Study: NCT01449266

Adverse event: moderate sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Five days after Dotarem® injection subject experienced moderate sepsis deemed not related. Subject was hospitalized and recovered after 15 days following antibiotic treatment.

This AE was considered as not related to the Dotarem® injection.
Frequency: 2 affected / 10 at risk

Adverse event: severe respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: This adverse event was considered as not related to the Dotarem® injection.
Frequency: 1 affected / 10 at risk

Adverse event: severe peripheral ischemia
Serious: yes
Organ System: Vascular disorders
Notes: This adverse event was considered as not related to the Dotarem® injection.
Frequency: 1 affected / 10 at risk

Adverse event: moderate thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: This adverse event was considered as not related to the Dotarem® injection.
Frequency: 1 affected / 10 at risk

Adverse event: severe urosepsis
Serious: yes
Organ System: Infections and infestations
Notes: This adverse event was considered as not related to the Dotarem® injection.
Frequency: 1 affected / 10 at risk

Adverse event: Dialysis device insertion
Serious: yes
Organ System: Surgical and medical procedures
Notes: This adverse event was considered as not related to the Dotarem® injection.
Frequency: 1 affected / 10 at risk

Adverse event: Nephrectomy
Serious: yes
Organ System: Surgical and medical procedures
Notes: This adverse event was considered as not related to the Dotarem® injection.
Frequency: 1 affected / 10 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: This adverse event was considered as not related to the Dotarem® injection.
Frequency: 5 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: This adverse event was considered as not related to the Dotarem® injection.
Frequency: 3 affected / 10 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: This adverse event was considered as not related to the Dotarem® injection.
Frequency: 3 affected / 10 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: This adverse event was considered as not related to the Dotarem® injection.
Frequency: 1 affected / 10 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: This adverse event was considered as not related to the Dotarem® injection.
Frequency: 1 affected / 10 at risk

Adverse event: influenza-like illness
Serious: no
Organ System: General disorders
Notes: This adverse event was considered as not related to the Dotarem® injection.
Frequency: 1 affected / 10 at risk

Adverse event: Thirst
Serious: no
Organ System: General disorders
Notes: This adverse event was considered as not related to the Dotarem® injection.
Frequency: 1 affected / 10 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: This adverse event was considered as not related to the Dotarem® injection.
Frequency: 1 affected / 10 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: This adverse event was considered as not related to the Dotarem® injection.
Frequency: 1 affected / 10 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: This adverse event was considered as not related to the Dotarem® injection.
Frequency: 1 affected / 10 at risk

Adverse event: Dizziness postural
Serious: no
Organ System: Nervous system disorders
Notes: This adverse event was considered as not related to the Dotarem® injection.
Frequency: 1 affected / 10 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Notes: This adverse event was considered as not related to the Dotarem® injection.
Frequency: 1 affected / 10 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: This adverse event was considered as not related to the Dotarem® injection.
Frequency: 1 affected / 10 at risk