78/100 · Elevated
Manufactured by Fresenius Kabi USA, LLC
Propranolol Hydrochloride Adverse Events: High Serious Reaction Rate
140,640 FDA adverse event reports analyzed
Last updated: 2026-05-12
PROPRANOLOL HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Fresenius Kabi USA, LLC. Based on analysis of 140,640 FDA adverse event reports, PROPRANOLOL HYDROCHLORIDE has a safety score of 78 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for PROPRANOLOL HYDROCHLORIDE include OFF LABEL USE, DRUG INEFFECTIVE, NAUSEA, HEADACHE, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PROPRANOLOL HYDROCHLORIDE.
Propranolol Hydrochloride has a safety concern score of 78 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 140,640 adverse event reports for this medication, which is primarily manufactured by Fresenius Kabi Usa, Llc.
The most commonly reported adverse events include Off Label Use, Drug Ineffective, Nausea. Of classified reports, 70.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High incidence of serious reactions, including cardiovascular and respiratory issues.
Significant number of drug interactions and overdose reports. Common gastrointestinal and neurological side effects reported. A notable number of mental health-related adverse events, including suicidal ideation and depression.
Patients taking Propranolol Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Propranolol Hydrochloride can interact with other drugs, leading to adverse effects. Overdose is a common issue, and patients should be monitored closely. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Propranolol Hydrochloride received a safety concern score of 78/100 (high concern). This is based on a 70.3% serious event ratio across 68,239 classified reports. The score accounts for 140,640 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 41,047, Male: 20,501, Unknown: 201. The most frequently reported age groups are age 53 (1,049 reports), age 50 (963 reports), age 64 (925 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 68,239 classified reports for PROPRANOLOL HYDROCHLORIDE:
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.
Propranolol Hydrochloride can interact with other drugs, leading to adverse effects. Overdose is a common issue, and patients should be monitored closely.
If you are taking Propranolol Hydrochloride, here are important things to know. The most commonly reported side effects include off label use, drug ineffective, nausea, headache, fatigue. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for serious cardiovascular and respiratory issues, especially in elderly patients. Be cautious with drug interactions and avoid concurrent use of other beta-blockers or similar medications. Report any mental health issues, including suicidal ideation, to healthcare providers immediately. 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.
Regulatory oversight is ongoing, with a focus on monitoring serious adverse events and drug interactions. Patients should report any adverse reactions promptly.
The FDA has received approximately 140,640 adverse event reports associated with Propranolol Hydrochloride. 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 Propranolol Hydrochloride include Off Label Use, Drug Ineffective, Nausea, Headache, Fatigue. By volume, the top reported reactions are: Off Label Use (7,261 reports), Drug Ineffective (5,332 reports), Nausea (4,279 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Propranolol Hydrochloride.
Out of 68,239 classified reports, 48,000 (70.3%) were classified as serious and 20,239 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 Propranolol Hydrochloride break down by patient sex as follows: Female: 41,047, Male: 20,501, Unknown: 201. 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 Propranolol Hydrochloride adverse events are: age 53: 1,049 reports, age 50: 963 reports, age 64: 925 reports, age 63: 881 reports, age 56: 880 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 Propranolol Hydrochloride adverse event reports is Fresenius Kabi Usa, Llc. 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 Propranolol Hydrochloride include: Diarrhoea, Dizziness, Product Use In Unapproved Indication, Vomiting, Dyspnoea. 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 Propranolol Hydrochloride 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.
Propranolol Hydrochloride has a safety concern score of 78 out of 100 (high 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. High incidence of serious reactions, including cardiovascular and respiratory issues.
Key safety signals identified in Propranolol Hydrochloride's adverse event data include: High rate of serious adverse events (70.3%). Multiple reports of drug interactions and overdose. Significant mental health-related adverse events, including suicidal ideation and depression. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Propranolol Hydrochloride can interact with other drugs, leading to adverse effects. Overdose is a common issue, and patients should be monitored closely. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Propranolol Hydrochloride.
Monitor for serious cardiovascular and respiratory issues, especially in elderly patients. Be cautious with drug interactions and avoid concurrent use of other beta-blockers or similar medications. Report any mental health issues, including suicidal ideation, to healthcare providers immediately.
Propranolol Hydrochloride has 140,640 adverse event reports on file with the FDA. Significant number of drug interactions and overdose reports. The volume of reports for Propranolol Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with a focus on monitoring serious adverse events and drug interactions. Patients should report any adverse reactions promptly. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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