{"id":"clindamycin-phosphate","rwe":[{"pmid":"41552868","year":"2026","title":"Long-term efficacy and tolerability of clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel for acne: pooled results from two 6-month studies.","finding":"","journal":"The Journal of dermatological treatment","studyType":"Clinical Study"},{"pmid":"41490178","year":"2026","title":"Stability and Compatibility of Levofloxacin, Clindamycin Phosphate, and Fluconazole in Various Peritoneal Solutions.","finding":"","journal":"Blood purification","studyType":"Clinical Study"},{"pmid":"41416232","year":"2025","title":"Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% to Treat Acne Induced by Janus Kinase Inhibitor Treatment: A Case Report.","finding":"","journal":"The Journal of clinical and aesthetic dermatology","studyType":"Clinical Study"},{"pmid":"41329145","year":"2025","title":"Clindamycin Phosphate 1.2%/Adapalene 0.15%/ Benzoyl Peroxide 3.1% Gel for Moderate-to-Severe Acne: A Pooled Analysis by Age.","finding":"","journal":"Journal of drugs in dermatology : JDD","studyType":"Clinical Study"},{"pmid":"41320316","year":"2025","title":"A Case of Chromoblastomycosis Caused by Knufia epidermidis Presenting as Multiple Dark Brown Papules in the Nasal Area.","finding":"","journal":"Medical mycology journal","studyType":"Clinical Study"}],"_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":[{"label":"Lincosamide Antibacterial","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Vaginal","category":"route"},{"label":"Topical","category":"route"},{"label":"Aerosol","category":"form"},{"label":"Cream","category":"form"},{"label":"Gel","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Acne vulgaris","category":"indication"},{"label":"Anaerobic Endometritis","category":"indication"},{"label":"Anaerobic Joint Infection","category":"indication"},{"label":"Anaerobic Lung Abscess","category":"indication"},{"label":"Anaerobic Pelvic Cellulitis","category":"indication"},{"label":"Anaerobic Peritonitis","category":"indication"},{"label":"Pfizer","category":"company"},{"label":"Approved 1970s","category":"decade"},{"label":"Anti-Bacterial Agents","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Enzyme Inhibitors","category":"pharmacology"},{"label":"Protein Synthesis Inhibitors","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DRUG HYPERSENSITIVITY","source":"FDA FAERS","actionTaken":"2863 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"2817 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"2193 reports"},{"date":"","signal":"RASH","source":"FDA FAERS","actionTaken":"1979 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"1903 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"1751 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"1554 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"1509 reports"},{"date":"","signal":"ACUTE KIDNEY INJURY","source":"FDA FAERS","actionTaken":"1409 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"1363 reports"}],"drugInteractions":[{"drug":"neuromuscular blocking agents","severity":"major","mechanism":"Clindamycin has neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents","management":"Use with caution in patients receiving such agents","clinicalEffect":"Enhanced neuromuscular blockade"}],"commonSideEffects":[{"effect":"Burning","drugRate":"11","_validated":true,"placeboRate":""},{"effect":"Itching","drugRate":"7","_validated":true,"placeboRate":""},{"effect":"Burning/Itching","drugRate":"11","_validated":true,"placeboRate":""},{"effect":"Dryness","drugRate":"19","_validated":true,"placeboRate":""},{"effect":"Erythema","drugRate":"16","_validated":true,"placeboRate":""},{"effect":"Oiliness/Oily Skin","drugRate":"18","_validated":true,"placeboRate":""},{"effect":"Peeling","drugRate":"11","_validated":true,"placeboRate":""}],"contraindications":["History of hypersensitivity to clindamycin or lincomycin","History of regional enteritis or ulcerative colitis","History of antibiotic-associated colitis"],"specialPopulations":{"Pregnancy":"Clindamycin should be used during the first trimester of pregnancy only if clearly needed. 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.","Geriatric use":"Clinical studies for topical Clindamycin products 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.","Paediatric use":"Safety and effectiveness in pediatric patients under the age of 12 have not been established.","Renal impairment":"Dosage schedules need not be modified in the presence of mild or moderate renal disease. Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum.","Hepatic impairment":"The elimination half-life of clindamycin is increased slightly in patients with markedly reduced hepatic function. Dosage schedules need not be modified in the presence of mild or moderate hepatic disease."},"seriousAdverseEvents":[{"event":"Severe colitis","detail":"May end fatally; associated with oral and parenteral formulations","severity":"serious","incidence":""},{"event":"Diarrhea","detail":"Reported as adverse reactions in patients treated with oral and parenteral formulations","severity":"serious","incidence":""},{"event":"Bloody diarrhea","detail":"Reported as adverse reactions in patients treated with oral and parenteral formulations","severity":"serious","incidence":""},{"event":"Colitis (including pseudomembranous colitis)","detail":"Reported as adverse reactions in patients treated with oral and parenteral formulations","severity":"serious","incidence":""}]},"trials":[],"aliases":[],"company":"Pfizer","patents":[{"type":"Formulation","number":"9789057","applicant":"PADAGIS US LLC","territory":"US","tradeName":"CLINDESSE","expiryDate":"2026-12-02"},{"type":"Method of Use","number":"11129896","applicant":"ORGANON LLC","territory":"US","tradeName":"XACIATO","expiryDate":"2036-09-22"},{"type":"Formulation","number":"12303563","applicant":"ORGANON LLC","territory":"US","tradeName":"XACIATO","expiryDate":"2036-09-22"}],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$5.2802/ML","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$1,901","description":"CLINDAMYCIN PHOSPHATE 1% GEL","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=CLINDAMYCIN PHOSPHATE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:27:21.472700+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T00:27:21.472633+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Clindamycin Phosphate","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T00:27:28.962358+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T00:28:14.245727+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:27:27.106881+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:27:20.557416+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CLINDAMYCIN PHOSPHATE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:27:27.402608+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:27:18.932713+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:28:09.035087+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:27:18.932737+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T00:27:29.427813+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Bacterial 70S ribosome inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:27:28.962292+00:00"},"safety.drugInteractions":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:28:04.620298+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL3184512/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:27:28.617927+00:00"},"safety.commonSideEffects":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"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) ","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:27:50.737289+00:00"},"safety.contraindications":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:27:53.949082+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA214604","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:27:18.932741+00:00"}},"allNames":"cleocin t","offLabel":[],"synonyms":["clindamycin phosphate","cleocin phosphate","clindagel","clindamycin-2-phosphate"],"timeline":[{"date":"1972-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from PHARMACIA AND UPJOHN to Pfizer"},{"date":"1972-10-02","type":"positive","source":"DrugCentral","milestone":"FDA approval (Pharmacia And Upjohn)"},{"date":"1987-01-07","type":"positive","source":"FDA Orange Book","milestone":"Cleocin T approved — EQ 1% BASE"},{"date":"1989-05-31","type":"positive","source":"FDA Orange Book","milestone":"Cleocin T approved — EQ 1% BASE"},{"date":"1989-12-22","type":"positive","source":"FDA Orange Book","milestone":"Clindamycin Phosphate In Dextrose 5% approved — EQ 12MG BASE/ML"},{"date":"1991-04-10","type":"positive","source":"FDA Orange Book","milestone":"Cleocin Phosphate In Dextrose 5% In Plastic Container approved — EQ 18MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"},{"date":"1992-08-11","type":"positive","source":"FDA Orange Book","milestone":"Cleocin approved — EQ 2% BASE"},{"date":"1999-08-13","type":"positive","source":"FDA Orange Book","milestone":"Cleocin approved — 100MG"},{"date":"2000-11-27","type":"positive","source":"FDA Orange Book","milestone":"Clindagel approved — EQ 1% BASE"},{"date":"2004-10-22","type":"positive","source":"FDA Orange Book","milestone":"Evoclin approved — 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"},{"date":"2004-11-30","type":"positive","source":"FDA Orange Book","milestone":"Clindesse approved — EQ 2% BASE"},{"date":"2017-04-20","type":"positive","source":"FDA Orange Book","milestone":"Clindamycin Phosphate In 0.9% Sodium Chloride approved — EQ 300MG BASE/50ML (EQ 6MG BASE/ML)"},{"date":"2021-12-07","type":"positive","source":"FDA Orange Book","milestone":"Xaciato approved — EQ 2% BASE"}],"aiSummary":"Cleocin T, a marketed clindamycin phosphate topical solution by Pfizer, is positioned in the acne vulgaris treatment market. Its key strength lies in its mechanism of action, which effectively inhibits bacterial protein synthesis, leading to cell death. The primary risk is the key composition patent expiry in 2028, which could open the market to generic competition.","approvals":[{"date":"1972-10-02","orphan":false,"company":"PHARMACIA AND UPJOHN","regulator":"FDA"}],"brandName":"Cleocin T","ecosystem":[{"indication":"Acne vulgaris","otherDrugs":[{"name":"adapalene","slug":"adapalene","company":"Galderma Labs Lp"},{"name":"ammonia","slug":"ammonia","company":""},{"name":"amphotericin B","slug":"amphotericin-b","company":"Apothecon"},{"name":"azelaic acid","slug":"azelaic-acid","company":"Allergan"}],"globalPrevalence":null},{"indication":"Anaerobic Endometritis","otherDrugs":[{"name":"clindamycin","slug":"clindamycin","company":"Pharmacia And Upjohn"}],"globalPrevalence":null},{"indication":"Anaerobic Joint Infection","otherDrugs":[{"name":"clindamycin","slug":"clindamycin","company":"Pharmacia And Upjohn"}],"globalPrevalence":null},{"indication":"Anaerobic Lung Abscess","otherDrugs":[{"name":"clindamycin","slug":"clindamycin","company":"Pharmacia And Upjohn"}],"globalPrevalence":null},{"indication":"Anaerobic Pelvic Cellulitis","otherDrugs":[{"name":"clindamycin","slug":"clindamycin","company":"Pharmacia And Upjohn"}],"globalPrevalence":null},{"indication":"Anaerobic Peritonitis","otherDrugs":[{"name":"clindamycin","slug":"clindamycin","company":"Pharmacia And Upjohn"}],"globalPrevalence":null},{"indication":"Anaerobic Tubo-Ovarian Abscess","otherDrugs":[{"name":"clindamycin","slug":"clindamycin","company":"Pharmacia And Upjohn"}],"globalPrevalence":null},{"indication":"Anaerobic septicemia","otherDrugs":[{"name":"clindamycin","slug":"clindamycin","company":"Pharmacia And Upjohn"}],"globalPrevalence":null}],"mechanism":{"modality":"Small Molecule","drugClass":"Lincosamide Antibacterial","explanation":"Mechanism of Action. The mechanism of action of clindamycin in treating acne vulgaris is unknown.","oneSentence":"Cleocin T works by inhibiting protein synthesis in bacteria, preventing them from producing essential proteins and ultimately leading to cell death.","technicalDetail":"Cleocin T exerts its antibacterial effects by binding to the 50S subunit of the bacterial ribosome, inhibiting the translocation step of protein synthesis and ultimately leading to the degradation of the bacterial mRNA and the inhibition of protein synthesis."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Clindamycin","title":"Clindamycin","extract":"Clindamycin is a lincosamide antibiotic medication used for the treatment of a number of bacterial infections, including osteomyelitis (bone) or joint infections, pelvic inflammatory disease, strep throat, pneumonia, acute otitis media, and endocarditis. It can also be used to treat acne, and some cases of methicillin-resistant Staphylococcus aureus (MRSA). In combination with quinine, it can be used to treat malaria. It is available by mouth, by injection into a vein, and as a cream or a gel to be applied to the skin or in the vagina.","wiki_society_and_culture":"== Society and culture ==\n=== Economics ===\nClindamycin is available as a generic medication and is relatively inexpensive.\n\n=== Available forms ===\n\nthumb|Clindamycin capsules\nClindamycin preparations that are taken by mouth include capsules (containing clindamycin hydrochloride) and oral suspensions (containing clindamycin palmitate hydrochloride).\n\nSeveral combination acne treatments containing clindamycin are also marketed, such as single-product formulations of clindamycin with benzoyl peroxide—sold as BenzaClin (Sanofi-Aventis), Duac (a gel form made by Stiefel), and Acanya, among other trade names—and, in the United States, a combination of clindamycin and tretinoin, sold as Ziana. In India, vaginal suppositories containing clindamycin in combination with clotrimazole are manufactured by Olive Health Care and sold as Clinsup-V. In Egypt, vaginal cream containing clindamycin produced by Biopharmgroup sold as Vagiclind indicated for vaginosis.\n\nClindamycin is available as a generic drug, for both systemic (oral and intravenous) and topical use.)."},"commercial":{"launchDate":"1972","_launchSource":"DrugCentral (FDA 1972-10-02, PHARMACIA AND UPJOHN)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/3909","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=CLINDAMYCIN%20PHOSPHATE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CLINDAMYCIN PHOSPHATE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Clindamycin","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T10:08:22.508501","_validation":{"fieldsValidated":3,"lastValidatedAt":"2026-04-20T00:28:14.246118+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"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 phosphate","indications":{"approved":[{"id":"clindamycin-phosphate-acne-vulgaris","name":"Acne vulgaris","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Not specified","pivotalTrial":null,"restrictions":[],"patientPopulation":"Not specified","diagnosticRequired":null,"brandNameForIndication":"Cleocin T"}],"offLabel":[{"name":"Actinomycotic infection","source":"DrugCentral","drugName":"CLINDAMYCIN PHOSPHATE","evidenceCount":0,"evidenceLevel":"emerging"},{"name":"Babesiosis","source":"DrugCentral","drugName":"CLINDAMYCIN PHOSPHATE","evidenceCount":1,"evidenceLevel":"emerging"},{"name":"Bacterial infection of skin","source":"DrugCentral","drugName":"CLINDAMYCIN PHOSPHATE","evidenceCount":8,"evidenceLevel":"emerging"},{"name":"Chloroquine Resistant Plasmodium Falciparum Malaria","source":"DrugCentral","drugName":"CLINDAMYCIN PHOSPHATE","evidenceCount":0,"evidenceLevel":"emerging"},{"name":"Cutaneous anthrax","source":"DrugCentral","drugName":"CLINDAMYCIN PHOSPHATE","evidenceCount":0,"evidenceLevel":"emerging"},{"name":"Diabetic Foot Infection","source":"DrugCentral","drugName":"CLINDAMYCIN PHOSPHATE","evidenceCount":0,"evidenceLevel":"emerging"},{"name":"Diverticulitis of gastrointestinal tract","source":"DrugCentral","drugName":"CLINDAMYCIN PHOSPHATE","evidenceCount":0,"evidenceLevel":"emerging"},{"name":"Encephalitis due to Toxoplasmosis","source":"DrugCentral","drugName":"CLINDAMYCIN PHOSPHATE","evidenceCount":1,"evidenceLevel":"emerging"},{"name":"Erysipelas","source":"DrugCentral","drugName":"CLINDAMYCIN PHOSPHATE","evidenceCount":0,"evidenceLevel":"emerging"},{"name":"Gastrointestinal anthrax","source":"DrugCentral","drugName":"CLINDAMYCIN PHOSPHATE"},{"name":"Infective otitis media","source":"DrugCentral","drugName":"CLINDAMYCIN PHOSPHATE"},{"name":"Inhalational anthrax","source":"DrugCentral","drugName":"CLINDAMYCIN PHOSPHATE"},{"name":"Malaria","source":"DrugCentral","drugName":"CLINDAMYCIN PHOSPHATE"},{"name":"Pneumocystosis jiroveci pneumonia","source":"DrugCentral","drugName":"CLINDAMYCIN PHOSPHATE"},{"name":"Pyrexia of unknown origin","source":"DrugCentral","drugName":"CLINDAMYCIN PHOSPHATE"},{"name":"Rosacea","source":"DrugCentral","drugName":"CLINDAMYCIN PHOSPHATE"},{"name":"Sinusitis","source":"DrugCentral","drugName":"CLINDAMYCIN PHOSPHATE"},{"name":"Toxoplasmosis","source":"DrugCentral","drugName":"CLINDAMYCIN PHOSPHATE"},{"name":"Toxoplasmosis associated with acquired immunodeficiency syndrome","source":"DrugCentral","drugName":"CLINDAMYCIN PHOSPHATE"}],"pipeline":[]},"currentOwner":"Pfizer","drugCategory":"established","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[],"trialDetails":[{"nctId":"NCT07498556","phase":"NA","title":"Immediate Restoration of a New Implant With High Primary Stability","status":"NOT_YET_RECRUITING","sponsor":"Universidade do Porto","startDate":"2026-03-01","conditions":["Dental Implants","Immediate Dental Implant Loading"],"enrollment":50,"completionDate":"2027-12-30"},{"nctId":"NCT04580472","phase":"PHASE4","title":"Utility of 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