82/100 · Critical
Manufactured by Sagent Pharmaceuticals
Clindamycin Phosphate Adverse Events: High Incidence of Serious Reactions
64,992 FDA adverse event reports analyzed
Last updated: 2026-05-12
CLINDAMYCIN PHOSPHATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Sagent Pharmaceuticals. Based on analysis of 64,992 FDA adverse event reports, CLINDAMYCIN PHOSPHATE 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 PHOSPHATE include DRUG HYPERSENSITIVITY, DRUG INEFFECTIVE, DIARRHOEA, RASH, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CLINDAMYCIN PHOSPHATE.
Clindamycin Phosphate 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 64,992 adverse event reports for this medication, which is primarily manufactured by Sagent Pharmaceuticals.
The most commonly reported adverse events include Drug Hypersensitivity, Drug Ineffective, Diarrhoea. Of classified reports, 73.0% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Serious reactions such as acute kidney injury and sepsis are common, with a high serious event rate of 73%.
A wide range of reactions, including gastrointestinal issues and skin reactions, are frequently reported. The drug is often used off-label, which may contribute to the high number of adverse events reported.
Patients taking Clindamycin Phosphate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Clindamycin Phosphate can interact with other drugs, leading to potential adverse effects. Warnings include drug interactions and the risk of serious infections. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Clindamycin Phosphate received a safety concern score of 82/100 (high concern). This is based on a 73.0% serious event ratio across 32,227 classified reports. The score accounts for 64,992 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: 18,592, Male: 11,109, Unknown: 75. The most frequently reported age groups are age 63 (461 reports), age 59 (446 reports), age 64 (440 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 32,227 classified reports for CLINDAMYCIN PHOSPHATE:
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 Phosphate can interact with other drugs, leading to potential adverse effects. Warnings include drug interactions and the risk of serious infections.
If you are taking Clindamycin Phosphate, here are important things to know. The most commonly reported side effects include drug hypersensitivity, drug ineffective, 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 Phosphate due to its high rate of serious adverse events. Healthcare providers should be vigilant in monitoring patients for signs of severe reactions.
The FDA has received approximately 64,992 adverse event reports associated with Clindamycin Phosphate. 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 Phosphate include Drug Hypersensitivity, Drug Ineffective, Diarrhoea, Rash, Nausea. By volume, the top reported reactions are: Drug Hypersensitivity (2,851 reports), Drug Ineffective (2,765 reports), Diarrhoea (2,179 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 Phosphate.
Out of 32,227 classified reports, 23,539 (73.0%) were classified as serious and 8,688 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 Phosphate break down by patient sex as follows: Female: 18,592, Male: 11,109, Unknown: 75. 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 Phosphate adverse events are: age 63: 461 reports, age 59: 446 reports, age 64: 440 reports, age 61: 438 reports, age 66: 427 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 Phosphate adverse event reports is Sagent Pharmaceuticals. 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 Phosphate include: Pain, Off Label Use, Fatigue, Acute Kidney Injury, Dyspnoea. 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 Phosphate 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 Phosphate 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. Serious reactions such as acute kidney injury and sepsis are common, with a high serious event rate of 73%.
Key safety signals identified in Clindamycin Phosphate's adverse event data include: High incidence of serious reactions (73%). Wide range of reactions including gastrointestinal, skin, and respiratory issues. Frequent off-label use. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Clindamycin Phosphate can interact with other drugs, leading to potential adverse effects. Warnings include drug interactions and the risk of serious infections. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Clindamycin Phosphate.
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 Phosphate has 64,992 adverse event reports on file with the FDA. A wide range of reactions, including gastrointestinal issues and skin reactions, are frequently reported. The volume of reports for Clindamycin Phosphate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Clindamycin Phosphate due to its high rate of serious adverse events. Healthcare providers should be vigilant in monitoring patients for signs of severe reactions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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