65/100 · Elevated
Manufactured by GlaxoSmithKline LLC
Sumatran Safety Profile: Common Reactions and Warnings
71,119 FDA adverse event reports analyzed
Last updated: 2026-05-12
SUMATRIPTAN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by GlaxoSmithKline LLC. Based on analysis of 71,119 FDA adverse event reports, SUMATRIPTAN has a safety score of 65 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 SUMATRIPTAN include DRUG INEFFECTIVE, HEADACHE, NAUSEA, MIGRAINE, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SUMATRIPTAN.
Sumatriptan has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 71,119 adverse event reports for this medication, which is primarily manufactured by Glaxosmithkline Llc.
The most commonly reported adverse events include Drug Ineffective, Headache, Nausea. Of classified reports, 49.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Headache and nausea are the most common reactions, with 3100 and 2796 reports respectively.
Serious adverse events account for 49.4% of all reports, indicating a significant risk. The drug is frequently reported to be ineffective, with 5398 cases. Drug interactions and overdose are notable concerns, with 361 and 309 reports respectively.
Patients taking Sumatriptan should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Sumatran can interact with other medications, and patients should be cautious about potential drug interactions. Overdose is also a concern, with 309 reports of incorrect doses being administered. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Sumatriptan received a safety concern score of 65/100 (elevated concern). This is based on a 49.4% serious event ratio across 36,864 classified reports. The score accounts for 71,119 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 28,705, Male: 5,040, Unknown: 180. The most frequently reported age groups are age 53 (628 reports), age 50 (570 reports), age 48 (558 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 36,864 classified reports for SUMATRIPTAN:
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.
Sumatran can interact with other medications, and patients should be cautious about potential drug interactions. Overdose is also a concern, with 309 reports of incorrect doses being administered.
If you are taking Sumatriptan, here are important things to know. The most commonly reported side effects include drug ineffective, headache, nausea, migraine, fatigue. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Report any side effects or concerns to your healthcare provider immediately. Follow the prescribed dosage and do not exceed the recommended amount. 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 closely monitors Sumatran's safety, and patients should report any adverse reactions to their healthcare provider. Regular monitoring is advised for patients with pre-existing conditions.
The FDA has received approximately 71,119 adverse event reports associated with Sumatriptan. 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 Sumatriptan include Drug Ineffective, Headache, Nausea, Migraine, Fatigue. By volume, the top reported reactions are: Drug Ineffective (5,398 reports), Headache (3,100 reports), Nausea (2,796 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Sumatriptan.
Out of 36,864 classified reports, 18,225 (49.4%) were classified as serious and 18,639 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 Sumatriptan break down by patient sex as follows: Female: 28,705, Male: 5,040, Unknown: 180. 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 Sumatriptan adverse events are: age 53: 628 reports, age 50: 570 reports, age 48: 558 reports, age 54: 556 reports, age 57: 553 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 Sumatriptan adverse event reports is Glaxosmithkline 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 Sumatriptan include: Pain, Dizziness, Vomiting, Dyspnoea, Anxiety. 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 Sumatriptan 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.
Sumatriptan has a safety concern score of 65 out of 100 (elevated 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. Headache and nausea are the most common reactions, with 3100 and 2796 reports respectively.
Key safety signals identified in Sumatriptan's adverse event data include: Headache and nausea are the most frequent reactions.. Serious adverse events are common, with a high percentage of reports being serious.. Ineffectiveness is a significant concern, with many reports of the drug not working.. Drug interactions and overdose are key safety signals.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Sumatran can interact with other medications, and patients should be cautious about potential drug interactions. Overdose is also a concern, with 309 reports of incorrect doses being administered. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Sumatriptan.
Report any side effects or concerns to your healthcare provider immediately. Follow the prescribed dosage and do not exceed the recommended amount.
Sumatriptan has 71,119 adverse event reports on file with the FDA. Serious adverse events account for 49.4% of all reports, indicating a significant risk. The volume of reports for Sumatriptan reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Sumatran's safety, and patients should report any adverse reactions to their healthcare provider. Regular monitoring is advised for patients with pre-existing conditions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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