{
 "query": "clindamycin",
 "ingredient": "clindamycin",
 "slug": "clindamycin",
 "rxcui": "2582",
 "brands": [
  "Cleocin",
  "Clindesse",
  "Clindacin",
  "Xaciato",
  "Clindagel",
  "Cleocin-T",
  "Clindamax"
 ],
 "names": [
  "clindamycin",
  "clindamycin hydrochloride",
  "clindamycin palmitate",
  "clindamycin palmitate hydrochloride",
  "clindamycin phosphate"
 ],
 "classes": [
  {
   "id": "D10AF",
   "name": "Antiinfectives for treatment of acne"
  },
  {
   "id": "G01AA",
   "name": "Antibiotics"
  },
  {
   "id": "J01FF",
   "name": "Lincosamides"
  }
 ],
 "alternatives": [
  "amphotericin b",
  "chloramphenicol",
  "erythromycin",
  "lincomycin",
  "meclocycline",
  "minocycline",
  "natamycin",
  "nystatin",
  "oxytetracycline",
  "sulfacetamide"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "TOPICAL": 92,
   "ORAL": 82,
   "INTRAVENOUS": 20,
   "INTRAMUSCULAR": 12,
   "VAGINAL": 6
  },
  "boxed_warning": "WARNING Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin hydrochloride and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of C. difficile . Because clindamycin hydrochloride therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate, as described in the INDICATIONS AND USAGE section. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections. C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CD...",
  "indications_and_usage": "INDICATIONS AND USAGE Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the WARNING box, before selecting clindamycin hydrochloride capsules, USP are the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and post...",
  "contraindications": "CONTRAINDICATIONS Clindamycin hydrochloride capsules are contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS See WARNING box. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin hydrochloride, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of C. difficile . C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated. A careful inquiry should be made concerning previous se...",
  "adverse_reactions": "ADVERSE REACTIONS The following reactions have been reported with the use of clindamycin. Gastrointestinal : Abdominal pain, pseudomembranous colitis, esophagitis, nausea, vomiting, and diarrhea (see WARNING box). The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment (see WARNINGS ). HypersensitivityReactions : Generalized mild to moderate morbilliform-like (maculopapular) skin rashes are the most frequently reported adverse reactions. Vesiculobullous rashes, as well as urticaria, have been observed during drug therapy. Rare instances of erythema multiforme, some resembling Stevens-Johnson syndrome, and a few cases of anaphylactoid reactions have also been reported. Skin and Mucous Membranes: Pruritus, vaginitis, and rare instances of exfoliative dermatitis have been reported. (See Hypersensitivity Reactions. ) Liver : Jaundice and abnormalities in liver function tests have been observed during clindamycin therapy. Renal : Although no direct relationship of clindamycin to renal damage has been established, renal dysfunction as evidenced by azotemia, oliguria, and/or proteinuria has been observed in rare instances. Hematopoietic : Transient...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients Patients should be counseled that antibacterial drugs, including clindamycin hydrochloride capsules, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When clindamycin hydrochloride capsules are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by clindamycin hydrochloride capsules or other antibacterial drugs in the future. Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Clindamycin hydrochloride",
  "manufacturer": "Proficient Rx LP",
  "application_number": "ANDA065061",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20220601",
  "set_id": "158e6c0c-1ca3-49a6-84fd-54d8fde7c2a7",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 34010,
  "serious": 23686,
  "death": 2338,
  "hospitalization": 11433,
  "primary_suspect": 33896,
  "top_reactions": [
   [
    "Drug Hypersensitivity",
    4142
   ],
   [
    "Drug Ineffective",
    2922
   ],
   [
    "Rash",
    2159
   ],
   [
    "Diarrhoea",
    2119
   ],
   [
    "Off Label Use",
    1872
   ],
   [
    "Nausea",
    1815
   ],
   [
    "Acute Kidney Injury",
    1610
   ],
   [
    "Chronic Kidney Disease",
    1517
   ],
   [
    "Fatigue",
    1437
   ],
   [
    "Pain",
    1430
   ],
   [
    "Pruritus",
    1278
   ],
   [
    "Dyspnoea",
    1220
   ],
   [
    "Pyrexia",
    1214
   ],
   [
    "Renal Failure",
    1099
   ],
   [
    "Headache",
    1071
   ]
  ],
  "by_year": {
   "2019": 5080,
   "2020": 3598,
   "2021": 3131,
   "2022": 2549,
   "2023": 2920,
   "2024": 2695,
   "2025": 2375,
   "2026": 1118
  },
  "by_year_primary": {
   "2019": 5078,
   "2020": 3597,
   "2021": 3115,
   "2022": 2540,
   "2023": 2901,
   "2024": 2680,
   "2025": 2352,
   "2026": 1099
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260806",
   "reason": "CGMP Deviations",
   "firm": "Baxter Healthcare Corporation",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260806",
   "reason": "CGMP Deviations",
   "firm": "Baxter Healthcare Corporation",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260806",
   "reason": "CGMP Deviations",
   "firm": "Baxter Healthcare Corporation",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260806",
   "reason": "CGMP Deviations",
   "firm": "Baxter Healthcare Corporation",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260806",
   "reason": "CGMP Deviations",
   "firm": "Baxter Healthcare Corporation",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260730",
   "reason": "Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.",
   "firm": "Heritage Pharmaceuticals Inc",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20251126",
   "reason": "Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250313",
   "reason": "CGMP Deviations",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20190315",
   "reason": "Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point",
   "firm": "Pfizer Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20190315",
   "reason": "Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point",
   "firm": "Pfizer Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20190315",
   "reason": "Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point",
   "firm": "Pfizer Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20130604",
   "reason": "Presence of Particulate Matter: Firm is recalling a small number of vials with very small reflective flakes consistent with delamination of the glass vial.",
   "firm": "Pharmacia & Upjohn LLC",
   "status": "Terminated"
  }
 ],
 "recall_total": 12,
 "drugsfda": {
  "applications": 115,
  "nda": 16,
  "anda": 86,
  "first_approval": "19700222",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 186,
  "labeling_recent": 26,
  "sponsors": [
   "ABBOTT LABS",
   "ABRAXIS PHARM",
   "ALEMBIC",
   "ALMAJECT",
   "AMNEAL",
   "AMNEAL PHARMS",
   "AMVIKA",
   "AUROBINDO PHARMA"
  ],
  "unapproved": false,
  "first_approval_fmt": "02/22/1970"
 },
 "trials": {
  "total": 341,
  "completed": 196,
  "terminated": 31,
  "with_results": 80,
  "industry": 115,
  "phase3": 70,
  "results_share": 0.40816326530612246,
  "terminated_share": 0.09090909090909091
 },
 "pubmed": {
  "rct": 456,
  "meta": 15,
  "recent_rct": 36,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "clindamycin",
   "Cleocin",
   "Clindesse",
   "Clindacin",
   "Xaciato",
   "Clindagel",
   "Cleocin-T",
   "Clindamax"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 2831188,
  "beneficiaries": 1931361,
  "spend": 43488842.57,
  "by_brand": [
   {
    "brand": "Clindamycin HCl",
    "claims": 2147011,
    "per_claim": 7.795734428,
    "is_generic": true
   },
   {
    "brand": "Clindamycin Phosphate",
    "claims": 677788,
    "per_claim": 38.249704863,
    "is_generic": true
   },
   {
    "brand": "Clindamycin (Pediatric)",
    "claims": 4953,
    "per_claim": 100.78187563,
    "is_generic": false
   },
   {
    "brand": "Cleocin",
    "claims": 479,
    "per_claim": 249.52841336,
    "is_generic": false
   },
   {
    "brand": "Clindesse",
    "claims": 251,
    "per_claim": 223.56498008,
    "is_generic": false
   },
   {
    "brand": "Clindacin P",
    "claims": 213,
    "per_claim": 110.69600939,
    "is_generic": false
   },
   {
    "brand": "Cleocin Phosphate",
    "claims": 164,
    "per_claim": 56.122987805,
    "is_generic": false
   },
   {
    "brand": "Clindacin",
    "claims": 74,
    "per_claim": 321.31175676,
    "is_generic": false
   },
   {
    "brand": "Cleocin T",
    "claims": 66,
    "per_claim": 108.87060606,
    "is_generic": false
   },
   {
    "brand": "Xaciato",
    "claims": 65,
    "per_claim": 215.41892308,
    "is_generic": false
   },
   {
    "brand": "Clindacin Etz",
    "claims": 54,
    "per_claim": 46.113888889,
    "is_generic": false
   },
   {
    "brand": "Cleocin HCl",
    "claims": 37,
    "per_claim": 6.4697297297,
    "is_generic": false
   },
   {
    "brand": "Clindagel",
    "claims": 33,
    "per_claim": 2146.5387879,
    "is_generic": false
   }
  ],
  "per_claim": 15.360633970615869
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "clindamycin",
  "matched": "clindamycin",
  "stewardship": [
   "KeyAccessGroup",
   "AccessGroup"
  ]
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 6131,
  "fills": 2831188,
  "per_million": 2165.5220352728256,
  "ratio": 0.7820734313825748,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 65,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "2,166 FDA reports naming it as the suspect drug per million Medicare fills, 0.8x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.8x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 62,
   "letter": "D",
   "why": [
    "456 randomized trials and 15 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "No Cochrane review found (-5)",
    "Only 41% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 85,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 7 Class II, 4 Class III across 86 generic makers (-7)",
    "26 label changes approved since 2021: the safety story is still moving (-8)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (86 applications)",
    "10 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 76,
 "grade": "B",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are drug hypersensitivity, rash, diarrhoea. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "Why this one over amphotericin b, chloramphenicol, erythromycin? What would make you pick one of those instead?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}