Cefaclor Side Effects
Medically reviewed by Drugs.com. Last updated on Sep 30, 2024.
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 adverse events
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
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]
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]
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
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]
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]
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]
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]
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]
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]
References
1. (2002) "Product Information. Ceclor (cefaclor)." Lilly, Eli and Company
2. (2001) "Product Information. Ceclor CD (cefaclor)." Dura Pharmaceuticals
3. Cerner Multum, Inc. "UK Summary of Product Characteristics."
4. Cerner Multum, Inc. "Australian Product Information."
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Further information
Cefaclor side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.