Cotempla xr-odt side effects by duration, gender and age - a phase IV clinical study of FDA data

< 1 month:

1. Pigmentation disorder (disturbances of human skin colour)
2. Pruritus (severe itching of the skin)
3. Rash
4. Abnormal behaviour
5. Anxiety
6. Drug ineffective
7. Abdominal discomfort
8. Drug effect increased
9. Dyskinesia (abnormality or impairment of voluntary movement)

1 - 6 months:

1. Abdominal pain

6 - 12 months:

1. Disturbance in attention
2. Trichotillomania (the compulsive urge to pull out (and in some cases, eat) one's own hair leading to noticeable hair loss, distress)

1 - 2 years:

1. Retching (strong involuntary effort to vomit)

2 - 5 years:

n/a

5 - 10 years:

n/a

10+ years:

n/a

not specified:

1. Affect lability (emotional incontinence)
2. Drug ineffective
3. Abdominal pain upper
4. Abnormal behaviour
5. Decreased appetite
6. Dizziness
7. Emotional disorder
8. Headache (pain in head)
9. Nausea (feeling of having an urge to vomit)
10. Retching (strong involuntary effort to vomit)

female:

1. Abdominal pain upper
2. Abdominal discomfort
3. Abnormal behaviour
4. Affect lability (emotional incontinence)
5. Anxiety
6. Disturbance in attention
7. Dizziness
8. Drug effect prolonged
9. Drug ineffective
10. Heart rate increased

male:

1. Drug ineffective
2. Affect lability (emotional incontinence)
3. Bronchitis (inflammation of the mucous membrane in the bronchial tubes)
4. Chest pain
5. Constipation
6. Dizziness
7. Drug effect increased
8. Dyskinesia (abnormality or impairment of voluntary movement)
9. Dyspnoea (difficult or laboured respiration)
10. Emotional disorder

0-1:

n/a

2-9:

1. Abnormal behaviour
2. Drug ineffective
3. Affect lability (emotional incontinence)
4. Anxiety
5. Arachnoid cyst
6. Dizziness
7. Gastrointestinal disorder (functional problems of gastrointestinal tract)
8. Impulsive behaviour
9. Nausea (feeling of having an urge to vomit)
10. Rash

10-19:

1. Abdominal pain
2. Anxiety
3. Abdominal pain upper
4. Affect lability (emotional incontinence)
5. Arthralgia (joint pain)
6. Chest pain
7. Constipation
8. Dizziness
9. Drug effect increased
10. Drug ineffective

20-29:

1. Abdominal discomfort
2. Vomiting

30-39:

n/a

40-49:

n/a

50-59:

n/a

60+:

n/a