Safety Alert Regarding Cotrimoxazole (Sulfamethoxazole and Trimethoprim) issued by DRAP and PRAC-EMA
Target Audience
Provincial Health Departments / Provincial Pharmacovigilance (PV) Centres
Manufacturers and importers of the sulfamethoxazoleātrimethoprim combination
Healthcare professionals
Patients
Background
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA), during its meeting held from 5ā8 May 2025, recommended an update to the product information for medicines containing the combination of sulfamethoxazole and trimethoprim (cotrimoxazole). This update includes the addition of ācirculatory shockā as an adverse drug reaction under the Undesirable Effects section of the Summary of Product Characteristics (SmPC), with a frequency classified as ānot known.ā
Trimethoprim/sulfamethoxazole, also known as co-trimoxazole, is an antimicrobial used fot the treatment and prevention ofĀ many bacterial infections.The FDA-Approved indications include acute infective exacerbation of chronic bronchitis, otitis media in pediatrics only, travelers diarrhea forĀ prophylaxis and treatment, urinary tract infections (UTI), shigellosis, prophylaxis and treatment of pneumocystis jirovecii, pneumonia/pneumocystis carinii pneumonia (PJP/PCP), and toxoplasmosis.
Circulatory shock is defined as acute circulatory failure which leads to inadequate cellular oxygen utilization, which can lead to multiorgan failure and death.Ā
Reports indicate that cases of circulatory shock, often accompanied by fever and unresponsive to standard hypersensitivity treatments, have occurred following use of this medicine. These cases were reported predominantly in immunocompromised patients. Patients experiencing symptoms such as fever, very low blood pressure, or increased heart rate after taking this medicine should seek emergency medical care, as these may be signs of shock.
šDRAP’s Regulatory Action in Pakistan
This safety concern was reviewed during the 6th meeting of the Pharmacovigilance Risk Assessment Expert Committee (PRAEC) held on 31 December 2025. In accordance with Rule 10(1)(h)(iv) of the Pharmacovigilance Rules, 2022, the committee decided that registration holders must update the SmPC and product labeling to include ācirculatory shockā as an adverse drug reaction with a frequency of ānot known,ā in alignment with the EMA-PRAC recommendation.
Therapeutic Goods Affected
Name: SulfamethoxazoleāTrimethoprim Combination
Description: A prescription antibiotic used for the treatment of various bacterial infections.
Advice for Healthcare Professionals
Healthcare professionals are advised that cases of circulatory shock, with a frequency of ānot known,ā have been reported in association with the sulfamethoxazoleātrimethoprim combination. These reactions may be accompanied by fever and may not respond to standard hypersensitivity treatments, particularly in immunocompromised patients. Healthcare professionals should advise patients to seek immediate medical attention if symptoms suggestive of circulatory shock develop.
Advice for Patients
Patients are advised to immediately consult their doctor or visit a hospital if they experience symptoms such as fever, very low blood pressure, or an increased heart rate after taking this medicine, as these may indicate circulatory shock.
Reporting of Adverse Drug Reactions (ADRs)
Healthcare professionals and patients are encouraged to report any adverse drug reactions associated with the sulfamethoxazoleātrimethoprim combination, or with any other medicines, through the Med Vigilance E-Reporting System available on the DRAP website. Adverse events may also be reported via the VigiMobile application.Ā
šAlsoĀ Read: How does Uppsala monitoring center is connected all around the world for ADRs monitoring and Pharmacovigilance?
References:
Drug Regulatory Authority of Pakistan. (2026, February 6). Safety alert of risk of circulatory shock with the sulfamethoxazole and trimethoprim drug combination. https://www.dra.gov.pk/safety_info/safety_communication/safety_updates/safety-alert-of-risk-of-circulatory-shock-with-the-sulfamethoxazole-and-trimethoprim-drug-combination/
Kemnic, T. R., & Coleman, M. (2022). Trimethoprim-sulfamethoxazole. In StatPearls. StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK513232/
Khorsand, S., & Khanna, A. K. (2023). Shock (circulatory). In ScienceDirect Topics in Medicine and Dentistry. Elsevier. https://www.sciencedirect.com/topics/medicine-and-dentistry/shock-circulatory
Disclaimer
This content is sharedĀ solely for educational and public awareness purposesĀ and is based onĀ publicly available DRAP safety alert notices. ItĀ does not represent an official DRAP communication, medical advice, or regulatory directive. ReadersĀ consult qualified healthcare professionalsĀ before making any medical or regulatory decisions.ar dapibus leo.
