Adacel

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 Adacel. If you are concerned about side effects, discuss the risks and benefits of Adacel with your doctor.

The following side effects have been reported by at least 1% of people taking Adacel. 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.

• Diarrhea
• dizziness
• loss of appetite
• lump at place of injection
• mild fever
• nausea
• redness, swelling, tenderness, or pain at place of injection

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

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

• confusion
• severe headache
• severe or continuing vomiting
• unusual irritability
• unusual sleepiness

Seek immediate medical attention if any of the following occur:

• collapse
• convulsions (seizures)
• crying for 3 or more hours
• periods of unconsciousness or lack of awareness
• severe fever (fever of 105°F [40.5°C] or more)
• symptoms of a serious allergic reaction (such as Hives, difficulty breathing, itchy rash on the hands or feet, or swelling of the face or throat)

Be sure to mention any side effect to your doctor, as it may mean that you are allergic to the vaccine. If so, it would not be safe for you to have more doses of the same type of vaccine.

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 Adacel.

Each dose (0.5 mL) of a sterile, uniform, cloudy, white suspension contains tetanus toxoid 5 Lf , diphtheria toxoid 2 Lf , pertussis toxoid (PT) 2.5 µg, filamentous haemagglutinin (FHA) 5 µg, pertactin (PRN) 3 µg, fimbriae types 2 and 3 (FIM) 5 µg, aluminum phosphate (adjuvant) 1.5 mg, and 0.6% (v/v) 2-phenoxyethanol. Manufacturing process residuals: formaldehyde and glutaraldehyde are present in trace amounts.

Do not use this vaccine if you:

• are allergic to any ingredients of Adacel
• had a previous encephalopathy (a condition affecting the brain) within 7 days of a previous pertussis vaccine
• had a previous episode of thrombocytopenia (decrease in platelets) or neurologic complication following a previous diphtheria and/or tetanus vaccine
• have an acute illness (except for minor illnesses without Fever, such as an upper respiratory tract infection)
• have had an allergic reaction to other tetanus, diphtheria, or pertussis vaccines

There may be an interaction between the pertussis - diphtheria - tetanus vaccine and any of the following:

• Acetaminophen
• immunosuppressive therapy (e.g., some medications used for the treatment of cancer, or for transplant recipients, or immune conditions)
• Azathioprine
• corticosteroids (e.g., budesonide, Dexamethasone, Hydrocortisone, fluticasone, Prednisone)
• Cyclosporine
• Fingolimod
• Glatiramer
• Hydroxyurea
• Imiquimod
• medications to treat cancer (e.g., Carboplatin, Cyclophosphamide, Doxorubicin, Ifosfamide, Vincristine)
• momoclonal antibodies (e.g., Belimumab, eculizumab, Golimumab, Infliximab)
• mycophenolate
• Tacrolimus
• Tofacitinib
• other vaccines
• Warfarin

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 Adacel. 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 Adacel.

Allergic reactions: Rarely, this vaccine may cause severe allergic reactions. For this reason, doctors often ask you to stay in the office for about 30 minutes after having the vaccine so that you can get medical care if you have an allergic reaction. If you notice the signs of a Anaphylaxis (severe allergic reaction) (hives; trouble breathing or swallowing; or swelling of the lips, face, throat, or tongue), get medical attention immediately.

Immune system: As with any vaccine, this vaccine may not be as effective for people with a weakened immune system (such as those who are on chemotherapy, who have had an organ transplant, or who have HIV).

Medical conditions: If you bruise easily, have a neurological disorder, have a bleeding problem, have a high fever, have poorly controlled Epilepsy, have had an allergic reaction to other vaccines, or have a family history of seizures, discuss with your doctor how Adacel may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Adacel, and whether any special monitoring is needed.

Vaccine protection: As with any vaccine, this vaccine may not protect 100% of people who receive it.

Pregnancy: This vaccine should not be used during pregnancy unless the benefits outweigh the risks. If you discover you may have been pregnant when you received Adacel, contact your doctor immediately.

Breast-feeding: It is not known if this vaccine passes into breast milk. If you are a breast-feeding mother and are taking Adacel, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.