Applies to cefaclor: oral capsules, oral extended-release tablets, oral for suspension.
Side effects include:
Diarrhea, genital pruritus or vaginitis, headache, nausea, vomiting, rash.
For Healthcare Professionals
Applies to cefaclor: oral capsule, oral powder for reconstitution, oral tablet chewable, oral tablet extended release.
General
ER TABLETS: The most commonly reported side effects included headache, rhinitis, diarrhea, and nausea.
IR CAPSULES: The most commonly reported side effects included abdominal pain, diarrhea, morbilliform eruptions, and hypersensitivity reactions.
CR/MR TABLETS: The most commonly reported side effects included headache, diarrhea, nausea, and vaginal moniliasis.
ORAL SUSPENSION: The most commonly reported side effects included diarrhea and hypersensitivity reactions.[Ref]
Gastrointestinal
ER TABLETS:
Common (1% to 10%): Abdominal pain, diarrhea, nausea
Uncommon (0.1% to 1%): Constipation, dyspepsia, flatulence, gastritis, nausea and vomiting, vomiting
Postmarketing reports: Pseudomembranous colitis symptoms
IR CAPSULES:
Common (1% to 10%): Diarrhea
Rare (0.01% to 0.1%): Nausea, vomiting
Frequency not reported: Abdominal pain, colitis, pseudomembranous colitis
CR/MR TABLETS:
Common (1% to 10%): Abdominal pain, diarrhea, nausea
Frequency not reported: Colitis, dyspepsia, pseudomembranous colitis, vomiting
ORAL SUSPENSION:
Common (1% to 10%): Diarrhea, gastrointestinal symptoms
Rare (0.01% to 0.1%): Colitis, pseudomembranous colitis, nausea, vomiting
Frequency not reported: Abdominal pain[Ref]
Dermatologic
ER TABLETS:
Common (1% to 10%): Pruritus
Uncommon (0.1% to 1%): Maculopapular rash, rash, sweating, urticaria
Frequency not reported: Erythema multiforme
Postmarketing reports: Face edema, Stevens-Johnson syndrome, toxic epidermal necrolysis
IR CAPSULES:
Common (1% to 10%): Morbilliform eruption
Very rare (less than 0.01%): Pruritus, urticaria
Frequency not reported: Erythema multiforme, face edema, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis
CR/MR TABLETS:
Common (1% to 10%): Pruritus, rash, urticaria
Frequency not reported: Erythema multiforme, erythema multiforme minor, face edema, morbilliform eruptions, Stevens-Johnson syndrome, toxic epidermal necrolysis
ORAL SUSPENSION:
Common (1% to 10%): Morbilliform eruptions
Uncommon (0.1% to 1%): Erythema multiforme, pruritus, rash, urticaria
Rare (0.01% to 0.1%): Erythema multiforme major, Stevens-Johnson syndrome, toxic epidermal necrolysis
Frequency not reported: Erythema multiforme minor, face edema[Ref]
Genitourinary
ER TABLETS:
Common (1% to 10%): Vaginal moniliasis, vaginitis
Uncommon (0.1% to 1%): Dysmenorrhea, dysuria, leukorrhea, menstrual disorder, nocturia
Postmarketing reports: Abnormal urinalysis, genital pruritus
IR CAPSULES:
Frequency not reported: Abnormal urinalysis, false positive test for urinary glucose, genital pruritus, vaginal moniliasis, vaginitis
CR/MR TABLETS:
Common (1% to 10%): Vaginal moniliasis, vaginitis
Frequency not reported: Abnormal urinalysis, genital pruritus, hematuria, proteinuria, pyuria
ORAL SUSPENSION:
Frequency not reported: Abnormal urinalysis, false positive test for urinary glucose, genital pruritus, hematuria, proteinuria, pyuria, vaginal moniliasis, vaginitis[Ref]
Respiratory
ER TABLETS:
Common (1% to 10%): Cough increased, pharyngitis, rhinitis
Uncommon (0.1% to 1%): Asthma, bronchitis, lung disorder, respiratory disorder, sinusitis
IR CAPSULES:
Frequency not reported: Dyspnea
CR/MR TABLETS:
Common (1% to 10%): Epistaxis
Frequency not reported: Dyspnea
ORAL SUSPENSION:
Frequency not reported: Dyspnea[Ref]
Hypersensitivity
Anaphylaxis may occur more frequently in patients with a history of penicillin allergy.
Hypersensitivity reaction symptoms may persist for several months.
Serum-sickness-like reactions were more frequently reported in pediatric patients and after a second/subsequent course of treatment; reactions have been characterized by arthritis/arthralgia, erythema multiforme, and rash with or without fever.[Ref]
ER TABLETS:
Uncommon (0.1% to 1%): Serum sickness-like reaction
Frequency not reported: Hypersensitivity reactions, severe hypersensitivity reactions
Postmarketing reports: Allergic reaction, anaphylactoid events, anaphylaxis, angioedema
IR CAPSULES:
Common (1% to 10%): Hypersensitivity reactions
Uncommon (0.1% to 1%): Serum sickness-like reaction
Frequency not reported: Anaphylactoid events, anaphylaxis, angioedema, severe hypersensitivity reactions
CR/MR TABLETS:
Rare (0.01% to 0.1%): Serum sickness-like reaction
Frequency not reported: Allergic reactions, anaphylactoid events, anaphylaxis, angioedema, severe hypersensitivity reactions
ORAL SUSPENSION:
Common (1% to 10%): Hypersensitivity reactions
Uncommon (0.1% to 1%): Serum sickness-like reactions
Rare (0.01% to 0.1%): Anaphylaxis, angioedema
Frequency not reported: Anaphylactoid events[Ref]
Musculoskeletal
ER TABLETS:
Common (1% to 10%): Back pain
Uncommon (0.1% to 1%): Arthralgia, creatine phosphokinase increased, myalgia, neck pain, somnolence
Frequency not reported: Arthritis
IR CAPSULES:
Frequency not reported: Arthralgia, arthritis
CR/MR TABLETS:
Frequency not reported: Arthralgia, arthritis
ORAL SUSPENSION:
Frequency not reported: Arthralgia, arthritis[Ref]
Nervous system
ER TABLETS:
Common (1% to 10%): Headache
Uncommon (0.1% to 1%): Dizziness, somnolence, tremor
Postmarketing reports: Hypertonia, paresthesia, reversible hyperactivity, syncope, vertigo
IR CAPSULES:
Rare (0.01% to 0.1%): Dizziness, hypertonia, reversible hyperactivity, somnolence
Frequency not reported: Paresthesia, seizures, syncope
CR/MR TABLETS:
Common (1% to 10%): Headache
Frequency not reported: Dizziness, hypertonia, paresthesia, reversible hyperactivity, seizures, somnolence, syncope
ORAL SUSPENSION:
Rare (0.01% to 0.1%): Dizziness, hypertonia, reversible hyperactivity, somnolence
Frequency not reported: Paresthesia, seizures, syncope[Ref]
Hematologic
Increased prothrombin time with/without clinical bleeding was reported in patients given IR capsules and warfarin concurrently.
Transient fluctuations in leukocyte count most commonly occurred in infants and young children.[Ref]
ER TABLETS:
Uncommon (0.1% to 1%): Eosinophils increased, erythrocyte count decreased, hemoglobin decreased, lymphocytes decreased, mean cell volume (MCV) increased, neutrophils segmented decreased, platelet count decreased
Postmarketing reports: Eosinophilia, hemolytic anemia, leukopenia, neutropenia, positive direct Coombs test, transient thrombocytopenia
IR CAPSULES:
Rare (0.01% to 0.1%): Agranulocytosis, aplastic anemia, hemolytic anemia, reversible neutropenia (may be of clinical significance), thrombocytopenia
Very rare (less than 0.01%): Positive Coombs test
Frequency not reported: Eosinophilia, pancytopenia, transient leukopenia, transient lymphocytosis
Postmarketing reports: Increased prothrombin time with/without clinical bleeding
CR/MR TABLETS:
Frequency not reported: Agranulocytosis, aplastic anemia, eosinophilia, hemolytic anemia, increased prothrombin time with/without clinical bleeding, leukopenia, lymphadenopathy, lymphocytosis, neutropenia (may be of clinical significance), positive direct Coombs test, transient fluctuations in leukocyte count, transient thrombocytopenia
ORAL SUSPENSION:
Uncommon (0.1% to 1%): Positive Coombs test
Rare (0.01% to 0.1%): Agranulocytosis, aplastic anemia, hemolytic anemia, reversible neutropenia (may be of clinical significance), thrombocytosis, thrombocytopenia
Frequency not reported: Eosinophilia, leukopenia, lymphadenopathy, pancytopenia, transient fluctuations in leukocyte count, transient lymphocytosis
Postmarketing reports: Increased prothrombin time with/without clinical bleeding[Ref]
Other
ER TABLETS:
Uncommon (0.1% to 1%): Accidental injury, chills, ear pain, fever, malaise, otitis media, pain, surgical procedure
IR CAPSULES:
Frequency not reported: Asthenia, fever
CR/MR TABLETS:
Common (1% to 10%): Asthenia, pain
Frequency not reported: Fever
ORAL SUSPENSION:
Rare (0.01% to 0.1%): Fever
Frequency not reported: Asthenia[Ref]
Metabolic
ER TABLETS:
Uncommon (0.1% to 1%): Albumin decreased, anorexia, calcium increased, phosphorus increased, potassium increased, sodium decreased/increased[Ref]
Cardiovascular
EXTENDED RELEASE (ER) TABLETS:
Uncommon (0.1% to 1%): Chest pain, congestive heart failure, edema, palpitation, peripheral edema
Postmarketing reports: Hypotension, limb edema, vasodilation
IMMEDIATE RELEASE (IR) CAPSULES:
Frequency not reported: Hemorrhage, hypotension, limb edema, vasodilation
MODIFIED RELEASE (CR/MR) TABLETS:
Frequency not reported: Limb edema, vasodilation
ORAL SUSPENSION:
Frequency not reported: Hemorrhage, hypotension, limb edema, vasodilation[Ref]
Hepatic
ER TABLETS:
Uncommon (0.1% to 1%): Alkaline phosphatase increased, ALT increased, GGT increased, total bilirubin increased
Postmarketing reports: Cholestasis, liver dysfunction, transient AST elevation
IR CAPSULES:
Rare (0.01% to 0.1%): Cholestatic jaundice, transient hepatitis
Frequency not reported: Elevated bilirubin, elevated LDH, slight alkaline phosphatase elevations, slight ALT elevations, slight AST elevations
CR/MR TABLETS:
Frequency not reported: Cholestasis, cholestatic jaundice, liver dysfunction, transient alkaline phosphatase elevations, transient ALT elevations, transient AST elevations, transient hepatitis
ORAL SUSPENSION:
Rare (0.01% to 0.1%): Cholestatic jaundice, liver dysfunction, transient hepatitis
Frequency not reported: Elevated bilirubin, elevated LDH, slight alkaline phosphatase elevations, slight ALT elevations, slight AST elevations[Ref]
Psychiatric
ER TABLETS:
Uncommon (0.1% to 1%): Anxiety, insomnia, nervousness
Postmarketing reports: Confusion
IR CAPSULES:
Rare (0.01% to 0.1%): Agitation, confusion, hallucinations, insomnia, nervousness
CR/MR TABLETS:
Frequency not reported: Agitation, confusion, hallucinations, insomnia, nervousness
ORAL SUSPENSION:
Rare (0.01% to 0.1%): Agitation, confusion, hallucinations, insomnia, nervousness[Ref]
Renal
ER TABLETS:
Uncommon (0.1% to 1%): Blood urea nitrogen (BUN) increased, creatinine increased
Postmarketing reports: Reversible interstitial nephritis
IR CAPSULES:
Rare (0.01% to 0.1%): Reversible interstitial nephritis
Frequency not reported: Renal dysfunction, slight BUN elevations, slight serum creatinine elevations, toxic nephropathy
CR/MR TABLETS:
Frequency not reported: Renal dysfunction, reversible interstitial nephritis, toxic nephropathy, transient serum creatinine increase, transient serum urea/BUN increase
ORAL SUSPENSION:
Rare (0.01% to 0.1%): Reversible interstitial nephritis
Frequency not reported: Renal dysfunction, slight elevation in serum creatinine, slight elevation in serum urea/BUN, toxic nephropathy[Ref]
Ocular
ER TABLETS:
Uncommon (0.1% to 1%): Conjunctivitis[Ref]
Immunologic
ER TABLETS:
Uncommon (0.1% to 1%): Flu syndrome, infection
IR CAPSULES:
Frequency not reported: Moniliasis, superinfection
CR/MR TABLETS:
Frequency not reported: Moniliasis
ORAL SUSPENSION:
Frequency not reported: Moniliasis, superinfection[Ref]
