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ActHIB Side Effects

Generic Name: haemophilus b conjugate (prp-t) vaccine

Note: This document contains side effect information about haemophilus b conjugate (prp-t) vaccine. Some of the dosage forms listed on this page may not apply to the brand name ActHIB.

For the Consumer

Applies to haemophilus b conjugate (prp-t) vaccine: intramuscular powder for solution, intramuscular powder for suspension, intramuscular solution

Along with its needed effects, haemophilus b conjugate (prp-t) vaccine (the active ingredient contained in ActHIB) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking haemophilus b conjugate (prp-t) vaccine:

More common Less common
  • Earache
  • redness or swelling in the ear
  • Chest pain
  • chills
  • convulsions (seizures)
  • cough
  • fever over 102 degrees F (39 degrees C)
  • lack or loss of strength
  • shortness of breath
  • sneezing
  • sore throat
  • tightness in the chest
  • troubled breathing
  • wheezing
Incidence not known
  • Bluish lips or skin
  • dizziness
  • fast heartbeat
  • hives
  • itching (especially of the feet or hands)
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • reddening of the skin (especially around the ears)
  • skin rash
  • swelling of the eyes, face, or inside of the nose
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • unusual tiredness or weakness (sudden and severe)

Some side effects of haemophilus b conjugate (prp-t) vaccine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Fever less than 102 degrees F (39 degrees C)
  • irritability
  • redness, pain, swelling, tenderness, or warm feeling at the injection site
  • reduced physical activity
  • restlessness
  • sleepiness
Less common
  • Prolonged crying lasting more than 4 hours
  • unusual high-pitched crying
Incidence not known
  • Hives or welts
  • sleepiness or unusual drowsiness

For Healthcare Professionals

Applies to haemophilus b conjugate (prp-t) vaccine: intramuscular powder for injection


The most common adverse events were pain and redness at the injection site, irritability, drowsiness, fever, loss of appetite, fussiness, and restlessness. Most symptoms occur in the first 48 hours, are mild, and resolve spontaneously.[Ref]


Very common (10% or more): Pain (49.4%), redness (29.4%), tenderness (20%), swelling (18.7%)
Common (1% to 10%): Induration
Very rare (less than 0.01%): Extensive swelling of vaccinated limb, injection site induration[Ref]

Nervous system

Very common (10% or more): Drowsiness (59.9%), decreased activity/lethargy (51.1%), sleepiness (19.9%)
Rare (less than 0.1%): Seizure with apnea, convulsion
Very rare (less than 0.01%): Convulsions (with or without fever), hypotonic-hyporesponsive episode (e.g. sudden onset of hypotonia, hyporesponsiveness, and pallor or cyanosis), somnolence, syncope, vasovagal responses to injection[Ref]


Very common (10% or more): Irritability (70.4%), fussiness (25.9%), restlessness (21.8%)
Common (1% to 10%): Nervousness
Uncommon (0.1% to 1%): Emotional lability, insomnia[Ref]


Very common (10% or more): Inconsolable crying (58.5%), fever (34.8%)
Common (1% to 10%): Otitis media
Uncommon (0.1% to 1%): Asthenia, fatigue, injury
Postmarketing reports: Peripheral edema[Ref]


Very common (10% or more): Loss of appetite (28.7%)[Ref]


Very common (10% or more): Diarrhea (14.6%), vomiting
Common (1% to 10%): Gastroenteritis
Uncommon (0.1% to 1%): Abdominal pain[Ref]


Common (1% to 10%): Rash erythematous
Uncommon (0.1% to 1%): Sweating increased, purpura
Very rare (less than 0.01%): Angioedema, rash, urticaria
Postmarketing reports: Pruritus[Ref]


Common (1% to 10%): Rhinitis, coughing, respiratory disorder, upper respiratory tract infection, bronchitis
Rare (less than 0.1%): Bilateral pneumonia
Very rare (less than 0.01%): Apnea in very premature infants[Ref]


Rare (less than 0.1%): Allergic reactions (including anaphylactic and anaphylactoid reactions)
Postmarketing reports: Other allergic/hypersensitivity reactions (including urticaria, angioedema)[Ref]


Uncommon (0.1% to 1%): Spastic paralysis[Ref]


Common (1% to 10%): Conjunctivitis[Ref]


Common (1% to 10%): Viral infection[Ref]


1. "Product Information. ActHIB (haemophilus b conjugate (PRP-T) vaccine)." sanofi pasteur, Swiftwater, PA.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

4. "Product Information. Hiberix (haemophilus b conjugate (PRP-T) vaccine)." GlaxoSmithKline, Research Triangle Park, NC.

Some side effects of ActHIB may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.