What the label lists and what reports show
Clindamycin side effects
Clindamycin's FDA label: “Hypersensitivity Reactions: Generalized mild to moderate morbilliform-like (maculopapular) skin rashes are the most frequently reported adverse reactions.” FAERS holds 8,968 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is drug hypersensitivity (750 reports).
- Generic listed
- In shortage
- Boxed warning
Check it at the source: the clindamycin FDA label on DailyMed (effective March 10, 2026, GLENMARK PHARMACEUTICALS INC., USA); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of XACIATO?XACIATO may cause serious side effects, including diarrhea. One type of diarrhea is caused by an infection in your intestines called Clostridioides difficile -associated diarrhea (CDAD), which may range in severity from mild diarrhea to colitis that can lead to death. If you have diarrhea after you use XACIATO, call your healthcare provider. The most common side effects of XACIATO include: Yeast infection in your vagina that may require treatment with an antifungal medicine. Vaginal discomfort including itching, burning, redness and dryness. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of XACIATO. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label (XACIATO), Organon LLC, effective February 19, 2026 (SPL set 0423007f-28fa-4159-bf58-9174626d2347), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsHypersensitivity Reactions: Generalized mild to moderate morbilliform-like (maculopapular) skin rashes are the most frequently reported adverse reactions.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
This table is printed in the Clindesse label published by Padagis Israel Pharmaceuticals Ltd of January 30, 2025; the label quoted above does not print one.
| Adverse Reactions | Clindesse N=85 n (%) | Placebo N=85 n (%) |
|---|---|---|
| Vaginosis fungal NOS | 12 (14) | 7 (8) |
| Headache NOS | 6 (7) | 2 (2) |
| Back Pain | 4 (5) | 1 (1) |
| Constipation | 2 (2) | 0 (0) |
| Urinary tract infection NOS | 2 (2) | 0 (0) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following reactions have been reported with the use of clindamycin. Infections and Infestations: Clostridioides difficile colitis Gastrointestinal: Abdominal pain, pseudomembranous colitis, nausea, vomiting, and diarrhea (see BOXED WARNING ). The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment (see WARNINGS ). Esophagitis and esophageal ulcer have been reported, particularly when taken in a lying position or with a small amount of water. An unpleasant or metallic taste has been reported after oral administration. Hypersensitivity Reactions: Generalized mild to moderate morbilliform-like (maculopapular) skin rashes are the most frequently reported adverse reactions. Vesiculobullous rashes, as well as urticaria, have been observed during drug therapy. Severe skin reactions such as Toxic Epidermal Necrolysis, some with fatal outcome, have been reported (see WARNINGS ). Cases of Acute Generalized Exanthematous Pustulosis (AGEP), erythema multiforme, some resembling Stevens-Johnson syndrome, anaphylactic shock, anaphylactic reaction, cutaneous vasculitis, symmetrical drug-related intertriginous and flexural exanthema and hypersensitivity have also been reported. Skin and Mucous Membranes: Pruritus, vaginitis, angioedema and rare instances of exfoliative dermatitis have been reported (see Hypersensitivity Reactions ). …
Source: FDA drug label, GLENMARK PHARMACEUTICALS INC., USA, effective March 10, 2026 (SPL set 8e66de7a-d9d4-4562-bc99-80489d482da4), via openFDA; the full label on DailyMed
What do FAERS reports show?
8,968 reports list clindamycin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 627 are coded as a death and 2,965 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 7 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Clindamycin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions