82/100 · Critical
Manufactured by Cipla USA Inc.
Cyproheptadine Reports Show High Incidence of Serious Adverse Events
129,800 FDA adverse event reports analyzed
Last updated: 2026-05-12
CYCLOBENZAPRINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Cipla USA Inc.. Based on analysis of 129,800 FDA adverse event reports, CYCLOBENZAPRINE has a safety score of 82 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 CYCLOBENZAPRINE include PAIN, FATIGUE, DRUG INEFFECTIVE, NAUSEA, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CYCLOBENZAPRINE.
Cyclobenzaprine has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 129,800 adverse event reports for this medication, which is primarily manufactured by Cipla Usa Inc..
The most commonly reported adverse events include Pain, Fatigue, Drug Ineffective. Of classified reports, 68.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Cyproheptadine reports show a high percentage of serious adverse events, particularly related to kidney issues and falls.
The most common reactions include pain, fatigue, and drug ineffectiveness, indicating potential efficacy concerns. Suicide attempts and death reports are notable, highlighting the need for careful patient monitoring.
Patients taking Cyclobenzaprine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Cyproheptadine can interact with other drugs, potentially affecting its efficacy or increasing the risk of adverse events. Patients should avoid alcohol and other CNS depressants. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Cyclobenzaprine received a safety concern score of 82/100 (high concern). This is based on a 68.8% serious event ratio across 47,387 classified reports. The score accounts for 129,800 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: 31,629, Male: 12,201, Unknown: 45. The most frequently reported age groups are age 58 (1,069 reports), age 61 (876 reports), age 55 (865 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 47,387 classified reports for CYCLOBENZAPRINE:
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.
Cyproheptadine can interact with other drugs, potentially affecting its efficacy or increasing the risk of adverse events. Patients should avoid alcohol and other CNS depressants.
If you are taking Cyclobenzaprine, here are important things to know. The most commonly reported side effects include pain, fatigue, drug ineffective, nausea, headache. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any new or worsening symptoms to their healthcare provider immediately. Avoid driving or operating heavy machinery if experiencing dizziness, fatigue, or other side effects. 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 has issued warnings about the serious nature of adverse events associated with Cyproheptadine, particularly for patients with kidney disease or those at risk of falls.
The FDA has received approximately 129,800 adverse event reports associated with Cyclobenzaprine. 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 Cyclobenzaprine include Pain, Fatigue, Drug Ineffective, Nausea, Headache. By volume, the top reported reactions are: Pain (4,870 reports), Fatigue (3,808 reports), Drug Ineffective (3,434 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Cyclobenzaprine.
Out of 47,387 classified reports, 32,607 (68.8%) were classified as serious and 14,780 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 Cyclobenzaprine break down by patient sex as follows: Female: 31,629, Male: 12,201, Unknown: 45. 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 Cyclobenzaprine adverse events are: age 58: 1,069 reports, age 61: 876 reports, age 55: 865 reports, age 64: 855 reports, age 56: 840 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 Cyclobenzaprine adverse event reports is Cipla Usa 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 Cyclobenzaprine include: Chronic Kidney Disease, Off Label Use, Diarrhoea, Fall, Arthralgia. 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 Cyclobenzaprine 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.
Cyclobenzaprine has a safety concern score of 82 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. Cyproheptadine reports show a high percentage of serious adverse events, particularly related to kidney issues and falls.
Key safety signals identified in Cyclobenzaprine's adverse event data include: Chronic kidney disease and acute kidney injury are frequent, indicating potential nephrotoxicity.. Falls and mobility decreased are common, suggesting a risk of falls and impaired mobility.. Suicide attempts and deaths are reported, indicating a risk of psychiatric adverse events.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Cyproheptadine can interact with other drugs, potentially affecting its efficacy or increasing the risk of adverse events. Patients should avoid alcohol and other CNS depressants. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Cyclobenzaprine.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Avoid driving or operating heavy machinery if experiencing dizziness, fatigue, or other side effects.
Cyclobenzaprine has 129,800 adverse event reports on file with the FDA. The most common reactions include pain, fatigue, and drug ineffectiveness, indicating potential efficacy concerns. The volume of reports for Cyclobenzaprine reflects both the drug's usage level and the vigilance of the reporting community.
The FDA has issued warnings about the serious nature of adverse events associated with Cyproheptadine, particularly for patients with kidney disease or those at risk of falls. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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