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

< 1 month:

1. Abdominal distension
2. Anaphylactic reaction (serious allergic reaction)
3. Cholecystitis (infection of gallbladder)
4. Dehydration (dryness resulting from the removal of water)
5. Dysgeusia (disorder of the sense of taste)
6. Grand mal convulsion (a type of generalized seizure that affects the entire brain)
7. Nausea (feeling of having an urge to vomit)

1 - 6 months:

n/a

6 - 12 months:

n/a

1 - 2 years:

n/a

2 - 5 years:

n/a

5 - 10 years:

n/a

10+ years:

n/a

not specified:

1. Haemorrhage intracranial (bleeding within the skull)
2. Abdominal distension
3. Abdominal pain
4. Alpha 1 foetoprotein increased
5. Anxiety
6. Arrhythmia (irregular heartbeat)
7. Back pain
8. Cardiac failure congestive
9. Chest pain
10. Deep vein thrombosis (blood clot in a major vein that usually develops in the legs and/or pelvis)

female:

1. Abdominal pain
2. Back pain
3. Cardiac failure congestive
4. Chest pain
5. Cholecystitis (infection of gallbladder)
6. Chronic kidney disease
7. Deep vein thrombosis (blood clot in a major vein that usually develops in the legs and/or pelvis)
8. Dehydration (dryness resulting from the removal of water)
9. Diabetes mellitus (diabetes, caused by a deficiency of the pancreatic hormone insulin)
10. Drug hypersensitivity

male:

1. Haemorrhage intracranial (bleeding within the skull)
2. Abdominal distension
3. Alpha 1 foetoprotein increased
4. Anaphylactic reaction (serious allergic reaction)
5. Anxiety
6. Arrhythmia (irregular heartbeat)
7. Chronic kidney disease
8. Drug ineffective

0-1:

n/a

2-9:

n/a

10-19:

n/a

20-29:

1. Drug ineffective

30-39:

1. Abdominal distension
2. Deep vein thrombosis (blood clot in a major vein that usually develops in the legs and/or pelvis)
3. Diabetes mellitus (diabetes, caused by a deficiency of the pancreatic hormone insulin)

40-49:

1. Abdominal distension
2. Chest pain
3. Gastric disorder (disease of stomach)

50-59:

1. Chronic kidney disease
2. Anaphylactic reaction (serious allergic reaction)
3. Anxiety
4. Arrhythmia (irregular heartbeat)
5. Back pain
6. Drug hypersensitivity
7. Grand mal convulsion (a type of generalized seizure that affects the entire brain)

60+:

1. Dehydration (dryness resulting from the removal of water)
2. Dysgeusia (disorder of the sense of taste)
3. Malaise (a feeling of general discomfort or uneasiness)
4. Nausea (feeling of having an urge to vomit)
5. Unexpected therapeutic effect
6. Haemorrhage intracranial (bleeding within the skull)
7. Abdominal distension
8. Abdominal pain
9. Abdominal pain upper
10. Alpha 1 foetoprotein increased