOSIS1
MENTAL STATUS CHANGES1
MEDICATION ERROR1
Macrocytosis1
Lung infiltration1
LETHARGY1
LACTIC ACIDOSIS1
LACRIMATION INCREASED1
INTERNATIONAL NORMALISED RATIO INCREASED1
INTERNATIONAL NORMALISED RATIO FLUCTUATION1
Intercepted drug prescribing error1
Incorrect dose administered1
ILEUS1
Hypophagia1
HYPERKALAEMIA1
HEPATOMEGALY1
HEPATOCELLULAR DAMAGE1
HEPATITIS TOXIC1
HEART RATE INCREASED1
HAPTOGLOBIN DECREASED1
GASTRITIS EROSIVE1
GAIT DISTURBANCE1
Febrile neutropenia1
FALL1
EYE PRURITUS1
EOSINOPHILIA1
ECCHYMOSIS1
DYSURIA1
DYSSTASIA1
DRUG TOXICITY1
Drug ineffective1
DIVERTICULUM INTESTINAL1
DISEASE PROGRESSION1
DECREASED APPETITE1
COUGH1
CONVULSION1
CONSTIPATION1
COMA1
Circumstance or information capable of leading to medication error1
BLOOD METHAEMOGLOBIN PRESENT1
BLOOD ALBUMIN INCREASED1
BLISTER1
Bladder pain1
ARTHRALGIA1
ARRHYTHMIA1
ANISOCYTOSIS1
AGITATION1
AGEUSIA1
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED1
ACQUIRED METHAEMOGLOBINAEMIA1
ABDOMINAL TENDERNESS1
Abdominal pain upper1
ABDOMINAL PAIN1
ABDOMINAL DISCOMFORT1





Toxicity information:

Toxicity class: 5
Toxicity type: N/A
LD50: 4361 mg/kg



External links:

ChEBML: CHEMBL1242
DrugBank: DB01438