Fredam

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Fredam

Quick Facts

Property Description
Active Ingredient Gliclazide (C15H21N3O3S)
Form Oral tablets (standard-release and modified-release [MR])
Pharmacological Class Oral Hypoglycemic Agent; Second-Generation Sulfonylurea
Common Use Control of High Blood Sugar (Hyperglycemia)
Origin Synthetic

Identity and Classification

Fredam is a synthetic, prescription-only medication primarily used to help control high blood sugar, known as hyperglycemia, in adults with Type 2 diabetes mellitus. The medicine's active ingredient is Gliclazide (INN), which classifies it as an oral hypoglycemic agent within the sulfonylurea family. Gliclazide is recognized as a second-generation sulfonylurea compound, distinguished by its high potency and a pharmacological profile that is clinically recognized to include beneficial anti-platelet effects, a feature that differentiates it from some older agents in its class.

Its core classification as an antidiabetic agent stems from its function as an insulin secretagogue, meaning it actively prompts the body's pancreatic beta cells to produce and release insulin. This mechanism addresses the foundational issue of insufficient or delayed insulin release, characteristic of the condition. Fredam is provided as a single-ingredient product, focusing solely on the actions of Gliclazide.


Composition, Forms, and General Purpose

The medication is available for oral administration in the form of oral tablets, which serve the broad therapeutic purpose of helping maintain healthier blood glucose levels. The final formulation uses the active Gliclazide ingredient combined with solid pharmaceutical excipients. Fredam is available in two main drug forms: standard-release tablets and modified-release tablets (MR).

The modified-release version is a key differentiator, as it is specifically engineered to release the Gliclazide gradually over an extended period. This sustained-release action is often preferred for long-term management as it supports consistent control of blood glucose throughout the day and typically allows for once-daily dosing. The drug’s ultimate therapeutic goal is to enable effective, long-term management of Type 2 diabetes by improving the body’s endogenous insulin function in a simple, oral format.

Regulatory References

  1. NIH LiverTox: Sulfonylureas

What side effects are possible with Fredam?

Possible Side Effects and Safety Information

The safety profile of Fredam (Gliclazide) is officially documented by government health authorities, primarily highlighting effects related to its core function as a glucose-lowering agent. Adverse reactions are classified by frequency and grouped into specific physiological systems.


Adverse Reaction Scope

Classification Effects and Affected Systems
Common Hypoglycaemia (low blood sugar), which is the most frequent adverse reaction listed in regulatory documents.
Uncommon Gastrointestinal disorders, including abdominal pain, nausea, vomiting, diarrhoea, and constipation.
Rare Blood and lymphatic system disorders, such as changes in blood cell counts (e.g., leucopenia, thrombocytopenia).
Frequency Not Known Severe dermatological reactions (e.g., Stevens-Johnson syndrome, DRESS) and Hepatobiliary disorders (hepatitis, cholestatic jaundice).

Serious Adverse Reactions and Safety Constraints

Clinically significant but rare adverse events include severe hypoglycemia, which can be prolonged, and severe skin reactions that are exceptionally reported in post-marketing data.

Safety documents also define specific limitations for use. The drug is contraindicated in conditions such as Type 1 diabetes, diabetic keto-acidosis, and diabetic pre-coma/coma. Furthermore, use is restricted in patients with severe renal or hepatic impairment due to the significantly increased risk of prolonged hypoglycemia.

Some effects are linked to exposure time: transient visual disturbances may occur upon treatment initiation due to changes in blood glucose levels. The risk of hypoglycemia is noted to increase if meals are irregular or skipped. The official safety framework is established by defining these serious events, classifying frequencies, and stating clear restrictions based on patient population and pre-existing conditions.

Overdose and Emergency Response

The official regulatory profile for Fredam overdose is defined by severe and prolonged hypoglycemia. This event is classified as a potentially life-threatening emergency, necessitating immediate medical intervention.

Documented Manifestations and Severe Outcomes

Overdose may present with serious neuroglycopenic symptoms, including confusion, stupor, and loss of consciousness (coma). Regulator-documented severe outcomes include the risk of seizures, permanent brain damage, and ultimately death. Other clinical signs include agitation, severe sweating, and tachycardia. The Central Nervous System and Metabolic systems are primarily affected.

Required Emergency Actions and Monitoring

Immediate medical attention must be sought for any suspected overdose. Urgent contact with emergency services is required.

Management involves the urgent administration of intravenous glucose. Hospital monitoring and observation must be maintained for at least 24 hours or more due to the risk of recurring hypoglycemia. No specific antidote is documented; however, drug clearance procedures like activated charcoal may be utilized as supporting measures.

Population-Specific Risks

Official labeling notes that elderly subjects and patients with impaired hepatic or renal function are especially susceptible to experiencing severe and prolonged hypoglycemic episodes following overdose.

Therapeutic Uses of Fredam

What Fredam Treats: Main Uses and Benefits

Fredam (Gliclazide) is an oral medication generally used to help manage the chronic metabolic condition of Type 2 diabetes mellitus in adults. It is relevant in settings where non-pharmacological means alone, such as diet and exercise, are not sufficient to control blood glucose.

Targeting Chronic High Blood Sugar in Type 2 Diabetes

Fredam is applied across therapeutic domains where high blood sugar, known as hyperglycemia, creates noticeable physiological strain. The medication is commonly used to help with the long-term management of this core issue. It supports the patient by assisting with the effective management of blood glucose levels, which contributes to easing the overall symptom load.

Alleviating Osmotic and Metabolic Symptoms

The medication may assist with easing manifestations of systemic imbalance such as excessive thirst (polydipsia), frequent urination (polyuria), and general fatigue associated with uncontrolled glucose. This medication can assist with maintaining functional stability and may contribute to improved comfort during periods when symptoms are more noticeable.


Quick Fact: Relevant for Systemic Imbalance

The medication is applied across domains where additional symptomatic support is needed, providing support that helps ease the overall symptom burden associated with chronic high blood sugar.

Eligibility and Restrictions for Use

Fredam (Gliclazide) is officially permitted for use only in adults with Type 2 diabetes mellitus when blood sugar control remains insufficient after changes to diet and exercise. The medicine's eligibility is defined by strict regulatory exclusions concerning age, physiological state, and pre-existing medical conditions. The use of Fredam is determined by the following official population guidelines:

Population Eligibility Status Official Regulatory Stance
Use is Contraindicated Type 1 diabetes; acute metabolic states like diabetic keto-acidosis or pre-coma; severe hepatic or renal insufficiency; known hypersensitivity to Gliclazide or other sulfonamides; pregnancy and lactation (breastfeeding).
Use is Restricted/Conditional Children and adolescents (under 18 years) are not recommended as safety and efficacy have not been established. Older adults require caution due to increased susceptibility to hypoglycemia. Conditional use also applies to patients with G6PD-deficiency or mild-to-moderate hepatic/renal impairment.

Regulatory documentation also places restrictions on use during periods of stress, such as major surgery or infection, and advises caution for undernourished patients or those with severe endocrine disorders.

What should I know about interactions with other medicines?

Fredam (Gliclazide) has documented interaction patterns that primarily modify its blood glucose-lowering activity. The most significant constraint is the contraindicated combination with Miconazole (systemic route or oromucosal gel), as co-administration is officially prohibited due to the risk of severely potentiating the hypoglycemic effect.

Regulatory documents define interactions that can either reinforce or counteract the medication's primary function. The blood glucose-lowering effect may be enhanced by co-administration with other antidiabetic agents, Beta-blockers, ACE Inhibitors, and certain NSAIDs (e.g., Phenylbutazone), with the latter acting partly via displacement from plasma proteins. Conversely, substances like Glucocorticoids (systemic) and Danazol are officially documented to reduce Fredam's activity by increasing blood glucose levels.

Pharmacokinetic interactions are recognized, as the metabolism of Gliclazide involves the CYP2C9 enzyme. Inhibitors of this enzyme, such as Fluconazole, can increase Gliclazide's overall plasma exposure (AUC), increasing the risk of potentiation. Additionally, the consumption of Alcohol or medicines containing it must be avoided, as it is documented to increase the hypoglycemic reaction, potentially resulting in coma. These interaction effects are noted to be particularly pronounced in the elderly population and those with severe hepatic or renal impairment.

Mechanism of Action

Fredam's pharmacological action involves non-selective and reversible antagonism at alpha-1 (alpha1) and alpha-2 (alpha2) adrenergic receptors within the systemic circulation. By competitively binding to these receptors on vascular smooth muscle cells, the drug prevents the binding and action of endogenous catecholamines, such as norepinephrine.

This alpha-adrenergic blockade reduces the typical catecholamine-mediated vasoconstriction. The resultant downstream physiological consequence is a direct vasodilation of peripheral blood vessels, leading to a decrease in total peripheral resistance and, consequently, a reduction in pressure within the vascular system.

Fredam may also exhibit lesser, non-selective affinity for other biological targets, including dopamine receptors and ATP-sensitive inward rectifier potassium channels ( KATP channels), contributing to additional complex cardiovascular and metabolic effects. Furthermore, the drug may elicit a direct, yet less pronounced, stimulatory effect on cardiac muscle, potentially through beta-adrenergic receptor activity, which can modulate heart rate and contractility independently of its primary alpha-blocking mechanism.

Dosage and Administration Information

Fredam (Gliclazide) is intended solely for oral administration and is generally utilized as part of a long-term management plan. The medicine is available as either Standard-Release (SR) tablets or Modified-Release (MR) tablets, with the use pattern determined by the specific formulation.


Administration Schedule and Constraints

Administration must occur in conjunction with a regular food intake, preferably with breakfast. The modified-release tablets are administered once daily in a single intake. To preserve the tablet's extended drug-release characteristics, MR tablets must be swallowed whole with water and must not be crushed, chewed, or divided. If a dose is forgotten, the next day's dose should not be increased; instead, the missed dose is skipped, and the regimen continues at the usual time.


Official Dosing Regimens

The dosage is adjusted in successive steps based on the patient's metabolic response. The Modified-Release (MR) form typically initiates treatment at 30 mg daily, with a maximum recommended daily dose of 120 mg. Dose increments usually occur at intervals of at least one month.

Conversely, the Standard-Release (SR) form is initiated at 40 mg to 80 mg daily, with a maximum recommended daily dose of 320 mg. For SR doses exceeding 160 mg daily, the total daily intake is usually administered in divided doses (twice daily).


Population-Specific Notes

The minimum daily starting dose is appropriate for older adults (aged 65 and above) and for patients with mild to moderate renal impairment. The safety and efficacy of Gliclazide have not been established for use in the pediatric population (children and adolescents).

Recent Clinical Evidence

Research Evidence / Overview of Studies for Fredam

Evidence for Managing High Blood Sugar (Glycemic Control) in Type 2 Diabetes

Research has explored Fredam (Gliclazide) in studies examining high blood sugar levels, or hyperglycemia, in adults with Type 2 diabetes. This investigation has primarily involved Randomized Controlled Trials (RCTs), alongside reviews that pool the findings of many such trials. These studies monitored outcomes such as a long-term blood sugar control marker known as Glycated Hemoglobin (often called HbA1c), as well as changes in glucose levels measured after fasting.

The studies monitored outcomes related to these blood sugar markers across a variety of adult populations with T2DM. Research examined its use alongside other therapies. Some trials reported how symptoms evolved in the observed populations, noting patterns related to maintaining blood sugar control over the intermediate term.

Studies on Long-Term Outcomes and Vascular Health

Beyond immediate blood sugar control, research was studied for its impact on outcomes related to systemic or functional imbalance and complications related to the vascular system. These investigations include large-scale, long-term randomized trials that followed patients for several years. These studies explored whether consistent blood sugar management was associated with differences in the incidence of serious microvascular events, such as kidney problems (nephropathy).

What remains uncertain here is that the microvascular findings were observed within a comprehensive approach to intensive control. This means that isolating the specific contribution of Gliclazide alone, separate from the overall approach to blood sugar lowering, is not fully established. Additionally, the clinical meaning of the findings related to platelet markers is not fully established.

Evidence Quality and Where Studies Are Limited

The body of evidence was observed in various settings and evidence quality varies across studies. The research highlights what is known—and what is still uncertain. Key limitations described in the research literature include that sample sizes were modest in some head-to-head comparisons. Furthermore, studies comparing it to certain new classes of diabetes medication over the very long term are lacking. Overall, the evidence for certain long-term effects and outcomes in every subgroup remains insufficient.

Key Studies & References Gliclazide (LiverTox: Clinical and Research Information on Drug-Induced Liver Injury)

Frequently Asked Questions (FAQ)

Common questions about Fredam (FAQ)


Q: How quickly can someone expect to feel the benefits of Fredam?

A: Regulatory documents indicate Fredam is absorbed and begins to stimulate insulin release shortly after administration. However, the effect on overall long-term blood sugar control is assessed over weeks or months of treatment, as measured by markers such as Glycated Hemoglobin (a long-term blood sugar marker).

Q: Is there a generic version of Fredam available?

A: Yes, Fredam contains the active ingredient Gliclazide, which is the internationally recognized generic name of the medicine. The official product information notes that generic versions containing Gliclazide are available from various manufacturers.

Q: Does Fredam interact with alcohol?

A: Regulatory documents state that alcohol consumption must be avoided while taking Fredam. Alcohol can significantly increase the blood sugar-lowering effect of the medication, which can lead to an increased risk of severe hypoglycemia (very low blood sugar).

Q: Can Fredam be taken safely with blood thinners (e.g., aspirin)?

A: Official information indicates that Fredam may increase the effect of some anticoagulant (blood thinning) medicines. Certain Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) may also enhance Fredam’s blood sugar-lowering effect. When these medicines are used concurrently, medical monitoring and possible dose adjustments may be required.

Q: Does Fredam interact with birth control pills?

A: Official prescribing information suggests that hormonal components, such as oestrogens and progestogens found in some birth control pills, may counteract the blood sugar-lowering action of Fredam. The combination may require blood sugar levels to be monitored.

Q: Does Fredam interact with common supplements (e.g., vitamins, herbal remedies)?

A: Regulatory warnings indicate that the herbal remedy St John's wort is documented to decrease the amount of Gliclazide in the blood and should therefore be avoided. Patients are generally advised to inform a healthcare provider about all supplements and herbal remedies being used.

Q: How long does Fredam stay in your system after stopping it?

A: Fredam's active ingredient, Gliclazide, has a half-life of approximately 10 to 20 hours, meaning half of the drug is cleared from the body during that time. The drug and its breakdown products are mainly removed via the urine and feces.

Q: What are the possible withdrawal symptoms if Fredam is stopped suddenly?

A: Regulatory guidance states that Fredam should not be stopped suddenly without consulting a healthcare professional. Abrupt discontinuation may lead to a worsening of the underlying condition, resulting in hyperglycemia (high blood sugar).

Q: Does Fredam have a known therapeutic window?

A: Fredam's dosage is based on a titration schedule with defined starting and maximum daily doses to achieve its therapeutic effect. The effectiveness of the drug is balanced against the risk of hypoglycemia (low blood sugar), which defines its therapeutic range.

Q: Why is Fredam sometimes combined with other active ingredients in a single pill?

A: Fredam is often used as part of combination therapy with other antidiabetic agents, such as Metformin. This strategy helps achieve more complete and comprehensive blood glucose control in patients with Type 2 diabetes. While Fredam is a single-ingredient product, combining it with others is a common management strategy.

Q: Does Fredam cause drowsiness or affect driving ability?

A: Official information confirms that symptoms of hypoglycemia (low blood sugar) can include dizziness and drowsiness. Since these effects can impair concentration and reaction time, official information advises caution regarding driving or operating machinery if a person experiences these symptoms.

Q: Are there any dietary restrictions to follow while taking Fredam?

A: The official product information notes that Fredam must be taken as part of a regular food intake, preferably with breakfast. This is done to help minimize the risk of low blood sugar (hypoglycemia). Beyond the avoidance of alcohol, no specific food groups are strictly prohibited.

Q: Why does Fredam sometimes cause stomach upset or nausea?

A: Gastrointestinal disorders, including nausea, vomiting, and abdominal pain, are listed as uncommon side effects of Fredam. Official guidance suggests taking the tablet with a meal, particularly breakfast, which may help reduce the chance of these effects.

Q: Is it normal to feel a bit dizzy when starting Fredam?

A: Yes, dizziness is a potential sign of hypoglycemia (low blood sugar), which is the most frequent adverse reaction. Since the risk of hypoglycemia may be increased during the initial weeks of treatment, it is possible to experience dizziness when starting Fredam.

Q: What are the most common side effects people report from taking Fredam?

A: According to regulatory safety documents, the most frequent adverse reaction is hypoglycemia (low blood sugar). Other uncommon effects include gastrointestinal disturbances such as abdominal pain, constipation, and vomiting.

Q: Is Fredam safe for people with a history of high blood pressure?

A: Fredam is used to treat Type 2 diabetes. Its use requires caution in patients with a history of heart or blood vessel disease. Patient information highlights that symptoms of severe hypoglycemia can include a fast heart rate or chest pain, which require immediate medical attention.

Q: What is Fredam's primary mechanism of action in the body?

A: Fredam’s primary mechanism of action for its prescribed use is as an insulin secretagogue. It works by targeting the cells in the pancreas to stimulate the release of insulin, which helps the body lower blood glucose levels.

Q: Why do some people report headaches after taking Fredam?

A: Headaches are a documented symptom of hypoglycemia (low blood sugar), the most frequent side effect associated with this medication. They can be reported alongside other symptoms of low blood sugar such as sweating and confusion.

Q: Can Fredam affect sleep (insomnia or increased sleepiness)?

A: Official safety information notes that sleep disorders or restless sleep are possible symptoms that may be experienced during a hypoglycemic episode. If blood sugar is consistently too low, it can potentially disrupt normal sleep patterns.

Q: What should be done if an allergic reaction to Fredam is suspected?

A: If a severe allergic reaction is suspected, such as a serious rash or blistering of the skin, patients are generally advised to discontinue the medication. Official guidance stresses the importance of seeking urgent medical attention at the first signs of a severe reaction.

Q: Can Fredam affect mental clarity or mood?

A: Yes, symptoms associated with hypoglycemia (low blood sugar) can include confusion, poor concentration, and agitation. These effects are generally linked to the way low blood sugar levels affect the central nervous system.

Q: What is the risk of drug interactions if taking multiple prescriptions with Fredam?

A: Fredam has a significant risk of drug interactions because many common medicines can either increase or decrease its blood sugar-lowering effect. Careful monitoring and possible dose adjustments may be required to maintain safe and effective treatment when multiple medications are used.

Q: Are there any warning signs that Fredam might be causing a serious side effect?

A: Yes, regulatory documents list warning signs for serious hypoglycemia, including intense sweating, palpitations, anxiety, and confusion. Signs of severe skin reactions, which are rare but serious, include the appearance of a rash, itching, or blisters.

Q: What is the difference between Fredam and a placebo in clinical trials?

A: Fredam is an active drug that stimulates insulin release and lowers blood glucose, which is its therapeutic effect. A placebo is an inactive substance used in clinical trials that contains no active drug and therefore does not have this biological effect.

Q: Can taking Fredam cause sun sensitivity?

A: Official product information suggests that Fredam belongs to a class of drugs that may cause photosensitivity, making the skin more reactive to sunlight. Due to the potential for photosensitivity, official documents advise precautions such as using sunscreen and wearing protective clothing.

Q: How does Fredam compare to other drugs in the same therapeutic class?

A: Fredam is a second-generation Sulfonylurea. It is pharmacologically distinct from some older agents in its class due to a profile that includes anti-platelet properties.

Q: Are there any genetic factors that influence how Fredam works for someone?

A: Official information indicates that Fredam is broken down by specific liver enzymes. Genetic variations in these enzymes can influence how quickly the drug is cleared from the body, which may affect the duration of its action and overall effectiveness.

Q: Why might a doctor prescribe Fredam over a similar, older drug?

A: Fredam is a second-generation drug in its class. Official information notes that it is distinguished by certain anti-platelet properties, and its use is associated with a different profile of hypoglycemia risk compared to some first-generation agents, which may influence prescribing preference.

How should Fredam be stored and disposed of?

How to Store and Dispose of Fredam?

The storage and disposal requirements for Fredam (Gliclazide tablets) are strictly defined by regulatory documents to maintain product integrity and ensure safe handling.


Storage Requirements

Condition Requirement
Temperature Store below 25 C (77 F).
Container Must be kept in the original package to protect from moisture.
Child Safety Keep out of the sight and reach of children.

The medication must not be stored above 25 C, as this risks compromising the stability of the active ingredient.


Disposal Instructions

Unused or expired Fredam must be disposed of in accordance with local regulations for pharmaceutical waste. The official labeling specifies that the tablets must not be thrown away via household waste or discarded through wastewater (e.g., flushing down the toilet).

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

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