Applies to diphtheria toxoid / pertussis, acellular / tetanus toxoid: intramuscular suspension.

Serious side effects

Along with its needed effects, diphtheria toxoid/pertussis, acellular/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 or nurse immediately if any of the following side effects occur while taking diphtheria toxoid/pertussis, acellular/tetanus toxoid:

Less common

• Crying for 3 or more hours
• fainting

Rare

• Blurred vision
• confusion
• difficulty with breathing or swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fever of 102.2 degrees F or more
• headache (severe or continuing)
• hives or welts
• itching, especially of the feet or hands
• reddening of the skin, especially around the ears
• seizures
• sleepiness (unusual and continuing)
• sweating
• swelling of the eyes, face, or inside of the nose
• unusual tiredness or weakness (sudden and severe)
• vomiting (severe or continuing)

Incidence not known

• Blood in the urine
• bloody or black, tarry stools
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain, discomfort, or tightness
• chills
• cough
• dizziness
• dry mouth
• fast heartbeat
• flushed, dry skin
• fruit-like breath odor
• inability to move the arms and legs
• increased hunger
• increased thirst
• increased urination
• large, flat, blue or purplish patches on the skin
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• loss of consciousness
• muscle pain or spasms
• nausea
• painful knees and ankles
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness and swelling on the skin, buttocks, legs, or ankles
• skin rash
• stiff neck
• stomach pain
• sudden numbness and weakness in the arms and legs
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• unexplained weight loss

Other side effects

Some side effects of diphtheria toxoid / pertussis, acellular / 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

• Body aches
• diarrhea
• fever of 99.5 degrees F or more
• redness, swelling, tenderness, pain, or a lump at the injection of site
• tiredness

Incidence not known

• Back pain
• injection site bruising
• muscle or joint pain
• weakness of the muscles in the face

For Healthcare Professionals

Applies to diphtheria toxoid / pertussis, acellular / tetanus toxoid: intramuscular suspension.

General

The most common adverse event was pain at the injection site.^[Ref]

Local

Very common (10% or more): Injection site pain (87.1%), injection site erythema (24.7%), injection site swelling (21%)

Postmarketing reports: Large (over 50 mm) injection site reactions, extensive limb swelling from the injection site beyond one or both joints, injection site bruising, sterile abscess^[Ref]

Nervous system

Very common (10% or more): Headache (43.7%),

Frequency not reported: Severe migraine with unilateral facial paralysis, nerve compression in neck and left arm

Postmarketing reports: Paresthesia, hypoesthesia, Guillain-Barre syndrome, brachial neuritis, facial palsy, convulsion, syncope, myelitis^[Ref]

Musculoskeletal

Very common (10% or more): Body ache or muscle weakness (30.4%), chills (15.1%), sore and swollen joints (11.3%)

Common (1% to 10%): Myalgia

Postmarketing reports: Myositis, muscle spasm^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (13.3%), diarrhea (10.3%)

Common (1% to 10%): Vomiting^[Ref]

Hypersensitivity

Postmarketing reports: Anaphylactic reaction, hypersensitivity reaction (angioedema, edema, rash, hypotension), Arthus hypersensitivity^[Ref]

Other

Very common (10% or more): Tiredness (30.2%), chills (15.1%)

Common (1% to 10%): Fever, malaise^[Ref]

Dermatologic

Common (1% to 10%): Rash

Postmarketing reports: Pruritus, urticaria^[Ref]

Cardiovascular

Postmarketing reports: Myocarditis^[Ref]

Hematologic

Common (1% to 10%): Lymph node swelling^[Ref]