Cefaclor

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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 Cefaclor

Property Description
Active Ingredient Cefaclor (as monohydrate)
Forms Capsule, Tablet, Oral Suspension/Liquid
Pharmacological Class Second-generation cephalosporin antibiotic
General Purpose Treatment of susceptible bacterial infections
Origin Semisynthetic

Type and Composition

Cefaclor is a semisynthetic beta-lactam antibiotic classified as a second-generation cephalosporin, which is primarily used to eliminate susceptible bacterial infections. This medication belongs to the broader cephalosporin pharmacological family, a group clinically recognized for its effectiveness against a wide variety of bacterial pathogens. The active substance is Cefaclor, typically prepared as Cefaclor monohydrate for stability and effective oral administration. The designation as a second-generation cephalosporin is a key differentiating factor, indicating a spectrum of activity expanded beyond earlier compounds, making it a reliable choice for treating common community-acquired illnesses.


Available Forms and General Purpose

Cefaclor is a single active ingredient product available in various oral dosage forms, including immediate-release capsules, tablets (including extended-release versions), and a powder for oral suspension which creates an oral liquid. This flexibility ensures the drug can be administered effectively across diverse patient groups, including pediatric patients and those with swallowing difficulties. Cefaclor is defined as a bactericidal agent, meaning its general purpose is to actively kill the infectious pathogens rather than just stopping them from multiplying. Its action is achieved through the inhibition of bacterial cell wall synthesis, a mechanism supported by pharmacological studies published globally. By disrupting this vital structural process, Cefaclor helps the body quickly clear the underlying infection.

What side effects are possible with Cefaclor?

Possible Side Effects and Safety Information

The safety profile for Cefaclor, a second-generation cephalosporin, is defined by official regulatory documentation that classifies adverse reactions by frequency and affected organ system. This information is derived from reports evaluated by government agencies such as the FDA and EMA.

Adverse Reaction Classification

Side effects are grouped into categories based on incidence reported in clinical studies and post-marketing surveillance:

  • Common (affecting 1% to 10%): Diarrhea, Eosinophilia, and Skin rash (morbilliform eruption). Transient elevations in liver enzymes and issues such as genital moniliasis are also listed in this category.
  • Uncommon (affecting 0.1% to 1%): Urticaria (Hives), Pruritus (Itching), and Serum Sickness-like reactions.

Systemic Safety Scope and Serious Events

Adverse reactions are formally organized by the physiological system affected, including Gastrointestinal Disorders (Diarrhea, Vomiting, Pseudomembranous colitis), Skin and Subcutaneous Tissue Disorders (Rash, Urticaria, Severe Cutaneous Adverse Reactions), and Blood and Lymphatic System Disorders (Eosinophilia, Thrombocytopenia, Agranulocytosis).

Serious Adverse Reactions, while rare, are explicitly documented and include Anaphylaxis and severe hypersensitivity reactions, Pseudomembranous Colitis, and potentially life-threatening skin conditions such as Stevens-Johnson Syndrome (SJS).

Population-Specific Notes

The regulatory safety profile mandates caution due to potential cross-hypersensitivity in individuals with a history of penicillin allergy. The official label notes that Serum Sickness-like reactions have been reported more frequently in children than in adults. Furthermore, the drug requires careful consideration when administered to patients with markedly impaired renal function.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory documents define the manifestations of Cefaclor overdose as primarily non-specific gastrointestinal disturbances. The documented clinical presentation typically includes nausea, vomiting, epigastric distress, and diarrhea. The severity of the gastrointestinal symptoms is stated to be related to the amount ingested.

Required Emergency Actions

Immediate medical help must be sought if the individual experiencing an overdose exhibits severe signs. Regulators mandate that emergency attention is required for manifestations such as collapse, trouble breathing, the development of seizures, or the inability to be awakened. This is also relevant because there is an officially recognized risk of central nervous system effects, particularly seizures, which may be heightened in patients with pre-existing renal impairment.

Official Management Procedures

Treatment is classified as primarily supportive since no specific antidote is known for Cefaclor overdose. Documented procedures for managing the event may include the use of activated charcoal to help limit absorption or the consideration of gastric emptying. Regulatory information explicitly notes that procedures such as hemodialysis or peritoneal dialysis have not been established as beneficial for treating Cefaclor overdose.

Therapeutic Uses of Cefaclor

What Cefaclor Treats: Main Uses and Benefits

The medicine is relevant across domains where short-term symptom management is appropriate. It is commonly used when short-term symptomatic assistance is needed to help ease the overall symptom burden. Cefaclor is considered relevant for easing symptoms associated with acute or disruptive episodes across several condition categories, including conditions presenting with systemic or localized discomfort in areas such as the respiratory system, skin and soft tissues, ear, and urinary tract.


Quick Fact: Relief for Heightened Symptoms

It may assist with symptom clusters that may appear suddenly or intensify over time.


This medication is applied across domains where additional symptomatic support is needed, and is relevant for easing symptom clusters that may become intense and disruptive in areas like the head, throat, and chest. It contributes to improved comfort during periods of heightened symptoms and supports the patient during difficult episodes. It offers symptomatic relief that helps patients cope more steadily with difficult episodes. “It is used in clinical settings marked by temporary physiological imbalance where symptoms create noticeable interference with daily comfort.”


The Therapeutic Domains

The medicine is commonly used to help with conditions characterized by periods of heightened symptoms, such as those that lead to: Respiratory Symptom Clusters (e.g., lower respiratory issues), Head, Throat, and Ear Discomfort, Skin and Tissue Manifestations, and Urinary Tract Comfort. It is applied during phases when symptoms become more noticeable, which may assist with functional stability.

Regulatory References

  1. NIH MedlinePlus overview on Cefaclor

Eligibility and Restrictions for Use

Who Can and Cannot Use Cefaclor?

The official eligibility profile for Cefaclor is defined by mandatory contraindications and patient-specific restrictions, according to governmental regulatory documents.

Contraindicated Populations

Cefaclor is contraindicated and must not be used by patients with a known hypersensitivity or allergy to any cephalosporin antibiotic. Patients with a major allergy to penicillin are also advised against use due to the documented risk of cross-hypersensitivity.

Age-Related Eligibility

Age Group Eligibility Status
Infants (< 1 month) Use Not Established (Safety and efficacy data are insufficient).
Children (≥ 1 month) Approved for use (Immediate-release formulations).
Older Adults Approved for use; no dose adjustment necessary if renal function is normal.

Conditional Use and Restrictions

Use is restricted or requires caution in specific patient groups. This includes individuals with a history of gastrointestinal disease, particularly colitis, and those with markedly impaired renal function. Cefaclor is generally administered during pregnancy and lactation only when considered essential, as trace amounts are excreted into breast milk and its use is classified as restricted.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines interactions with other substances and products as formally documented in government regulatory sources, strictly addressing changes to drug levels, clinical outcome, or absorption requirements.

Documented Interaction Patterns

Pharmacokinetic and Absorption Constraints

Co-administration of the renal transporter inhibitor Probenecid with Cefaclor leads to an inhibition of Cefaclor's renal excretion. This interaction mechanism results in an increased systemic exposure of Cefaclor.

Antacids containing Magnesium or Aluminum Hydroxide are documented to diminish the overall extent of absorption (AUC) of Cefaclor extended-release tablets. Therefore, administration of the antacid must be separated by at least 1 hour from the Cefaclor extended-release dose.

Pharmacodynamic and Clinical Outcome Interactions

There have been reports of increased prothrombin time (INR) when Cefaclor is co-administered with oral anticoagulants, such as Warfarin. This requires careful consideration.

As a general regulatory caution for the cephalosporin class, co-administration with other potentially nephrotoxic agents, including Aminoglycosides, may increase the risk of kidney-related effects.

Interactions with Food and Tests

Interaction with food is formulation-dependent: the absorption of Cefaclor extended-release tablets is enhanced by food, while the immediate-release capsule's extent of absorption is unaffected by food. Furthermore, Cefaclor may cause a positive direct Coombs' test and can interfere with specific copper-reduction methods used for urine glucose testing, leading to false-positive results.

Mechanism of Action

Blocking the Bacterial Cell Wall Assembly

Cefaclor’s mechanism is initiated by its function as an irreversible inhibitor of bacterial Penicillin-Binding Proteins (PBPs), a class of enzymes essential for constructing the microbe’s rigid structural layer. By permanently blocking the transpeptidation reaction required for peptidoglycan cross-linking, the drug directly compromises the integrity of the bacterial cell wall, a structure unique to the pathogen.


The Cascade to Bactericidal Action

The structural failure caused by PBP inhibition triggers a self-destructive process within the pathogen by activating bacterial autolytic enzymes (autolysins). This rapid chain of events leads to the cell membrane rupturing under osmotic pressure (lysis), resulting in the bactericidal (pathogen-killing) physiological effect that leads to the elimination of susceptible microbial populations.


️ Mechanistic Constraints: Resistance

The efficacy of this mechanism is limited by microbial defenses such as the production of beta-lactamase enzymes, which chemically inactivate Cefaclor before it can bind its target. Furthermore, bacterial strains with genetically altered PBPs (low-affinity targets) are not inhibited, preventing the desired pathogen-killing effect.

Dosage and Administration Information

Cefaclor is administered exclusively by the oral route in several labeled dosage forms, including immediate-release capsules, tablets, and oral suspension, as well as extended-release (ER) tablets. The drug must be taken according to specific schedules and administration conditions outlined in official prescribing information.

Official Dosing and Frequency

Patient Group Standard Labeled Regimen Maximum Daily Dosage
Adults (IR) 250 mg every 8 hours (three times daily) 4 g (4000 mg)
Adults (ER) 375 mg to 500 mg every 12 hours (twice daily) 1 g (1000 mg)
Pediatric 20 mg/kg/day divided every 8 hours 1 g (1000 mg)

For more serious infections, the immediate-release adult dose may be doubled to 500 mg every 8 hours. The total daily pediatric dose may also be increased to 40 mg/kg/day, administered in divided doses every 8 or 12 hours.

Administration Requirements

Relation to Meals: Immediate-release forms (capsules/suspension) can be taken with or without food. In contrast, extended-release tablets should be taken with a meal to enhance absorption.

Special Conditions: Extended-release tablets must be swallowed whole; they must not be crushed, cut, or chewed. For the oral suspension, the bottle must be shaken well before each measured dose is administered.

Course Duration: Therapy generally lasts 7 to 10 days. Treatment for infections caused by beta-haemolytic streptococci requires a minimum duration of 10 days.

Population Adjustments: Dosage adjustment is not usually required for patients with moderate or severe renal impairment. For patients undergoing hemodialysis, a supplementary dose is required to maintain therapeutic levels during the interdialytic period.

Recent Clinical Evidence

Research evidence / Overview of studies for Cefaclor

This overview describes the types of official research that have explored Cefaclor, the study designs used, and what remains uncertain in the evidence base. It focuses on the patterns observed in group studies and avoids offering any individual medical advice or clinical interpretation.


Evidence for Use in Respiratory Symptom Clusters

Research has examined Cefaclor in the context of conditions associated with acute or disruptive episodes in the respiratory system, such as pneumonia and the worsening of chronic bronchitis. The evidence base includes comparative Randomized Controlled Trials (RCTs) against other antibiotic agents, alongside analyses of clinical studies referenced by health regulators. Researchers monitored several key outcomes related to physical discomfort and recovery, including how patient symptoms changed over the short-term study period and whether the infectious bacteria were tracked for eradication.

Findings describe patterns observed in the studies where clinical response and bacteriological response rates were measured across the included patient groups. Despite the existence of regulatory evidence, long-term outcomes following Cefaclor treatment are not fully established or consistently tracked in the available data.


Evidence for Use in Head, Throat, and Ear Discomfort

Cefaclor was evaluated in numerous prospective, comparative RCTs and open-label trials for conditions characterized by fluctuating or episodic manifestations in the ear, throat, and head, frequently comparing Cefaclor to other antibiotic agents. These studies explored patient groups, primarily infants and young children, and focused on outcomes describing episodic or acute changes, including changes in symptom severity and the bacteriological response to treatment.

Certainty remains low for some of the historical comparisons. The current clinical landscape often features treatment guidelines that prioritize newer or different antibiotic classes, suggesting that while the evidence was accepted for regulatory approval, its comparative evidence is lacking in modern guideline standards for all first-line uses.


Research in Specific Patient Groups and Key Limitations

Cefaclor was evaluated in a range of specific patient groups, including infants and young children. However, data for certain groups remain insufficient to draw strong, definitive conclusions separate from the general patient population. Evidence quality varies across studies, with some relying on older methodologies or retrospective analysis. Limited information for long-term outcomes is available for most indications, meaning the effects of treatment beyond the short-term course are not fully established.

Key Studies & References

  1. Cefaclor Capsule, DailyMed - Labeling Information
  2. Cefaclor - Drug Information Portal (MedlinePlus)

Frequently Asked Questions (FAQ)

Common questions about Cefaclor (FAQ)


Q: What are the main drug interactions mentioned in Cefaclor's official labeling?

A: Regulatory documents describe a few main interaction patterns. For example, Cefaclor's exposure in the body may be increased by the co-administration of Probenecid, and its absorption can be reduced by antacids containing Magnesium or Aluminum Hydroxide. There have also been reports of changes in clotting measures, such as increased prothrombin time, when Cefaclor is used alongside oral anticoagulants like Warfarin.

Q: Can Cefaclor interact with common pain relievers?

A: Official drug interaction databases do not commonly list Cefaclor as having a clinically significant interaction with over-the-counter pain relievers such as acetaminophen (Paracetamol) or common NSAIDs.

Q: What are the known potential interactions between Cefaclor and blood thinners?

A: The official documentation notes that when Cefaclor is used with oral anticoagulants—often called blood thinners—such as Warfarin, there have been reports of changes in blood clotting measurements. Due to this potential change, using both medications concurrently requires discussion with a healthcare provider.

Q: What should I know about Cefaclor if I have kidney issues?

A: Official information indicates that dosage adjustments are not usually required for patients who have moderate to severe kidney impairment. However, use requires caution for individuals with markedly impaired renal function. For patients undergoing hemodialysis, the prescribing information mentions special dose considerations may apply.

Q: Is Cefaclor generally well-tolerated according to official reports?

A: Official reports classify adverse reactions by how frequently they occur. Common side effects reported in clinical studies include gastrointestinal symptoms like diarrhea and mild hypersensitivity reactions like skin rash. These effects are generally reported to occur in a small percentage of patients (between 1% and 10%).

Q: What kind of infections is Cefaclor usually prescribed for?

A: Cefaclor is indicated for treating infections caused by susceptible strains of bacteria. According to regulatory labeling, this includes certain infections of the respiratory tract (like pneumonia and bronchitis exacerbations), the ear (otitis media), the throat (pharyngitis/tonsillitis), the skin and skin structure, and the urinary tract.

Q: Is Cefaclor a type of penicillin?

A: No, Cefaclor is classified as a second-generation cephalosporin antibiotic, not a penicillin. However, because both drug classes are structurally related beta-lactam antibiotics, official warnings note a potential risk of cross-hypersensitivity (an allergic reaction) in patients with a known allergy to penicillin.

Q: How quickly does Cefaclor typically start working?

A: The antibacterial activity of the drug begins once it has been absorbed into the bloodstream. Following oral intake of the immediate-release form in a fasting state, the concentration of Cefaclor in the serum usually reaches its highest point within 30 to 60 minutes.

Q: What is the average duration of treatment with Cefaclor?

A: The total duration of therapy for most infections is generally between 7 and 10 days. Treatment for infections caused by beta-haemolytic streptococci is documented to require a minimum duration of 10 days, according to regulatory standards.

Q: Can Cefaclor be used to treat viral infections?

A: Official regulatory information specifies that Cefaclor is an antibiotic and works only against infections caused by bacteria. It is not effective for treating viral infections, such as the common cold or the flu.

Q: Is it common to feel tired while taking Cefaclor?

A: General tiredness or fatigue is not listed as a common side effect in official documents. Rare adverse event reports have included somnolence (drowsiness), but the regulatory label notes that a causal relationship to the drug is uncertain.

Q: Can Cefaclor cause changes in appetite?

A: While not consistently listed among the most common adverse events, some official resources include loss of appetite in the full spectrum of possible side effects that have been reported with Cefaclor.

Q: Are there any serious side effects associated with Cefaclor that official documents mention?

A: Yes, official labeling explicitly documents rare but severe risks. These include serious allergic reactions like Anaphylaxis, severe skin conditions such as Stevens-Johnson Syndrome (SJS), and severe gastrointestinal issues like Pseudomembranous colitis.

Q: Does Cefaclor impact the effectiveness of birth control pills?

A: Authoritative drug resources indicate that, similar to other antibiotics, Cefaclor may potentially reduce the effectiveness of hormonal contraceptives (birth control pills) for some women. Official prescribing information contains details regarding potential risks.

Q: Is there a risk of developing a rash while taking Cefaclor?

A: Yes, official regulatory documents list morbilliform eruptions (skin rash) as a Common adverse event. This type of reaction was reported in approximately 1% of patients during clinical trials.

Q: Can Cefaclor be used for respiratory infections?

A: Cefaclor is indicated for treating a range of respiratory tract infections. This includes acute bacterial exacerbations of chronic bronchitis and certain types of pneumonia, provided the infection is caused by susceptible organisms.

Q: Does Cefaclor affect blood sugar levels?

A: Official labeling does not describe a direct effect on blood sugar levels. However, it is noted that Cefaclor may interfere with certain lab tests used to measure glucose in the urine, potentially leading to false-positive results.

Q: What is the main purpose of Cefaclor's extended-release formulation?

A: The extended-release (ER) formulation is designed to provide a slower and more sustained release of the active medication. The purpose is to maintain effective drug concentrations over a longer period, which allows for a less frequent dosing schedule compared to the immediate-release forms.

Q: Is it true that Cefaclor can cause dizziness?

A: Regulatory documents list dizziness as an effect that has been reported rarely during post-marketing surveillance. However, the label clarifies that the causal connection between the drug and this side effect is considered uncertain.

Q: What does official data say about Cefaclor and liver function?

A: Official adverse reaction reports frequently mention that slight, transient elevations of liver enzyme values, such as AST and ALT, can occur. These elevations are often temporary. More serious liver conditions like transient hepatitis or cholestatic jaundice have been reported, but only rarely.

Q: Can Cefaclor be prescribed for urinary tract infections (UTIs)?

A: Yes, Cefaclor is an approved treatment for certain uncomplicated urinary tract infections (UTIs), such as cystitis, when the infection is confirmed to be caused by susceptible strains of designated bacteria.

Q: Is Cefaclor used for skin and soft tissue infections?

A: Cefaclor is indicated in regulatory documents for the treatment of uncomplicated infections of the skin and skin structure. As with all indications, this use is limited to infections confirmed to be caused by susceptible bacterial strains.

Q: How is Cefaclor eliminated from the body?

A: Cefaclor is primarily removed from the body by the kidneys through a process called renal excretion. Official data indicates that a significant portion of the dose, typically between 60% and 85%, is excreted unchanged in the urine within eight hours of administration.

Q: What kind of evidence supports the use of Cefaclor for the conditions it treats?

A: The regulatory approval for Cefaclor is based on evidence from Randomized Controlled Trials (RCTs) and similar studies. This research examined patient groups and tracked outcomes such as clinical response (improvement of symptoms) and bacteriological response (elimination of the infectious pathogen) to support its use.

Q: Can Cefaclor cause changes in sleep patterns?

A: Adverse events related to sleep and behavior, such as insomnia (difficulty sleeping) and hyperactivity, have been reported rarely in official documents. The label notes that the certainty regarding the causal link to the drug is uncertain.

Q: Is Cefaclor available as a generic drug?

A: Yes, the active substance, Cefaclor, is available in several generic formulations. This is evidenced by its listing in generic forms (e.g., Cefaclor Capsules, USP) in official drug information databases.

Q: Are there any food or beverage restrictions when using Cefaclor?

A: The main instruction involves taking the extended-release form with food to enhance absorption. While official documents note interactions with certain antacids, there are no general, broad restrictions on common beverages mentioned in the prescribing information.

Q: Are there specific patient groups who should avoid Cefaclor?

A: Yes, Cefaclor is strictly contraindicated for patients with a known allergy to any cephalosporin antibiotic or a major penicillin allergy. Additionally, safety and efficacy data have not been established for use in infants younger than one month of age.

Q: Does the efficacy of Cefaclor change based on the type of infection?

A: Yes, regulatory documents emphasize that Cefaclor is only indicated for infections caused by bacterial strains that are susceptible to the drug. If the specific bacteria causing an infection is resistant to Cefaclor, the drug is not expected to be effective.

How should Cefaclor be stored and disposed of?

The required storage conditions for Cefaclor depend on the specific formulation as documented in regulatory labeling.

Formulation Required Storage Condition Stability/Handling Constraint
Capsules/Tablets Controlled Room Temperature (20 C to 25 C) Protect from light and excessive moisture.
Oral Suspension (Liquid) Refrigerator (2 C to 8 C) Do not freeze; Discard any unused portion after 14 days of refrigeration.

All forms must be kept in the container they were dispensed in, tightly closed, and stored out of the sight and reach of children. Unused or expired Cefaclor must be disposed of according to local regulatory requirements, preferably through an official medicine take-back program.

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

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