Cleocin Vaginal Cream

Last updated on RxList: 5/21/2021
Cleocin Vaginal Cream Side Effects Center

What Is Cleocin Vaginal Cream?

Cleocin (clindamycin phosphate) Vaginal Cream is an antibiotic used in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis). Cleocin Vaginal Cream is available in generic form.

What Are Side Effects of Cleocin Vaginal Cream?

Common side effects of Cleocin Vaginal Cream include:

Dosage for Cleocin Vaginal Cream

The recommended dose is one applicatorful of Cleocin vaginal cream 2%, (5 grams containing approximately 100 mg of clindamycin phosphate) intravaginally, preferably at bedtime, for 3 or 7 consecutive days in non-pregnant patients and for 7 consecutive days in pregnant patients.

What Drugs, Substances, or Supplements Interact with Cleocin Vaginal Cream?

Cleocin Vaginal Cream may interact with other neuromuscular blocking agents. Tell your doctor all medications and supplements you use.

Cleocin Vaginal Cream During Pregnancy and Breastfeeding

During pregnancy, Cleocin vaginal cream may be used during the first trimester. Consult your doctor before using Cleocin vaginal cream if you are in the second or third trimester of your pregnancy. This drug passes into breast milk when taken in oral form. It is unknown if it passes into breast milk when used intravaginally. Consult your doctor before breastfeeding.

Additional Information

Our Cleocin (clindamycin phosphate) Vaginal Cream 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.

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Cleocin Vaginal Cream Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Call your doctor at once if you have:

  • any change in bowel habits;
  • severe stomach pain, diarrhea that is watery or bloody;
  • little or no urination; or
  • a metallic taste in your mouth (after clindamycin injection).

Common side effects may include:

  • nausea, vomiting, stomach pain;
  • mild skin rash; or
  • vaginal itching or discharge;

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.

Read the entire detailed patient monograph for Cleocin Vaginal Cream (Clindamycin Phosphate Vaginal Cream, USP)

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Cleocin Vaginal Cream Professional Information

SIDE EFFECTS

Clinical trials

Non-Pregnant Women

In clinical trials involving non-pregnant women, 1.8% of 600 patients who received treatment with CLEOCIN Vaginal Cream 2% for 3 days and 2.7% of 1325 patients who received treatment for 7 days discontinued therapy due to drug-related adverse events. Medical events judged to be related, probably related, possibly related, or of unknown relationship to vaginally administered clindamycin phosphate vaginal cream 2%, were reported for 20.7% of the patients receiving treatment for 3 days and 21.3% of the patients receiving treatment for 7 days. Events occurring in ≥1% of patients receiving clindamycin phosphate vaginal cream 2% are shown in Table 1.

TABLE 1 – Events Occurring in ≥1% of Non-pregnant Patients Receiving Clindamycin Phosphate Vaginal Cream 2%

EventCLEOCIN Vaginal Cream
3 Day
n=600
7 Day
n=1325
Urogenital
  Vaginal moniliasis7.710.4
  Vulvovaginitis6.04.4
  Vulvovaginal disorder3.25.3
  Trichomonal vaginitis01.3
Body as a Whole
  Moniliasis (body)1.30.2

Other events occurring in <1% of the clindamycin vaginal cream 2% groups include:

Urogenital system: vaginal discharge, metrorrhagia, urinary tract infection, endometriosis, menstrual disorder, vaginitis/vaginal infection, and vaginal pain.

Body as a whole: localized abdominal pain, generalized abdominal pain, abdominal cramps, halitosis, headache, bacterial infection, inflammatory swelling, allergic reaction, and fungal infection.

Digestive system: nausea, vomiting, constipation, dyspepsia, flatulence, diarrhea, and gastrointestinal disorder.

Endocrine system: hyperthyroidism.

Central nervous system: dizziness and vertigo.

Respiratory system: epistaxis.

Skin: pruritus (non-application site), moniliasis, rash, maculopapular rash, erythema, and urticaria.

Special senses: taste perversion.

Pregnant Women

In a clinical trial involving pregnant women during the second trimester, 1.7% of 180 patients who received treatment for 7 days discontinued therapy due to drug-related adverse events. Medical events judged to be related, probably related, possibly related, or of unknown relationship to vaginally administered clindamycin phosphate vaginal cream 2%, were reported for 22.8% of pregnant patients. Events occurring in ≥1% of patients receiving either clindamycin phosphate vaginal cream 2% or placebo are shown in Table 2.

TABLE 2 -Events Occurring in ≥1% of Pregnant Patients Receiving Clindamycin Phosphate Vaginal Cream 2% or Placebo

EventCLEOCIN Vaginal CreamPlacebo
7 DAY
n=180
7 Day
n=184
Urogenital
  Vaginal moniliasis13.37.1
  Vulvovaginal disorder6.77.1
  Abnormal labor1.10.5
Body as a Whole
  Fungal infection1.70
Skin
  Pruritus, non-application site1.10

Other events occurring in <1% of the clindamycin vaginal cream 2% group include:

Urogenital system: dysuria, metrorrhagia, vaginal pain, and trichomonal vaginitis.
Body as a whole: upper respiratory infection.
Skin: pruritus (topical application site) and erythema.

Post-Marketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

In the post-marketing period, there have been case reports of pseudomembranous colitis with the use of clindamycin phosphate vaginal cream.

Other Clindamycin Formulations

Clindamycin vaginal cream affords minimal peak serum levels and systemic exposure (AUCs) of clindamycin compared to 100 mg oral clindamycin dosing. Although these lower levels of exposure are less likely to produce the common reactions seen with oral clindamycin, the possibility of these and other reactions cannot be excluded presently. Data from well-controlled trials directly comparing clindamycin administered orally to clindamycin administered vaginally are not available.

The following adverse reactions and altered laboratory tests have been reported with the oral or parenteral use of clindamycin:

Gastrointestinal

Abdominal pain, esophagitis, nausea, vomiting, diarrhea and pseudomembranous colitis. (See WARNINGS.)

Hematopoietic

Transient neutropenia (leukopenia), eosinophilia, agranulocytosis, and thrombocytopenia have been reported. No direct etiologic relationship to concurrent clindamycin therapy could be made in any of these reports.

Hypersensitivity Reactions

Maculopapular rash and urticaria have been observed during drug therapy. Generalized mild to moderate morbilliform-like skin rashes are the most frequently reported of all adverse reactions. Rare instances of erythema multiforme, some resembling Stevens-Johnson syndrome, have been associated with clindamycin. A few cases of anaphylactoid reactions have been reported. If a hypersensitivity reaction occurs, the drug should be discontinued.

Liver

Jaundice and abnormalities in liver function tests have been observed during clindamycin therapy.

Musculoskeletal

Rare instances of polyarthritis have been reported.

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.

Read the entire FDA prescribing information for Cleocin Vaginal Cream (Clindamycin Phosphate Vaginal Cream, USP)

© Cleocin Vaginal Cream Patient Information is supplied by Cerner Multum, Inc. and Cleocin Vaginal Cream Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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