August 30, 2016
Recommended Topic Related To:

Clindets

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Clindets




Clindets Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 3/18/2016

Clindets (clindamycin) is a topical solution of an antibiotic used for treating acne. Side effects of Clindets include:

  • skin burning
  • itching
  • dryness
  • redness
  • oiliness, and
  • peeling

A thin film dose of Clindets should be applied to affected areas twice daily with an applicator. Clindets may interact with other neuromuscular blocking agents. Tell your doctor all medications and supplements you use. During pregnancy, Clindets should only be used if prescribed. It is unknown if Clindets passes into breast milk. Oral and intravenous forms of clindamycin pass into breast milk. Consult your doctor before breastfeeding.

Our Clindets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Clindets FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trial Adverse Drug Reactions

The safety was assessed in 150 acne vulgaris patients from a placebo-controlled study in which CLINDETS® or placebo (vehicle) pledgets were applied twice daily over a period of 11 weeks. The number of patients with worsening scores of erythema, peeling and burning is presented in Table 1.

Table 1: Patients with worsening signs or symptoms of acne in a CLINDETS® Clinical Trial

Local Tolerance*
Signs and Symptoms Treatment Number of Patients with Worsening Score
Week 2
n/N (%)
Week 5
n/N (%)
Week 8
n/N (%)
Week 11
n/N(%)
General disorders and
administrative site conditions
Erythema CLINDETS® 1/73 (1.4) 2/72 (2.8) 0 0
Vehicle 1/72 (1.4) 2/70 (2.9) 0 0
Peeling CLINDETS® 2/73 (2.7) 2/72 (2.8) 1/73 (1.4) 0
Vehicle 1/72 (1.4) 3/70 (4.3) 0 0
Burning CLINDETS® 4/73 (5.5) 1/72 (1.4) 2/73 (2.7) 1/73 (1.4)
Vehicle 4/72 (5.6) 4/70 (5.7) 0 0
* Change from Baseline of Signs and Symptoms|

Number of patients reporting common (≥1%) treatment emergent adverse reactions are provided in Table 2.

Table 2: Most common drug related adverse reactions reported by ≥1% of patients in a CLINDETS® Clinical Trial

Adverse Drug Reaction CLINDETS®
% N=75
Vehicle
% N=75
Nervous system
disorders
Paresthesia - 1.3
Headache 1.3 -
Gastrointestinal
disorders
Diarrhea 1.3 1.3
Nausea 1.3 -

Additional Adverse Drug Reactions Reported In Other Clindamycin Phosphate Clinical Trials

The following additional common adverse drug reactions (≥ 1%) have been reported in clinical trials involving other clindamycin phosphate formulations:

Skin and subcutaneous disorders: pruritus, rash, stinging, dryness, oiliness, small red bumps (including gram negative folliculitis pustules).

Immune system disorders: urticaria, whealing, swollen lips.

Gastrointestinal disorders: abdominal cramping.

Post-Market Adverse Drug Reactions

Immune system disorders: allergic reaction.

Gastrointestinal disorders: bloody diarrhea, colitis (including pseudomembranous colitis) (See WARNINGS, Gastrointestinal, CDAD).

Read the entire FDA prescribing information for Clindets (Clindamycin)

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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