Archifar Adverse Reactions

The following adverse reactions have been identified following clinical studies with meropenem. Their frequency is presented in Frequency of Adverse Reactions (data derived from clinical trial data sources) using CIOMS III frequency classification and then listed by MedDRA SOC and at the preferred level.
Frequencies of occurrence of undesirable effects are defined as: Very common (≥1/10; ≥10%); common (≥1/100 to <1/10; ≥1% to <10%); uncommon (≥1/1000 to <1/100; ≥0.1% to <1%); rare (≥1/10,000 to <1/1000; ≥0.01% to <0.1%); very rare (<1/10,000; <0.01%).
Frequency of Adverse Reactions (Data Derived from Clinical Trial Data Sources): Infections and Infestations: Uncommon: Oral and vaginal candidiasis.
Blood and Lymphatic System Disorders: Common: Thrombocythaemia. Uncommon: Eosinophilia, thrombocytopenia, leucopenia, neutropenia.
Nervous System Disorders: Common: Headache. Uncommon: Paraesthesiae. Rare: Convulsions.
Gastrointestinal Disorders: Common: Diarrhoea, vomiting, nausea, abdominal pain.
Hepatobiliary Disorders: Increased common alanine aminotransferase, aspartate aminotransferase, blood alkaline phosphatase, blood lactate dehydrogenase and γ-glutamyltransferase. Uncommon: Increased blood bilirubin.
Skin and Subcutaneous Tissue Disorders: Common: Rash, pruritis. Uncommon: Urticaria.
General Disorders and Administration Site Conditions: Common: Inflammation, pain. Uncommon: Thrombophlebitis. Not Known: Pain at the injection site.
The following adverse reactions have been identified from post-marketing clinical trials and spontaneous reports. Their frequency is presented in Reporting Rate of Adverse Reactions (data derived from a combination of post-marketing clinical trial and spontaneous sources) using CIOMS III frequency classification and then listed by MedDRA SOC and at the preferred level.
Frequencies of occurrence of undesirable effects are defined as: Very common (≥1/10; ≥10%); common (≥1/100 to <1/10; ≥1% to <10%); uncommon (≥1/1000 to <1/100; ≥0.1% to <1%); rare (≥1/10,000 to <1/1000; ≥0.01% to <0.1%); very rare (<1/10,000; <0.01%).
Reporting Rate of Adverse Reactions (Data Derived from a Combination of Post-Marketing Clinical Trial and Spontaneous Sources): Blood and Lymphatic System Disorders: Rare: Agranulocytosis. Very Rare: Haemolytic anaemia.
Immune System Disorders: Very Rare: Angioedema, manifestations of anaphylaxis.
Gastrointestinal Disorders: Very Rare: Pseudomembranous colitis.
Skin and Subcutaneous Tissue Disorders: Very Rare: Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme.