82/100 · Critical
Manufactured by Bausch Health US, LLC
Clindamycin Adverse Events: High Seriousness and Diverse Reactions
56,070 FDA adverse event reports analyzed
Last updated: 2026-05-12
CLINDAMYCIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Bausch Health US, LLC. Based on analysis of 56,070 FDA adverse event reports, CLINDAMYCIN 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 CLINDAMYCIN include DRUG INEFFECTIVE, DRUG HYPERSENSITIVITY, DIARRHOEA, RASH, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CLINDAMYCIN.
Clindamycin 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 56,070 adverse event reports for this medication, which is primarily manufactured by Bausch Health Us, Llc.
The most commonly reported adverse events include Drug Ineffective, Drug Hypersensitivity, Diarrhoea. Of classified reports, 75.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Clindamycin reports include a high percentage of serious adverse events, particularly kidney and respiratory issues.
The drug is associated with a wide range of reactions, indicating potential for diverse side effects. Reports show significant occurrences of gastrointestinal and skin reactions, suggesting these are common issues.
Patients taking Clindamycin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Clindamycin can interact with other drugs, leading to adverse effects. Warnings include potential for drug interactions, especially with other antibiotics and antifungals. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Clindamycin received a safety concern score of 82/100 (high concern). This is based on a 75.1% serious event ratio across 27,443 classified reports. The score accounts for 56,070 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: 15,625, Male: 9,704, Unknown: 61. The most frequently reported age groups are age 63 (404 reports), age 61 (400 reports), age 64 (377 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 27,443 classified reports for CLINDAMYCIN:
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.
Clindamycin can interact with other drugs, leading to adverse effects. Warnings include potential for drug interactions, especially with other antibiotics and antifungals.
If you are taking Clindamycin, here are important things to know. The most commonly reported side effects include drug ineffective, drug hypersensitivity, diarrhoea, rash, nausea. 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. Follow prescribed dosing instructions carefully to minimize the risk of adverse reactions. 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 clindamycin due to its high rate of serious adverse events. Healthcare providers should be vigilant and consider alternative treatments for patients with a history of severe reactions.
The FDA has received approximately 56,070 adverse event reports associated with Clindamycin. 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 Clindamycin include Drug Ineffective, Drug Hypersensitivity, Diarrhoea, Rash, Nausea. By volume, the top reported reactions are: Drug Ineffective (2,358 reports), Drug Hypersensitivity (2,314 reports), Diarrhoea (1,877 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Clindamycin.
Out of 27,443 classified reports, 20,617 (75.1%) were classified as serious and 6,826 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 Clindamycin break down by patient sex as follows: Female: 15,625, Male: 9,704, Unknown: 61. 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 Clindamycin adverse events are: age 63: 404 reports, age 61: 400 reports, age 64: 377 reports, age 62: 371 reports, age 59: 370 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 Clindamycin adverse event reports is Bausch Health Us, 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 Clindamycin include: Pain, Acute Kidney Injury, Chronic Kidney Disease, Off Label Use, Fatigue. 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 Clindamycin 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.
Clindamycin 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. Clindamycin reports include a high percentage of serious adverse events, particularly kidney and respiratory issues.
Key safety signals identified in Clindamycin's adverse event data include: Acute and chronic kidney injury are among the most reported serious adverse events.. Respiratory issues such as dyspnoea and pneumonia are also frequently reported.. Skin reactions like rash and pruritus are common, indicating potential for allergic responses.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Clindamycin can interact with other drugs, leading to adverse effects. Warnings include potential for drug interactions, especially with other antibiotics and antifungals. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Clindamycin.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Follow prescribed dosing instructions carefully to minimize the risk of adverse reactions.
Clindamycin has 56,070 adverse event reports on file with the FDA. The drug is associated with a wide range of reactions, indicating potential for diverse side effects. The volume of reports for Clindamycin reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors clindamycin due to its high rate of serious adverse events. Healthcare providers should be vigilant and consider alternative treatments for patients with a history of severe reactions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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