Evoclin Side Effects
Generic Name: clindamycin topical
Please note - some side effects for Evoclin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Evoclin - for the Consumer
Evoclin Foam
All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Evoclin Foam:
Seek medical attention right away if any of these SEVERE side effects occur when using Evoclin Foam:Burning sensation on treated areas; dry or itchy skin; headache.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood or mucus in stools; severe or persistent diarrhea; stomach cramps or pain; swelling, redness, burning, or peeling of your skin.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .
TopEvoclin Side Effects - for the Professional
Evoclin
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
A total of 439 subjects with mild to moderate acne vulgaris were treated once daily for 12 weeks with Evoclin Foam.
The incidence of adverse reactions occurring in ≥1% of the subjects in clinical trials comparing Evoclin Foam, and its vehicle is presented in Table 1.
| Adverse Reactions | Number (%) of Subjects | |
| Evoclin Foam | Vehicle Foam | |
| N = 439 | N = 154 | |
| Headache | 12 (3%) | 1 (1%) |
| Application site burning | 27 (6%) | 14 (9%) |
| Application site pruritus | 5 (1%) | 5 (3%) |
| Application site dryness | 4 (1%) | 5 (3%) |
| Application site reaction, not otherwise specified | 3 (1%) | 4 (3%) |
In a contact sensitization study, none of the 203 subjects developed evidence of allergic contact sensitization to Evoclin Foam.
Postmarketing Experience
The following adverse reactions have been identified during post approval use of Evoclin Foam: application site pain, application site erythema, diarrhea, urticaria, abdominal pain, hypersensitivity, rash, abdominal discomfort, nausea, seborrhea, application site rash, dizziness, and pain of skin. 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.
Abdominal pain and gastrointestinal disturbances, as well as gram-negative folliculitis, have also been reported in association with the use of topical formulations of clindamycin. Orally and parenterally administered clindamycin have been associated with severe colitis, which may end fatally.
TopSide Effects by Body System - for Healthcare Professionals
Gastrointestinal
Gastrointestinal side effects have included diarrhea in patients treated with topical clindamycin (less than 0.1% incidence), although in most cases it resolved despite continued therapy. Bloody diarrhea and colitis (including pseudomembranous colitis) have been reported rarely with topical clindamycin. In general, these cases involved extemporaneously prepared solutions of clindamycin hydrochloride. Rarely, heartburn, nausea, vomiting, constipation, and abdominal pain have been reported during vaginal use of clindamycin cream. Gastrointestinal disturbances have also been reported with the use of topical clindamycin.
Clindamycin has not been shown to have significant effects on colon flora. In one study, Clostridium difficile was detected in the stool of 4 of 19 patients receiving topical clindamycin for eight weeks. No Clostridium difficile was detected in the stool of patients receiving placebo. However, the difference was not statistically significant. Diarrhea was not reported in any patient.
Local
Local side effects have been frequently reported with the use of topical clindamycin. These have included transient drying, followed by erythema, burning, peeling, and itching. Contact dermatitis has been reported infrequently. Oiliness or oily skin has also been reported.
The foam, gel, and lotion formulations are less drying than the solution formulation, which contains alcohol.
Genitourinary
Genitourinary side effects have included vulvar irritation during use of vaginal clindamycin cream. Yeast overgrowth resulting in the development of fungal vaginitis has been reported. Symptomatic vaginal candida infection has also been reported in approximately 10% of women treated with intravaginal clindamycin.
Nervous system
Nervous system side effects have been reported rarely. Headache, dizziness, and vertigo have been reported with the use of clindamycin vaginal cream.
Other
Other side effects have included one case of ringing in the ear and partial hearing loss believed to be caused by clindamycin.
A 14-year-old boy developed reproducible ringing in his right ear and hearing loss while using topical clindamycin and after discontinuing use. He underwent a complete physical exam and labs which failed to find a cause for his symptoms. The patient was restarted on benzoyl peroxide/clindamycin topical and the ringing in his ear increased. He was told to stop all medications and was started on methylprednisolone. The tinnitus decreased in 1 to 2 days with no improvement in the hearing deficit. After the third time he was restarted on benzoyl peroxide/clindamycin gel, the tinnitus returned at an increased level together with right-sided headaches within 1 to 2 days. The patient again stopped using the benzoyl peroxide and clindamycin gel and the tinnitus returned to a low level over 1 to 2 days. It is believed that the clindamycin component played a part in this patient's tinnitus and hearing loss.
TopMore Evoclin resources
- Evoclin Prescribing Information (FDA)
- Evoclin Foam MedFacts Consumer Leaflet (Wolters Kluwer)
- Evoclin Topical Advanced Consumer (Micromedex) - Includes Dosage Information
- Evoclin Consumer Overview
- Clindamycin Topical Prescribing Information (FDA)
- Cleocin T Gel MedFacts Consumer Leaflet (Wolters Kluwer)
- Cleocin Vaginal Advanced Consumer (Micromedex) - Includes Dosage Information
- Clinda-Derm Prescribing Information (FDA)
- ClindaMax Cream MedFacts Consumer Leaflet (Wolters Kluwer)
- Clindacin P Prescribing Information (FDA)
- Clindagel Prescribing Information (FDA)
- Clindamax Prescribing Information (FDA)
- Clindesse Cream MedFacts Consumer Leaflet (Wolters Kluwer)
- Clindesse Prescribing Information (FDA)
- Clindesse Consumer Overview
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