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Prohibit Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Prohibit in Detail - Patient Information: Side Effects
Getting haemophilus influenzae disease is much riskier than getting Hib vaccine. However, a vaccine, like any medicine, is capable of causing serious problems, such as severe allergic reactions. The risk of Hib vaccine causing serious harm, or death, is extremely small.
Seek emergency medical attention or contact your doctor immediately if any of the following rare but serious side effects from Hib vaccine are experienced:
- a serious allergic reaction including swelling of the lips, tongue, or face; difficulty breathing; closing of the throat; hives; paleness; weakness; dizziness; or a fast heart beat within a few minutes to a few hours after the shot;
- high fever; or
- behavior changes.
Other less serious side effects may be more likely to occur. Talk to your doctor if you experience:
- fever over 101 degrees Fahrenheit (about up to 1 child in 20); or
- redness, warmth, or swelling where the shot was given (up to about 1 child in 4).
If these problems happen, they usually start within a day of vaccination. They may last 2-3 days.
Your doctor may recommend reducing fever and pain by giving the child an aspirin-free pain reliever such as acetaminophen (Tylenol, Tempra, others) or ibuprofen (Motrin, Advil, others) when the shot is given and for the next 24 hours. Your healthcare provider can tell you the appropriate dosages of these medications..
Side effects other than those listed here may also occur. Contact your doctor about any side effect that seems unusual or that is especially bothersome.
Read the entire detailed patient monograph for Prohibit (Haemophilus b Conjugate Vaccine) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Prohibit FDA Prescribing Information: Side Effects
When ProHIBiT (haemophilus b conjugate vaccine) ® alone was given to over 1,000 adults and children, no serious adverse reactions were observed.15,20,25,34 Thrombocytopenia was seen in one adult but a causative relationship was not established.
When ProHIBiT (haemophilus b conjugate vaccine) ® was given with DTP and Inactivated Poliovirus Vaccine (IPV) to 55,000 Finnish children, the rate and extent of serious adverse reactions were not different from those seen when DTP or IPV were administered alone.25,35 Allergic reactions such as urticaria were infrequently observed.15,35
Adverse reactions following vaccination with ProHIBiT (haemophilus b conjugate vaccine) ® (without DTP) in subjects 15 to 24 months of age are summarized in Table 6.34
TABLE 634: Percentage of Subjects 15 to 24 Months
of Age Developing Local or Systemic Reactions to One Dose of Haemophilus b Conjugate
Vaccine (Diphtheria Toxoid-Conjugate)
|No. of Subjects*||6 Hours||Reaction 24 Hours||48 Hours|
|Fever > 38.3°C||281||1.1||2.1||1.8|
|* Not all subjects had measurements at all time periods.|
Other adverse reactions temporally associated with administration of ProHIBiT (haemophilus b conjugate vaccine) ® including diarrhea, vomiting, and crying were reported at a frequency of ≤ 1.2%. Fever of 39°C or more occurred in < 1%, while irritability, sleepiness, or anorexia were reported in 16.1%.34
Adverse reactions in clinical evaluations among 689 children, 7 to 14 months of age, 24 hours after receiving a single dose of ProHIBiT (haemophilus b conjugate vaccine) ® , were observed and compared to 139 children who received a saline placebo. There were no significant differences in the reaction rates for fever, erythema, induration, and tenderness between the two groups.15
A post-marketing surveillance study was conducted between April 1988 and July 1989 in the United States in 50,007 children 16 to 60 months of age. At Southern California Kaiser Permanente, 29,309 of these children were followed closely to determine the number of systemic and local reactions occurring within 6, 24, and 48 hours post-vaccination with ProHIBiT (haemophilus b conjugate vaccine) ® alone. These reactions are summarized in Table 7.15
TABLE 715: Post-Marketing Surveillance Study in
Subjects 16-60 Months of Age Experiencing Adverse Reactions (n=29,309)
|6 Hours||Reaction % 24 Hours||48 Hours|
|Fever > 38.9°C||2||2||2|
In 50 children who had received licensed Haemophilis b Conjugate Vaccine in infancy and a booster dose of ProHIBiT (haemophilus b conjugate vaccine) ® at 12 months of age, the adverse experience profile was similar as summarized in Table 8.15
TABLE 815: Adverse Experiences with ProHIBiT (haemophilus b conjugate vaccine) ®
given as a Booster at 12 to 15 Months of Age Primary Series either with Haemophilus
b Conjugate Vaccine (Diphtheria CRM197Protein Conjugate) or Haemophilus
b Conjugate Vaccine (Meningococcal Protein Conjugate) (n=50)
|6 Hours||Reaction % 24 Hours||48 Hours|
|Fever > 38.9°C||0||0||2|
Other adverse reactions reported with administration of ProHIBiT (haemophilus b conjugate vaccine) ® included urticaria, seizure, and renal failure.15,34 Guillain-Barré syndrome (GBS) rarely has been reported.36 However, a cause and effect relationship for these adverse events has not been established.
Reporting of Adverse Events
Reporting by parents or guardians of all adverse events occurring after vaccine administration should be encouraged. Adverse events following immunization with vaccine should be reported by the health-care provider to the US Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS). Reporting forms and information about reporting requirements or completion of the form can be obtained from VAERS through a toll-free number 1-800-822-7967.32,33,37
Health-care providers also should report these events to the Director of Medical Affairs, Connaught Laboratories, Inc., a Pasteur Mérieux Connaught Company, Route 611, P. O. Box 187, Swiftwater, PA 18370 or call 1-800-822-2463.
Read the entire FDA prescribing information for Prohibit (Haemophilus b Conjugate Vaccine) »
Additional Prohibit Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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