{"id":"shingrix","rwe":[],"tags":[],"safety":{"safetySignals":[{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"Reported 285 times"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"Reported 220 times"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"Reported 204 times"},{"date":"","signal":"HERPES ZOSTER","source":"FDA FAERS","actionTaken":"Reported 185 times"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"Reported 167 times"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"Reported 163 times"},{"date":"","signal":"RASH","source":"FDA FAERS","actionTaken":"Reported 160 times"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"Reported 154 times"},{"date":"","signal":"ARTHRALGIA","source":"FDA FAERS","actionTaken":"Reported 153 times"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"Reported 149 times"}],"drugInteractions":[{"drug":"Live, attenuated influenza vaccines","action":"Avoid","effect":"Decreased immune response"},{"drug":"Live vaccines","action":"Avoid","effect":"Decreased immune response"},{"drug":"Other vaccines","action":"Monitor","effect":"Unknown"},{"drug":"Immunosuppressive therapies","action":"Monitor","effect":"Decreased immune response"},{"drug":"Interferon-alpha","action":"Monitor","effect":"Decreased immune response"},{"drug":"Interferon-gamma","action":"Monitor","effect":"Decreased immune response"},{"drug":"Corticosteroids","action":"Monitor","effect":"Decreased immune response"},{"drug":"Azathioprine","action":"Monitor","effect":"Decreased immune response"},{"drug":"Cyclophosphamide","action":"Monitor","effect":"Decreased immune response"},{"drug":"Cyclosporine","action":"Monitor","effect":"Decreased immune response"},{"drug":"Methotrexate","action":"Monitor","effect":"Decreased immune response"},{"drug":"Sirolimus","action":"Monitor","effect":"Decreased immune 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response"},{"drug":"Cyclophosphamide","action":"Monitor","effect":"Decreased immune response"},{"drug":"Cyclosporine","action":"Monitor","effect":"Decreased immune response"}],"commonSideEffects":[{"effect":"Pain","drugRate":"78%","severity":"common","organSystem":""},{"effect":"Myalgia","drugRate":"45%","severity":"common","organSystem":""},{"effect":"Fatigue","drugRate":"45%","severity":"common","organSystem":""},{"effect":"Headache","drugRate":"38%","severity":"common","organSystem":""},{"effect":"Redness","drugRate":"38%","severity":"common","organSystem":""},{"effect":"Shivering","drugRate":"27%","severity":"common","organSystem":""},{"effect":"Swelling","drugRate":"26%","severity":"common","organSystem":""},{"effect":"Fever","drugRate":"21%","severity":"common","organSystem":""},{"effect":"Gastrointestinal symptoms","drugRate":"17%","severity":"common","organSystem":""},{"effect":"Pain Grade 3","drugRate":"10%","severity":"common","organSystem":""},{"effect":"Myalgia Grade 3","drugRate":"9%","severity":"common","organSystem":""},{"effect":"Fatigue Grade 3","drugRate":"9%","severity":"common","organSystem":""},{"effect":"Shivering Grade 3","drugRate":"7%","severity":"common","organSystem":""},{"effect":"Headache Grade 3","drugRate":"6%","severity":"common","organSystem":""},{"effect":"Redness >100 mm","drugRate":"3%","severity":"common","organSystem":""},{"effect":"Swelling >100 mm","drugRate":"1%","severity":"common","organSystem":""},{"effect":"GI Grade 3","drugRate":"2%","severity":"common","organSystem":""},{"effect":"Fever Grade 3","drugRate":"1%","severity":"common","organSystem":""}],"contraindications":["History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or after a previous dose of SHINGRIX."],"specialPopulations":{"Pregnancy":"There is currently no ACIP recommendation for RZV use in pregnancy. Providers should consider delaying RZV until after pregnancy. There is no recommendation for pregnancy testing prior to vaccination.","Geriatric use":"There are limited data on the use of RZV in patients without a history of varicella, with or without a history of varicella vaccination.","Paediatric use":"Children and adolescents who have received live-attenuated varicella vaccines are at lower risk for shingles than are those who experienced varicella.","Renal impairment":"text","Hepatic impairment":"text"},"seriousAdverseEvents":[]},"trials":[],"aliases":[],"company":"GSK","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=shingrix","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:39:24.574495+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Shingrix","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-19T23:39:39.364768+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:39:38.081198+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:39:24.596044+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=shingrix","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:39:38.816427+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Envelope glycoprotein E vaccine antigen","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:39:39.364364+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL4297975/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:39:39.265737+00:00"}},"offLabel":[],"timeline":[{"date":"2006-01-01","type":"neutral","_source":"Wikipedia","milestone":"EMA issued marketing authorization for zoster vaccine","regulator":"EMA"},{"date":"2013-09-01","type":"neutral","_source":"Wikipedia","milestone":"UK NHS started offering shingles vaccination","regulator":"none"},{"date":"2013-09-01","type":"positive","_source":"Wikipedia","milestone":"People aged 70 or 79 offered the vaccine","regulator":"none"},{"date":"2018-03-01","type":"positive","_source":"Wikipedia","milestone":"Shingrix approved for medical use in EU","regulator":"EMA"},{"date":"2021-01-01","type":"neutral","_source":"Wikipedia","milestone":"Vaccination","regulator":"none"}],"_dailymed":{"setId":"c46e8702-5680-462b-a093-0c7720f77020","title":"SHINGRIX (ZOSTER VACCINE RECOMBINANT, ADJUVANTED) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]","labeler":""},"aiSummary":"Shingrix is a marketed vaccine by GSK for preventing herpes zoster (shingles) in adults aged 50 years and older. It reduces the incidence of herpes zoster, a disease caused by reactivation of the varicella zoster virus. Shingles provokes a painful rash with blisters and can be followed by chronic pain and other complications. Older people are more often affected, as are people with weakened immune systems. Vaccination can prevent both shingles and postherpetic neuralgia. Shingrix has shown significant commercial success with $1.07B in revenue and a large number of trials and publications. Its mechanism is focused on reducing the incidence of herpes zoster.","brandName":"Shingrix","ecosystem":[],"isGeneric":true,"mechanism":{"target":"Varicella zoster virus","novelty":"Best-in-class","modality":"Vaccine","drugClass":"Vaccine","explanation":"","oneSentence":"","technicalDetail":"Shingrix is a recombinant zoster vaccine that contains a non-infectious, non-replicating form of the varicella zoster virus. It is administered via a two-dose regimen, with the second dose given 2-6 months after the first dose. The vaccine stimulates the production of antibodies and T-cells that help to protect against the virus."},"_companyIR":{"url":"https://www.gsk.com/investors","revenueRefs":[],"pipelineRefs":[]},"_wikipedia":{"title":"Zoster vaccine","extract":"A zoster vaccine is a vaccine that reduces the incidence of herpes zoster, a disease caused by reactivation of the varicella zoster virus, which is also responsible for chickenpox. Shingles provokes a painful rash with blisters and can be followed by chronic pain and other complications. Older people are more often affected, as are people with weakened immune systems (immunosuppression). Both shingles and postherpetic neuralgia can be prevented by vaccination.","wiki_history":"==History==\n=== European Union ===\n\nIn 2006, the European Medicines Agency (EMA) issued a marketing authorization for the zoster vaccine to Sanofi Pasteur for routine vaccination in individuals aged 60 and over.\n\nShingrix was approved for medical use in the European Union in March 2018, with an indication for the prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN) in adults 50 years of age or older.\n\n=== United Kingdom ===\n\nFrom 2013, the UK National Health Service (NHS) started offering shingles vaccination to elderly people. People aged either 70 or 79 on 1 September 2013, were offered the vaccine. People aged 71 to 78 on that date would only have an opportunity to have the shingles vaccine after reaching the age of 79. The original intention was for people aged between 70 and 79 to be vaccinated, but the NHS later said that the vaccination program was being staggered as it would be impractical to vaccinate everyone in their 70s in a single year.\n\nIn 2021, vaccination against shingles is available on the NHS to people aged 70 to 79. Since 2023, the shingles vaccines is being offered to healthy people turning 65.\n\n===United States===\nZostavax was developed by Merck & Co. and approved and licensed by the US Food and Drug Administration (FDA) in May 2006, Shingrix is a zoster vaccine developed by GlaxoSmithKline that was approved in the United States in October 2017. Shingrix, which provides strong protection against shingles and PHN, was preferred over Zostavax","wiki_medical_uses":"== Medical uses ==\nZoster vaccination is used to prevent shingles and its complications, including postherpetic neuralgia., which is given as a single shot, Shingrix is given as two identical intramuscular doses, two to six months apart.<!---citation for \"identical\"---> Shingrix provides high levels of immunity for at least 7 years after vaccination, but it is possible the vaccine may provide protection for much longer.\n\nA large randomized clinical trial showed Shingrix reduced the incidence of shingles 96.6% (relative risk reduction, RRR) in the 50–59 age group, and 91.3% (relative risk reduction, RRR) in those over age 70. The absolute decrease in risk (absolute risk reduction, ARR) of herpes zoster following immunization over three and a half years is 3.3% (3.54% down to 0.28%) while the decrease in the risk of postherpetic neuralgia is 0.3% (0.34% down to 0.06%).\n\n===Zostavax===\nthumb|Zostavax vaccine\nThe Zostavax vaccine (both single dose and two-dose regime) is likely effective at protecting people from herpes zoster disease for a duration of up to three years. The degree of longer term protection (beyond 4 years from the initial vaccination) is not clear. The need for re-vaccination after the first full vaccine schedule is complete remains to be confirmed. The FDA originally recommended it for individuals 60 years of age or older who are not severely allergic to any of its components and who meet the following requirements:\n* do not have a weakened immune system due to"},"commercial":{"yoyGrowth":"-5.5%","revenueYear":2024,"annualCostUS":"$0 FOR ALMOST EVERYONE","annualRevenue":4300,"genericStatus":"Generic — off-patent","revenueSource":"Verified: GSK AR","currentRevenue":"$1.07B","revenueCurrency":"USD","patientPopulation":"1 in 3 people will get shingles in their lifetime, More than 99% of adults over 50 years old","peakSalesEstimate":"Not publicly reported","revenueConfidence":"verified"},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=shingrix","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=shingrix","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://www.ebi.ac.uk/chembl/","fields":["molecular"],"source":"ChEMBL (EMBL-EBI)"},{"id":4,"url":"https://en.wikipedia.org/wiki/shingrix","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://open.fda.gov/apis/drug/event/","fields":["safetySignals"],"source":"FDA FAERS"},{"id":6,"url":"https://www.ema.europa.eu/","fields":["regulatoryStatus"],"source":"European Medicines Agency (EMA)"},{"id":7,"url":"https://list.essentialmeds.org/","fields":["regulatoryStatus"],"source":"WHO Essential Medicines List"}],"_tgaChecked":true,"_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T08:36:44.774207+00:00","fieldsConflicting":0,"overallConfidence":0.95},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"CRV-101","company":"Curevo","advantage":"matches efficacy of Shingrix while potentially demonstrating an improved tolerability profile"},{"name":"mRNA-based shingles vaccine candidate","company":"Pfizer and BioNTech","advantage":"targets a favorable safety profile and scalability to counterbalance Shingrix’s market dominance"},{"name":"Zostavax","company":"Historical","advantage":"less pronounced in recombinant products"}],"genericName":"shingrix","indications":{"approved":[{"name":"Prevention of herpes zoster (shingles) in adults aged 50 years and older","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_drugWebsite":{"url":"https://www.shingrix.com","content":"For US Residents\n\nSelect Language\n \nPrescribing Information\nVisit US HCP Site\nSign up\n\nSearch\n\nABOUT \nSIDE EFFECTS\nFAQs\nGET SHINGRIX \n\n$0 FOR ALMOST EVERYONE | Learn more\n\nSHINGLES DOESN’T CARE. \nBUT SHINGRIX PROTECTS.\n\nMore than 99% of adults over 50 years old already have the virus that causes shingles inside them. If you’re one of them, it can reactivate at any time, and cause pain that lasts for weeks and can be disruptive.\n\n1 in 3 people will get shingles in their lifetime.\n\nSHINGRIX is an FDA-approved vaccine for the prevention of shingles (herpes zoster) in adults 50 years and older. SHINGRIX is not used to prevent chickenpox.\n\nLEARN MORE\n\nHELP PREVENT SHINGLES WITH SHINGRIX\n\nWHAT IS SHINGLES?\n\nShingles, also known as herpes zoster, is a painful, blistering rash caused by the reactivation of the varicella zoster virus (the same virus that causes chickenpox). The shingles rash can last for several weeks and interfere with everyday activities like work, time with family, and even sleeping.\n\nLEARN MORE ABOUT SHINGLES\n\nSHINGLES SYMPTOMS\n\nMost people who get shingles experience acute pain, and many describe it as a burning sensation. The most common complication of shingles is pain that can last for months or even years. SHINGRIX is not indicated to prevent complications from shingles.\n\nLEARN MORE ABOUT SHINGLES\n\nWHAT IS SHINGRIX?\n\nSHINGRIX is a vaccine given as a 2-dose series. In clinical trials, it was proven to be more than 90% effective in preventing shingles in adults 50 years and older. Completing both doses is the only way to get the full protection offered by SHINGRIX. Simply schedule your second dose when you’re getting your first.\n\nCommon side effects seen with SHINGRIX had a median duration of 2 to 3 days. Learn more about the most common side effects in the Important Safety Information below.\n\nLEARN MORE ABOUT SHINGRIX\n\nSHINGRIX IS $0 FOR ALMOST EVERYONE*\n\n$0 if you’re on Medicare Part D,\n\n$0 for 98% of privately insured people.\n\nLEARN MORE\n\n*Coverage"},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT06162494","phase":"PHASE4","title":"Recombinant Zoster Vaccine in Young Adult Solid Organ Transplant Recipients","status":"ENROLLING_BY_INVITATION","sponsor":"Ann & Robert H Lurie Children's Hospital of Chicago","startDate":"2024-03-18","conditions":"Varicella Zoster","enrollment":80},{"nctId":"NCT05703607","phase":"PHASE1, PHASE2","title":"A Study to Learn About a Modified RNA Vaccine Against Shingles in Healthy Adults","status":"TERMINATED","sponsor":"Pfizer","startDate":"2023-01-25","conditions":"Shingles, Herpes Zoster Infection, Human","enrollment":485},{"nctId":"NCT07485283","phase":"PHASE4","title":"Recombinant Herpes Zoster Vaccine for Prevention of Cardiovascular Events and Dementia","status":"NOT_YET_RECRUITING","sponsor":"Tor Biering-Sørensen","startDate":"2026-03","conditions":"Cardiovascular Disease, Dementia","enrollment":162000},{"nctId":"NCT06489964","phase":"NA","title":"Addressing Unfunded Vaccines Through a Co-payment Mechanism in Pharmacies","status":"RECRUITING","sponsor":"Canadian Immunization Research Network","startDate":"2025-10-23","conditions":"Preventable Disease, Vaccine","enrollment":600},{"nctId":"NCT07481604","phase":"PHASE2","title":"Safety and Immunogenicity of CVI-VZV-001 in Adults Aged 50 Years and Above","status":"NOT_YET_RECRUITING","sponsor":"CHA Vaccine Institute Co., Ltd.","startDate":"2026-04","conditions":"Herpes Zoster","enrollment":135},{"nctId":"NCT07280741","phase":"PHASE4","title":"Recombinant Herpes Zoster Vaccine in Patients With Autoimmune Rheumatic Diseases Under Immunomodulators","status":"RECRUITING","sponsor":"University of Sao Paulo General Hospital","startDate":"2025-12-02","conditions":"Autoimmune Rheumatic Diseases","enrollment":200},{"nctId":"NCT05580458","phase":"PHASE1, PHASE2","title":"Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population","status":"RECRUITING","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2023-03-13","conditions":"Herpes Zoster","enrollment":225},{"nctId":"NCT07443709","phase":"PHASE2","title":"Zoster Vaccine to Enhance Protection Against Zoster in Solid-organ Transplantation","status":"NOT_YET_RECRUITING","sponsor":"Oriol Manuel","startDate":"2026-04","conditions":"Zoster; 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