Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Bexsero (Meningococcal-vaccine). If you are concerned about side effects, discuss the risks and benefits of Bexsero (Meningococcal-vaccine) with your doctor.

The following side effects have been reported by at least 1% of people taking Bexsero (Meningococcal-vaccine). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• appetite changes (infants and young children)
• Diarrhea (infants and young children)
• drowsiness
• dry, itchy skin
• Fever
• general feeling of being unwell
• headache
• joint pain
• irritability (infants and young children)
• limb pain in the arm or leg at the place of injection
• muscle aches
• nausea
• pain, warmth, redness, tenderness, swelling, hardening at the place of injection
• sleepiness (infants)
• vomiting (infants)

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• feeling faint or fainting
• high fever (over 40°C)
• rash
• shortness of breath or difficulty breathing
• signs of an allergic reaction (e.g., rash, itching or Hives)
• unusual or persistent crying (infants)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• seizures or convulsions
• signs of a serious allergic reaction (shortness of breath; wheezing; trouble breathing; hives; swelling of the lips, tongue, or throat)
• signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
• collapse (e.g., sudden onset of muscle floppiness, lack of awareness and paleness or bluish skin in young children)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Bexsero (Meningococcal-vaccine).

Each 0.5 mL of white opalescent suspension contains 175 µg of multicomponent N. meningitidis serogroup B protein adsorbed to aluminum hydroxide. Nonmedicinal ingredients: histidine, sodium chloride, sucrose and water for injection. Supplied in a 0.5 mL pre-filled syringe. Syringe tip cap may contain natural rubber latex.

Do not use Bexsero (Meningococcal-vaccine) if you are allergic to meningococcal vaccine or any ingredients of Bexsero (Meningococcal-vaccine).

There may be an interaction between meningococcal vaccine (group B) and any of the following:

• acetaminophen
• immunosuppressants
• Adalimumab
• Azathioprine
• Belimumab
• corticosteroids (e.g., budesonide, Dexamethasone, Hydrocortisone, fluticasone, Prednisone)
• Cyclosporine
• eculizumab
• Etanercept
• Everolimus
• Fingolimod
• Golimumab
• Hydroxyurea
• Leflunomide
• Infliximab
• medications to treat cancer (e.g., Carboplatin, Cyclophosphamide, Doxorubicin, Ifosfamide, Vincristine)
• Methotrexate
• Obinutuzumab
• Ozanimod
• Rituximab
• Sirolimus
• Tacrolimus
• Tocilizumab
• non-steroidal anti-inflammatory medications (NSAIDs; e.g., Diclofenac, ibuprofen, Naproxen)
• other vaccines

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Bexsero (Meningococcal-vaccine). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Bexsero (Meningococcal-vaccine).

Allergies: This vaccine contains a small amount of the antibiotic kanamycin. If you or your child have an allergy to kanamycin, talk to your doctor before receiving the injection.

Bleeding problems: There is a risk of increased bleeding or bruising when any intramuscular injection is given to a person who has a bleeding disorder or is taking medications to thin the blood. The safety and effectiveness of this vaccine have not been established for people with thrombocytopenia (low platelets) or bleeding disorders. If you have these conditions, discuss the risks and benefits of this vaccine with your doctor.

Breathing problems: When given to very premature babies, there is the risk that the vaccine may cause problems breathing, such as the infant temporarily stopping breathing. There is also a significant benefit to giving this vaccine to very premature babies. Discuss the risks and benefits with your doctor and whether any special monitoring is needed.

Fever: A doctor may decide to delay this vaccine if the person receiving the vaccine has an acute infection or fever. Mild infections without fever, such as colds, usually do not require delay of the vaccine.

Immune problems: When used for people with impaired immune systems, meningococcal vaccines may not create enough of an antibody response to protect against infections caused by these bacteria. Also, this vaccine may not be effective for people receiving immunosuppressive therapy (e.g., some medications used to treat cancer or for transplant recipients).

Pre-medication: Your doctor may suggest that infants and children receive antifever medications (e.g., Acetaminophen, Ibuprofen) before or after receiving the vaccine. Follow the instructions given by your doctor.

Protection: This vaccine can only protect against the types of bacteria specific to this vaccine and, as with other vaccines, may not provide 100% protection for everyone who receives the vaccine.

Pregnancy: This vaccine should only be used during pregnancy if the benefits outweigh the risks. If you discover you were pregnant when you received this vaccine, contact your doctor as soon as possible.

Breast-feeding: It is not known if meningococcal vaccine (group B) passes into breast milk. If you are a breast-feeding mother and may be given this vaccine, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding or wait until you have stopped breast-feeding to receive the vaccine.

Children: The safety and effectiveness of this vaccine have not been established for infants under the age of 2 months.

Adults: The safety and effectiveness of this vaccine have not been established for adults over the age of 50.