Table 4

The ADRs recorded per case study

Case studyTotal ADRs reportedCOS affectedADR terms given in case report (/73)
Byrne, et al 32Bruxism
Funny feeling in his tummy
Sleepwalking
Kobayashi, et al 124Arthritis
Churg-Strauss syndrome
Diminished sensation of pain and touch
Dysesthesia
Gait disturbance developed
Higher rheumatoid factor
Muscle atrophy
Muscle weakness in arm
Myalgia
Numbness and pain of fingers
Polyarthralgia
Right paranasal sinusitis
Kocyigit, et al 31Anxiety
Hallucination
Insomnia
Montoro De Francisco, et al 11Fever
Scholz, et al 52Decline in school performance
Irritability
Nervousness
Reduced attention span
Restlessness
Skillman, et al (1/2)71Crying when waking
Disorientated when waking
Irritable
Night terrors
Sleepwalking
Separation anxiety
Tantrums
Skillman, et al (2/2)52Anxiety
Separation anxiety
Difficulty falling asleep without parent
Stomach pain
Nausea
Star102Abdominal pain
Anxiety
Change in mood
Change in sleeping patterns
Depression
Felt he was going crazy
Nausea
Sleeping badly
Suicidal ideation
Vomiting
  • The case reports identify eight patients who presented with a leukotriene receptor antagonist-induced ADR. The ADR terms as described in the case reports are given.

  • ADR, adverse drug reaction; COS, Core Outcome Set.