For the Consumer

Applies to ceftazidime: injection powder for solution

Along with its needed effects, ceftazidime 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 ceftazidime:

Less common

• Abdominal or stomach cramps or tenderness
• bloating
• bluish color
• changes in skin color
• diarrhea, watery and severe, which may also be bloody
• fever
• increased thirst
• itching of the vagina or genital area
• nausea or vomiting
• pain
• pain during sexual intercourse
• swelling at the site of injection
• swelling of the foot or leg
• tenderness
• thick, white vaginal discharge with no odor or with a mild odor
• unusual tiredness or weakness
• unusual weight loss
• white patches in the mouth or throat or on the tongue
• white patches with diaper rash

Rare

• Back, leg, or stomach pains
• bleeding gums
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chills
• cough
• dark urine
• difficulty with breathing
• difficulty with swallowing
• dizziness
• fast heartbeat
• general body swelling
• headache
• hives
• itching
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• nosebleeds
• pale skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• shortness of breath
• skin rash
• sore throat
• tightness in the chest
• wheezing
• yellowing of the eyes or skin

Incidence not known

• Agitation
• bloody or cloudy urine
• blurred vision
• change in consciousness
• chest pain
• clay-colored stools
• confusion
• coughing up blood
• decreased frequency or amount of urine
• diarrhea
• difficult or painful urination
• drowsiness
• hallucinations
• increased blood pressure
• increased menstrual flow or vaginal bleeding
• increased thirst
• irritability
• loss of consciousness
• lower back or side pain
• muscle twitching or jerking
• nosebleeds
• paralysis
• prolonged bleeding from cuts
• red or black, tarry stools
• red or dark brown urine
• rhythmic movement of the muscles
• seizures
• sores, ulcers, or white spots on the lips or in the mouth
• stiff neck
• sudden decrease in the amount of urine
• swelling of the face, fingers, or lower legs
• swollen or painful glands
• troubled breathing
• unpleasant breath odor
• unusual bleeding or bruising
• vomiting of blood
• watery or bloody diarrhea
• weight gain

Some side effects of ceftazidime 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

• Red streaks on the skin
• swelling, tenderness, or pain at the injection site

For Healthcare Professionals

Applies to ceftazidime: injectable powder for injection, intravenous powder for injection, intravenous solution

Hepatic

Common (1% to 10%): Transient elevations in 1 or more liver enzymes (alkaline dehydrogenase, ALT, AST, GGT)

Very rare (less than 0.01%): Jaundice

Postmarketing reports: Cholestasis, hyperbilirubinemia, liver dysfunction

Local

Common (1% to 10%): Inflammation, pain, phlebitis, thrombophlebitis

Frequency not reported: Superficial desquamation around injection site

Inflammation and pain occurred after IM administration.

Phlebitis and thrombophlebitis occurred with IV administration.

Hematologic

Approximately 5% of patients developed a positive Coombs test.

Common (1% to 10%): Eosinophilia, positive Coombs test, thrombocytosis

Uncommon (0.1% to 1%): Leukopenia, neutropenia, thrombocytopenia

Frequency not reported: Agranulocytosis, hemolytic anemia, lymphocytosis, positive Coombs test without hemolysis

Postmarketing reports: Aplastic anemia, pancytopenia, prothrombin time prolonged

Dermatologic

Common (1% to 10%): Maculopapular rash, rash, urticarial rash

Uncommon (0.1% to 1%): Pruritus

Very rare (less than 0.01%): Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis

Frequency not reported: Drug reaction with eosinophilia and systemic symptoms (DRESS)

Postmarketing reports: Urticaria

Gastrointestinal

Pseudomembranous colitis may have been presented as diarrhea or colitis.

Common (1% to 10%): Diarrhea

Uncommon (0.1% to 1%): Abdominal pain, antibacterial agent-associated colitis/diarrhea, colitis, nausea, vomiting

Frequency not reported: Pseudomembranous colitis

Metabolic

Common (1% to 10%): Transient elevations in LDH

Postmarketing reports: False-positive test for urinary glucose

Renal

Uncommon (0.1% to 1%): Transient elevations of blood urea/blood urea nitrogen (BUN)/serum creatinine

Very rare (less than 0.01%): Acute renal failure, interstitial nephritis

Postmarketing reports: Renal dysfunction, toxic nephropathy

Nervous system

Neurological sequelae occurred in patients with renal dysfunction who did not receive appropriate dose adjustments and included coma, convulsions, encephalopathy, myoclonia, and tremor.

Uncommon (0.1% to 1%): Dizziness, headache

Very rare (less than 0.01%): Bad taste, paresthesia,

Frequency not reported: Asterixis, coma, convulsions, encephalopathy, myoclonia, neurological sequelae, neuromuscular excitability, seizures, tremor

Immunologic

Uncommon (0.1% to 1%): Candidiasis, oral thrush

Genitourinary

Uncommon (0.1% to 1%): Vaginitis

Other

Uncommon (0.1% to 1%): Fever

Hypersensitivity

Very rare (less than 0.01%): Anaphylaxis, angioedema

Postmarketing reports: Allergic reactions

Anaphylaxis included bronchospasm, cardiopulmonary arrest, and/or hypotension.

Cardiovascular

Very rare (less than 0.01%): Hypotension

Frequency not reported: Hot flushes

Postmarketing reports: Cardiopulmonary arrest, hemorrhage

Respiratory

Very rare (less than 0.01%): Bronchospasm