Consists of Folic Acid, Mecobalamin
What are the possible side effects of Folic Acid (Cobal F)?
Get emergency medical help if you have any of these signs of an allergic reaction to Folic Acid (Cobal F): hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Less serious side effects are more likely, but may include:
-
nausea, loss of appetite;
-
bloating, gas;
-
bitter or unpleasant taste in your mouth;
-
sleep problems;
-
depression; or
-
feeling excited or irritable.
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 Folic Acid (Cobal F) in details
Allergic sensitization has been reported following both oral and parenteral administration of Folic Acid (Cobal F).
Folic Acid (Cobal F) is relatively nontoxic in man. Rare instances of allergic responses to Folic Acid (Cobal F) preparations have been reported and have included erythema, skin rash, itching, general malaise, and respiratory difficulty due to bronchospasm. One patient experienced symptoms suggesting anaphylaxis following injection of the drug. Gastrointestinal side effects, including anorexia, nausea, abdominal distention, flatulence, and a bitter or bad taste, have been reported in patients receiving 15 mg Folic Acid (Cobal F) daily for 1 month. Other side effects reported in patients receiving 15 mg daily include altered sleep patterns, difficulty in concentrating, irritability, overactivity, excitement, mental depression, confusion, and impaired judgment. Decreased vitamin B12 serum levels may occur in patients receiving prolonged Folic Acid (Cobal F) therapy.
In an uncontrolled study, orally administered Folic Acid (Cobal F) was reported to increase the incidence of seizures in some epileptic patients receiving phenobarbital, primidone, or diphenylhydantoin. Another investigator reported decreased diphenylhydantoin serum levels in folate-deficient patients receiving diphenylhydantoin who were treated with 5 mg or 15 mg of Folic Acid (Cobal F) daily.
CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088 OR LEADING PHARMA, LLC AT 844-740-7500.
What is the most important information I should know about Folic Acid (Cobal F)?
You should not use this medication if you have ever had an allergic reaction to Folic Acid (Cobal F).
Before you take Folic Acid (Cobal F), tell your doctor if you have kidney disease (or if you are on dialysis), an infection, if you are an alcoholic, or if you have any type of anemia that has not been diagnosed by a doctor and confirmed with laboratory testing.
Talk to your doctor about taking Folic Acid (Cobal F) during pregnancy or while breast-feeding.
Folic Acid (Cobal F) is sometimes used in combination with other medications to treat pernicious anemia. However, Folic Acid (Cobal F) will not treat Vitamin B12 deficiency and will not prevent possible damage to the spinal cord. Take all of your medications as directed.
Folic Acid (Cobal F) contraindications
Because it may mask the hematologic abnormalities while neurological damage progresses, Folic Acid (Cobal F) should not be used in the therapy of patients with vitamin B12 deficiency of any cause, unless there is associated folate deficiency. The Folic Acid (Cobal F) content of one tablet a day however, is unlikely to mask pernicious anemia should this condition be present. Also, pregnancy during pernicious anemia is very rare.
Side effects of Mecobalamin (Cobal F) in details
Body as a Whole: Infrequent: Allergic reaction, chills, and malaise.
Cardiovascular System: Infrequent: Flushing, hot flashes, hypertension, palpitations, postural hypotension, syncope, tachycardia, and vasodilation.
Dermatological: Infrequent: Acne, alopecia, hirsutism, maculopapular rash, skin discoloration, and urticaria. Rare: Angioedema, erythema, exfoliative dermatitis, fungal dermatitis, herpes zoster, leukoderma, multiforme erythema, petechial rash, pustular rash, Stevens-Johnson syndrome, and vesiculobullous rash.
Digestive System: Infrequent: Dysphagia, eructation, gastritis, gingivitis, increased appetite, increased salivation, liver function tests abnormal, and mouth ulceration. Rare: Gastrointestinal hemorrhage, glossitis, gum hemorrhage, gum hyperplasia, hematemesis, hemorrhagic colitis, hepatitis, melena, stomach ulcer, stomatitis, and tongue edema.
Endocrine System: Rare: Goiter and hypothyroidism.
Hematologic and Lymphatic System: Infrequent: Ecchymosis and leukopenia. Rare: Anemia, eosinophilia, fibrin decrease, fibrinogen decrease, iron deficiency anemia, leukocytosis, lymphocytosis, macrocytic anemia, petechia, and thrombocytopenia.
Metabolic and Nutritional Disorders: Infrequent: Aspartate transaminase increased. Rare: Alcohol intolerance, alkaline phosphatase increase, alanine transaminase increase, bilirubinemia, general edema, gamma glutamyl transpeptidase increase, and hyperglycemia.
Musculoskeletal System: Infrequent: Arthritis, leg cramps, myasthenia, and twitching. Rare: Bursitis, muscle atrophy, pathological fracture, and tendinous contracture.
Nervous System: Frequent: Confusion and paresthesia. Infrequent: Akathisia, apathy, aphasia, CNS depression, depersonalization, dysarthria, dyskinesia, euphoria, hallucinations, hostility, hyperkinesia, hypertonia, libido decreased, memory decrease, mind racing, movement disorder, myoclonus, panic attack, paranoid reaction, personality disorder, psychosis, sleep disorder, stupor, and suicidal ideation. Rare: Choreoathetosis, delirium, delusions, dysphoria, dystonia, extrapyramidal syndrome, faintness, grand mal convulsions, hemiplegia, hyperalgesia, hyperesthesia, hypokinesia, hypotonia, manic depression reaction, muscle spasm, neuralgia, neurosis, paralysis, and peripheral neuritis.
Respiratory System: Infrequent: Yawn. Rare: Hiccup and hyperventilation.
Special Senses: Frequent: Amblyopia. Infrequent: Abnormality of accommodation, conjunctivitis, dry eyes, ear pain, photophobia, taste perversion, and tinnitus. Rare: Deafness, lacrimation disorder, oscillopsia, parosmia, ptosis, strabismus, taste loss, uveitis, and visual field defect.
Urogenital System: Infrequent: Abnormal ejaculation, hematuria, impotence, menorrhagia, polyuria, and urinary incontinence. Rare: Acute kidney failure, anorgasmia, breast abscess, breast neoplasm, creatinine increase, cystitis, dysuria, epididymitis, female lactation, kidney failure, kidney pain, nocturia, urinary retention, and urinary urgency.
Postmarketing Experience
The following adverse events (not listed above in clinical trials or other sections of the prescribing information) have been identified during postapproval use of LAMICTAL. Because these events 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.
Blood and Lymphatic: Agranulocytosis, hemolytic anemia.
Gastrointestinal: Esophagitis.
Hepatobiliary Tract and Pancreas: Pancreatitis.
Immunologic: Lupus-like reaction, vasculitis.
Lower Respiratory: Apnea.
Musculoskeletal: Rhabdomyolysis has been observed in patients experiencing hypersensitivity reactions.
Neurology: Exacerbation of Parkinsonian symptoms in patients with pre-existing
Parkinson's disease, tics.
Non-site Specific: Progressive immunosuppression.
Mecobalamin (Cobal F) contraindications
Hypersensitivity to mecobalamin or other vit B12-containing, cobalamin products or cobalt.
References
- DailyMed. "ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E: 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).
- DTP/NCI. "folic acid: 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).
- European Chemicals Agency - ECHA. "Folic acid: 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 Cobal F 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 Cobal F. 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
Consumer reported side effects
No survey data has been collected yetConsumer reviews
There are no reviews yet. Be the first to write one! |
Information checked by Dr. Sachin Kumar, MD Pharmacology
