45/100 · Moderate
Manufactured by Macleods Pharmaceuticals Limited
Candesartan Adverse Events: Mostly Non-Serious, but Serious Reactions Notable
128,662 FDA adverse event reports analyzed
Last updated: 2026-05-12
CANDESARTAN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Macleods Pharmaceuticals Limited. Based on analysis of 128,662 FDA adverse event reports, CANDESARTAN has a safety score of 45 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for CANDESARTAN include OFF LABEL USE, DYSPNOEA, FATIGUE, NAUSEA, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CANDESARTAN.
Candesartan has a safety concern score of 45 out of 100, placing it in the moderate concern category based on analysis of FDA adverse event data. The FDA has received approximately 128,662 adverse event reports for this medication, which is primarily manufactured by Macleods Pharmaceuticals Limited.
The most commonly reported adverse events include Off Label Use, Dyspnoea, Fatigue. Of classified reports, 96.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of adverse events are non-serious, but serious reactions such as pneumonia and acute kidney injury are reported.
Fatigue, nausea, and dizziness are among the most common side effects. There is a notable diversity in reported reactions, indicating a wide range of potential side effects.
Patients taking Candesartan should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Candesartan can cause hypotension and dizziness, and it is contraindicated with certain drugs like nonsteroidal anti-inflammatory drugs (NSAIDs). This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Candesartan received a safety concern score of 45/100 (moderate concern). This is based on a 96.3% serious event ratio across 33,478 classified reports. The score accounts for 128,662 total adverse event reports and 100 distinct reaction types. This moderate score is typical for widely prescribed medications with established safety profiles.
Adverse event reports by sex: Female: 17,139, Male: 13,048, Unknown: 48. The most frequently reported age groups are age 40 (967 reports), age 73 (897 reports), age 65 (866 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 33,478 classified reports for CANDESARTAN:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Candesartan can cause hypotension and dizziness, and it is contraindicated with certain drugs like nonsteroidal anti-inflammatory drugs (NSAIDs).
If you are taking Candesartan, here are important things to know. The most commonly reported side effects include off label use, dyspnoea, fatigue, nausea, diarrhoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of hypotension and dizziness, especially when starting or adjusting the dose. Inform your healthcare provider about any existing conditions or other medications you are taking. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor candesartan for safety, and updates will be provided as necessary. Patients should report any adverse reactions to their healthcare provider.
The FDA has received approximately 128,662 adverse event reports associated with Candesartan. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Candesartan include Off Label Use, Dyspnoea, Fatigue, Nausea, Diarrhoea. By volume, the top reported reactions are: Off Label Use (3,515 reports), Dyspnoea (3,170 reports), Fatigue (3,158 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Candesartan.
Out of 33,478 classified reports, 32,247 (96.3%) were classified as serious and 1,231 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Candesartan break down by patient sex as follows: Female: 17,139, Male: 13,048, Unknown: 48. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Candesartan adverse events are: age 40: 967 reports, age 73: 897 reports, age 65: 866 reports, age 70: 826 reports, age 79: 820 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Candesartan adverse event reports is Macleods Pharmaceuticals Limited. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Candesartan include: Dizziness, Headache, Pain, Drug Ineffective, Vomiting. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Candesartan to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Candesartan has a safety concern score of 45 out of 100 (moderate concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. The majority of adverse events are non-serious, but serious reactions such as pneumonia and acute kidney injury are reported.
Key safety signals identified in Candesartan's adverse event data include: Acute kidney injury and pneumonia are key safety signals, indicating potential renal and respiratory risks.. Drug intolerance and hypersensitivity reactions suggest possible allergic or adverse drug reactions.. Hypotension and dizziness are frequent, indicating potential cardiovascular side effects.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Candesartan can cause hypotension and dizziness, and it is contraindicated with certain drugs like nonsteroidal anti-inflammatory drugs (NSAIDs). Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Candesartan.
Monitor for signs of hypotension and dizziness, especially when starting or adjusting the dose. Inform your healthcare provider about any existing conditions or other medications you are taking.
Candesartan has 128,662 adverse event reports on file with the FDA. Fatigue, nausea, and dizziness are among the most common side effects. The volume of reports for Candesartan reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor candesartan for safety, and updates will be provided as necessary. Patients should report any adverse reactions to their healthcare provider. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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