Cefachlor

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Cefachlor

Property Description
Active ingredient Cefaclor (INN)
Form Oral (Capsules, Tablets, Suspension)
Pharmacological class beta-Lactam Antibiotic
General purpose To eliminate susceptible pathogenic bacteria
Origin Semisynthetic

What Type of Medicine is Cefaclor?

Cefaclor is the International Nonproprietary Name (INN) for the active ingredient in this medication, classified as a semisynthetic beta-lactam antibiotic belonging to the second-generation cephalosporin class. This classification identifies it as an antimicrobial agent used to target and eliminate susceptible pathogenic bacteria. The compound is derived from the natural cephalosporin nucleus but is chemically altered to enhance its activity, resulting in its semisynthetic origin. Cefaclor's efficacy is clinically recognized for managing a wide range of bacterial organisms, including many common respiratory pathogens.

Composition, Forms, and General Purpose

Cefaclor is a single-ingredient product formulated exclusively for oral administration, and it is available in multiple formats, which is a key differentiating factor for patient care. The primary dosage forms include capsules, standard or extended-release tablets, and a powder or granules for oral suspension. The liquid suspension is crucial for easy dosing across patient groups, particularly infants and children. The medicine's general purpose is anchored in its powerful bactericidal activity: it is designed to actively destroy bacteria by preventing them from building a stable cell wall, effectively stopping the progression of the infection. Cefaclor's unique chemical structure, as a second-generation cephalosporin, grants it activity against strains resistant to certain first-generation compounds.

Distinguishing Cefaclor from Other Antibiotics

Cefaclor’s bactericidal mechanism involves disrupting the bacteria’s cell wall synthesis, providing a specific strategy for fighting infection, distinguishing it from bacteriostatic agents that only slow bacterial growth. While sharing the beta-lactam core with penicillins, Cefaclor's second-generation status offers a broader spectrum of coverage compared to its predecessors. This enhanced profile makes it a frequently utilized option for empirical therapy where the precise causative pathogen may not yet be known, a common neutral use scenario in outpatient settings. Popular brand equivalents containing this INN include Ceclor and Distaclor.

Regulatory References

  1. Cefaclor: MedlinePlus Drug Information

What side effects are possible with Cefachlor?

Possible side effects and safety information

The official safety profile for Cefaclor, as documented by regulatory bodies, classifies potential adverse reactions based on their system-organ class and reported frequency.

Common and Gastrointestinal Reactions

The most frequently reported adverse events in regulatory documents are generally classified as common (occurring in 1% to 10% of users). These primarily involve the gastrointestinal system, including diarrhea, nausea, and abdominal pain. Other common reactions include headache, pruritus, and skin rashes.

System-Organ Class and Seriousness

Adverse reactions are formally grouped by the system affected. Immune System Disorders are of regulatory concern, including hypersensitivity reactions and documented cross-sensitivity with penicillins. Rare, but clinically serious, adverse reactions officially noted include Anaphylaxis, severe skin disorders like Stevens-Johnson Syndrome (SJS), and severe colitis such as Pseudomembranous Colitis. Onset of colitis symptoms may occur during or after treatment.

Population-Specific and Exposure Notes

Safety notes address certain populations and conditions. Serum sickness-like reactions have been reported more frequently in pediatric patients than in adults, typically appearing a few days after treatment initiation. For patients with renal impairment, caution is advised, as the cephalosporin class is associated with a risk of seizures if dosage is not appropriately reduced. Cefaclor is also noted to cause a false-positive result for glucose in the urine when using specific copper reduction tests, a non-clinical laboratory interference.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Cefaclor overdose describes both common acute manifestations and the potential for severe, dose-related systemic effects.

Documented Overdose Manifestations

Acute Cefaclor overdose may initially result in gastrointestinal disturbances, including nausea, vomiting, and epigastric distress. Diarrhea is also documented, with its severity noted as being dose-related in regulatory prescribing information.

Severe Outcomes and Population Risk

Taking too much Cefaclor can pose a serious risk of Central Nervous System (CNS) toxicity. This risk, associated with the cephalosporin drug class, includes the potential for seizures and other neurotoxicity symptoms such as encephalopathy.

Patients with markedly impaired renal function are specifically identified in prescribing information as being at heightened risk for seizures and neurotoxicity, as are the elderly and individuals with pre-existing CNS disorders.

Required Emergency Actions

The most important action is to seek immediate medical attention. Because of the risk of severe CNS events, emergency services must be contacted immediately if an individual has collapsed, experienced a seizure, has trouble breathing, or cannot be awakened after ingestion. Additionally, regulators recommend calling a poison control helpline.

Management is primarily symptomatic and supportive, as no specific antidote is known. Gastrointestinal decontamination, such as gastric lavage, is generally considered by health professionals only following ingestion of amounts exceeding a specific high threshold (e.g., five times the normal total daily dose).

Therapeutic Uses of Cefachlor

The primary therapeutic role of Cefaclor is applied in clinical settings that involve acute or unstable symptom patterns caused by susceptible bacterial pathogens across several key domains, and may assist with maintaining functional stability. It is commonly used to help with symptoms related to inflammatory or irritative states.

The medication is relevant for easing a range of acute conditions presenting with disruptive symptom manifestations. These commonly include infections of the upper and lower respiratory tract (such as pneumonia, bronchitis, tonsillitis, and sinusitis), middle ear infections (otitis media), urinary tract infections (UTIs), and localized skin structure infections. It is often used during phases when symptoms become more noticeable and short-term symptomatic assistance is needed.

“Cefaclor is applied across therapeutic domains where additional symptomatic support is needed, contributing to improved comfort during periods of heightened symptoms.”

This application assists with managing challenging symptom clusters like severe sore throat, ear pain, painful urination, and localized redness or swelling, which interfere with daily functioning. By providing supportive relief, the medication contributes to easing the overall symptom load and supports patients during episodes of heightened discomfort.


Quick Fact: Relief for Acute Symptom Clusters Cefaclor is commonly used when groups of symptoms, such as fever, cough, and congestion, or localized pain and inflammation, appear suddenly or intensify over time, providing supportive relief when symptoms interfere with routine activities.

Regulatory References

  1. NIH MedlinePlus overview of Cefaclor uses

Eligibility and Restrictions for Use

Eligibility and Contraindications

Official regulatory documents define specific populations that are eligible, restricted, or prohibited from using Cefaclor.

Category Regulatory Status Affected Population
Absolute Contraindication Contraindicated Patients with known hypersensitivity to cephalosporins or a history of severe allergic reaction to penicillin [Source 1.1, 3.4].
Age Restriction Not Established / Contraindicated Infants less than one month of age (safety and effectiveness are not established) [Source 2.2]. Children under 16 for extended-release tablet forms [Source 2.2].
Conditional Use Caution Required Patients with a history of colitis or gastrointestinal disease [Source 1.1]. Patients with markedly impaired renal function [Source 2.1].

Pregnancy and Lactation Eligibility

Cefaclor is categorized for use in pregnancy (FDA Category B) and should be administered only if clearly needed, as adequate, well-controlled studies in pregnant women are not available [Source 3.1]. During breastfeeding, caution is advised because trace amounts of Cefaclor are detected in breast milk, and the effect on the nursing infant is not fully known [Source 3.3]. Use in older adults is generally permitted at standard doses, but close consideration is necessary for those with pre-existing severe renal impairment [Source 3.4]. These population constraints strictly define eligibility based on labeled risks.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents describe several interactions affecting Cefaclor's disposition or the effects of co-administered medicines, structured around pharmacokinetic and pharmacodynamic domains. No medicinal products are formally labeled as contraindicated combinations due to interaction risk.


Documented Pharmacokinetic Interactions

  • Probenecid: Co-administration with this substance leads to increased and prolonged cefaclor serum concentrations. This is due to the inhibition of Cefaclor's renal tubular secretion, a key pathway for its removal from the body.
  • Antacids: Antacids containing Magnesium Hydroxide or Aluminum Hydroxide diminish the extent of Cefaclor absorption. Regulatory information specifies that Cefaclor absorption is lessened if the antacid is taken within one hour of administration.
  • Food: For the immediate-release forms, taking Cefaclor with food causes the peak plasma concentration to decrease and the time to reach this maximum concentration to be delayed, although the overall amount absorbed remains unchanged.

Documented Pharmacodynamic Interactions

  • Oral Anticoagulants (e.g., Warfarin): Concomitant use with Cefaclor has been associated with an enhancement of the anticoagulant effect. This interaction is officially documented as requiring close monitoring of the patient's International Normalized Ratio (INR) or Prothrombin Time (PT).

Population-Specific Notes

  • In patients with markedly impaired renal function, the serum half-life of Cefaclor is slightly prolonged, a factor noted in the official prescribing information.

Mechanism of Action

Irreversible Disruption of the Bacterial Cell Wall

Cefaclor's core function is the covalent inhibition of bacterial enzymes known as Penicillin-Binding Proteins (PBPs), which are critical for the final stage of cell wall assembly (peptidoglycan cross-linking). By permanently blocking these enzymes, the drug creates a structurally unstable cell wall that cannot withstand the internal osmotic pressure. This highly specific action leads to immediate bacterial cell lysis (rupture) and a definitive bactericidal effect.

Constraints and Mechanistic Limitations

The mechanism's efficacy is constrained by bacterial resistance factors, primarily the production of beta-lactamase enzymes. These enzymes chemically inactivate Cefaclor by hydrolyzing its beta-lactam ring before it can bind to the PBPs. Furthermore, the mechanism is neutralized by the emergence of altered PBPs with reduced affinity for the drug, preventing the essential irreversible binding and allowing the bacterial cell wall synthesis pathway to continue unimpaired.

Dosage and Administration Information

How Cefaclor is Used

Cefaclor is administered exclusively by the oral route and is available in formulations including immediate-release (IR) capsules, extended-release (ER) tablets, and a powder for oral suspension. The specific use pattern—including dose, frequency, and timing—is dictated by the formulation and the treated condition.

Administration and Dosing Principles

The standard adult dose for most infections utilizing the IR forms is 250 mg every 8 hours (three times daily). For more severe infections, this dose may be increased to 500 mg every 8 hours, with the maximum daily dose generally not exceeding 4 grams. The ER tablets are typically administered twice daily (every 12 hours) at doses of 375 mg or 500 mg.

Administration Constraint Immediate-Release Forms (Capsule/Suspension) Extended-Release Forms (Tablet)
Timing Relative to Food May be taken with or without food. Must be taken with meals for proper absorption.
Physical Handling No restrictions. Must not be cut, crushed, or chewed to preserve the release mechanism.

Duration and Population-Specific Use

For infections caused by beta-haemolytic streptococci, the administration course must be maintained for a minimum of 10 days to prevent post-infection complications. Pediatric patients (aged 1 month and older) are managed using a weight-based dosage typically ranging from 20 mg/kg/day to 40 mg/kg/day, divided and given two or three times daily. Dose modification is usually not required for older adults with normal renal function, but specific regimens are necessary for patients undergoing hemodialysis.

Recent Clinical Evidence

Research evidence / Overview of studies for Cefachlor

Evidence for Use in Respiratory Tract Infections

Research has explored Cefaclor through various studies, including Randomized Controlled Trials (RCTs) and systematic reviews, with studies focused on bacterial upper respiratory conditions (like pharyngitis, tonsillitis, and sinusitis) and lower respiratory conditions (such as bronchitis and pneumonia). These studies are used in research exploring how symptoms change over time when infections are present. Researchers examined outcomes related to physical discomfort and systemic or functional imbalance. Studies monitored changes related to the time frame where symptom changes were measured following the initiation of the prescribed course. However, research so far indicates that evidence is limited regarding outcomes beyond the short-term treatment window. Long-term effects are not fully established.


Evidence for Use in Otitis Media and Skin Structure Infections

The research base for middle ear infections (Otitis Media) includes Randomized Controlled Trials (RCTs) and comparative studies. For Skin and Skin Structure Infections (SSSI), evidence was derived from short-term RCTs and clinical experience summaries. These studies were applied in research contexts involving fluctuating or unstable symptoms. Findings describe patterns observed in these studies related to episodes of acute otitis media recurring during the observation period. Studies report how symptoms evolved in the observed populations, and findings describe patterns associated with pathogen clearance.


Evidence in Special Populations and Uncertainties

Cefaclor was studied for use in distinct age groups, primarily adults and children. Research describes findings for paediatric patients starting from one month of age in studies of otitis media and respiratory infections. However, data for certain groups remain insufficient: the safety and efficacy parameters are not fully established for use in infants under one month of age. Key limitations include the fact that the follow-up durations were limited across many core studies. Evidence quality varies across studies when Cefaclor was compared to certain newer generation antibiotics, and findings describe group patterns, not personal outcomes.

Key Studies & References Cefaclor FDA Approved Drug Label and Package Insert (DailyMed)

Frequently Asked Questions (FAQ)

Common questions about Cefachlor (FAQ)


Q: How quickly does Cefachlor usually start to work after the first dose?

Cefaclor’s mechanism of action, which targets the bacterial cell wall, is described as leading to rapid bacterial cell rupture (lysis). The drug reaches its peak concentration in the bloodstream approximately 0.5 to 1 hour after administration. This indicates how quickly the compound is working at a chemical level.


Q: How long does the antibiotic Cefachlor stay in your system?

The time it takes for Cefaclor levels to fall by half, known as the serum half-life, is generally reported as 0.5 to 1 hour in people with normal kidney function. Regulatory documents indicate that the majority of the drug is excreted unchanged in the urine within about 8 hours.


Q: Are there any common foods or drinks that should be avoided while taking Cefachlor?

Official product information does not list a comprehensive set of common foods or drinks that must be avoided. However, for immediate-release forms, the presence of food is associated with a delayed peak concentration of the drug in the body. Certain antacids containing magnesium or aluminum may also reduce the amount of Cefaclor absorbed if they are taken within one hour of the antibiotic.


Q: Is it common for Cefachlor to cause stomach upset?

Gastrointestinal reactions are among the most frequently reported side effects. According to official documents, common reactions (occurring in 1% to 10% of users) include diarrhea, nausea, and abdominal pain. These are the symptoms often generally described by patients as 'stomach upset'.


Q: Does Cefachlor affect the effectiveness of birth control pills?

Regulatory-based interaction data indicates that antibiotics, including those in Cefaclor's class, may potentially reduce the effects of conjugated estrogens, which are ingredients in some forms of oral contraceptives. This potential interaction is noted in the official product information.


Q: Can Cefachlor be taken with pain relievers like ibuprofen?

Regulatory documents list interactions with Probenecid, Oral Anticoagulants, and specific Antacids. Ibuprofen, which is a nonsteroidal anti-inflammatory drug (NSAID), is not included among the documented interactions in the official product information.


Q: Is Cefachlor considered safe for people with liver disease?

While official information advises caution regarding impaired kidney function, it does not fully detail specific guidance or contraindications related to pre-existing liver disease. Regulatory documents note that rare cases of transient hepatitis and cholestatic jaundice have been reported in the adverse events profile.


Q: Why is completing the full course of Cefachlor important?

Official patient information describes completing the entire course of Cefaclor as a way to support successful treatment outcomes. This adherence is also important to help reduce the development of antibiotic-resistant bacteria, which could affect the drug's effectiveness in the future.


Q: Does Cefachlor interact with alcohol, according to regulatory information?

Regulatory documents detailing pharmacokinetic and pharmacodynamic interactions for Cefaclor do not list an interaction with alcohol. This means that a specific, medically documented interaction between the drug and alcohol is not noted in the official product information.


Q: Can Cefachlor cause tiredness or fatigue?

Tiredness or fatigue is not specifically listed as a common side effect in regulatory documents. However, somnolence (sleepiness) has been reported rarely, and official sources note that the causal relationship between the drug and this reaction is considered uncertain.


Q: What is the difference between Cefachlor and amoxicillin?

Cefaclor is classified by regulatory bodies as a second-generation cephalosporin antibiotic, whereas amoxicillin belongs to the penicillin class of drugs. Both share a similar underlying mechanism of action that inhibits bacterial cell wall synthesis, but their chemical structures and spectrums of activity are distinct.


Q: What does the term 'broad-spectrum' mean in relation to Cefachlor?

Cefaclor is described as a broad-spectrum antibiotic in the drug’s microbiology section. This term means the drug is active against a relatively wide range of different types of bacteria, encompassing both Gram-positive and Gram-negative microorganisms.


Q: How often do people report developing an allergic reaction to Cefachlor?

According to official reports, general hypersensitivity reactions (allergic reactions) are described as occurring in approximately 1.5% of patients. More severe allergic reactions, such as anaphylaxis, are officially documented as being reported rarely.


Q: Does Cefachlor have an effect on gut bacteria?

Regulatory warnings indicate that antibiotic use may carry the risk of a superinfection, which is the overgrowth of non-susceptible organisms. As an antibiotic, Cefaclor's activity against susceptible bacteria could potentially lead to a shift in the balance of microorganisms, including those in the gut.


Q: Can taking Cefachlor cause trouble sleeping?

Insomnia (trouble sleeping) is listed in official documents as a reaction reported only rarely. Furthermore, regulatory documents explicitly state that the causal relationship between the use of Cefaclor and the occurrence of insomnia is considered uncertain.


Q: Are there specific symptoms that indicate a less common side effect from Cefachlor?

Official safety documentation notes that central nervous system reactions are rarely reported. These include symptoms such as reversible hyperactivity, nervousness, agitation, confusion, and dizziness. Official sources also note that the causal relationship is sometimes uncertain.


Q: What happens if I miss a dose of Cefachlor?

Regulatory-based patient instructions describe that if a dose is missed, it should be taken as soon as it is remembered. If, however, it is already close to the time for the next scheduled dose, the instructions indicate that the missed dose should be skipped and the normal schedule resumed.


Q: Do studies show Cefachlor is effective against Staph infections?

Yes, official labeling specifies Cefaclor is indicated for use in treating skin and skin structure infections caused by susceptible bacteria. This includes infections caused by Staphylococcus aureus (Staph), which is one of the specific pathogens listed in the drug's microbiology section.


Q: Does Cefachlor have an effect on mood or behavior?

Official documents report rare occurrences of certain central nervous system effects, such as reversible hyperactivity, agitation, nervousness, and confusion. However, it is officially noted that the causal relationship between these changes in mood or behavior and the drug is uncertain.


Q: Can Cefachlor make my skin more sensitive to the sun?

Photosensitivity (increased skin sensitivity to the sun) is not listed as a documented adverse reaction associated with Cefaclor in the official regulatory documents or safety profiles.


Q: Can Cefachlor be used for urinary tract infections (UTIs)?

Yes, Cefaclor is officially indicated for treating certain infections of the urinary tract, provided the infection is caused by specific susceptible bacteria. Official indications cover conditions such as pyelonephritis (kidney infection) and cystitis (bladder infection).


Q: Does Cefachlor interact with antacids or acid reducers?

Official documents confirm that Cefaclor's absorption is diminished when taken with antacids that contain Magnesium Hydroxide or Aluminum Hydroxide. Regulatory information does not currently list interaction data for other types of acid reducers, such as PPIs or H2 blockers.


Q: What are the signs of a non-allergic sensitivity to Cefachlor?

Official documents primarily describe allergic and severe adverse reactions, such as anaphylaxis. While a dedicated section on non-allergic sensitivity signs is not provided, the general side effect listings do describe a range of common and rare symptoms that have been observed.

How should Cefachlor be stored and disposed of?

The required storage conditions for Cefaclor depend on the medication's form, and all storage must be out of the sight and reach of children.

Storage Requirements

Form Temperature Range Specific Protection Stability Constraint
Capsules/Tablets Controlled Room Temperature (15 C to 30 C or below 25 C) Store in original, tightly closed container, protected from light and moisture. None (as dry product)
Reconstituted Suspension Refrigerated (2 C to 8 C); Do not freeze Keep bottle tightly closed; Shake well before use. Must be discarded after 14 days.

Disposal Instructions

Regulatory documents mandate that Cefaclor must not be disposed of via wastewater or general household trash. Patients should consult a pharmacist for instructions on how to properly discard any unused or expired medication, ensuring compliance with local pharmaceutical waste disposal requirements.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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