{"id":"clindamycin","rwe":[],"_fda":{"id":"82336e93-d012-4057-87c4-4202b5ccdcb8","set_id":"00fe3546-a166-412f-a543-0ae7763c0ca0","openfda":{"unii":["EH6D7113I8"],"route":["TOPICAL"],"rxcui":["197519"],"spl_id":["82336e93-d012-4057-87c4-4202b5ccdcb8"],"brand_name":["Clindamycin Phosphate"],"spl_set_id":["00fe3546-a166-412f-a543-0ae7763c0ca0"],"package_ndc":["63629-8632-1"],"product_ndc":["63629-8632"],"generic_name":["CLINDAMYCIN PHOSPHATE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["CLINDAMYCIN PHOSPHATE"],"manufacturer_name":["Bryant Ranch Prepack"],"application_number":["ANDA214604"],"original_packager_product_ndc":["45802-128"]},"version":"106","warnings":["WARNINGS Orally and parenterally administered clindamycin has been associated with severe colitis which may result in patient death. Use of the topical formulation of clindamycin results in absorption of the antibiotic from the skin surface. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. Studies indicate a toxin(s) produced by clostridia is one primary cause of antibiotic-associated colitis. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus. Endoscopic examination may reveal pseudomembranous colitis. Stool culture for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically. When significant diarrhea occurs, the drug should be discontinued. Large bowel endoscopy should be considered to establish a definitive diagnosis in cases of severe diarrhea. Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen the condition. Vancomycin has been found to be effective in the treatment of antibiotic-associated pseudomembranous colitis produced by Clostridium difficile . The usual adult dosage is 500 milligrams to 2 grams of vancomycin orally per day in three to four divided doses administered for 7 to 10 days. Cholestyramine or colestipol resins bind vancomycin in vitro . If both a resin and vancomycin are to be administered concurrently, it may be advisable to separate the time of administration of each drug. Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of oral and parenteral therapy with clindamycin."],"pregnancy":["Pregnancy: Teratogenic effects In clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters has not been associated with an increased frequency of congenital abnormalities. There are no adequate studies in pregnant women during the first trimester of pregnancy. Clindamycin should be used during the first trimester of pregnancy only if clearly needed."],"overdosage":["OVERDOSAGE Topically applied clindamycin phosphate can be absorbed in sufficient amounts to produce systemic effects (see WARNINGS )."],"description":["DESCRIPTION Clindamycin phosphate topical lotion, 1% contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The lotion contains cetostearyl alcohol (2.5%); glycerin; glyceryl stearate SE (with potassium monostearate); isostearyl alcohol (2.5%); methylparaben (0.3%); sodium lauroyl sarcosinate; stearic acid; and purified water. The structural formula is represented below: The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1‑ methyl- trans -4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo -α-D- galacto ‑ octopyranoside 2-(dihydrogen phosphate)."],"precautions":["PRECAUTIONS General Clindamycin phosphate should be prescribed with caution in atopic individuals. Drug Interactions Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. Pregnancy: Teratogenic effects In clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters has not been associated with an increased frequency of congenital abnormalities. There are no adequate studies in pregnant women during the first trimester of pregnancy. Clindamycin should be used during the first trimester of pregnancy only if clearly needed. Nursing Mothers It is not known whether clindamycin is excreted in breast milk following use of clindamycin phosphate. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Clindamycin has the potential to cause adverse effects on the breast-fed infant's gastrointestinal flora. Monitor the breast-fed infant for possible adverse effects on the gastrointestinal flora, such as diarrhea, candidiasis (thrush, diaper rash) or rarely, blood in the stool indicating possible antibiotic-associated colitis. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clindamycin and any potential adverse effects on the breast-fed child from clindamycin or from the underlying maternal condition. Clinical Considerations If used during lactation and clindamycin phosphate topical lotion is applied to the chest, care should be taken to avoid accidental ingestion by the infant. Pediatric Use Safety and effectiveness in pediatric patients under the age of 12 have not been established. Geriatric Use Clinical studies for clindamycin phosphate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients."],"how_supplied":["HOW SUPPLIED Clindamycin phosphate topical lotion, 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following size: 60 mL plastic squeeze bottle – NDC: 63629-8632-1 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Protect from freezing. Rx Only Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504"],"microbiology":["Microbiology Clindamycin inhibits bacterial protein synthesis by binding to the 23S RNA of the 50S subunit of the ribosome. Clindamycin is bacteriostatic. Antimicrobial Activity Clindamycin is active in vitro against most isolates of Propionibacterium acnes; however, the clinical significance is unknown. Resistance Resistance to clindamycin is most often caused by modification of specific bases of the 23S ribosomal RNA. Cross-resistance between clindamycin and lincomycin is complete. Because the binding sites for these antibacterial drugs overlap, cross resistance is sometimes observed among lincosamides, macrolides and streptogramin B. Macrolide-inducible resistance to clindamycin occurs in some isolates of macrolide-resistant bacteria."],"geriatric_use":["Geriatric Use Clinical studies for clindamycin phosphate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients."],"pediatric_use":["Pediatric Use Safety and effectiveness in pediatric patients under the age of 12 have not been established."],"effective_time":"20240322","nursing_mothers":["Nursing Mothers It is not known whether clindamycin is excreted in breast milk following use of clindamycin phosphate. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Clindamycin has the potential to cause adverse effects on the breast-fed infant's gastrointestinal flora. Monitor the breast-fed infant for possible adverse effects on the gastrointestinal flora, such as diarrhea, candidiasis (thrush, diaper rash) or rarely, blood in the stool indicating possible antibiotic-associated colitis. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clindamycin and any potential adverse effects on the breast-fed child from clindamycin or from the underlying maternal condition. Clinical Considerations If used during lactation and clindamycin phosphate topical lotion is applied to the chest, care should be taken to avoid accidental ingestion by the infant."],"pharmacokinetics":["Pharmacokinetics Following multiple topical applications of clindamycin phosphate at a concentration equivalent to 10 mg clindamycin per mL in an isopropyl alcohol and water solution, very low levels of clindamycin are present in the serum (0–3 ng/mL) and less than 0.2% of the dose is recovered in urine as clindamycin. Although clindamycin phosphate is inactive in vitro , rapid in vivo hydrolysis converts this compound to the antibacterially active clindamycin."],"adverse_reactions":["ADVERSE REACTIONS In 18 clinical studies of various formulations of clindamycin phosphate using placebo vehicle and/or active comparator drugs as controls, patients experienced a number of treatment emergent adverse dermatologic events [see table below]. Number of Patients Reporting Events Treatment Emergent Adverse Event Solution n=553(%) Gel n=148(%) Lotion n=160(%) Burning 62 (11) 15 (10) 17 (11) Itching 36 ( 7) 15 (10) 17 (11) Burning/Itching 60 (11) # ( – ) # ( – ) Dryness 105 (19) 34 (23) 29 (18) Erythema 86 (16) 10 ( 7) 22 (14) Oiliness/Oily Skin 8 ( 1) 26 (18) 12* (10) Peeling 61 (11) # ( – ) 11 ( 7) # not recorded * of 126 subjects Orally and parenterally administered clindamycin has been associated with severe colitis which may end fatally. Cases of diarrhea, bloody diarrhea and colitis (including pseudomembranous colitis) have been reported as adverse reactions in patients treated with oral and parenteral formulations of clindamycin and rarely with topical clindamycin (see WARNINGS ). Abdominal pain, gastrointestinal disturbances, gram-negative folliculitis, eye pain and contact dermatitis have also been reported in association with the use of topical formulations of clindamycin. To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch ."],"contraindications":["CONTRAINDICATIONS Clindamycin phosphate topical lotion is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin, a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis."],"drug_interactions":["Drug Interactions Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents."],"general_precautions":["General Clindamycin phosphate should be prescribed with caution in atopic individuals."],"mechanism_of_action":["Mechanism of Action The mechanism of action of clindamycin in treating acne vulgaris is unknown."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Mechanism of Action The mechanism of action of clindamycin in treating acne vulgaris is unknown. Pharmacokinetics Following multiple topical applications of clindamycin phosphate at a concentration equivalent to 10 mg clindamycin per mL in an isopropyl alcohol and water solution, very low levels of clindamycin are present in the serum (0–3 ng/mL) and less than 0.2% of the dose is recovered in urine as clindamycin. Although clindamycin phosphate is inactive in vitro , rapid in vivo hydrolysis converts this compound to the antibacterially active clindamycin. Microbiology Clindamycin inhibits bacterial protein synthesis by binding to the 23S RNA of the 50S subunit of the ribosome. Clindamycin is bacteriostatic. Antimicrobial Activity Clindamycin is active in vitro against most isolates of Propionibacterium acnes; however, the clinical significance is unknown. Resistance Resistance to clindamycin is most often caused by modification of specific bases of the 23S ribosomal RNA. Cross-resistance between clindamycin and lincomycin is complete. Because the binding sites for these antibacterial drugs overlap, cross resistance is sometimes observed among lincosamides, macrolides and streptogramin B. Macrolide-inducible resistance to clindamycin occurs in some isolates of macrolide-resistant bacteria."],"indications_and_usage":["INDICATIONS AND USAGE Clindamycin phosphate topical lotion is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS , WARNINGS and ADVERSE REACTIONS )."],"adverse_reactions_table":["
Treatment EmergentAdverse Event
Solutionn=553(%)
Geln=148(%)
Lotionn=160(%)
Burning
62 (11)
15 (10)
17 (11)
Itching
36 ( 7)
15 (10)
17 (11)
Burning/Itching
60 (11)
# ( – )
# ( – )
Dryness
105 (19)
34 (23)
29 (18)
Erythema
86 (16)
10 ( 7)
22 (14)
Oiliness/Oily Skin
8 ( 1)
26 (18)
12* (10)
Peeling
61 (11)
# ( – )
11 ( 7)
"],"spl_unclassified_section":["For External Use"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Apply a thin film of clindamycin phosphate topical lotion twice daily to affected area. Lotion: Shake well immediately before using. Keep all liquid dosage forms in containers tightly closed."],"spl_product_data_elements":["Clindamycin Phosphate clindamycin phosphate CLINDAMYCIN PHOSPHATE CLINDAMYCIN CETOSTEARYL ALCOHOL GLYCERIN GLYCERYL STEARATE SE ISOSTEARYL ALCOHOL METHYLPARABEN SODIUM LAUROYL SARCOSINATE STEARIC ACID WATER clindamycin-structure"],"package_label_principal_display_panel":["Clindamycin Phosphate 1% Lotion, #60 Label"]},"tags":[],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"3055 reports"},{"date":"","signal":"DRUG HYPERSENSITIVITY","source":"FDA FAERS","actionTaken":"3031 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"2470 reports"},{"date":"","signal":"RASH","source":"FDA FAERS","actionTaken":"2246 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"2152 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"1951 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"1775 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"1685 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"1540 reports"},{"date":"","signal":"ACUTE KIDNEY INJURY","source":"FDA FAERS","actionTaken":"1521 reports"}],"drugInteractions":[],"commonSideEffects":[{"effect":"Morbilliform-like (maculopapular) skin rashes","drugRate":"","severity":"common","organSystem":""},{"effect":"Diarrhea","drugRate":"","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"","severity":"common","organSystem":""},{"effect":"Abdominal pain","drugRate":"","severity":"common","organSystem":""},{"effect":"Pruritus","drugRate":"","severity":"common","organSystem":""},{"effect":"Unpleasant or metallic taste","drugRate":"","severity":"common","organSystem":""},{"effect":"Urticaria","drugRate":"","severity":"common","organSystem":""},{"effect":"Vesiculobullous rashes","drugRate":"","severity":"common","organSystem":""},{"effect":"Vaginitis","drugRate":"","severity":"common","organSystem":""},{"effect":"Transient neutropenia (leukopenia)","drugRate":"","severity":"common","organSystem":""},{"effect":"Eosinophilia","drugRate":"","severity":"common","organSystem":""},{"effect":"Jaundice","drugRate":"","severity":"common","organSystem":""},{"effect":"Abnormalities in liver function tests","drugRate":"","severity":"common","organSystem":""}],"contraindications":["Acute nephropathy","Atopic dermatitis","Bloody Stools","Breastfeeding (mother)","Candidal vulvovaginitis","Crohn's disease","Diarrhea","Eczema","Erythroderma","Hepatic failure","Inflammatory dermatosis","Pregnancy, function","Pseudomembranous enterocolitis","Sunburn","Ulcerative colitis"],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[{"effect":"Clostridioides difficile colitis","drugRate":"","severity":"serious"},{"effect":"Pseudomembranous colitis","drugRate":"","severity":"serious"},{"effect":"Toxic Epidermal Necrolysis","drugRate":"","severity":"serious"},{"effect":"Stevens-Johnson syndrome","drugRate":"","severity":"serious"},{"effect":"Acute Generalized Exanthematous Pustulosis (AGEP)","drugRate":"","severity":"serious"},{"effect":"Anaphylactic shock","drugRate":"","severity":"serious"},{"effect":"Anaphylactic reaction","drugRate":"","severity":"serious"},{"effect":"Acute kidney injury","drugRate":"","severity":"serious"},{"effect":"Agranulocytosis","drugRate":"","severity":"serious"},{"effect":"Drug reaction with eosinophilia and systemic symptoms (DRESS)","drugRate":"","severity":"serious"}]},"status":"approved","trials":["NCT02295579","NCT00997048","NCT03717506","NCT01800825","NCT01951768","NCT01929278","NCT00841776","NCT03357419","NCT01613092","NCT07392047","NCT07421804","NCT03431701","NCT02899702","NCT00000640","NCT00219570","NCT01472900","NCT06702345","NCT05421312","NCT07202052","NCT02054676","NCT05465304","NCT02465632","NCT03779360","NCT07205107","NCT02578043","NCT01945450","NCT03511118","NCT03578965","NCT06120140","NCT05849090","NCT02141217","NCT00000674","NCT02446782","NCT00664248","NCT02005666","NCT01235546","NCT03261830","NCT04512638","NCT01744730","NCT05106803","NCT05137119","NCT01788384","NCT01915732","NCT06291181","NCT07253805","NCT06158451","NCT00671749","NCT01063270","NCT03033472","NCT03234517"],"aliases":["Cleocin","Dalacin"],"patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.1784/ML","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$64","description":"CLINDAMYCIN (PEDI) 75 MG/5 ML","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=clindamycin","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:58:04.876925+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-19T23:58:25.623121+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:58:10.411017+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-19T23:58:04.008019+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=clindamycin","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:58:10.652745+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:58:02.403966+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:58:02.403995+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA 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the treatment of acne vulgaris. Its key strength lies in its mechanism of action, binding to the 50S ribosomal subunit to inhibit bacterial protein synthesis, providing excellent anaerobic coverage. The primary risk is the key composition patent expiry in 2028, which may increase competition from other generics.","brandName":"Cleocin","companyId":"unknown","ecosystem":[],"mechanism":{"target":"50S ribosomal protein L10","novelty":"","modality":"Small molecule","drugClass":"Lincosamide antibiotic","explanation":"Clindamycin is notable for excellent penetration into bone and abscesses, and strong activity against anaerobes and gram-positive cocci. The topical formulation is widely used for acne. Its main limitation is the risk of Clostridioides difficile colitis, requiring careful patient selection.","oneSentence":"Lincosamide antibiotic that binds the 50S ribosomal subunit, inhibiting bacterial protein synthesis with excellent anaerobic coverage.","technicalDetail":"","_target_confidence":0.5},"commercial":null,"references":[],"_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-19T23:58:25.623223+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"companyName":"Generic (originally Upjohn/Pfizer)","competitors":[],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"genericName":"clindamycin","indications":{"approved":[{"name":"Acne vulgaris","diseaseId":"acne-vulgaris","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Anaerobic Endometritis","diseaseId":"anaerobic-endometritis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Anaerobic Joint Infection","diseaseId":"anaerobic-joint-infection","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Anaerobic Lung Abscess","diseaseId":"anaerobic-lung-abscess","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Anaerobic Pelvic Cellulitis","diseaseId":"anaerobic-pelvic-cellulitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Anaerobic Peritonitis","diseaseId":"anaerobic-peritonitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Anaerobic Tubo-Ovarian Abscess","diseaseId":"anaerobic-tubo-ovarian-abscess","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Anaerobic septicemia","diseaseId":"anaerobic-septicemia","approvalDate":"","lineOfTherapy":"","approvalCountry":"United 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joint","diseaseId":"infectious-disorder-of-joint","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Inflammatory Disease of Female Pelvic Organs","diseaseId":"inflammatory-disease-of-female-pelvic-organs","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Intra-Abdominal Anaerobic Abscess","diseaseId":"intra-abdominal-anaerobic-abscess","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Osteomyelitis due to Staphylococcus aureus","diseaseId":"osteomyelitis-due-to-staphylococcus-aureus","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Pneumococcal pneumonia","diseaseId":"pneumococcal-pneumonia","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Pneumonia due to Streptococcus","diseaseId":"pneumonia-due-to-streptococcus","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Prevention of Bacterial 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