Clindamycin palmitate hydrochloride

What Clindamycin palmitate hydrochloride is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

CLEOCIN PEDIATRIC (clindamycin palmitate HCl) is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci and staphylococci. …

— FDA label: Cleocin Pediatric, Pharmacia & Upjohn Company LLC, effective June 1, 2026. Read the full label on DailyMed →

Label quoted: the one for the most common form (granule, for solution, oral), Cleocin Pediatric, Pharmacia & Upjohn Company LLC; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

The FDA has 9 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Related medical specialties

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

This label has a boxed warning. Read it on the full label →

9 of 9 FDA labels for this medicine have a boxed warning.

Clindamycin palmitate hydrochloride boxed warning: what the label says

Quoted from the boxed warning of the FDA-approved label.

WARNING Clostridioides difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin 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.

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Because clindamycin 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 antibacterial drug 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 antibacterial drug use not directed against C.difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C.difficile, and surgical evaluation should be instituted as clinically indicated.

— FDA label: Cleocin Pediatric, Pharmacia & Upjohn Company LLC, effective June 1, 2026. Read the full label on DailyMed →

Clindamycin palmitate hydrochloride side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

The following reactions have been reported with the use of clindamycin. Infections and infestations: Clostridioides difficile colitis Gastrointestinal: Abdominal pain, pseudomembranous colitis, esophagitis, esophageal ulcer, nausea, vomiting and diarrhea (see BOXED WARNING). The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment (see WARNINGS). An unpleasant or metallic taste has been reported after oral administration.

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Hypersensitivity Reactions: 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. Severe skin reactions such as toxic epidermal necrolysis, some with fatal outcome, have been reported (See WARNINGS). Cases of acute generalized exanthematous pustulosis (AGEP), erythema multiforme, some resembling Stevens-Johnson syndrome, anaphylactic shock, anaphylactic reaction, acute myocardial ischemia with or without myocardial infarction occurring as part of an allergic reaction, cutaneous vasculitis, symmetrical drug-related intertriginous and flexural exanthema, and hypersensitivity have also been reported. Skin and Mucous Membranes: Pruritus, vaginitis, angioedema, 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: Acute kidney injury (See WARNINGS). Hematopoietic: Transient neutropenia (leukopenia) and eosinophilia have been reported. Reports of agranulocytosis and thrombocytopenia have been made. No direct etiologic relationship to concurrent clindamycin therapy could be made in any of the foregoing. Immune system: Drug reaction with eosinophilia and systemic symptoms (DRESS) cases have been reported. Musculoskeletal: Cases of polyarthritis have been reported.

— FDA label: Cleocin Pediatric, Pharmacia & Upjohn Company LLC, effective June 1, 2026. Read the full label on DailyMed →

Clindamycin palmitate hydrochloride drug interactions

Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.

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. Clindamycin is metabolized predominantly by CYP3A4, and to a lesser extent by CYP3A5, to the major metabolite clindamycin sulfoxide and minor metabolite N-desmethylclindamycin.

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Therefore inhibitors of CYP3A4 and CYP3A5 may increase plasma concentrations of clindamycin and inducers of these isoenzymes may reduce plasma concentrations of clindamycin. In the presence of strong CYP3A4 inhibitors, monitor for adverse reactions. In the presence of strong CYP3A4 inducers such as rifampicin, monitor for loss of effectiveness. In vitro studies indicate that clindamycin does not inhibit CYP1A2, CYP2C9, CYP2C19, CYP2E1 or CYP2D6 and only moderately inhibits CYP3A4.

— FDA label: Cleocin Pediatric, Pharmacia & Upjohn Company LLC, effective June 1, 2026. Read the full label on DailyMed →

Clindamycin palmitate hydrochloride dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

If significant diarrhea occurs during therapy, this antibacterial drug should be discontinued (see BOXED WARNING). Concomitant administration of food does not adversely affect the absorption of clindamycin palmitate HCl contained in CLEOCIN PEDIATRIC Flavored Granules. Serious infections: 8–12 mg/kg/day (4–6 mg/lb/day) divided into 3 or 4 equal doses. Severe infections: 13–16 mg/kg/day (6.5–8 mg/lb/day) divided into 3 or 4 equal doses.

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More severe infections: 17–25 mg/kg/day (8.5–12.5 mg/lb/day) divided into 3 or 4 equal doses. In pediatric patients weighing 10 kg or less, ½ teaspoon (37.5 mg) three times a day should be considered the minimum recommended dose. Clindamycin should be dosed based on total body weight regardless of obesity. Serious infections due to anaerobic bacteria are usually treated with CLEOCIN PHOSPHATE ® Sterile Solution. However, in clinically appropriate circumstances, the physician may elect to initiate treatment or continue treatment with CLEOCIN PEDIATRIC. NOTE: In cases of ß-hemolytic streptococcal infections, treatment should be continued for at least 10 days. Reconstitution Instructions: When reconstituted with water as follows, each 5 mL (teaspoon) of solution contains clindamycin palmitate HCl equivalent to 75 mg clindamycin. Reconstitute bottles of 100 mL with 75 mL of water. Add a large portion of the water and shake vigorously; add the remainder of the water and shake until the solution is uniform. Storage Conditions: Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Do NOT refrigerate the reconstituted solution; when chilled, the solution may thicken and be difficult to pour. The solution is stable for 2 weeks at room temperature.

— FDA label: Cleocin Pediatric, Pharmacia & Upjohn Company LLC, effective June 1, 2026. Read the full label on DailyMed →

Clindamycin palmitate hydrochloride in pregnancy

Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a 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. Clindamycin should be used during the first trimester of pregnancy only if clearly needed. There are no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy.

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Because animal reproduction studies are not always predictive of the human response, this drug should be used during pregnancy only if clearly needed. Reproduction studies performed in rats and mice using oral doses of clindamycin up to 600 mg/kg/day (3.2 and 1.6 times the highest recommended adult human dose based on mg/m 2, respectively) or subcutaneous doses of clindamycin up to 250 mg/kg/day (1.3 and 0.7 times the highest recommended adult human dose based on mg/m 2, respectively) revealed no evidence of teratogenicity.

— FDA label: Cleocin Pediatric, Pharmacia & Upjohn Company LLC, effective June 1, 2026. Read the full label on DailyMed →

Clindamycin palmitate hydrochloride and breastfeeding

Quoted from the nursing mothers / lactation part of the FDA-approved label.

Limited published data based on breast milk sampling reports that clindamycin appears in human breast milk in the range of less than 0.5 to 3.8 mcg/mL. Clindamycin has the potential to cause adverse effects on the breast-fed infant's gastrointestinal flora. If oral or intravenous clindamycin is required by a nursing mother, it is not a reason to discontinue breastfeeding, but an alternate drug may be preferred.

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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 antibacterial drug-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.

— FDA label: Cleocin Pediatric, Pharmacia & Upjohn Company LLC, effective June 1, 2026. Read the full label on DailyMed →

When Clindamycin palmitate hydrochloride should not be used

Quoted from the “Contraindications” section of the FDA-approved label.

This drug is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.

— FDA label: Cleocin Pediatric, Pharmacia & Upjohn Company LLC, effective June 1, 2026. Read the full label on DailyMed →

Clindamycin palmitate hydrochloride overdose

Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).

Significant mortality was observed in mice at an intravenous dose of 855 mg/kg and in rats at an oral or subcutaneous dose of approximately 2618 mg/kg. In the mice, convulsions and depression were observed. Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum.

— FDA label: Cleocin Pediatric, Pharmacia & Upjohn Company LLC, effective June 1, 2026. Read the full label on DailyMed →

Forms and how it is given

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

• Bryant Ranch Prepack2 products
• NorthStar Rx LLC1 product
• Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1 product
• Pharmacia & Upjohn Company LLC1 product
• Aurobindo Pharma Limited1 product
• Chartwell RX, LLC1 product
• Rising Pharma Holdings, Inc.1 product
• Amneal Pharmaceuticals of New York LLC1 product

FDA approval history

• ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (6)

• ANDA062644Pfizer · April 7, 1986
• ANDA201821Rising · August 28, 2012
• ANDA202409Aurobindo Pharma Ltd · April 30, 2013
• ANDA203513Amneal Pharms · March 13, 2014
• ANDA206958Chartwell Rx · May 5, 2017
• ANDA207047Somerset Theraps LLC · May 11, 2018

Shortage status

To be discontinued · updated March 26, 2026 · first posted March 26, 2026

Ask your pharmacist whether your product is affected and what the options are.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

1. July 30, 2026 · Class II · Ongoing · D-0768-2026

   Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.

   CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-603-51 — Heritage Pharmaceuticals Inc

Official identifiers

Next steps

• Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
• Latest FDA drug recallsAll medicines, newest first
• Cleocin PediatricBrand page: products, maker and price
• SepsisCondition named on the label: hospitals that treat it
• Bryant Ranch PrepackMaker or distributor
• NorthStar Rx LLCMaker or distributor
• Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.Maker or distributor
• All prescription drugs A to ZSearch by generic, brand or Spanish name

Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Cleocin Pediatric, Pharmacia & Upjohn Company LLC, effective June 1, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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