72/100 · Elevated
Manufactured by Chartwell RX, LLC
Doxycycline Adverse Events: High Serious Reaction Rate
181,718 FDA adverse event reports analyzed
Last updated: 2026-05-12
DOXYCYCLINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Chartwell RX, LLC. Based on analysis of 181,718 FDA adverse event reports, DOXYCYCLINE has a safety score of 72 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 DOXYCYCLINE include DRUG INEFFECTIVE, NAUSEA, OFF LABEL USE, FATIGUE, RASH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DOXYCYCLINE.
Doxycycline has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 181,718 adverse event reports for this medication, which is primarily manufactured by Chartwell Rx, Llc.
The most commonly reported adverse events include Drug Ineffective, Nausea, Off Label Use. Of classified reports, 72.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Nausea and rash are the most common adverse reactions.
Serious reactions, including kidney and respiratory issues, are prevalent. Drug ineffectiveness and off-label use are reported.
Patients taking Doxycycline should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Doxycycline can interact with antacids and iron supplements, reducing its absorption. It may also exacerbate photosensitivity and should be used with caution in patients with pre-existing liver or kidney conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Doxycycline received a safety concern score of 72/100 (elevated concern). This is based on a 72.4% serious event ratio across 64,453 classified reports. The score accounts for 181,718 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: 37,099, Male: 21,470, Unknown: 142. The most frequently reported age groups are age 44 (1,373 reports), age 43 (1,136 reports), age 59 (966 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 64,453 classified reports for DOXYCYCLINE:
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.
Doxycycline can interact with antacids and iron supplements, reducing its absorption. It may also exacerbate photosensitivity and should be used with caution in patients with pre-existing liver or kidney conditions.
If you are taking Doxycycline, here are important things to know. The most commonly reported side effects include drug ineffective, nausea, off label use, fatigue, rash. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow prescribed dosage and duration of treatment to minimize side effects. Inform healthcare providers about any existing health conditions or medications to avoid potential interactions. 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 doxycycline safety, and any serious adverse events should be reported to healthcare providers immediately.
The FDA has received approximately 181,718 adverse event reports associated with Doxycycline. 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 Doxycycline include Drug Ineffective, Nausea, Off Label Use, Fatigue, Rash. By volume, the top reported reactions are: Drug Ineffective (5,031 reports), Nausea (4,770 reports), Off Label Use (4,436 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Doxycycline.
Out of 64,453 classified reports, 46,685 (72.4%) were classified as serious and 17,768 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 Doxycycline break down by patient sex as follows: Female: 37,099, Male: 21,470, Unknown: 142. 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 Doxycycline adverse events are: age 44: 1,373 reports, age 43: 1,136 reports, age 59: 966 reports, age 63: 935 reports, age 64: 932 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 Doxycycline adverse event reports is Chartwell Rx, 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 Doxycycline include: Diarrhoea, Pain, Dyspnoea, Headache, 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 Doxycycline 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.
Doxycycline has a safety concern score of 72 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. Nausea and rash are the most common adverse reactions.
Key safety signals identified in Doxycycline's adverse event data include: High incidence of serious reactions (72.4%). Multiple gastrointestinal and skin reactions. Reports of chronic kidney disease and pneumonia. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Doxycycline can interact with antacids and iron supplements, reducing its absorption. It may also exacerbate photosensitivity and should be used with caution in patients with pre-existing liver or kidney conditions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Doxycycline.
Follow prescribed dosage and duration of treatment to minimize side effects. Inform healthcare providers about any existing health conditions or medications to avoid potential interactions.
Doxycycline has 181,718 adverse event reports on file with the FDA. Serious reactions, including kidney and respiratory issues, are prevalent. The volume of reports for Doxycycline reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors doxycycline safety, and any serious adverse events should be reported to healthcare providers immediately. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Chartwell RX, LLC and compare their safety profiles:
The following drugs share commonly reported adverse reactions with DOXYCYCLINE:
Drugs related to DOXYCYCLINE based on therapeutic use, drug class, or shared indications: