azilsartan medoxomil


EMA4



General information:


Withdrawn ID: EMA4
Canonical SMILES:
Standard InChI:
Standard InChIKey:
ATC class(es): C09CA09
Molecular Formula: C30H24N4O8
Molweight: 568.534



Withdrawal information:


Withdrawn due to drug safety reasons:No



Side-effects:

Total reported cases (submitted by medical professionals) with azilsartan medoxomil as primary suspect: 356


Reported final outcomes:
Hospitalization (initial or prolonged): 86
Intervention required to prevent permanent impairment/damage: 29
Death: 17
Life-Threatening condition: 5
Disability: 4


Reported side-effects:

Side-effect Case number
DIZZINESS30
Drug ineffective27
Product odour abnormal27
Wrong technique in product usage process27
HYPONATRAEMIA23
HYPOTENSION21
DIARRHOEA18
RENAL FAILURE17
HYPERKALAEMIA16
NAUSEA16
BLOOD SODIUM DECREASED15
LOSS OF CONSCIOUSNESS15
ASTHENIA14
FATIGUE14
HYPERTENSION14
MUSCLE SPASMS14
Poor quality drug administered14
BLOOD PRESSURE INCREASED13
DEATH12
Product storage error11
BLOOD PRESSURE DECREASED10
Headache10
Product contamination10
Incorrect product storage9
Product quality issue9
Blood creatinine increased8
Dyspnoea8
Hypersensitivity8
HYPOKALAEMIA8
Poor quality product administered8
Product dispensing error8
Rash8
SYNCOPE8
Cough7
Arthralgia6
CHEST PAIN6
Feeling abnormal6
WEIGHT DECREASED6
CONVULSION5
Decreased appetite5
Malaise5
PALPITATIONS5
Peripheral swelling5
Product packaging quantity issue5
VOMITING5
Abdominal discomfort4
Acute kidney injury4
Alopecia4
Blood pressure fluctuation4
Blood pressure inadequately controlled4
BLOOD PRESSURE SYSTOLIC INCREASED4
Dehydration4
Drug intolerance4
Dry mouth4
Lip swelling4
Myocardial infarction4
OEDEMA PERIPHERAL4
Pain4
Paraesthesia4
Product closure removal difficult4
Product taste abnormal4
URINARY RETENTION4
Weight increased4
Abdominal pain upper3
ANGIOEDEMA3
Arrhythmia3
ATRIAL FIBRILLATION3
BLOOD POTASSIUM DECREASED3
Cardiac failure3
Cerebrovascular accident3
Chest discomfort3
CONDITION AGGRAVATED3
Confusional state3
Drug dispensing error3
Dysuria3
FALL3
GLOMERULAR FILTRATION RATE DECREASED3
Gout3
HEART RATE IRREGULAR3
Hyperhidrosis3
HYPERTENSIVE CRISIS3
MUSCULAR WEAKNESS3
MYALGIA3
Oliguria3
Pain in extremity3
Pollakiuria3
Prescribed underdose3
Product physical issue3
Rash generalised3
RENAL FAILURE ACUTE3
RENAL IMPAIRMENT3
Swelling3
Aphasia2
Blood cholesterol increased2
Blood potassium increased2
Blood pressure abnormal2
Blood pressure systolic decreased2
Burning sensation2
Chills2
COMA2
Constipation2
Dizziness postural2
Dysgeusia2
Dysphonia2
Dysstasia2
Eczema2
ELECTROLYTE IMBALANCE2
Erectile dysfunction2
Expired product administered2
Flatulence2
Flushing2
Gait disturbance2
Heart rate decreased2
HEART RATE INCREASED2
Ill-defined disorder2
Lethargy2
Mental status changes2
Migraine2
Nasal congestion2
Nasopharyngitis2
NO ADVERSE EVENT2
Oedema2
Off label use2
Pneumonia2
Product commingling2
Product dose omission2
Product packaging issue2
Product prescribing error2
Pruritus2
Pulmonary embolism2
RASH PRURITIC2
Respiratory failure2
Retching2
Seizure2
Sleep disorder2
Sprue-like enteropathy2
Thirst2
TRANSIENT ISCHAEMIC ATTACK2
TREATMENT NONCOMPLIANCE2
Unevaluable event2
URINE OUTPUT DECREASED2
Urticaria2
Vision blurred2
WITHDRAWAL HYPERTENSION2
Abdominal distension1
Abdominal pain lower1
Abnormal behaviour1
Abnormal dreams1
Ageusia1
ALANINE AMINOTRANSFERASE INCREASED1
Anal incontinence1
ANAPHYLACTIC REACTION1
Anaphylactic shock1
Androgenetic alopecia1
Aneurysm1
Anxiety1
Aphthous ulcer1
ASPARTATE AMINOTRANSFERASE INCREASED1
Atrioventricular block1
Basal cell carcinoma1
Bladder disorder1
BLOOD CHLORIDE DECREASED1
Blood creatinine abnormal1
BLOOD ELECTROLYTES ABNORMAL1
Blood magnesium decreased1
Blood pressure diastolic decreased1
Blood testosterone decreased1
Blood urea abnormal1
Blood uric acid increased1
Blue toe syndrome1
Bradycardia1
BRONCHITIS1
Bundle branch block left1
C-reactive protein increased1
Cardiac death1
Cardiogenic shock1
CARDIOMYOPATHY1
Cardiovascular disorder1
Cellulitis1
Chronic kidney disease1
Coeliac disease1
Coronary artery disease1
Cyanosis1
Cystitis1
DEAFNESS BILATERAL1
Dermatitis1
DERMATITIS ALLERGIC1
Drug dose omission1
Drug effect decreased1
Drug effective for unapproved indication1
Drug ineffective for unapproved indication1
Drug interaction1
Drug prescribing error1
Dry eye1
Dyspepsia1
Dysphagia1
Dyspnoea at rest1
DYSPNOEA EXERTIONAL1
Ear pain1
ECONOMIC PROBLEM1
Electrolyte depletion1
Emotional distress1
Epigastric discomfort1
Eructation1
Eye discharge1
Eyelid margin crusting1
Feeling hot1
Fluid retention1
Foreign body1
Frequent bowel movements1
Gallbladder disorder1
Gastric ulcer1
Gastrointestinal pain1
Gastrointestinal sounds abnormal1
Gouty arthritis1
Haematoma1
Haemodialysis1
Haemoglobin decreased1
Head discomfort1
Hearing impaired1
Heart alternation1
Helicobacter gastritis1
Hepatitis toxic1
Hospitalisation1
Hyperadrenalism1
Hyperaldosteronism1
Hyperuricaemia1
Hypoaesthesia1
Hypochloraemia1
Hypotonia1
Inappropriate antidiuretic hormone secretion1
Inappropriate schedule of drug administration1
Incoherent1
INCONTINENCE1
Incorrect dosage administered1
Insomnia1
Intentional dose omission1
Intentional product use issue1
Intercepted product prescribing error1
Irritable bowel syndrome1
Joint swelling1
Lactose intolerance1
Left ventricular hypertrophy1
Ligament sprain1
Limb injury1
Liver disorder1
Madarosis1
MALIGNANT HYPERTENSION1
Memory impairment1
Micturition disorder1
Micturition urgency1
Middle insomnia1
Migraine with aura1
Mobility decreased1
Musculoskeletal discomfort1
Musculoskeletal pain1
Myocarditis1
Nail growth abnormal1
Nasal dryness1
Nasal inflammation1
Nasal operation1
Neurodermatitis1
Neutropenia1
Ocular hyperaemia1
Oesophageal ulcer1
Orthostatic hypotension1
Overdose1
OXYGEN SATURATION DECREASED1
Pancreatic carcinoma1
Pancreatitis1
Photophobia1
PLATELET COUNT DECREASED1
Pleural effusion1
Pneumothorax1
Poisoning1
Polyuria1
Presyncope1
Product administration error1
Product colour issue1
Product container issue1
Product dispensing issue1
Product lot number issue1
Product prescribing issue1
PRODUCT SUBSTITUTION ISSUE1
Product use in unapproved indication1
Product use issue1
Prostatic specific antigen increased1
Protein total increased1
Psoriasis1
PULMONARY MASS1
Pulmonary oedema1
Purpura1
Quality of life decreased1
Rash papular1
REBOUND EFFECT1
Refusal of treatment by patient1
Renal cyst1
Renal failure chronic1
RENAL NEOPLASM1
Renal tubular necrosis1
Respiratory tract infection1
Respiratory tract infection bacterial1
Rhabdomyolysis1
Rhinorrhoea1
Sebaceous gland disorder1
Sinus bradycardia1
Sinus disorder1
Sinus headache1
Somnolence1
Stasis dermatitis1
Stress1
Sudden death1
Swelling face1
Therapeutic product effect decreased1
Therapy cessation1
Thinking abnormal1
Throat tightness1
Tongue coated1
Tremor1
Undersensing1
Unresponsive to stimuli1
Upper limb fracture1
Urge incontinence1
Urinary hesitation1
Urine odour abnormal1
Vascular dementia1
VENTRICULAR ARRHYTHMIA1
Visual impairment1
White blood cell count increased1
Wrist fracture1





Toxicity information:

Toxicity type: N/A



External links:

ChEBML: CHEMBL2028661
DrugBank: DB08822