Azilsartan Kamedoxomil side effects: what 2,981 FDA adverse event reports show
Drug class
Angiotensin ii receptor blocker
Brand names
Azilsartan Medoxomil
Who reports
2,981 reports · 71% serious · 250 with death outcome · 50% female
Used for
Azilsartan medoxomil is indicated for the treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the class to which this drug principally belongs.
What it is
Azilsartan medoxomil, a prodrug, is hydrolyzed to azilsartan in the gastrointestinal tract during absorption. Azilsartan is an angiotensin II receptor blocker. The drug substance used in the d.
Boxed warning
FETAL TOXICITY When pregnancy is detected, discontinue azilsartan medoxomil as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] . Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] .
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 78 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Product odour abnormal | 43 | 29.2 21.7–39.4ROR 29.7 · χ² 1,141 / p 3e-250 | 28.8 EB05 22.3 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious n=9 | no trial data cached |
| Glomerular filtration rate decreased | 25 | 14.5 9.8–21.5ROR 14.7 · χ² 301 / p 8e-68 | 14.1 EB05 9.7 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious PRR 12.8 · ♀ 71% (drug 50%) · 96% clinician | no trial data cached |
| Adrenal insufficiency | 20 | 11.8 7.6–18.2ROR 11.8 · χ² 186 / p 1e-42 | 10.9 EB05 7.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 · 100% clinician | no trial data cached |
| Cerebral infarction | 39 | 11.2 8.2–15.3ROR 11.4 · χ² 353 / p 4e-79 | 10.8 EB05 8.0 · IC025 +2.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 9.1 · 92% clinician | no trial data cached |
| Proteinuria | 26 | 9.7 6.6–14.2ROR 9.8 · χ² 194 / p 2e-44 | 8.9 EB05 6.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · 96% clinician | no trial data cached |
| Incorrect product storage | 18 | 9.5 6.0–15.1ROR 9.6 · χ² 129 / p 4e-30 | 8.3 EB05 5.3 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious n=5 | no trial data cached |
| Blood potassium increased | 19 | 8.2 5.3–12.9ROR 8.3 · χ² 114 / p 7e-27 | 7.2 EB05 4.7 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 4.6 | no trial data cached |
| Renal impairment | 97 | 8.2 6.7–9.9ROR 8.4 · χ² 604 / p 1e-133 | 7.9 EB05 6.7 · IC025 +2.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 6.9 | no trial data cached |
| Interstitial lung disease | 52 | 7.6 5.8–9.9ROR 7.7 · χ² 291 / p 2e-65 | 7.2 EB05 5.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 · 98% clinician | no trial data cached |
| Hyperkalaemia (high potassium) | 36 | 7.3 5.2–10.0ROR 7.3 · χ² 188 / p 4e-43 | 6.7 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · 94% clinician | no trial data cached |
| Product dispensing error | 22 | 7.1 4.7–10.8ROR 7.2 · χ² 110 / p 6e-26 | 6.3 EB05 4.4 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious n=2 | no trial data cached |
| Palmar-plantar erythrodysaesthesia syndrome | 23 | 6.9 4.6–10.4ROR 7.0 · χ² 111 / p 4e-26 | 6.2 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 · 96% clinician | no trial data cached |
| Tubulointerstitial nephritis | 18 | 6.8 4.3–10.7ROR 6.8 · χ² 83 / p 5e-20 | 5.9 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Bacteraemia | 11 | 6.6 3.6–11.9ROR 6.6 · χ² 47 / p 4e-12 | 5.3 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Hepatic function abnormal | 33 | 6.3 4.5–8.8ROR 6.3 · χ² 141 / p 8e-33 | 5.8 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · 91% clinician | no trial data cached |
| Altered state of consciousness | 19 | 6.2 4.0–9.7ROR 6.2 · χ² 78 / p 6e-19 | 5.5 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Hypothyroidism | 28 | 6.2 4.3–8.9ROR 6.2 · χ² 117 / p 2e-27 | 5.7 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 · 96% clinician | no trial data cached |
| Hypertension (high blood pressure) | 162 | 5.4 4.6–6.2ROR 5.6 · χ² 578 / p 5e-128 | 5.3 EB05 4.6 · IC025 +2.1 3/3 methods agree | Likely indication confounding term in indications | serious PRR 4.9 | no trial data cached |
| Blood pressure decreased | 49 | 5.2 3.9–6.9ROR 5.3 · χ² 162 / p 2e-37 | 5.0 EB05 3.9 · IC025 +1.8 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 4.3 | no trial data cached |
| Blood creatinine increased | 47 | 5.1 3.8–6.7ROR 5.1 · χ² 149 / p 1e-34 | 4.8 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 3.8 | no trial data cached |
| Gout | 12 | 4.7 2.7–8.3ROR 4.7 · χ² 31 / p 1e-8 | 4.0 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Drug level increased | 11 | 4.7 2.6–8.4ROR 4.7 · χ² 28 / p 6e-8 | 4.0 EB05 2.4 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 4.2 | no trial data cached |
| Taste disorder | 13 | 4.6 2.7–7.9ROR 4.6 · χ² 33 / p 5e-9 | 4.0 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Blood pressure increased | 98 | 4.5 3.7–5.5ROR 4.6 · χ² 265 / p 7e-60 | 4.4 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 3.8 | no trial data cached |
| Cytokine release syndrome | 12 | 4.4 2.5–7.8ROR 4.4 · χ² 29 / p 5e-8 | 3.8 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Blood pressure systolic increased | 12 | 4.3 2.4–7.6ROR 4.3 · χ² 27 / p 9e-8 | 3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree | Likely indication confounding term in indications | serious PRR 3.8 | no trial data cached |
| End stage renal disease | 11 | 4.2 2.3–7.6ROR 4.2 · χ² 24 / p 6e-7 | 3.6 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Cerebral haemorrhage | 21 | 4.1 2.7–6.3ROR 4.2 · χ² 47 / p 4e-12 | 3.8 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 · ♀ 24% (drug 50%) · 90% clinician | no trial data cached |
| Cardiac failure (heart failure) | 47 | 4.1 3.1–5.5ROR 4.2 · χ² 108 / p 1e-25 | 4.0 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 3.3 · 91% clinician | no trial data cached |
| Product physical issue | 10 | 3.5 1.9–6.6ROR 3.5 · χ² 16 / p 4e-5 | 3.1 EB05 1.8 · IC025 +0.6 | Reporting / coding artifact | serious n=3 | no trial data cached |
| Blood pressure fluctuation | 12 | 3.5 2.0–6.2ROR 3.5 · χ² 19 / p 6e-6 | 3.2 EB05 2.0 · IC025 +0.7 | Lab value / disease marker | serious PRR 2.4 | no trial data cached |
| Platelet count decreased | 50 | 3.3 2.5–4.3ROR 3.3 · χ² 78 / p 4e-19 | 3.2 EB05 2.5 · IC025 +1.2 3/3 methods agree | Lab value / disease marker | serious PRR 3.0 · ♀ 71% (drug 50%) · 94% clinician | no trial data cached |
| Gamma-glutamyltransferase increased | 10 | 3.2 1.7–5.9ROR 3.2 · χ² 13 / p 2e-4 | 2.9 EB05 1.7 · IC025 +0.4 | Lab value / disease marker | serious PRR 2.7 | no trial data cached |
| Blood creatine phosphokinase increased | 13 | 3.1 1.8–5.4ROR 3.1 · χ² 17 / p 2e-5 | 2.9 EB05 1.8 · IC025 +0.6 | Lab value / disease marker | serious PRR 2.8 | no trial data cached |
| Limb injury | 11 | 2.9 1.6–5.2ROR 2.9 · χ² 11 / p 4e-4 | 2.6 EB05 1.6 · IC025 +0.4 | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Wrong technique in product usage process | 75 | 2.6 2.1–3.3ROR 2.7 · χ² 74 / p 5e-18 | 2.6 EB05 2.1 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 4.3 | no trial data cached |
| Neutrophil count decreased | 15 | 2.6 1.6–4.3ROR 2.6 · χ² 13 / p 1e-4 | 2.5 EB05 1.6 · IC025 +0.4 | Lab value / disease marker | serious PRR 2.1 | no trial data cached |
| Throat tightness | 10 | 2.6 1.4–4.8ROR 2.6 · χ² 8 / p 0.002 | 2.4 EB05 1.4 · IC025 +0.2 | Not in label — unassessed | serious PRR 2.4 | no trial data cached |
| Lactic acidosis | 11 | 2.4 1.3–4.3ROR 2.4 · χ² 8 / p 0.003 | 2.3 EB05 1.4 · IC025 +0.2 | Not in label — unassessed | serious PRR 2.0 | no trial data cached |
| Malignant neoplasm progression | 32 | 2.2 1.6–3.1ROR 2.2 · χ² 20 / p 4e-6 | 2.2 EB05 1.6 · IC025 +0.5 | Reporting / coding artifact | serious PRR 1.8 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Hypertension (high blood pressure) | 162 | 5.4 4.6–6.2ROR 5.6 · χ² 578 / p 5e-128 | 5.3 EB05 4.6 · IC025 +2.1 3/3 methods agree | Likely indication confounding term in indications | serious PRR 4.9 | no trial data cached |
| Blood pressure increased | 98 | 4.5 3.7–5.5ROR 4.6 · χ² 265 / p 7e-60 | 4.4 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 3.8 | no trial data cached |
| Renal impairment | 97 | 8.2 6.7–9.9ROR 8.4 · χ² 604 / p 1e-133 | 7.9 EB05 6.7 · IC025 +2.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 6.9 | no trial data cached |
| Wrong technique in product usage process | 75 | 2.6 2.1–3.3ROR 2.7 · χ² 74 / p 5e-18 | 2.6 EB05 2.1 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 4.3 | no trial data cached |
| Interstitial lung disease | 52 | 7.6 5.8–9.9ROR 7.7 · χ² 291 / p 2e-65 | 7.2 EB05 5.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 · 98% clinician | no trial data cached |
| Platelet count decreased | 50 | 3.3 2.5–4.3ROR 3.3 · χ² 78 / p 4e-19 | 3.2 EB05 2.5 · IC025 +1.2 3/3 methods agree | Lab value / disease marker | serious PRR 3.0 · ♀ 71% (drug 50%) · 94% clinician | no trial data cached |
| Blood pressure decreased | 49 | 5.2 3.9–6.9ROR 5.3 · χ² 162 / p 2e-37 | 5.0 EB05 3.9 · IC025 +1.8 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 4.3 | no trial data cached |
| Cardiac failure (heart failure) | 47 | 4.1 3.1–5.5ROR 4.2 · χ² 108 / p 1e-25 | 4.0 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 3.3 · 91% clinician | no trial data cached |
| Blood creatinine increased | 47 | 5.1 3.8–6.7ROR 5.1 · χ² 149 / p 1e-34 | 4.8 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 3.8 | no trial data cached |
| Product odour abnormal | 43 | 29.2 21.7–39.4ROR 29.7 · χ² 1,141 / p 3e-250 | 28.8 EB05 22.3 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious n=9 | no trial data cached |
| Cerebral infarction | 39 | 11.2 8.2–15.3ROR 11.4 · χ² 353 / p 4e-79 | 10.8 EB05 8.0 · IC025 +2.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 9.1 · 92% clinician | no trial data cached |
| Hyperkalaemia (high potassium) | 36 | 7.3 5.2–10.0ROR 7.3 · χ² 188 / p 4e-43 | 6.7 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · 94% clinician | no trial data cached |
| Hepatic function abnormal | 33 | 6.3 4.5–8.8ROR 6.3 · χ² 141 / p 8e-33 | 5.8 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · 91% clinician | no trial data cached |
| Malignant neoplasm progression | 32 | 2.2 1.6–3.1ROR 2.2 · χ² 20 / p 4e-6 | 2.2 EB05 1.6 · IC025 +0.5 | Reporting / coding artifact | serious PRR 1.8 | no trial data cached |
| Hypothyroidism | 28 | 6.2 4.3–8.9ROR 6.2 · χ² 117 / p 2e-27 | 5.7 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 · 96% clinician | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Adrenal insufficiency — n=20, PRR 11.8
- Proteinuria — n=26, PRR 9.7
- Interstitial lung disease — n=52, PRR 7.6
- Hyperkalaemia — n=36, PRR 7.3
- Palmar-plantar erythrodysaesthesia syndrome — n=23, PRR 6.9
- Hepatic function abnormal — n=33, PRR 6.3
- Hypothyroidism — n=28, PRR 6.2
- Cerebral haemorrhage — n=21, PRR 4.1
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Azilsartan Kamedoxomil?
In FDA FAERS, the most frequently co-reported reaction terms for Azilsartan Kamedoxomil are hypertension, blood pressure increased, renal impairment, interstitial lung disease, platelet count decreased, blood pressure decreased. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Azilsartan Kamedoxomil have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: FETAL TOXICITY When pregnancy is detected, discontinue azilsartan medoxomil as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] . Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] .
Do FAERS signals prove that Azilsartan Kamedoxomil causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID c09103d8-c094-473d-a303-bbb4f334aa8c, effective 20260420; matched on
openfda.generic_name.exact:"AZILSARTAN KAMEDOXOMIL") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 118 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.