Friladar Side effects

• Side effects of Friladar in details
• Friladar contraindications
• Friladar reviews

What are the possible side effects of Friladar?

Get emergency medical help if you have any signs of an allergic reaction to Friladar: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• pale or yellowed skin, dark colored urine, fever, confusion or weakness; or

• severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Friladar side effects may include:

• headache;

• dizziness, weakness;

• nausea; or

• flu symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Friladar in details

The following serious adverse reactions are discussed in more detail below and elsewhere in the labeling:

• Hypoglycemia
• Hemolytic anemia

In clinical trials, the most common adverse reactions with Friladar were hypoglycemia, dizziness, asthenia, headache, and nausea.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Approximately 2,800 patients with type 2 diabetes have been treated with Friladar in the controlled clinical trials. In these trials, approximately 1,700 patients were treated with Friladar for at least 1 year.

Table 1 summarizes adverse events, other than hypoglycemia, that were reported in 11 pooled placebocontrolled trials, whether or not considered to be possibly or probably related to study medication. Treatment duration ranged from 13 weeks to 12 months. Terms that are reported represent those that occurred at an incidence of ≥5% among Friladar-treated patients and more commonly than in patients who received placebo.

Table 1. Eleven Pooled Placebo-Controlled Trials ranging from 13 weeks to 12 months : Adverse Events (Excluding Hypoglycemia) Occurring in ≥5% of Friladar-treated Patients and at a Greater Incidence than with Placebo*

	Friladar N=745 %	Placebo N=294 %
Headache	8.2	7.8
Accidental InjuryInsufficient information to determine whether any of the accidental injury events were associated with hypoglycemia

Hypoglycemia

In a randomized, double-blind, placebo-controlled monotherapy trial of 14 weeks duration, patients already on sulfonylurea therapy underwent a 3-week washout period then were randomized to Friladar 1 mg, 4 mg, 8 mg or placebo. Patients randomized to Friladar 4 mg or 8 mg underwent forced-titration from an initial dose of 1 mg to these final doses, as tolerated. The overall incidence of possible hypoglycemia (defined by the presence of at least one symptom that the investigator believed might be related to hypoglycemia; a concurrent glucose measurement was not required) was 4% for Friladar 1 mg, 17% for Friladar 4 mg, 16% for Friladar 8 mg and 0% for placebo. All of these events were self-treated.

In a randomized, double-blind, placebo-controlled monotherapy trial of 22 weeks duration, patients received a starting dose of either 1 mg Friladar or placebo daily. The dose of Friladar was titrated to a target fasting plasma glucose of 90–150 mg/dL. Final daily doses of Friladar were 1, 2, 3, 4, 6 or 8 mg. The overall incidence of possible hypoglycemia (as defined above for the 14-week trial) for Friladar vs. placebo was 19.7% vs. 3.2%. All of these events were selftreated.

Weight Gain

Friladar, like all sulfonylureas, can cause weight gain.

Allergic Reactions

In clinical trials, allergic reactions, such as pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions, occurred in less than 1% of Friladar-treated patients. These may resolve despite continued treatment with Friladar. There are postmarketing reports of more serious allergic reactions (e.g., dyspnea, hypotension, shock).

Laboratory Tests

Elevated Serum Alanine Aminotransferase (ALT)

In 11 pooled placebo-controlled trials of Friladar, 1.9% of Friladar-treated patients and 0.8% of placebo-treated patients developed serum ALT greater than 2 times the upper limit of the reference range.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Friladar. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

• Serious hypersensitivity reactions, including anaphylaxis, angioedema, and Stevens-Johnson Syndrome
• Hemolytic anemia in patients with and without G6PD deficiency
• Impairment of liver function (e.g. with cholestasis and jaundice), as well as hepatitis, which may progress to liver failure.
• Porphyria cutanea tarda, photosensitivity reactions and allergic vasculitis
• Leukopenia, agranulocytosis, aplastic anemia, and pancytopenia
• Thrombocytopenia (including severe cases with platelet count less than 10,000/μL) and thrombocytopenic purpura
• Hepatic porphyria reactions and disulfiram-like reactions
• Hyponatremia and syndrome of inappropriate antidiuretic hormone secretion (SIADH), most often in patients who are on other medications or who have medical conditions known to cause hyponatremia or increase release of antidiuretic hormone
• Dysgeusia
• Alopecia

What is the most important information I should know about Friladar?

• Friladar may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Friladar with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol while you are taking Friladar; it may increase the risk of low blood sugar. Rarely, alcohol may interact with Friladar and cause a serious reaction with symptoms such as flushing, nausea, vomiting, dizziness, or stomach pain. Discuss any questions or concerns with your doctor.
• Carry an ID card at all times that says you have diabetes. Check your blood sugar levels as directed by your doctor. If they are often higher or lower than they should be and you take Friladar exactly as prescribed, tell your doctor.
• Proper diet, regular exercise, and regular blood sugar testing are important for best results with Friladar. Follow the diet and exercise program given to you by your health care provider.
• It may be harder to control your blood sugar during times of stress such as fever, infection, injury, or surgery. Talk with your doctor about how to control your blood sugar if any of these occur. Do not change the dose of your medicine without checking with your doctor.
• Friladar may cause low blood sugar levels. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.
• Risk of low blood sugar may be increased by severe or prolonged exercise, drinking alcohol, or skipping meals.
• Friladar is a sulfonylurea. It may increase the risk of death from heart disease. Talk with your doctor about the benefits and risks of this or other therapies to treat your condition.
• Friladar may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Friladar. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Tell your doctor or dentist that you take Friladar before you receive any medical or dental care, emergency care, or surgery.
• Lab tests, including fasting blood glucose and hemoglobin A, may be performed while you use Friladar. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Friladar with caution in the ELDERLY; they may be more sensitive to its effects, especially low blood sugar levels.
• Friladar should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Friladar may cause harm to the fetus or newborn. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Friladar while you are pregnant. It is not known if Friladar is found in breast milk. Do not breast-feed while taking Friladar.

When used for long periods of time, Friladar may not work as well. If your blood sugar has been under control and then becomes hard to manage, contact your doctor. Do not change the dose of your medicine without checking with your doctor.

Friladar contraindications

Friladar is not suitable for the treatment of insulin-dependent (type I) diabetes mellitus (eg, for the treatment of diabetics with a history of ketoacidosis), of diabetic ketoacidosis, or of diabetic precoma or coma. Friladar must not be used in patients hypersensitive to Friladar, other sulfonylureas, other sulfonamides, or any of the excipients (risk of hypersensitivity reactions).

No experience has been gained concerning the use of Friladar in patients with severe impairment of liver function and in dialysis patients. In patients with severe impairment of renal or hepatic function, a changeover to insulin is indicated, not least to achieve optimal metabolic control.

Use in pregnancy & lactation: To avoid risk of harm to the child, Friladar must not be taken during pregnancy; a changeover to insulin is necessary. Patients planning a pregnancy must inform their physician and should changeover to insulin. Ingestion of Friladar with the breastmilk may harm the child. Therefore, Friladar must not be taken by breastfeeding women. Either a changeover to insulin or a complete discontinuation of breastfeeding is necessary.

References

1. DailyMed. "GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. DTP/NCI. "glimepiride: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
3. European Chemicals Agency - ECHA. "1-[[4-[2-(3-Ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)-ethyl]phenyl]sulphonyl]-3-trans-(4-methylcyclohexyl)urea.: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Friladar are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Friladar. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology