How side effects are graded

Side effects are graded from 1 to 4. Grade 1 is very mild and grade 4 is very serious.

How side effects are discovered
Side effects grades
Common side effects & grades table

How side effects are discovered

Most information about the risk of side effects comes from the studies when the drugs were first developed. This is why it is important to report all side effects if you take part in a trial.

Trials collect information about how often all side effects occur and how serious they are. But studies for new HIV drugs only use relatively small groups of people for relatively short periods.

Some side effects only become apparent after the drugs have been approved and they have been used by thousands more people.

Knowing what the risk of side effects are for a particular drug -– ie what percentage of people get these side effects – can help you to make an informed decision about which drugs to choose. Where a side effect is very common, knowing what percentage of people who needed to change therapy because of it, is useful too.

Information can be provided by your doctor, a community treatment organisation, your friends or the internet. It is usually also included in the information that you should get with all drugs.

Although there are slightly different details for reporting the severity of each side effect, medical research grades these from 1 to 4. Grade 1 is mild and grade 4 is serious, life threatening or requiring hospitalisation.

Side effect grades

GRADE 1 (Mild)
Transient (goes away after a short time) or mild discomfort; no limitation in activity; no medical intervention/therapy required.

GRADE 2 (Moderate)
Your daily activity is affected mild to moderately – some assistance may be needed; no or minimal medical intervention/therapy required.

GRADE 3 (Severe)
Your daily activity is markedly reduced – some assistance usually required; medical intervention/therapy required, hospitalisation or hospice care possible.

GRADE 4 (Potentially life threatening)
Extreme limitation to daily activity, significant assistance required; significant medical intervention/therapy, hospitalisation or hospice care very likely.

Side effects and grades table

An indication of grading (based on US NIH Division of AIDS) is shown below together with specific details for some of the most common side effects.

SIDE EFFECTS GRADED
Side effect	Grade 1	Grade 2	Grade 3	Grade 4
Diarrhoea	3-4 loose stools a day OR mild diarrhoea lasting less than one week	5-7 loose stool a day OR diarrhoea lasting more than one week	Bloody diarrhoea OR over 7 loose stools a day OR needing IV treatment OR feeling dizzy when standing	Hospitalisation required (possible also for Grade 3)
Fatigue	Normal activity reduced by less than 25%	Normal activity reduced by reduced by 25-50 %	Normal activity reduced by over 50 % – cannot work	Unable to care for yourself
Liver toxicity: AST or ALT levels	1.25-2.5 Upper Limit Normal	>2.5-5.0 ULN	5.0-7.5 ULN	>7.5 ULN
Mood disturbance	Mild anxiety, able to continue daily tasks	Moderate anxiety/disturbance, interfering with ability to work, etc	Severe mood changes requiring medical treatment Unable to work	Acute psychosis, suicidal thoughts
Nausea	Mild OR transient reasonable food intake	Moderate discomfort OR intake decreased for less than 3 days	Severe discomfort OR minimal food intake for more than 3 days	Hospitalisation required
Rash	Redness or itchy skin on part or whole body	Rash that breaks skin, hard or soft pimples OR light peeling/scaling	Blistering, open ulcers, wet peeling, serious rash over large areas	Severe rash, Stevens Johnson syndrome. Severe broken skin, etc
Vomiting	2-3 episodes a day OR mild vomiting for less than one week	4-5 episodes a day OR mild vomiting for more than one week	Severe vomiting of all food and fluids over 24 hours OR needing IV treatment OR feeling dizzy when standing	Hospitalisation for IV treatment (possibly also for Grade 3)

SIDE EFFECTS GRADED

Side effect

Grade 1

Grade 2

Grade 3

Grade 4

Diarrhoea

3-4 loose stools a day OR mild diarrhoea lasting less than one week

5-7 loose stool a day OR diarrhoea lasting more than one week

Bloody diarrhoea OR over 7 loose stools a day OR needing IV treatment OR feeling dizzy when standing

Hospitalisation required (possible also for Grade 3)

Fatigue

Normal activity reduced by less than 25%

Normal activity reduced by reduced by 25-50 %

Normal activity reduced by over 50 % – cannot work

Unable to care for yourself

Liver toxicity: AST or ALT levels

1.25-2.5 Upper Limit Normal

>2.5-5.0 ULN

5.0-7.5 ULN

>7.5 ULN

Mood disturbance

Mild anxiety, able to continue daily tasks

Moderate anxiety/disturbance, interfering with ability to work, etc

Severe mood changes requiring medical treatment Unable to work

Acute psychosis, suicidal thoughts

Nausea

Mild OR transient reasonable food intake

Moderate discomfort OR intake decreased for less than 3 days

Severe discomfort OR minimal food intake for more than 3 days

Hospitalisation required

Rash

Redness or itchy skin on part or whole body

Rash that breaks skin, hard or soft pimples OR light peeling/scaling

Blistering, open ulcers, wet peeling, serious rash over large areas

Severe rash, Stevens Johnson syndrome. Severe broken skin, etc

Vomiting

2-3 episodes a day OR mild vomiting for less than one week

4-5 episodes a day OR mild vomiting for more than one week

Severe vomiting of all food and fluids over 24 hours OR needing IV treatment OR feeling dizzy when standing

Hospitalisation for IV treatment (possibly also for Grade 3)