Increase in transaminase
 
Infections and infestations
     Influenza

Localised infection

Nasopharyngitis
 
Injury, poisoning and procedural complications
   Contusion
  
Investigations
     Blood pressure increased

Blood lactate dehydrogenase increased

Body temperature increased

Weight decreased

Weight increased
 
Metabolism and nutrition disorders
     Alcohol intolerance

Anorexia

Decreased appetite

Dehydration

Gout
 
Musculoskeletal and connective tissue disorders
   Arthralgia

Myalgia

Muscle spasms

Pain in extremity

Back pain

Bone pain
 Muscle tightness

Muscular weakness

Shoulder pain

Muscle twitching
 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
     Multiple myeloma

Myelofibrosis
 
Nervous system disorders
 Headache
 Dizziness

Migraine

Paraesthesia
 Clonus

Dysgeusia

Hypoaesthesia

Hypogeusia

Neuropathy peripheral

Transverse sinus thrombosis
 
Psychiatric disorders
   Insomnia
 Depression

Abnormal dreams
 
Renal and urinary disorders
     Protein urine present
 
Reproductive system and breast disorders
     Vaginal haemorrhage
 
Respiratory, thoracic and mediastinal disorders
   Pulmonary embolism*
 Cough

Rhinorrhoea

Dry throat

Dyspnoea

Nasal congestion

Painful respiration
 
Skin and subcutaneous tissue disorders
   Pruritus

Ecchymosis

Rash
 Alopecia

Photosensitivity reaction

Acne

Dermatitis contact

Dry skin

Eczema

Erythema

Exfoliative rash

Hair growth abnormal

Prurigo

Purpura

Rash papular

Rash pruritic

Skin nodule

Skin odour abnormal

Urticaria
 
Vascular disorders
   Flushing
 Deep vein thrombosis

Hypotension

Peripheral embolism

Peripheral ischaemia

Phlebitis

Thrombophlebitis superficial

Thrombosis

* see section 4.4

c. Description of selected adverse reactions

In addition the reactions listed below have been deemed to be related to romiplostim treatment.

Thrombocytosis

Based on an analysis of all adult ITP patients receiving romiplostim in 4 controlled and 5 uncontrolled clinical studies, 3 events of thrombocytosis were reported, n = 271. No clinical sequelae were reported in association with the elevated platelet counts in any of the 3 subjects.

Thrombocytopenia after cessation of treatment

Based on an analysis of all adult ITP patients receiving romiplostim in 4 controlled and 5 uncontrolled clinical studies, 4 events of thrombocytopenia after cessation of treatment were reported, n = 271 (see section 4.4).

Progression of existing Myelodysplastic Syndromes (MDS)

Based on available data from a randomized clinical study in su