Note: This document contains side effect information about clindamycin topical. Some dosage forms listed on this page may not apply to the brand name Clindacin P.

Applies to clindamycin topical: vaginal cream, vaginal gel/jelly, vaginal suppository. Other dosage forms:

• topical foam, topical gel/jelly, topical lotion, topical pad, topical solution

Serious side effects of Clindacin P

Along with its needed effects, clindamycin topical (the active ingredient contained in Clindacin P) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking clindamycin topical:

More common

• Itching of the vagina or genital area
• pain during sexual intercourse
• thick, white vaginal discharge with no odor or with mild odor

Less common

• Diarrhea
• dizziness
• headache
• nausea or vomiting
• stomach pain or cramps

Rare

• Burning, itching, rash, redness, swelling or other signs of skin problems not present before use of this medicine

Incidence not known

• Agitation
• black, tarry stools
• chest pain
• chills
• clay-colored stools
• coma
• cough
• dark urine
• decreased urine output
• dizziness
• fever
• headache
• irritability
• loss of appetite
• muscle twitching
• painful or difficult urination
• seizures
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swelling of the face, ankles, or hands
• swollen glands
• trouble breathing
• unpleasant breath odor
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting of blood
• yellow eyes or skin

Other side effects of Clindacin P

Some side effects of clindamycin topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Blistering, peeling, or loosening of the skin
• hives, itching, skin rash
• joint or muscle pain
• rash with flat lesions or small raised lesions on the skin
• red irritated eyes
• red skin lesions, often with a purple center
• redness of the skin

For Healthcare Professionals

Applies to clindamycin topical: topical foam, topical gel, topical kit, topical lotion, topical solution, topical swab, vaginal cream, vaginal gel, vaginal suppository.

Dermatologic

Lotion:

Very common (10% or more): Dryness (Up to 18%), erythema (Up to 14%), itching (Up to 11%), oiliness/oily skin (Up to 10%)

Common (1% to 10%): Seborrhea, skin problems, peeling, skin irritation, urticaria

Frequency not reported: Gram-negative folliculitis/folliculitis, contact dermatitis

Postmarketing reports: Rash, pruritus, blisters, papular pruritic skin rash, hair loss, skin inflammation, scaling, skin discoloration

Topical Gel:

Very common (10% or more): Dryness (Up to 23%), oiliness/oily skin (Up to 18%), itching (Up to 10%)

Common (1% to 10%): Erythema

Frequency not reported: Acne aggravated, erythema, scaly rash, skin disorder, gram-negative folliculitis, contact dermatitis

Topical Solution:

Very common (10% or more): Skin dryness (Up to 19%), erythema (Up to 16%), peeling (Up to 11%)

Common (1% to 10%): Skin oiliness/oily skin, skin problems, itching, irritation, urticaria

Frequency not reported: Gram-negative folliculitis, contact dermatitis

Vaginal Cream:

Frequency not reported: Rash, exanthema, urticaria, skin candida, pruritus (non-application site), rash macular, erythema, maculopapular rash^[Ref]

Genitourinary

Vulvovaginal candidiasis, fungal infection, dysuria, and proteinuria occurred more frequently in pregnant patients given this drug compared to placebo for 7 days.^[Ref]

Lotion:

Common (1% to 10%): Urinary tract infection

Postmarketing reports: Fertility disorders, bladder infection

Topical Solution:

Common (1% to 10%): Vaginitis

Vaginal Cream:

Very common (10% or more): Cervicitis/vaginitis (Up to 14%), vulvovaginal moniliasis/candidiasis (Up to 13.3%)

Common (1% to 10%): Vulvovaginal irritation/disorder/pain, vulvovaginitis trichomonal, Candida infection

Frequency not reported: Urinary tract/vaginal infection, menstrual disorder, metrorrhagia, vaginal discharge, endometriosis, proteinuria, dysuria

Postmarketing reports: Pelvic pain

Vaginal Suppository:

Common (1% to 10%): Vulvovaginal disorder, vaginal pain, vaginal moniliasis

Frequency not reported: Menstrual disorder, dysuria, vaginal discharge, vaginitis/vaginal infection^[Ref]

Local

Lotion:

Very common (10% or more): Application site burning/itching (Up to 11%)

Topical Gel:

Frequency not reported: Application site burning/dryness/erythema

Vaginal Cream:

Frequency not reported: Pruritus (topical application site)^[Ref]

Gastrointestinal

Lotion:

Common (1% to 10%): Diarrhea

Uncommon (0.1% to 1%): Vomiting

Frequency not reported: Abdominal pain, gastrointestinal disturbances

Postmarketing reports: Nausea, acute colitis, bloating, constipation, colored tongue, dyspepsia, flatulence, gastrointestinal distress/reflux, heartburn, pseudomembranous colitis, rectal bleeding

Topical Gel:

Frequency not reported: Abdominal pain, gastrointestinal disturbances, diarrhea, bloody diarrhea (including pseudomembranous colitis)

Topical Solution:

Common (1% to 10%): Diarrhea, vomiting, nausea, abdominal cramps/pain

Uncommon (0.1% to 1%): Gastrointestinal disturbances

Frequency not reported: Bloody diarrhea (including pseudomembranous colitis)

Vaginal Cream:

Frequency not reported: Heartburn, nausea, vomiting, diarrhea, constipation, localized/generalized abdominal pain, abdominal cramps, breath odor/halitosis, dyspepsia, flatulence, gastrointestinal disorder

Postmarketing reports: Pseudomembranous colitis, abdominal distension

Vaginal Suppository:

Frequency not reported: Abdominal cramps, localized/general abdominal pain^[Ref]

Nervous system

Lotion:

Very common (10% or more): Burning sensation (Up to 11%)

Postmarketing reports: Headache, dizziness, facial numbness, metallic taste, voice loss

Topical Gel:

Very common (10% or more): Burning sensation (up to 10%)

Topical Solution:

Very common (10% or more): Burning sensation (Up to 11%)

Vaginal Cream:

Frequency not reported: Dizziness, headache, vertigo, taste perversion^[Ref]

Other

Lotion:

Common (1% to 10%): Dental procedure

Postmarketing reports: Facial swelling, fungal infection

Topical Gel:

Frequency not reported: Smarting

Topical Solution:

Common (1% to 10%): Dental procedure

Vaginal Cream:

Common (1% to 10%): Abnormal labor, fungal infection

Frequency not reported: Bacterial infection, inflammation, microbiology test abnormal, candida infection/moniliasis (body), inflammatory swelling

Postmarketing reports: Pain

Vaginal Suppository:

Common (1% to 10%): Fungal infection^[Ref]

Abnormal labor occurred in 1.1% of pregnant patients (in their second trimester) compared to 0% of patients given placebo for 7 days.

Fungal infections occurred in 1.7% of pregnant patients (in their second trimester) compared to 0% of patients given placebo for 7 days.^[Ref]

Respiratory

Lotion:

Common (1% to 10%): Sore throat/tonsillitis/laryngitis

Uncommon (0.1% to 1%): Upper respiratory tract infection/cough/tracheitis

Postmarketing reports: Epistaxis

Topical Solution:

Common (1% to 10%): Sinusitis/congestion

Vaginal Cream:

Frequency not reported: Epistaxis, upper respiratory tract infection^[Ref]

Musculoskeletal

Lotion:

Uncommon (0.1% to 1%): Fracture

Topical Solution:

Common (1% to 10%): Fracture

Vaginal Cream:

Postmarketing reports: Back pain

Vaginal Suppository:

Frequency not reported: Flank pain^[Ref]

Immunologic

Lotion:

Common (1% to 10%): Cold/flu

Vaginal Cream:

Frequency not reported: Hypersensitivity^[Ref]

Ocular

Lotion:

Frequency not reported: Stinging of the eye, eye pain

Postmarketing reports: Eye irritation

Topical Gel:

Frequency not reported: Eye pain

Topical Solution:

Frequency not reported: Stinging of the eye, eye pain^[Ref]

Cardiovascular

Lotion:

Postmarketing reports: Edema, rapid heartbeat, chest tightness

Topical Solution:

Frequency not reported: Sensation of warmth^[Ref]

Renal

Vaginal Cream:

Frequency not reported: Glycosuria

Vaginal Suppository:

Frequency not reported: Pyelonephritis^[Ref]

Hypersensitivity

Lotion:

Postmarketing reports: Allergic reaction

Vaginal Cream:

Frequency not reported: Allergic reaction^[Ref]

Metabolic

Lotion:

Postmarketing reports: Weight loss

Vaginal Cream:

Frequency not reported: Hyperthyroidism^[Ref]

Hematologic

Lotion:

Postmarketing reports: Leukopenia^[Ref]

Hepatic

Topical Gel:

Postmarketing reports: Elevated liver enzymes^[Ref]