78/100 · Elevated
Manufactured by ARS Pharmaceuticals Operations, Inc.
Adrenaline Reports Show High Serious Event Rate and Diverse Reactions
96,806 FDA adverse event reports analyzed
Last updated: 2026-05-12
ADRENALINUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ARS Pharmaceuticals Operations, Inc.. Based on analysis of 96,806 FDA adverse event reports, ADRENALINUM 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 ADRENALINUM include DRUG INEFFECTIVE, HEADACHE, SINUSITIS, PRODUCT DOSE OMISSION ISSUE, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ADRENALINUM.
Adrenalinum 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 96,806 adverse event reports for this medication, which is primarily manufactured by Ars Pharmaceuticals Operations, Inc..
The most commonly reported adverse events include Drug Ineffective, Headache, Sinusitis. Of classified reports, 62.8% 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 the high number of serious events is concerning.
A wide variety of reactions are reported, indicating potential for multiple side effects. Report volume is substantial, providing a comprehensive dataset for analysis.
Patients taking Adrenalinum should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Adrenaline has been associated with a range of drug interactions, including potential for anaphylaxis and other severe allergic reactions. Healthcare providers should be cautious when administering this drug to patients with known allergies. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Adrenalinum received a safety concern score of 78/100 (high concern). This is based on a 62.8% serious event ratio across 38,817 classified reports. The score accounts for 96,806 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: 21,047, Male: 11,998, Unknown: 54. The most frequently reported age groups are age 60 (428 reports), age 66 (404 reports), age 52 (401 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 38,817 classified reports for ADRENALINUM:
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.
Adrenaline has been associated with a range of drug interactions, including potential for anaphylaxis and other severe allergic reactions. Healthcare providers should be cautious when administering this drug to patients with known allergies.
If you are taking Adrenalinum, here are important things to know. The most commonly reported side effects include drug ineffective, headache, sinusitis, product dose omission issue, fatigue. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should strictly follow the prescribed dosage and administration schedule to avoid potential adverse reactions. Healthcare providers should be vigilant in monitoring patients for signs of serious adverse events and report any issues to the FDA. 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 is closely monitoring the safety of Adrenaline, and healthcare providers should report any adverse events to the agency. Patients should be informed about the potential risks and side effects of the drug and seek medical attention if they exp
The FDA has received approximately 96,806 adverse event reports associated with Adrenalinum. 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 Adrenalinum include Drug Ineffective, Headache, Sinusitis, Product Dose Omission Issue, Fatigue. By volume, the top reported reactions are: Drug Ineffective (4,161 reports), Headache (2,845 reports), Sinusitis (2,811 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Adrenalinum.
Out of 38,817 classified reports, 24,370 (62.8%) were classified as serious and 14,447 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 Adrenalinum break down by patient sex as follows: Female: 21,047, Male: 11,998, Unknown: 54. 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 Adrenalinum adverse events are: age 60: 428 reports, age 66: 404 reports, age 52: 401 reports, age 64: 401 reports, age 62: 397 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 Adrenalinum adverse event reports is Ars Pharmaceuticals Operations, Inc.. 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 Adrenalinum include: Covid-19, Pain, Dyspnoea, Nausea, Pneumonia. 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 Adrenalinum 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.
Adrenalinum 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. The majority of adverse events are non-serious, but the high number of serious events is concerning.
Key safety signals identified in Adrenalinum's adverse event data include: High number of serious events (24,370 out of 38,817, 62.8%). Diverse range of reactions, including cardiovascular, respiratory, and gastrointestinal issues. Multiple reports of drug hyper-sensitivity and anaphylactic reactions. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Adrenaline has been associated with a range of drug interactions, including potential for anaphylaxis and other severe allergic reactions. Healthcare providers should be cautious when administering this drug to patients with known allergies. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Adrenalinum.
Patients should strictly follow the prescribed dosage and administration schedule to avoid potential adverse reactions. Healthcare providers should be vigilant in monitoring patients for signs of serious adverse events and report any issues to the FDA.
Adrenalinum has 96,806 adverse event reports on file with the FDA. A wide variety of reactions are reported, indicating potential for multiple side effects. The volume of reports for Adrenalinum reflects both the drug's usage level and the vigilance of the reporting community.
The FDA is closely monitoring the safety of Adrenaline, and healthcare providers should report any adverse events to the agency. Patients should be informed about the potential risks and side effects of the drug and seek medical attention if they exp For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
The following drugs share commonly reported adverse reactions with ADRENALINUM:
Drugs related to ADRENALINUM based on therapeutic use, drug class, or shared indications: