Pentacel Side Effects

Generic name: diphtheria toxoid / haemophilus b conjugate (prp-t) vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid

Medically reviewed by Drugs.com. Last updated on Nov 6, 2023.

Note: This document contains side effect information about diphtheria toxoid / haemophilus b conjugate (prp-t) vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid. Some dosage forms listed on this page may not apply to the brand name Pentacel.

Applies to diphtheria toxoid / haemophilus b conjugate (prp-t) vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid: intramuscular powder for suspension, intramuscular suspension.

Serious side effects of Pentacel

Along with its needed effects, diphtheria toxoid/haemophilus b conjugate (prp-t) vaccine/pertussis, acellular/poliovirus vaccine, inactivated/tetanus toxoid 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 immediately if any of the following side effects occur while taking diphtheria toxoid / haemophilus b conjugate (prp-t) vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid:

More common

• Chest pain or tightness
• confusion
• coughing
• crying, persistent and inconsolable, occurring within 48 hours and lasting 3 or more hours
• decreased urination
• diarrhea
• dizziness
• dry mouth
• fainting
• fever
• increase in heart rate
• lightheadedness
• loss of appetite
• nausea
• noisy, rapid, or trouble breathing
• sneezing
• sore throat
• stomach pain
• sunken eyes
• thirst
• unusual tiredness or weakness
• wrinkled skin

Incidence not known

• Bluish color of the fingernails, lips, skin, palms, or nail beds
• chills
• cold or flu-like symptoms
• drowsiness
• fainting
• fast heartbeat
• general feeling of illness
• hives
• hoarseness
• irritation
• itching
• joint pain, stiffness, or swelling
• rash
• redness of the skin
• runny nose
• severe headache
• slow breathing
• sneezing
• stiff neck or back
• stuffy nose
• swelling of the eyelids, face, lips, hands, or feet

Other side effects of Pentacel

Some side effects of diphtheria toxoid / haemophilus b conjugate (prp-t) vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid 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

• Irritability
• tenderness at the injection site
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Incidence not known

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• change in skin color at the injection site
• paleness of the skin
• sleepiness or unusual drowsiness
• vomiting

For Healthcare Professionals

Applies to diphtheria toxoid / haemophilus b conjugate (prp-t) vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid: intramuscular kit.

Psychiatric

Very common (10% or more): Fussiness/irritability (76.9%)

Postmarketing reports: Screaming

Other

Very common (10% or more): Inconsolable crying (59.3%), fever (16.3%)

Rare (less than 0.1%): Death

Postmarketing reports: Vaccination failure/therapeutic response decreased^[Ref]

Four deaths occurred in the clinical trials. Causes of death were asphyxia due to suffocation, head trauma, Sudden Infant Death Syndrome, and neuroblastoma which occurred at 8, 23, 52, and 256 days post-vaccination respectively.^[Ref]

Nervous system

Very common (10% or more): Decreased activity/lethargy (45.8%)

Rare (less than 0.1%): Seizures, encephalopathy

Frequency not reported: Hypotonia^[Ref]

Four patients experienced a seizure within 7 days of vaccination. One case of encephalopathy occurred 30 days post-vaccination and was secondary to cardiac arrest after cardiac surgery.^[Ref]

Local

Very common (10% or more): Injection site tenderness (56.1%), increase in arm circumference (33.6%), injection site redness (17.3%)

Common (1% to 10%): Injection site swelling

Postmarketing reports: Injection site reactions (including inflammation, mass, abscess, sterile abscess), extensive swelling of the injected limb (including swelling involving adjacent joints)^[Ref]

Hypersensitivity

Postmarketing reports: Anaphylaxis/anaphylactic reaction, hypersensitivity (such as rash and urticaria)^[Ref]

Respiratory

Frequency not reported: Asthma

Postmarketing reports: Apnea, cough^[Ref]

Asthma was a serious adverse event that occurred within 30 days following the 4th dose of vaccine.^[Ref]

Immunologic

Frequency not reported: Bronchiolitis, gastroenteritis, pneumonia

Postmarketing reports: Meningitis, rhinitis, viral infection^[Ref]

Bronchiolitis, gastroenteritis, and pneumonia were serious adverse events that occurred within 30 days following the 4th dose of vaccine.^[Ref]

Cardiovascular

Postmarketing reports: Cyanosis, pallor^[Ref]

Dermatologic

Postmarketing reports: Erythema, skin discoloration^[Ref]

Metabolic

Postmarketing reports: Decreased appetite^[Ref]

Gastrointestinal

Postmarketing reports: Vomiting, diarrhea^[Ref]

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer