Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Shingrix powder and suspension for suspension for injection, Herpes zoster vaccine (recombinant, adjuvanted)
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Varicella-zoster virus may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
What Shingrix is used for Shingrix is a vaccine that helps to protect adults against shingles (herpes zoster) and post-herpetic neuralgia (PHN), the long-lasting nerve pain that follows shingles. Shingrix is given to:
- adults 50 years and above;
- adults 18 years and above who are at increased risk of shingles. Shingrix cannot be used to prevent chickenpox (varicella). What shingles is
- Shingles is a rash with blisters that is often painful. It usually occurs in one part of the body and can last for several weeks.
- Shingles is caused by the same virus that causes chickenpox.
- After you have had chickenpox, the virus that caused it stays in your body in nerve cells.
- Sometimes, after many years, if your immune system (the body's natural defences) becomes weaker (due to age, an illness or a medicine you are taking), the virus can cause shingles. Complications related to shingles Shingles may lead to complications. The most common complication of shingles is: • long-lasting nerve pain – called post-herpetic neuralgia or PHN. After the shingles blisters heal, you may get pain which can last for months or years and may be severe. Other complications of shingles are: • scars where the blisters have been. • skin infections, weakness, muscle paralysis and loss of hearing or vision – these are less common. How Shingrix works
1
Shingrix reminds your body about the virus that causes shingles. This helps your immune system (the body's natural defences) stay prepared to fight the virus and protect you against shingles and its complications. 2.
What you need to know before you take it
e Shingrix
You must not be given Shingrix if • you are allergic to the active substances or any of the other ingredients of this vaccine (listed in section 6). Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. You must not be given Shingrix if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist. Warnings and precautions Talk to your doctor or pharmacist before you receive Shingrix if: • you have a severe infection with a high temperature (fever). In these cases, the vaccination may have to be postponed until you have recovered. A minor infection such as a cold should not be a problem, but talk to your doctor first; • you have a bleeding problem or bruise easily. If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before you receive Shingrix. Fainting can occur before or after any needle injection. Therefore tell the doctor or nurse if you fainted with a previous injection. Shingrix cannot be used as a treatment if you already have shingles or shingles-related complications. As with all vaccines, Shingrix may not fully protect all people who are vaccinated. Other medicines and Shingrix Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription, or have recently received any other vaccine. Shingrix can be given at the same time as other vaccines such as seasonal influenza vaccine (inactivated, unadjuvanted), 23-valent pneumococcal polysaccharide vaccine, 13-valent pneumococcal conjugate vaccine, reduced antigen diphtheria tetanus acellular pertussis vaccine, COVID-19 mRNA vaccine, or respiratory syncytial virus (RSV) vaccine (recombinant, adjuvanted). A different injection site will be used for each vaccine. You may be more likely to experience fever and/or shivering when 23-valent pneumococcal polysaccharide vaccine is given at the same time as Shingrix. You may be more likely to experience chills, tiredness, fever, stomach and digestive complaints (including nausea, vomiting, diarrhoea and/or stomach pain), headache, muscle pain, or joint pain when a COVID-19 mRNA vaccine is given at the same time as Shingrix. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this vaccine. Driving and using machines Some of the effects mentioned below in section 4 "Possible side effects" may temporarily affect the ability to drive or use machines. Do not drive or use machines if you are feeling unwell.
2
Shingrix contains polysorbate 80, sodium and potassium This medicine contains 0.08 mg of polysorbate 80 per dose. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies. This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'. This medicine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially 'potassium-free'. 3.
How to take it
• •
Shingrix is given as an injection into a muscle (usually in the upper arm). You will receive 2 injections 2 months apart. If flexibility in the vaccination schedule is necessary, the second dose can be administered between 2 and 6 months after the first dose. Based on your medical condition, your doctor may also recommend that you receive the second injection 1 month after the first injection. You will be informed when you should come back for the second dose of Shingrix.
•
Make sure you finish the complete vaccination course. This will maximise the protection offered by Shingrix. Shingrix can be given if you have already been vaccinated with a live attenuated herpes zoster vaccine. Speak to your doctor for more information. 4.
Possible side effects
Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Possible side effects
reported during clinical trials and after marketing of Shingrix: Very common (may occur with more than 1 in 10 doses of the vaccine): • headache • stomach and digestive complaints (including nausea, vomiting, diarrhoea and/or stomach pain) • muscle pain (myalgia) • pain, redness and swelling where the injection is given • feeling tired • chills • fever Common (may occur with up to 1 in 10 doses of the vaccine): • itching where the injection is given (pruritus) • generally feeling unwell Uncommon (may occur with up to 1 in 100 doses of vaccine) • swollen glands in the neck, armpit or groin • joint pain • hardness of the skin where the injection is given Rare (may occur with up to 1 in 1 000 doses of the vaccine) • allergic reactions including rash, hives (urticaria), swelling of the face, tongue or throat which may cause difficulty in swallowing or breathing (angioedema) Very rare (may occur with up to 1 in 10 000 doses of the vaccine) • a neurological disorder that usually starts with pins and needles and weakness of the limbs and may progress to paralysis of part or all of the body (Guillain-Barré syndrome) 3
Most of these side effects are mild to moderate in intensity and are not long-lasting. Immunocompromised adults aged 18-49 years may experience more side effects compared to immunocompromised adults aged ≥ 50 years. Adults aged 50-69 years may experience more side effects compared to adults aged ≥ 70 years. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
Shingrix
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month. Store in a refrigerator (2 °C – 8 °C). Do not freeze. Store in the original package in order to protect from light. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6.
Contents of the pack and other information
What Shingrix contains The active substances are:
•
After reconstitution, one dose (0.5 mL) contains: Varicella Zoster Virus1 glycoprotein E antigen2 1 2
50 micrograms
Varicella Zoster Virus = VZV adjuvanted with AS01B containing: plant extract Quillaja saponaria Molina, fraction 21 (QS-21) 50 micrograms 3-O-desacyl-4'-monophosphoryl lipid A (MPL) from Salmonella minnesota 50 micrograms
The glycoprotein E is a protein present in the Varicella Zoster Virus. This protein is not infectious. The adjuvant (AS01B) is used to improve the body's response to the vaccine. The other ingredients are:
• o o
Powder: Sucrose, polysorbate 80 (E 433), sodium dihydrogen phosphate dihydrate (E 339), dipotassium phosphate (E 340). Suspension: Dioleoyl phosphatidylcholine (E 322), cholesterol, sodium chloride, disodium phosphate anhydrous (E 339), potassium dihydrogen phosphate (E 340) and water for injections. 4
See Section 2 "Shingrix contains polysorbate 80, sodium and potassium". What Shingrix looks like and contents of the pack Powder and suspension for suspension for injection. The powder is white. The suspension is an opalescent, colourless to pale brownish liquid. One pack of Shingrix consists of: • Powder (antigen) for 1 dose in a vial • Suspension (adjuvant) for 1 dose in a vial Shingrix is available in a pack size of 1 vial of powder and 1 vial of suspension or in a pack size of 10 vials of powder and 10 vials of suspension. Not all pack sizes may be marketed Marketing Authorisation Holder GlaxoSmithKline UK Limited 79 New Oxford Street London WC1A 1DG United Kingdom Manufacturer GlaxoSmithKline Biologicals SA Rue de l'Institut 89 1330 Rixensart Belgium Other formats: To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only) Please be ready to give the following information: Product name Shingrix Reference number 19494/0263 This is a service provided by the Royal National Institute of Blind People. This leaflet was last revised in February 2026 Trade marks are owned by or licensed to the GSK group of companies. © 2026 GSK group of companies or its licensor. ————————————————————————————————————————
5
The following information is intended for healthcare professionals only: Shingrix is presented as a vial with a brown flip-off cap containing the powder (antigen) and a vial with a blue-green flip-off cap containing the suspension (adjuvant). The powder and the suspension must be reconstituted prior to administration. Antigen
Adjuvant
Powder
Suspension
1 dose (0.5 mL) The powder and suspension should be inspected visually for any foreign particulate matter and/or variation of appearance. If either is observed, do not reconstitute the vaccine. How to prepare Shingrix Shingrix must be reconstituted prior to administration. 1. 2. 3.
Withdraw the entire contents of the vial containing the suspension into a syringe with a suitable needle (21G to 25G). Add the entire contents of the syringe into the vial containing the powder. Shake gently until the powder is completely dissolved.
The reconstituted vaccine is an opalescent, colourless to pale brownish liquid. The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or variation of appearance. If either is observed, do not administer the vaccine. After reconstitution, the vaccine should be used promptly; if this is not possible, the vaccine should be stored in a refrigerator (2 °C – 8 °C). If not used within 6 hours it should be discarded. Before administration 1. 2.
Withdraw the entire contents of the vial containing the reconstituted vaccine into the syringe. Change the needle so that you are using a new needle to administer the vaccine.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
6
Frequently asked questions about Shingrix powder and suspension for suspension for injection, Herpes zoster vaccine (recombinant, adjuvanted)
How do I take Shingrix powder and suspension for suspension for injection, Herpes zoster vaccine (recombinant, adjuvanted)?
Shingrix powder and suspension for suspension for injection, Herpes zoster vaccine (recombinant, adjuvanted) comes as oral solution. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Shingrix powder and suspension for suspension for injection, Herpes zoster vaccine (recombinant, adjuvanted)?
The active substance in Shingrix powder and suspension for suspension for injection, Herpes zoster vaccine (recombinant, adjuvanted) is varicella-zoster virus.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Shingrix powder and suspension for suspension for injection, Herpes zoster vaccine (recombinant, adjuvanted), as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Shingrix powder and suspension for suspension for injection, Herpes zoster vaccine (recombinant, adjuvanted) without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: varicella-zoster virus
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Shingrix is indicated for prevention of herpes zoster (HZ) and post‑herpetic neuralgia (PHN), in:
• adults 50 years of age or older;
• adults 18 years of age or older at increased risk of HZ.
The use of Shingrix should be in accordance with official recommendations.
4.2. Posology and method of administration
Posology
The primary vaccination schedule consists of two doses of 0.5 mL each: an initial dose followed by a second dose 2 months later.
If flexibility in the vaccination schedule is necessary, the second dose can be administered between 2 and 6 months after the first dose (see section 5.1).
For subjects who are or might become immunodeficient or immunosuppressed due to disease or therapy, and whom would benefit from a shorter vaccination schedule, the second dose can be given 1 to 2 months after the initial dose (see section 5.1).
The need for booster doses following the primary vaccination schedule has not been established (see section 5.1).
Shingrix can be given with the same schedule in individuals previously vaccinated with live attenuated HZ vaccine (see section 5.1).
Shingrix is not indicated for prevention of primary varicella infection (chickenpox).
Paediatric population
The safety and efficacy of Shingrix in children and adolescents have not been established.
No data are available.
Method of administration
For intramuscular injection only, preferably in the deltoid muscle.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Prior to immunisation
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.
As with other vaccines, vaccination with Shingrix should be postponed in subjects suffering from an acute severe febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
As with any vaccine, a protective immune response may not be elicited in all vaccinees.
The vaccine is for prophylactic use only and is not intended for treatment of established clinical disease.
Shingrix should not be administered intravascularly or intradermally.
Subcutaneous administration is not recommended.
Maladministration via the subcutaneous route may lead to an increase in transient local reactions.
Shingrix should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following intramuscular administration to these subjects.
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic‑clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints.
There are no safety, immunogenicity or efficacy data to support replacing a dose of Shingrix with a dose of another HZ vaccine.
Excipients
This medicinal product contains 0.08 mg of polysorbate 80 per dose.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium‑free'.
This medicinal product contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially 'potassium‑free'.
4.5. Interaction with other medicinal products and other forms of interaction
Shingrix can be given concomitantly with seasonal influenza vaccine (inactivated, unadjuvanted), 23‑valent pneumococcal polysaccharide vaccine (PPV23), 13‑valent pneumococcal conjugate vaccine (PCV13), reduced antigen diphtheria‑tetanus‑acellular pertussis vaccine (dTpa), coronavirus disease 2019 (COVID-19) messenger ribonucleic acid (mRNA) vaccine or respiratory syncytial virus (RSV) vaccine (recombinant, adjuvanted). The vaccines should be administered at different injection sites.
The adverse reactions of fever and shivering were more frequent when PPV23 vaccine was co‑administered with Shingrix (16% and 21%, respectively) compared to when Shingrix was given alone (7% for both adverse reactions).
In adults aged 50 years and above, systemic adverse reactions that are very commonly reported (see Table 1; such as myalgia 32.9%, fatigue 32.2%, and headache 26.3%), and arthralgia, uncommonly reported, following administration of Shingrix alone were reported with increased frequency when Shingrix was co-administered with a COVID-19 mRNA vaccine (myalgia 64%, fatigue 51.7%, headache 39%, arthralgia 30.3%).
Concomitant administration of Shingrix with other vaccines than those listed above has not been studied.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no data from the use of Shingrix in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or post‑natal development (see section 5.3).
As a precautionary measure, it is preferable to avoid the use of Shingrix during pregnancy.
Breast‑feeding
The effect on breast‑fed infants of administration of Shingrix to their mothers has not been studied.
It is unknown whether Shingrix is excreted in human milk.
Fertility
Animal studies do not indicate direct or indirect effects with respect to fertility in males or females (see section 5.3).
4.7. Effects on ability to drive and use machines
Shingrix may have a minor influence on the ability to drive and use machines in the 2‑
3 days following vaccination. Fatigue and malaise may occur following administration (see section 4.8).
4.8. Undesirable effects
Summary of the safety profile
In adults aged 50 years and above, the most frequently reported adverse reactions were pain at the injection site (68.1% overall/dose; 3.8% severe/dose), myalgia (32.9% overall/dose; 2.9% severe/dose), fatigue (32.2% overall/dose; 3.0% severe/dose) and headache (26.3% overall/dose; 1.9% severe/dose). Most of these reactions were not long‑lasting (median duration of 2 to 3 days). Reactions reported as severe lasted 1 to 2 days.
In adults ≥ 18 years of age who are immunodeficient or immunosuppressed due to disease or therapy (referred to as immunocompromised (IC)), the safety profile was consistent with that observed in adults 50 years and above. There are limited data in adults aged 18‑49 years at increased risk of HZ who are not IC.
Overall, there was a higher incidence of some adverse reactions in younger age groups:
- studies in IC adults ≥ 18 years of age (pooled analysis): the incidence of pain at the injection site, fatigue, myalgia, headache, shivering and fever was higher in adults aged 18‑49 years compared to those aged 50 years and above.
- studies in adults ≥ 50 years of age (pooled analysis): the incidence of myalgia, fatigue, headache, shivering, fever and gastrointestinal symptoms was higher in adults aged 50‑69 years compared to those aged 70 years and above.
Tabulated list of adverse reactions
The safety profile presented below is based on a pooled analysis of data generated in placebo-controlled clinical studies on 5 887 adults 50‑69 years of age and 8 758 adults ≥ 70 years of age. Of these 14 645 adults, 7 408 were included in a long-term follow-up extension study over a follow-up period of approximately 11 years after vaccination.
In clinical studies in IC adults ≥ 18 years of age (1 587 subjects) the safety profile is consistent with the data presented in Table 1 below.
Adverse reactions reported during post‑marketing surveillance are also tabulated below.
Adverse reactions reported are listed according to the following frequency:
Very common
Common
Uncommon
Rare
Very rare
(≥ 1/10)
(≥ 1/100 to < 1/10)
(≥ 1/1 000 to < 1/100)
(≥ 1/10 000 to < 1/1 000)
(< 1/10 000)
Within each frequency grouping the adverse reactions are reported in the order of decreasing seriousness.
Table 1: Adverse Reactions
System Organ Class1
Frequency
Adverse reactions
Blood and lymphatic system disorders
Uncommon
lymphadenopathy
Immune system disorders
Rare
hypersensitivity reactions including rash, urticaria, angioedema2
Nervous system disorders
Very common
headache
Very rare
Guillain-Barré syndrome3
Gastrointestinal disorders
Very common
gastrointestinal symptoms (including nausea, vomiting, diarrhoea and/or abdominal pain)
Musculoskeletal and connective tissue disorders
Very common
myalgia
Uncommon
arthralgia
General disorders and administration site conditions
Very common
injection site reactions (such as pain, redness, swelling), fatigue, chills, fever
Common
injection site pruritus, malaise
Uncommon
injection site induration
1According to MedDRA (medical dictionary for regulatory activities) terminology
2Adverse reactions from spontaneous reporting
3 See 'Description of selected adverse reactions'
Description of selected adverse reactions
Post-marketing observational studies of the risk of Guillain-Barré syndrome
In 2 similar post-marketing observational studies in the US among individuals aged 65 years or older, an increased risk of Guillain-Barré syndrome (estimated 3 to 7 excess cases per million doses administered) was observed during the 42 days following any dose of Shingrix. In further analyses, the increased risk was observed following the first dose of Shingrix (estimated 6 to 12 excess cases of Guillain-Barré syndrome per million doses administered), but no increased risk was observed following the second dose.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store.
4.9. Overdose
No case of overdose has been reported.
💬 Ask about this leaflet
Ask anything about Shingrix powder and suspension for suspension for injection, Herpes zoster vaccine (recombinant, adjuvanted). The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.