82/100 · Critical
Manufactured by Pharmacia & Upjohn Company LLC
Clindamycin Hydrochloride Adverse Events Show High Serious Reaction Rate
7,817 FDA adverse event reports analyzed
Last updated: 2026-05-12
CLINDAMYCIN HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Pharmacia & Upjohn Company LLC. Based on analysis of 7,817 FDA adverse event reports, CLINDAMYCIN HYDROCHLORIDE 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 HYDROCHLORIDE include DIARRHOEA, RASH, NAUSEA, OFF LABEL USE, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CLINDAMYCIN HYDROCHLORIDE.
Clindamycin Hydrochloride 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 7,817 adverse event reports for this medication, which is primarily manufactured by Pharmacia & Upjohn Company Llc.
The most commonly reported adverse events include Diarrhoea, Rash, Nausea. Of classified reports, 76.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Diarrhoea, rash, and nausea are the most common adverse reactions.
Serious reactions, including acute kidney injury and chronic kidney disease, are prevalent. Drug hypersensitivity and allergic reactions are significant safety concerns. There is a notable diversity in adverse reactions, indicating a wide range of potential side effects.
Patients taking Clindamycin Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Clindamycin Hydrochloride can cause drug hypersensitivity and allergic reactions, which may lead to severe conditions like acute generalised exanthematous pustulosis and toxic skin eruption. It is important to monitor patients for signs of these reac This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Clindamycin Hydrochloride received a safety concern score of 82/100 (high concern). This is based on a 76.1% serious event ratio across 3,342 classified reports. The score accounts for 7,817 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: 2,009, Male: 1,077, Unknown: 2. The most frequently reported age groups are age 47 (65 reports), age 62 (58 reports), age 61 (57 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 3,342 classified reports for CLINDAMYCIN HYDROCHLORIDE:
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 Hydrochloride can cause drug hypersensitivity and allergic reactions, which may lead to severe conditions like acute generalised exanthematous pustulosis and toxic skin eruption. It is important to monitor patients for signs of these reac
If you are taking Clindamycin Hydrochloride, here are important things to know. The most commonly reported side effects include diarrhoea, rash, nausea, off label use, pain. 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 signs of severe reactions, such as difficulty breathing, swelling, or hives, to their healthcare provider immediately. Follow the prescribed dosage and administration instructions 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 has not issued specific warnings for Clindamycin Hydrochloride based on this data, but healthcare providers should be vigilant about monitoring patients for serious adverse reactions and drug hypersensitivity.
The FDA has received approximately 7,817 adverse event reports associated with Clindamycin Hydrochloride. 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 Hydrochloride include Diarrhoea, Rash, Nausea, Off Label Use, Pain. By volume, the top reported reactions are: Diarrhoea (277 reports), Rash (265 reports), Nausea (246 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 Hydrochloride.
Out of 3,342 classified reports, 2,542 (76.1%) were classified as serious and 800 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 Hydrochloride break down by patient sex as follows: Female: 2,009, Male: 1,077, Unknown: 2. 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 Hydrochloride adverse events are: age 47: 65 reports, age 62: 58 reports, age 61: 57 reports, age 56: 53 reports, age 58: 52 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 Hydrochloride adverse event reports is Pharmacia & Upjohn Company 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 Hydrochloride include: Dyspnoea, Drug Ineffective, Drug Hypersensitivity, Headache, 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 Hydrochloride 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 Hydrochloride 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. Diarrhoea, rash, and nausea are the most common adverse reactions.
Key safety signals identified in Clindamycin Hydrochloride's adverse event data include: Acute kidney injury and chronic kidney disease are reported as serious adverse events.. Drug hypersensitivity and allergic reactions are frequent, with multiple types of hypersensitivity reported.. Infections, including pneumonia and sinusitis, are common, with some cases being severe.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Clindamycin Hydrochloride can cause drug hypersensitivity and allergic reactions, which may lead to severe conditions like acute generalised exanthematous pustulosis and toxic skin eruption. It is important to monitor patients for signs of these reac Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Clindamycin Hydrochloride.
Patients should report any signs of severe reactions, such as difficulty breathing, swelling, or hives, to their healthcare provider immediately. Follow the prescribed dosage and administration instructions to minimize the risk of adverse reactions.
Clindamycin Hydrochloride has 7,817 adverse event reports on file with the FDA. Serious reactions, including acute kidney injury and chronic kidney disease, are prevalent. The volume of reports for Clindamycin Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA has not issued specific warnings for Clindamycin Hydrochloride based on this data, but healthcare providers should be vigilant about monitoring patients for serious adverse reactions and drug hypersensitivity. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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