Cefaclor Side Effects
Medically reviewed by Drugs.com. Last updated on Sep 28, 2022.
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]
More about cefaclor
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References
1. Product Information. Ceclor (cefaclor). Lilly, Eli and Company. 2002.
2. Product Information. Ceclor CD (cefaclor). Dura Pharmaceuticals. 2001.
3. Cerner Multum, Inc. UK Summary of Product Characteristics.
4. Cerner Multum, Inc. Australian Product Information.
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.