Vexpinem 500 Adverse Reactions

The evaluation of adverse reactions is based on the following definition of frequency: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1 /1000), Very rare (<1/10,000), Not known (cannot be estimated from the available data).
The following reactions are rare, very rare, and/or their frequency cannot be estimated from the available data, but they may be serious: Anaphylactic reactions: angioedema, toxic epidermal necrolysis/Stevens-Johnson syndrome, exfoliative dermatitis, acute renal failure; Pseudomembranous colitis; Seizures or convulsions.
Infections and infestations: Rare: superinfections with Candida or Stenotrophomonas maltophilia.
Immune system disorders: Rare: erythema multiforme, anaphylactic reactions, severe allergic reactions (immediately).
Nervous system disorders: Uncommon: myoclonic activity, somnolence, dizziness, vertigo, headache, psychic disturbances, including hallucinations, paraesthesia, confusional states or convulsions.
Rare: encephalopathy.
Respiratory, thoracic and mediastinal disorders: Very rare: hyperventilation, dyspnoea.
Gastrointestinal disorders: Uncommon: nausea, vomiting, diarrhoea, staining of teeth and/or tongue.
Rare: pseudomembranous colitis, taste perversion.
Not known: haemorrhagic colitis, gastro-enteritis, abdominal pain, glossitis, tongue papillar hypertrophy, heartburn, pharyngeal pain, increased salivation.
Hepato-biliary disorders: Common: mild increases in serum transaminases, bilirubin and/or serum alkaline phosphatase.
Rare: hepatitis with liver failure.
Very rare: fulminant hepatitis
Skin and subcutaneous tissue disorders: Common: rash, pruritus, urticaria.
Rare: erythema multiforme, Stevens-Johnson syndrome, angioedema, toxic epidermal necrolysis, exfoliative dermatitis.
Not known: flushing, cyanosis, hyperhidrosis, skin texture changes, pruritus vulvae.
Musculoskeletal and connective tissue disorders: Very rare: asthenia and aggravation of myasthenia gravis.
Not known: polyarthralgia and chest discomfort/pain.
Renal and urinary disorders: Rare: oliguria/anuria and polyuria.
Very rare: acute renal failure, elevated serum creatinine and blood urea, a harmless urine discoloration, not to be confused with haematuria, has been seen in children.
General disorders and administration site conditions: Common: erythema, local pain and induration, thrombophlebitis.
Rare: asthenia/weakness.
Unknown: fever including drug fever.