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Flagyl/Flagyl Forte

Flagyl/Flagyl Forte Adverse Reactions

metronidazole

Manufacturer:

Kalventis Sinergi Farma
The information highlighted (if any) are the most recent updates for this brand.
Full Prescribing Info
Adverse Reactions
Flagyl Suspension: Gastrointestinal disorders: Epigastric pain, nausea, vomiting, diarrhea.
Oral mucositis, taste disorders, anorexia.
Reversible cases of pancreatitis.
Tongue discoloration/ furry tongue (e.g. due to fungal overgrowth).
Immune system disorders: Angioedema, anaphylactic shock.
Nervous system disorders: Peripheral sensory neuropathy.
Headache, convulsions, dizziness.
Reports of encephalopathy (e.g. confusion) and subacute cerebellar syndrome (e.g. ataxia, dysarthria, gait impairment, nystagmus, and tremor ), which may resolve with discontinuation of the drug.
Aseptic meningitis.
Psychiatric disorders: Psychotic disorders including confusion, hallucinations.
Depressed mood.
Eye disorders: Transient vision disorders such as diplopia, myopia, blurred vision, decreased visual acuity, changes in color vision.
Optic neuropathy/neuritis.
Blood and lymphatic system disorders: Cases of agranulocytosis, neutropenia and thrombocytopenia have been reported.
Mild reversible leucopenia in some patients has been reported.
Hepatobiliary disorders:
Increase in liver enzymes (AST, ALT, alkaline phosphatase), cholestatic or mixed hepatitis and hepatocellular liver injury, sometimes with jaundice, have been reported.
Cases of liver failure requiring liver transplant have been reported in patients treated with metronidazole in combination with other antibiotics.
Skin and subcutaneous tissue disorders: Rash, pruritus, flushing, urticaria.
Pustular eruptions.
General disorders and administration site conditions: Fever.
Flagyl Suppository: The frequency of adverse events listed below is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Blood and lymphatic system disorders: Very rare: Agranulocytosis, neutropenia, thrombocytopenia, pancytopenia.
Not known: Leucopenia.
Immune system disorders: Rare: Anaphylaxis.
Not known: Angioedema, urticaria, fever.
Metabolism and nutrition disorders: Not known: Anorexia.
Psychiatric disorders: Very rare: Psychotic disorders, including confusion and hallucinations.
Not known: Depressed mood.
Nervous system disorders: Very rare: Encephalopathy (eg. confusion, fever, headache, hallucinations, paralysis, light sensitivity, disturbances in sight and movement, stiff neck) and subacute cerebellar syndrome (eg. ataxia, dysathria, gait impairment, nystagmus and tremor) which may resolve on discontinuation of the drug.
Drowsiness, dizziness, convulsions, headaches.
Not known: During intensive and/or prolonged metronidazole therapy, peripheral sensory neuropathy or transient epileptiform seizures have been reported. In most cases neuropathy disappeared after treatment was stopped or when dosage was reduced.
Aseptic menigitis.
Eye disorders: Very rare: Vision disorders such as diplopia and myopia, which, in most cases, is transient.
Not known: Optic neuropathy/neuritis.
Gastrointestinal disorders: Not known: Taste disorders, oral mucositis, furred tongue, nausea, vomiting, gastrointestinal disturbances such as epigastric pain and diarrhoea.
Hepatobiliary disorders: Very rare: Increase in liver enzymes (AST, ALT, alkaline phosphatase), cholestatic or mixed hepatitis and hepatocellular liver injury, jaundice and pancreatitis which is reversible on drug withdrawal.
Cases of liver failure requiring liver transplant have been reported in patients treated with metronidazole in combination with other anitibiotic drugs.
Skin and subcutaneous tissue disorders: Very rare: Skin rashes, pustular eruptions, pruritis, flushing.
Not known: Erythema multiforme, Stevens-Johnson syndrome or toxic epidermal necrolysis.
Musculoskeletal, connective tissue and bone disorders: Very rare: Myalgia, arthralgia.
Renal and Urinary disorders: Very rare: Darkening of urine (due to metronidazole metabolite).
Flagyl Forte: Gastrointestinal disorders: Epigastric pain, nausea, vomiting, diarrhea.
Oral mucositis, taste disorders, anorexia.
Reversible cases of pancreatitis.
Tongue discoloration/furry tongue (e.g. due to fungal overgrowth).
Immune system disorders: Angioedema, anaphylactic shock.
Nervous system disorders: Peripheral sensory neuropathy.
Headache, convulsions, dizziness.
Reports of encephalopathy (e.g. confusion ) and subacute cerebellar syndrome (e.g. ataxia, dysarthria, gait impairment, nystagmus, and tremor which may resolve with discontinuation of the drug.
Aspetic meningitis.
Psychiatric disorders: psychiatric disorders including confuison, hallucinations.
Depressed mood.
Eye disorders: Transient vision disorders such as diplopia, myopia, blurred vision, decreased visual acuity, changes in colored vision.
Optic neuropathy/neuritis.
Blood and lympathic system disorders: Cases of agranulocytosis, neutropenia and thrombocytopenia have been reported.
Mild reversible leucopenia in some patients has been reported.
Hepatobiliary disorders: Increase in liver enzymes (AST, ALT, alkaline phosphatase), cholestatic or mixed hepatitis and hepatocellular liver injury, sometimes with jaundice, have been reported.
Cases of liver failure requiring liver transplant have been reported in patients treated with metronidazole in combination with other antibiotic drugs.
Skin and subcutaneous tissue disorders: Rash, pruritus, flushing, urticaria.
Pustular eruptions.
General disorders and administration site conditions: Fever.
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