OpenPV Signal Explorer
FAERS disproportionality dashboard
← All drugs
Drug

Azilsartan Kamedoxomil

118 flagged reaction(s) · 1,757 total co-reports · max PRR 29.2
Important: Reactions below are the flagged terms from this drug’s FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate disproportionality in spontaneous reporting, not causation. Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
Reaction Co-reports (a) PRR ROR Signal
1 Product Odour Abnormal 43 29.2 29.7 signal
2 Glomerular Filtration Rate Decreased 25 14.5 14.7 signal
3 Adrenal Insufficiency 20 11.8 11.8 signal
4 Cerebral Infarction 39 11.2 11.4 signal
5 Proteinuria 26 9.7 9.8 signal
6 Incorrect Product Storage 18 9.5 9.6 signal
7 Blood Potassium Increased 19 8.2 8.3 signal
8 Renal Impairment 97 8.2 8.4 signal
9 Interstitial Lung Disease 52 7.6 7.7 signal
10 Hyperkalaemia 36 7.3 7.3 signal
11 Product Dispensing Error 22 7.1 7.2 signal
12 Palmar-plantar Erythrodysaesthesia Syndrome 23 6.9 7.0 signal
13 Erythema Multiforme 9 6.8 6.8 signal
14 Tubulointerstitial Nephritis 18 6.8 6.8 signal
15 Bacteraemia 11 6.6 6.6 signal
16 Hepatic Function Abnormal 33 6.3 6.3 signal
17 Altered State Of Consciousness 19 6.2 6.2 signal
18 Hypothyroidism 28 6.2 6.2 signal
19 Thrombotic Microangiopathy 8 5.8 5.8 signal
20 Poor Quality Product Administered 8 5.5 5.5 signal
21 Hypertension 162 5.4 5.6 signal
22 Blood Pressure Decreased 49 5.2 5.3 signal
23 Blood Creatinine Increased 47 5.1 5.1 signal
24 Myocarditis 8 5.0 5.0 signal
25 Pneumocystis Jirovecii Pneumonia 7 4.9 4.9 signal
26 Gout 12 4.7 4.7 signal
27 Drug Level Increased 11 4.7 4.7 signal
28 Iron Deficiency Anaemia 6 4.6 4.6 signal
29 Taste Disorder 13 4.6 4.6 signal
30 Blood Pressure Increased 98 4.5 4.6 signal
31 Cytokine Release Syndrome 12 4.4 4.4 signal
32 Blood Pressure Systolic Increased 12 4.3 4.3 signal
33 End Stage Renal Disease 11 4.2 4.2 signal
34 Toxic Epidermal Necrolysis 9 4.2 4.2 signal
35 Cholecystitis 7 4.1 4.2 signal
36 Subarachnoid Haemorrhage 6 4.1 4.1 signal
37 Cerebral Haemorrhage 21 4.1 4.2 signal
38 Cardiac Failure 47 4.1 4.2 signal
39 Hyperthyroidism 8 3.9 3.9 signal
40 Product Packaging Issue 5 3.8 3.8 signal
41 Arteriosclerosis 5 3.7 3.7 signal
42 Thyroid Disorder 8 3.7 3.7 signal
43 Sinus Bradycardia 5 3.6 3.6 signal
44 Drug Eruption 9 3.6 3.6 signal
45 Product Physical Issue 10 3.5 3.5 signal
46 Blood Pressure Fluctuation 12 3.5 3.5 signal
47 Metastases To Bone 8 3.4 3.4 signal
48 Subdural Haematoma 7 3.4 3.4 signal
49 Hyperbilirubinaemia 5 3.4 3.4 signal
50 Platelet Count Decreased 50 3.3 3.3 signal
51 Wound Infection 5 3.2 3.2 signal
52 Gamma-glutamyltransferase Increased 10 3.2 3.2 signal
53 Nephropathy Toxic 5 3.2 3.2 signal
54 Pharyngeal Oedema 7 3.2 3.2 signal
55 Product Taste Abnormal 6 3.1 3.1 signal
56 Blood Creatine Phosphokinase Increased 13 3.1 3.1 signal
57 Rebound Effect 5 3.1 3.1 signal
58 Internal Haemorrhage 5 3.1 3.1 signal
59 Spinal Pain 5 3.0 3.0 signal
60 Disseminated Intravascular Coagulation 6 3.0 3.0 signal
61 Covid-19 Pneumonia 5 3.0 3.0 signal
62 Autoimmune Disorder 4 2.9 2.9 no signal
63 Knee Operation 4 2.9 2.9 no signal
64 Limb Injury 11 2.9 2.9 signal
65 Prescribed Underdose 8 2.8 2.8 signal
66 Hypotonia 4 2.8 2.8 no signal
67 Shock 9 2.8 2.8 signal
68 Hypothermia 4 2.8 2.8 no signal
69 Sluggishness 4 2.8 2.8 no signal
70 Eyelid Ptosis 4 2.8 2.8 no signal
71 Inappropriate Antidiuretic Hormone Secretion 4 2.8 2.8 no signal
72 Injection Site Discomfort 4 2.7 2.7 no signal
73 Product Use Complaint 6 2.7 2.7 signal
74 Breast Pain 4 2.6 2.6 no signal
75 Sudden Death 4 2.6 2.6 no signal
76 Wrong Technique In Product Usage Process 75 2.6 2.7 signal
77 Neutrophil Count Decreased 15 2.6 2.6 signal
78 Throat Tightness 10 2.6 2.6 signal
79 Product Packaging Quantity Issue 4 2.6 2.6 no signal
80 Injection Site Nodule 4 2.6 2.6 no signal
81 Stevens-johnson Syndrome 8 2.5 2.5 signal
82 Hypertensive Crisis 4 2.5 2.5 no signal
83 Lactic Acidosis 11 2.4 2.4 signal
84 Diabetes Mellitus Inadequate Control 6 2.4 2.4 no signal
85 Colon Cancer 5 2.4 2.4 no signal
86 Therapy Partial Responder 5 2.3 2.3 no signal
87 Drug Dispensing Error 5 2.3 2.3 no signal
88 Pemphigus 4 2.3 2.3 no signal
89 Thinking Abnormal 6 2.3 2.3 no signal
90 Hair Colour Changes 4 2.2 2.2 no signal
91 Malignant Neoplasm Progression 32 2.2 2.2 signal
92 Injection Site Induration 4 2.2 2.2 no signal
93 Angioedema 13 2.1 2.1 signal
94 Myelosuppression 10 2.1 2.1 signal
95 Eye Discharge 3 2.1 2.1 no signal
96 Diabetic Ketoacidosis 7 2.1 2.1 no signal
97 Metastases To Liver 5 2.0 2.0 no signal
98 Dialysis 4 2.0 2.0 no signal
99 Glycosylated Haemoglobin Increased 7 2.0 2.0 no signal
100 Blood Glucose Fluctuation 3 1.9 1.9 no signal
101 Product Dose Omission 18 1.9 1.9 no signal
102 Product Availability Issue 6 1.9 1.9 no signal
103 Spinal Operation 3 1.7 1.7 no signal
104 Bone Marrow Failure 5 1.7 1.7 no signal
105 Product Storage Error 21 1.7 1.7 no signal
106 Osteonecrosis Of Jaw 6 1.7 1.7 no signal
107 Cytomegalovirus Infection 4 1.7 1.7 no signal
108 Gastric Cancer 6 1.6 1.6 no signal
109 Neoplasm Progression 8 1.6 1.6 no signal
110 Expired Product Administered 7 1.5 1.5 no signal
111 Colitis Ulcerative 9 1.4 1.4 no signal
112 Drug Effective For Unapproved Indication 5 1.2 1.2 no signal
113 Hepatic Cancer 4 1.2 1.2 no signal
114 Therapeutic Response Shortened 5 1.1 1.1 no signal
115 Intentional Overdose 9 1.0 1.0 no signal
116 Injection Site Pruritus 9 1.0 1.0 no signal
117 Gynaecomastia 4 0.9 0.9 no signal
118 Device Dislocation 4 0.6 0.6 no signal