Spiramycin 1.5million unit tablets
Requires a prescription from a doctor or prescriber
Official documents, adverse reaction reporting, and safety monitoring
Report a side effect
Submit a Yellow Card report to the MHRA
Safety monitoring data
Yellow Card reports
The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.
View Drug Analysis Profile
Suspected adverse reactions reported for Spiramycin
Browse all iDAP reports
Interactive Drug Analysis Profiles for all medicines
Report a side effect
Submit a Yellow Card report to the MHRA
Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
EudraVigilance
The European Medicines Agency (EMA) collects suspected adverse reaction reports from across the EU/EEA through the EudraVigilance system. Search for safety data on this medicine.
View EudraVigilance report
Suspected adverse reactions reported for Spiramycin
About EudraVigilance
Learn about EU pharmacovigilance and safety monitoring
EudraVigilance data is published by the European Medicines Agency (EMA). A suspected adverse reaction is not necessarily caused by the medicine.
1 branded products available
Therapeutically similar medicines
Similarity is based on WHO Anatomical Therapeutic Chemical (ATC) classification and on a factual NHS dm+d therapeutic-grouping code prefix. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
Check stock at pharmacies and supply information
Pharmacy stock checkers
Search for this medicine at major UK pharmacy chains. These links open the retailer's own website — results depend on their current online catalogue.
Supply & safety information
Official UK regulator monitoring and safety alerts
Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. Shortage and safety information sourced from MHRA drug safety updates (gov.uk, Crown Copyright under OGL v3.0).
Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
Browse tools
SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. BNF code shown is the factual mapping value distributed by NHS Business Services Authority (NHSBSA) in the dm+d supplementary file under OGL v3.0; it is not affiliated with, nor licensed from, the publishers of the British National Formulary. ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 4 · Randomised trials: 1 · 1973–2025
Showing the 50 most relevant studies, sorted by most relevant.
Ribeiro SK, Mariano IM, Cunha ACR, et al.
2025
Toxoplasmosis is a globally prevalent zoonotic parasitic disease. Neonates with congenital infection can develop severe long-term sequelae, which can be mitigated or prevented through early diagnosis and therapeutic approaches. In this context, the main objective of this study was to describe the main treatments and evaluate the effectiveness of the current treatment protocols for gestational and congenital toxoplasmosis to prevent vertical transmission and to reduce clinical manifestations in neonates. This systematic review with a meta-analysis searched digital databases (PUBMED, SCOPUS, WEB OF SCIENCE, EMBASE, and COCHRANE) for observational cohort studies published between 1 January 2013 and 29 January 2025, evaluating treatment effectiveness in gestational and congenital toxoplasmosis. Risk ratios (RRs) were calculated using random effects models to assess infection risk and clinical manifestations in neonates. The study quality was assessed following the Joanna Briggs Institute protocol and fifty-six studies from 16 countries were included, comprising 11,090 pregnant women and 4138 children. Studies were predominantly from Brazil (38%), France, and Italy. Only 9% of the studies indicated knowledge of the serological status of the pregnant woman before the gestational stage. Of 10,148 women with confirmed toxoplasmosis, 8600 received treatment, with 18% of their children infected, compared to a 58% infection rate in untreated mothers' children. Meta-analysis showed that treatment reduced infection risk (RR = 0.34 [0.21; 0.57]) and clinical manifestations (RR = 0.30 [0.17; 0.56]). While spiramycin or triple therapy showed similar effects, triple therapy demonstrated more consistent results (RR: 0.22 [0.15; 0.32]) compared to spiramycin alone (RR: 0.54 [0.06; 4.67]). In conclusion, treatment protocols for congenital or gestational toxoplasmosis have proven to be effective in reducing the risk of infection and clinical manifestations in neonates. Regarding the type of treatment, although they have similar responses, the use of triple therapy shows more consistent responses than isolated spiramycin. It can be also concluded that prevention and mitigation of congenital toxoplasmosis require standardized treatment protocols, improved diagnostic methods, and educational programs for women of childbearing age, as treatment initiation timing and protocol choice are crucial factors in determining outcomes.
Abstract licence: CC BY
Shim SR, Lee Y, In SM, et al.
2024
- Hearing Loss
- Deafness
- Tinnitus
The increased risk of hearing loss with macrolides remains controversial. We aimed to systematically review and meta-analyze data on the clinical risk of hearing loss, tinnitus, and ototoxicity following macrolide use. A systematic search was conducted across PubMed, MEDLINE, Cochrane, and Embase databases from database inception to May 2023. Medical Subject Heading (MeSH) terms and text keywords were utilized, without any language restrictions. In addition to the electronic databases, two authors manually and independently searched for relevant studies in the US and European clinical trial registries and Google Scholar. Studies that involved (1) patients who had hearing loss, tinnitus, or ototoxicity after macrolide use, (2) intervention of use of macrolides such as azithromycin, clarithromycin, erythromycin, fidaxomicin, roxithromycin, spiramycin, and/or telithromycin, (3) comparisons with specified placebos or other antibiotics, (4) outcomes measured as odds ratio (OR), relative risk (RR), hazard ratio (HR), and mean difference for ototoxicity symptoms using randomized control trial (RCT)s and observational studies (case-control, cross-section, and cohort studies) were included. Data extraction was performed independently by two extractors, and a crosscheck was performed to identify any errors. ORs along with their corresponding 95% confidence intervals (CIs) were estimated using random-effects models. The Preferred Reporting Items for Systematic Reviews and Meta-analyses reporting guidelines for RCTs and Meta-Analysis of Observational Studies in Epidemiology guidelines for observational studies were followed. We assessed the hearing loss risk after macrolide use versus controls (placebos and other antibiotics). Based on data from 13 studies including 1,142,021 patients (n = 267,546 for macrolide and n = 875,089 for controls), the overall pooled OR was 1.25 (95% CI 1.07-1.47). In subgroup analysis by study design, the ORs were 1.37 (95% CI 1.08-1.73) for RCTs and 1.33 (95% CI 1.24-1.43) for case-control studies, indicating that RCT and case-control study designs showed a statistically significant higher risk of hearing loss. The group with underlying diseases such as multiple infectious etiologies (OR, 1.16 [95% CI 0.96-1.41]) had a statistically significant lower risk than the group without (OR, 1.53 [95% CI 1.38-1.70] P = .013). The findings from this systematic review and meta-analysis suggest that macrolide antibiotics increase the risk of hearing loss and that healthcare professionals should carefully consider this factor while prescribing macrolides.
Abstract licence: CC BY
Laurent Mandelbrot, F. Kieffer, R. Sitta, et al.
American Journal of Obstetrics and Gynecology, 2018
Anne Brisson-Noel, P. Trieu-Cuot, P. Courvalin
The Journal of antimicrobial chemotherapy, 1988
J. Menninger, D. Otto
Antimicrobial Agents and Chemotherapy, 1982
D. Portnoy, M. Whiteside, E. Buckley, et al.
Annals of internal medicine, 1984
Shannon M. Mitchell, J. Ullman, A. Teel, et al.
Chemosphere, 2015
J. Montoya, K. Laessig, M. Fazeli, et al.
European Journal of Medical Research, 2021
Susan M. Poulsen, Christine B. Kofoed, B. Vester
Journal of molecular biology, 2000
S. Etewa, D. A. A. El-Maaty, R. Hamza, et al.
Journal of Parasitic Diseases, 2018
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
4.5 to 6.2 hours
Mechanism
The mechanism of action of macrolides has been a matter of controversy for some time.
Food interactions
1 warning
Human targets
None mapped
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
30-39%
Half-life
18 to 32 years
Young persons (18 to 32 years of age): Approximately 4.5…
Protein binding
10-25%
Volume of distribution
300 L
Metabolism
Elimination
Clearance
80%
Enterohepatic…
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
Spiramycin is a 16-membered ring macrolide discovered in 1952 as a product of Streptomyces ambofaciens that has been available in oral formulations since 1955, and parenteral formulations since 1987. Resistant organisms include Enterobacteria, pseudomonads, and moulds.
Known interactions with other medications. Always consult a healthcare professional.
Showing 50 of 84 interactions
Cholestatic hepatitis (abdominal pain; nausea; vomiting; yellow eyes or skin).
Gastrointestinal toxicity, specifically acute colitis (abdominal pain and tenderness; bloody stools; fever).
Intestinal injury (abdominal pain and tenderness).
Ulcerated esophagitis (chest pain; heartburn).
How the body processes this drug — absorption, distribution, metabolism, and elimination
Spiramycin has slower rate of absorption than Erythromycin. It has a high pKa (7.9) which could be a result of high degree of ionization in acidic medium of the stomach.
Young persons (18 to 32 years of age): Approximately 4.5 to 6.2 hours.
Elderly persons (73 to 85 years of age): Approximately 9.8 to 13.5 hours.
Oral: 5.5-8 hours, Rectal in children: 8 hours
Enterohepatic recycling could also occur.
Only 4 to 14% of an administered dose is eliminated through renal-urinary excretion route.
ATC J01RA04
ATC J01FA02
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Show
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Spiramycin
Additional database identifiers
DrugBank citations
If you use DrugBank data in your research, please cite the following publications:
Show earlier publications
Structured knowledge from the free knowledge base
ATC classifications (Wikidata)
Linked open data from Wikidata (Q422265), a free and open knowledge base operated by the Wikimedia Foundation. Data is available under the Creative Commons CC0 1.0 Public Domain Dedication.