Geniclor Side effects

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

What are the possible side effects of Geniclor?

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

Call your doctor at once if you have any of these serious side effects:

• diarrhea that is watery or bloody;

• easy bruising or bleeding, severe tingling, numbness, pain, muscle weakness;

• unusual bleeding;

• seizure (convulsions);

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

• jaundice (yellowing of the skin or eyes);

• fever, chills, body aches, flu symptoms, swollen glands, rash or itching, joint pain, or general ill feeling;

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or

• increased thirst, loss of appetite, swelling, weight gain, feeling short of breath, urinating less than usual or not at all.

Less serious side effects may include:

• nausea, vomiting, stomach pain, mild diarrhea;

• stiff or tight muscles;

• feeling restless or hyperactive;

• unusual or unpleasant taste in your mouth;

• mild itching or skin rash;

• dizziness, drowsiness; or

• vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Geniclor in details

Clinical Trials

There were 3272 patients treated with multiple doses of Geniclor extended-release tablets in controlled clinical trials and an additional 211 subjects in pharmacology studies. There were no deaths in these trials thought to be related to toxicity from Geniclor extended-release tablets. Treatment was discontinued in 1.7% of patients due to adverse events thought to be possibly or probably drug-related.

The following adverse clinical and laboratory events were reported during the Geniclor extended-release tablets clinical trials conducted in North America at doses of 375 mg or 500 mg BID; however, relatedness of the adverse events to the drug was not assigned by clinical investigators during the trials.

Adverse reactions occurring during the clinical trials with Geniclor extended-release tablets with an incidence of less than 1% but greater than 0.1% included the following (listed alphabetically):

Accidental injury, anorexia, anxiety, arthralgia, asthma, bronchitis, chest pain, chills, congestive heart failure, conjunctivitis, constipation, dizziness, dysmenorrhea, dyspepsia, dysuria, ear pain, edema, fever, flatulence, flu syndrome, gastritis, infection, insomnia, leukorrhea, lung disorder, maculopapular rash, malaise, menstrual disorder, myalgia, nausea and vomiting, neck pain, nervousness, nocturia, otitis media, pain, palpitation, peripheral edema, rash, respiratory disorder, sinusitis, somnolence, surgical procedure, sweating, tremor, urticaria, vomiting.

NOTE: One case of serum-sickness-like reaction was reported among the 3272 adult patients treated with Geniclor extended-release tablets during the controlled clinical trials. These reactions have also been reported with the use of Geniclor in other oral formulations and are seen more frequently in pediatric patients than in adults. These reactions are characterized by findings of erythema multiforme, rash, and other skin manifestations accompanied by arthritis/arthralgia, with or without fever, and differ from classic serum sickness in that there is infrequently associated lymphadenopathy and proteinuria, no circulating immune complexes and no evidence to date of sequelae of the reaction. While further investigation is ongoing, serum-sickness-like reactions appear to be due to hypersensitivity and more often occur during or following a second (or subsequent) course of therapy with Geniclor. Such reactions have been reported with overall occurrence ranging from 1 in 200 (0.5%) in one focused trial; to 2 in 8346 (0.024%) in overall clinical trials (with an incidence in pediatric patients in clinical trials of 0.055%); to 1 in 38,000 (0.003%) in spontaneous event reports. Signs and symptoms usually occur a few days after initiation of therapy and subside within a few days after cessation of therapy. Occasionally these reactions have resulted in hospitalization, usually of short duration (median hospitalization = 2 to 3 days, based on postmarketing surveillance studies). In those patients requiring hospitalization, the symptoms have ranged from mild to severe at the time of admission with more of the severe reactions occurring in pediatric patients.

In Postmarketing Experience

In addition to the events reported during clinical trials with Geniclor extended-release tablets, the following adverse experiences are among those that have been reported during worldwide postmarketing surveillance: allergic reaction, anaphylactoid reaction, angioedema, face edema, hypotension, Stevens-Johnson syndrome, syncope, paresthesia, vasodilatation and vertigo.

Other Adverse Reactions Associated With Other Formulations of Geniclor

In addition to the above, the following other adverse reactions and altered laboratory tests have been associated with Geniclor in other oral formulations:

Clinical

Severe hypersensitivity reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and anaphylaxis, have been reported rarely. Anaphylactoid events may be manifested by solitary symptoms, including angioedema, edema (including face and limbs), paresthesias, syncope, or vasodilatation. Anaphylaxis may be more common in patients with a history of penicillin allergy. Rarely, hypersensitivity symptoms may persist for several months.

Symptoms of pseudomembranous colitis may appear either during or after antibiotic treatment.

Laboratory

Abnormal urinalysis, eosinophilia, leukopenia, neutropenia, transient elevations in AST, and transient thrombocytopenia have been reported.

Cephalosporin-Class Reactions

In addition to the adverse reactions listed above, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics:

Clinical

Confusion, erythema multiforme, genital pruritus, hepatic dysfunction including cholestasis, hemolytic anemia, reversible hyperactivity, hypertonia, and reversible interstitial nephritis.

Laboratory

Positive direct Coombs’ test.

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

• Geniclor suspension only works against bacteria; it does not treat viral infections (eg, the common cold).
• Long-term or repeated use of Geniclor suspension may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
• Diabetes patients - Geniclor suspension may cause the results of some tests for urine glucose to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine.
• Be sure to use Geniclor suspension for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
• Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.
• Use Geniclor suspension with caution in the ELDERLY; they may be more sensitive to its effects.
• PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Geniclor suspension while you are pregnant. Geniclor suspension is found in breast milk. If you are or will be breast-feeding while you use Geniclor suspension, check with your doctor. Discuss any possible risks to your baby.

Geniclor contraindications

Geniclor extended-release tablets are contraindicated in patients with known hypersensitivity to Geniclor and other cephalosporins.

References

1. DailyMed. "CEFACLOR: 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. "cefaclor: 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. "Cefaclor: 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 Geniclor 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 Geniclor. 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.

User reports

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Information checked by Dr. Sachin Kumar, MD Pharmacology