eosinophilia, international normalised ratio (INR) increased
Rare:
Prothrombin time (PT) prolonged
Immune system disorders
Not known*:
Hypersensitivity**, manifested by isolated spontaneous reports including, but not limited to pulmonary eosinophilia, vesicobullous rash with mucous membrane involvement and sensation of oropharyngeal swelling
Not known*:
Anaphylaxis**
Not known*:
Infusion reactions including the following symptoms: tachycardia, wheezing, pyrexia, rigors, systemic flushing, vertigo, syncope and metallic taste
Metabolism and nutrition disorders
Uncommon:
Decreased appetite, hyperglycaemia, electrolyte imbalance
Psychiatric disorders
Common:
Anxiety, insomnia
Nervous system disorders
Common:
Dizziness, headache
Uncommon:
Paraesthesia, taste disorder, tremor
Not known*:
Peripheral neuropathy**
Ear and labyrinth disorders
Uncommon:
Vertigo
Cardiac disorders
Uncommon:
Supraventricular tachycardia, extrasystole
Vascular disorders
Common:
Hypertension, hypotension
Uncommon:
Flushes
Respiratory, thoracic and mediastinal disorders
Not known*:
Eosinophilic pneumonia1**
Gastrointestinal disorders
Common:
Gastrointestinal and abdominal pain, nausea, vomiting, constipation, diarrhoea, flatulence, bloating and distension
Uncommon:
Dyspepsia, glossitis
Hepatobiliary disorders
Common:
Liver function tests abnormal2 (increased alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase (ALP))
Rare:
Jaundice
Skin and subcutaneous tissue disorders
Common:
Rash, pruritus
Uncommon:
Urticaria
Musculoskeletal and connective tissue disorders
Common:
Limb pain, serum creatine phosphokinase (CPK)1 increased
Uncommon:
Myositis, increased myoglobin, muscular weakness, muscle pain, arthralgia, serum lactate dehydrogenase (LDH) increased
Not known*:
Rhabdomyolysis3 **
Renal and urinary disorders
Uncommon:
Renal impairment, including renal failure and renal insufficiency, serum creatinine increased
Reproductive system and breast disorders
Uncommon:
Vaginitis
General disorders and administration site conditions
Common:
Infusion site reactions, pyrexia, asthenia
Uncommon:
Fatigue, pain
* Based on post-marketing reports. Since these reports are from a population of uncertain size and are subject to confounding factors, it is not possible to reliably estimate their frequency or establish a causal relationship to exposure to the medicinal product.
** See section 4.4.
1 While the exact incidence of eosinophilic pneumonia associated with daptomycin is unknown, to date the reporting rate of spontaneous reports is very low (<1/10,000).
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