Applies to cefadroxil: oral capsule, oral powder for suspension, oral tablet.

Serious side effects of Cefadroxil

Along with its needed effects, cefadroxil 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 cefadroxil:

Rare

• Black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• blood in the urine or stools
• chills
• clay-colored stools
• cough or hoarseness
• dark-colored urine
• diarrhea
• difficulty with moving
• feeling of discomfort
• fever
• fever with or without chills
• flushing or redness of the skin
• general feeling of tiredness or weakness
• headache
• inflammation of the joints
• itching
• joint or muscle pain
• light-colored stools
• lower back or side pain
• muscle aches
• muscle pain or stiffness
• painful or difficult urination
• pinpoint red spots on the skin
• rash
• red skin lesions, often with a purple center
• red, irritated eyes
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach pain, continuing
• swollen lymph glands
• unusual bleeding or bruising
• unusually warm skin
• vomiting
• yellow eyes or skin

Incidence not known

• Abdominal or stomach cramps or tenderness
• back, leg, or stomach pains
• bloating
• chest pain
• coughing up blood
• diarrhea, watery and severe, which may also be bloody
• difficulty with breathing or swallowing
• dizziness
• fast heartbeat
• general body swelling
• high fever
• hives
• increased menstrual flow or vaginal bleeding
• increased thirst
• itching
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• nausea
• nosebleeds
• pain
• pale skin
• paralysis
• prolonged bleeding from cuts
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• seizures
• shortness of breath
• sudden decrease in the amount of urine
• swollen or painful glands
• tightness in the chest
• unpleasant breath odor
• unusual tiredness or weakness
• unusual weight loss
• vomiting of blood
• wheezing

Other side effects of Cefadroxil

Some side effects of cefadroxil 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:

Rare

• Acid or sour stomach
• belching
• heartburn
• indigestion
• stomach discomfort, upset, or pain

Incidence not known

• Hives or welts
• itching of the vagina or genital area
• itching or pain of the genital area
• pain during sexual intercourse
• redness of the skin
• thick, white vaginal discharge with no odor or with a mild odor

For Healthcare Professionals

Applies to cefadroxil: oral capsule, oral powder for reconstitution, oral tablet.

Gastrointestinal

Mild to life-threatening pseudomembranous colitis has been reported in patients given this drug; this side effect may occur during or after treatment.^[Ref]

Common (1% to 10%): Abdominal discomfort, abdominal pain, diarrhea, dyspepsia, glossitis, nausea, vomiting

Very rare (less than 0.01%): Pseudomembranous colitis

Frequency not reported: Colitis^[Ref]

Dermatologic

Common (1% to 10%): Allergic exanthema, pruritus, rash, urticaria

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

Frequency not reported: Toxic epidermal necrolysis^[Ref]

Immunologic

Uncommon (0.1% to 1%): Opportunistic organism/fungal growth, thrush

Rare (0.01% to 0.1%): Serum sickness, serum sickness-like reactions

Frequency not reported: Superinfection^[Ref]

Genitourinary

Uncommon (0.1% to 1%): Genital candidiasis/genital moniliasis/vaginal mycoses

Rare (0.01% to 0.1%): Genital pruritus, vaginitis^[Ref]

Hematologic

Agranulocytosis, eosinophilia, leukopenia, neutropenia, and/or thrombocytopenia occurred during prolonged treatment, but usually subsided upon discontinuation of treatment.^[Ref]

Rare (0.01% to 0.1%): Agranulocytosis, eosinophilia, leukopenia, moderate transient neutropenia/neutropenia, thrombocytopenia

Very rare (less than 0.01%): Direct/indirect positive Coombs tests, hemolytic anemia (immunologic origin)

Frequency not reported: Aplastic anemia, pancytopenia, prolonged prothrombin time^[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Angioneurotic edema/angioedema

Very rare (less than 0.01%): Anaphylactic shock, immediate allergic reaction

Frequency not reported: Allergies, anaphylaxis^[Ref]

Allergies included anaphylaxis, angioedema, pruritus, rash, and urticaria. Most allergy symptoms subsided upon treatment discontinuation.^[Ref]

Other

Rare (0.01% to 0.1%): Drug fever/fever

Very rare (less than 0.01%): Fatigue^[Ref]

Hepatic

Rare (0.01% to 0.1%): Liver dysfunction

Very rare (less than 0.01%): Cholestasis, idiosyncratic liver failure, minor transaminase elevations (ALT, AST, alkaline phosphatase)

Frequency not reported: Elevated bilirubin^[Ref]

Renal

Rare (0.01% to 0.1%): Interstitial nephritis

Frequency not reported: Increased blood urea nitrogen (BUN), increased creatinine, renal dysfunction, toxic nephropathy^[Ref]

Musculoskeletal

Rare (0.01% to 0.1%): Arthralgia^[Ref]

Nervous system

Very rare (less than 0.01%): Dizziness, headache, sleeplessness

Frequency not reported: Seizures^[Ref]

Metabolic

Frequency not reported: Elevated lactate dehydrogenase (LDH)^[Ref]

Cardiovascular

Frequency not reported: Hemorrhage^[Ref]

Psychiatric

Very rare (less than 0.01%): Nervousness^[Ref]