Last reviewed 2026-04-20 · How we verify

CLINDAMYCIN PALMITATE HYDROCHLORIDE

At a glance

Approved indications

No approved indications tracked.

Boxed warnings

• WARNING Clostridium 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 . 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 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.

Common side effects

• Pseudomembranous colitis
• Abdominal pain
• Nausea
• Vomiting
• Diarrhea
• Generalized mild to moderate morbilliform-like (maculopapular) skin rashes
• Vesiculobullous rashes
• Urticaria
• Erythema multiforme
• Anaphylactoid reactions
• Pruritus
• Vaginitis

Key clinical trials

• Utility of Single-dose Oral Antibiotic Prophylaxis in Prevention of Surgical Site Infection in Dermatologic Surgery (PHASE4)
• Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
• Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
• Comparison of Microneedling and CTG for Gingival Augmentation- A RCT (PHASE2)
• The Effect of Prophylactic Antibiotics on Surgical Site Infection Lower Limb Skin Excisions (NA)
• Compound Adapalene and Clindamycin Hydrochloride Gel in Treatment of Patients With Acne (PHASE1, PHASE2)
• Systemic and Topical Treatments for Rash Secondary to Erlotinib in Lung Cancer (PHASE2)
• The Efficacy and Safety Study of Clindamycin Palmitate Hydrochloride Dispersible Tablet Treatment of Bacterial Vaginosis (PHASE4)

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• CLINDAMYCIN PALMITATE HYDROCHLORIDE CI brief — competitive landscape report
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