DISCLAIMER: This publication is intended for healthcare professionals. The information provided aims to update on medication safety issues and should not substitute clinical judgment. While reasonable care has been taken to verify the accuracy of the information at the time of publication, the NPRA shall not be held liable for any loss arising from the use of or reliance on this publication.

 

Overview of Product(s)

Clindamycin is a lincosamide antibiotic indicated for the treatment of infections caused by susceptible anaerobic bacteria, susceptible strains of Gram-positive aerobic bacteria (such as streptococci, staphylococci, and pneumococci), and susceptible strains of Chlamydia trachomatis.¹ In Malaysia, clindamycin is available in various dosage forms, including oral capsules, parenteral injection (solution for injection), and topical preparations.² Oral clindamycin capsules are formulated as clindamycin hydrochloride, a stable, very water-soluble salt with acidic properties.^3,4 Currently, seven clindamycin hydrochloride capsule products are registered with the Drug Control Authority (DCA).²

 

Overview of Safety Concern

Oesophagitis refers to inflammation of the oesophagus, which may progress to oesophageal ulcer in more severe cases.⁵ Both conditions may arise from multiple factors, including drug-induced injury.⁶ Drug-related mechanisms involve direct irritation of the oesophageal mucosa, particularly with prolonged contact due to capsule retention in the oesophagus. Such reactions have been reported in association with oral medications, including clindamycin, under certain conditions of use.

 

Source of Safety Concern

The product registration holder (PRH) for products containing clindamycin hydrochloride oral capsules has notified the National Pharmaceutical Regulatory Agency (NPRA) regarding an update to the product information (PI) in relation to the risk of oesophagitis and oesophageal ulcer. This update is based on recommendations from the French National Agency for Medicines and Health Products Safety (ANSM). As informed by the PRH, the ANSM has recommended strengthening the safety information and including additional measures aimed at minimising this risk.

 

Background of the Safety Issue

Antibiotic-induced oesophageal injury may underdiagnosed in clinical practice because symptoms may mimic gastroesophageal reflux disease (GERD).⁶ However, endoscopic evaluation reveals solitary or multiple ulcerative lesions with defined borders as characteristic of drug-induced injury, which is distinct from the typical presentation of acid reflux.

The mechanism by which clindamycin may cause oesophageal injury is attributed to its low pH when dissolved in solution. This acidic property may cause direct irritation of the oesophageal mucosa, particularly with prolonged mucosal contact, resulting in mucosal injury that most commonly occurs in the distal or middle oesophagus.^6,7

Patient-related factors play a significant role and are among the most commonly identified contributors to drug-induced oesophagitis.⁶ Key factors include ingestion of medication with insufficient water (41.6%) and administration in a recumbent position (22.9%), both of which may increase the risk of oesophageal retention. In addition, elderly patients (≥65 years) may be at higher risk due to reduced oesophageal motility, higher prevalence of polypharmacy, and prolonged recumbency. Anatomical changes, including external oesophageal compression (e.g., by an enlarged heart), may further contribute to delayed oesophageal transit and increased risk of oesophagitis or oesophageal ulcer.

Based on published case reports, symptoms of oesophageal injury have been observed to occur early, with onset typically within the first 5 days of clindamycin ingestion^6,8,9, and commonly present as odynophagia^6,9, dysphagia^6,8, or retrosternal/chest pain^6,8. These symptoms are generally reversible and may resolve following discontinuation of clindamycin and appropriate management.^6,8

 

Local Adverse Drug Reaction Reports¹⁰

To date, the NPRA has received 449 reports involving 755 adverse events suspected to be related to clindamycin-containing products. No cases of oesophagitis and oesophageal ulcer associated with clindamycin have been reported locally.

 

Regulatory Action

NPRA has completed a review of the potential risk of oesophagitis and oesophageal ulcer associated with clindamycin. On 15 January 2026, a directive [NPRA.600-1/9/13(75) Jld. 1] was issued for all registration holders of clindamycin hydrochloride oral capsule products to update the local package inserts and consumer medication information leaflets (Risalah Maklumat Ubat untuk Pengguna) to reflect this safety information.

 

Advice for Health Care Professionals

• Be aware that the risk of oesophagitis and oesophageal ulcer has been reported with clindamycin capsule, particularly with improper administration.
• Advise the patient to take clindamycin capsules with a full glass of water and remain upright for at least 30 minutes after administration.
• Emphasise to the patient the importance of adherence to these instructions to reduce the risk of oesophagitis and oesophageal ulcer.
• Advise patients to seek medical attention if they experience symptoms such as pain or difficulty when swallowing, or chest pain.
• Consider discontinuation of clindamycin if oesophageal injury is suspected, and manage it accordingly.
• Report all suspected adverse events related to clindamycin-containing products to the NPRA.

 

References

1. National Pharmaceutical Regulatory Agency (NPRA). DALACIN C CAPSULE 150MG [Package Insert]. QUEST3+ Product Search. 2024 Apr 26 [cited 2025 May 29] Available from: http://www.npra.gov.my
2. National Pharmaceutical Regulatory Agency (NPRA). QUEST3+ Product Search [Internet]. 2026 [cited 2026 Mar 30] Available from: https://www.npra.gov.my
3. British Pharmacopoeia Commission. British Pharmacopoeia 2026. London: The Stationery Office; 2026. Clindamycin Hydrochloride.
4. United States Pharmacopeial Convention. USP 47–NF 42. Rockville (MD): United States Pharmacopeial Convention; 2024. Clindamycin Hydrochloride.
5. Esophagitis [Internet]. Cleveland Clinic; 2023 [cited 2025 Jan 7]. Available from: https://my.clevelandclinic.org/health/diseases/10138-esophagitis
6. Bestari MB, Agustanti N, Abdurachman SA. Clindamycin-Induced Esophageal Injury: Is It an Underdiagnosed Entity? Clinical Medicine Insights: Case Reports. 2019;12:1–4. Available from: https://doi.org/10.1177/117954761988405
7. Abdi S, Masbough F, Nazari M, Abbasinazari M. Drug-induced esophagitis and helpful management for healthcare providers. Gastroenterol Hepatol Bed Bench. 2022;15(3):219-224. Available from: https://doi.org/10.22037/ghfbb.v15i3.2591
8. Rutt AL, Wang CE. Reaction to Clindamycin Causing Laryngitis and Esophagitis. Ear, Nose & Throat Journal. 2021;100(6):437-438. Available from: https://doi.org/10.1177/0145561319875138
9. Benić MS, Karlović K, Čubranić A. Clindamycin-induced necrotising oesophagitis. Postgrad Med J. 2016;92:741. Available from: https://doi.org/10.1136/postgradmedj-2016-134386
10. National Pharmaceutical Regulatory Agency (NPRA). The Malaysian National ADR Database (QUEST) [Internet]. 2024 [cited 2025 May 29]. Available from: https://www.npra.gov.my (access restricted)

 

Written by: Nafiza Mohd. Ismail

Reviewed/Edited by: Lim Sze Gee, Dr Rema Panickar, Noor'ain Shamsuddin, Norleen Mohamed Ali