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Side Effect?

Complete a RxISK Report

1 Contact details

2 The person

3 The drug

4 Other meds

5 Side effect

6 RxISK score

7 Impact

8 Drug review

9 Preview

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I acknowledge that I have read and fully understand the Terms and Privacy Policy (see links below) of Data Based Medicine Americas Ltd. and its family of websites. Further, I acknowledge that I have read and fully understand the risks, limitations, and conditions of use of email to send me a copy of the RxISK Report. Other than an email address, I will not provide any personally identifiable information for myself or the person who may have experienced a side effect.
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Share*
- Yes, please share my comments to help others
- No, I don't want my comments to be shared
We would like your permission to publish some of your comments from the report. These questions are marked [share#]. Sharing stories and not just numbers of reports is hugely valuable in allowing others to learn from your experience and understand their own. PLEASE NOTE THAT NO CONTACT DETAILS WILL BE PUBLISHED.
Section 1 — Contact details
Contact information is necessary to email you a copy of the RxISK report and RxISK score.
Email*
Enter Email Confirm Email
May we contact you?*
- Yes
- No
The RxISK research team may want to follow up with you to clarify or get additional information for research.

Section 2 — About the person who experienced the side effect
Supply as much information as you can. Include any medical history or other information you believe may help in the assessment of the side effect.
Who experienced the suspected side effect?
- Me
- My child
- Someone in my care
- My patient
- My client (I am a lawyer)
Gender*
- Male
- Female
- Other
Country*
Age*
Years | Months*
- Years
- Months
- Days
Known medical conditions

Please list one condition per line. Click on the plus sign (+) at the end to add another entry.
Medication allergies (please specify)
Allergic to: Reaction experienced:

Please list one medication allergy per line. Click on the plus sign (+) at the end to add another entry.

Section 3 — About the drug suspected to have caused the side effect
A person who has experienced a side effect should consult a health care practitioner about this and ideally bring this report with them.
Suspect drug*
Which drug do you suspect is causing (or has caused) the side effect? Please enter only one drug.

Suspect drug start date*

Please provide the approximate start date of the suspect drug.

Change	Year	Month	Day	Dose	Unit	Frequency

Suspect drug dose/frequency changes

Please provide the approximate date of any dose/frequency changes (if applicable). Click on the plus sign (+) at the end to add another entry.

Change	Year	Month	Day	Dose	Unit	Frequency

Suspect drug stop date

Please provide the approximate date of stopping the suspect drug (if applicable).

Change	Year	Month	Day

Reason for taking the suspect drug

Section 4 — About other drugs or medications used at the same time
The side effect may have been caused by other prescription drugs or non-prescription medications, or by the combination of products.
List any other PRESCRIPTION DRUGS the person was taking at the same time as the suspect drug.
Prescription drug name Reason for taking How long taking? Any changes around the date of the primary side effect?

Click on the plus sign (+) at the end to add another entry.
List any NON-PRESCRIPTION MEDICATIONS (e.g., supplements, herbals, vitamins, etc.) the person was taking at the same time as the suspect drug.
Non-prescription medication name Reason for taking

Click on the plus sign (+) at the end to add another entry.
Other relevant information (e.g., smoking, pregnancy, alcohol use, etc.)

Section 5 — About the primary side effect
Provide as much information as possible to describe the primary side effect, including dates, symptoms experienced and their severity.
Describe the primary side effect you suspect was caused by the drug and its impact on the person in as much detail as possible. [share#]*
#No contact details will be published.

Primary side effect timeline

Change	Year	Month	Day	Severity

Please provide the approximate start date and the dates of any changes to the primary side effect. Click on the plus sign (+) at the end to add another entry.

At present the primary side effect
- is continuing
- has stopped
What impact did the primary side effect have? (select all boxes that apply)
- Mild
- Unpleasant, but did not affect everyday activities
- Bad enough to affect everyday activities
- Bad enough to see a doctor
- Bad enough to be admitted to hospital
- Caused serious illness
- Caused death
- Other
Date of death
If you selected "Other" above, please provide more detail on the impact of the primary side effect.
Provide available details of laboratory tests (e.g., blood and urine tests, bone density scans, etc.) performed in connection with the primary side effect.
Describe any treatment taken for the primary side effect (e.g., pain relievers).
List any other side effects you suspect were caused by the drug.

Please list one side effect per line. Click on the plus sign (+) at the end to add another entry.
How is the person feeling now?
- Better (no more symptoms)
- Getting better
- Continuing bad (still has symptoms)
- Getting worse
- Died

Section 6 — RxISK causality score
These questions help assess the likelihood that the primary side effect is linked to the suspect drug.
Do you link the side effect to:*
- Starting or taking the drug
- Reducing dose / Tapering off the drug
- Stopping the drug
- Not sure
Did the side effect start before or after REDUCING the dose of the drug?*
- Side effect started after reducing the dose
- Side effect was there before reducing the dose
- Didn't reduce the dose
Was the side effect different from the original condition for which the drug was prescribed?*
- Different from the original condition
- Re-emergence of original condition
- Don't know
Did the side effect start after STOPPING the drug?*
- Side effect started or got worse after stopping
- Side effect stayed the same after stopping
- Didn't stop the drug
Did the side effect improve or clear up if the person RESTARTED the drug?*
- Cleared on restarting
- Didn't clear
- Didn't restart
Did the side effect improve if the person INCREASED the dose of the drug?*
- Improved on increasing the dose
- Didn't improve on increasing the dose
- Didn't increase the dose
How soon after RESTARTING the drug or INCREASING the dose did the problem improve?*
- Cleared within a week
- Cleared within a month
- Cleared after a month
- Didn't restart the drug or increase the dose
Did the problem improve on a related drug?*
- Cleared with related drug
- Didn't clear with related drug
- Didn't try a related drug
Has the person ever experienced the SAME side effect on STOPPING another drug? (If the experience was different in any way answer "No.")*
- Yes, on the same type of drug
- Yes, on another type of drug
- No
- Don't know
Has the person ever experienced any OTHER side effects on STOPPING another drug?*
- Yes, on the same type of drug
- Yes, on another type of drug
- No
Could anything else be causing this side effect?*
- Yes
- No
- Don't know
What else do you suspect might be causing this side effect?
Are there previous reports of side effects on STOPPING the drug in the RxISK database or in a drug regulator database (e.g., FDA, Health Canada, Yellow Card) or elsewhere?*
- Yes
- No
- Don't know
Did the side effect begin after the person STARTED the drug?*
- Side effect began after starting the drug
- Side effect began before starting the drug
- Don't know
Did the side effect begin or get worse after a dose INCREASE?*
- Began/got worse after dose increase
- No change with dose increase
- Didn't increase the dose
Did the side effect improve when the person LOWERED the dose?
- Improved on lowering the dose
- Didn't improve on lowering the dose
- Didn't lower the dose
Did the side effect improve when the person STOPPED the drug?*
- Cleared on stopping the drug
- Didn't clear on stopping the drug
- Didn't stop the drug
Did the side effect clear up with ANOTHER treatment?*
- Cleared with another treatment
- Didn't clear with another treatment
- Didn't try another treatment
Did the side effect reappear or get worse when the person RESTARTED the drug?*
- Reappeared or got worse on restarting
- Didn't reappear or get worse on restarting
- Didn't restart the drug
Has the person ever experienced this side effect before on any other drug? (If the experience was different in any way answer "No.")*
- Yes, on same type of drug
- Yes, on another drug
- No
Has the person ever experienced this side effect when not on a drug? (If the experience was different in any way answer "No.")*
- Yes
- No
- Don't know
Could anything else be causing this side effect?*
- Yes
- No
- Don't know
What else do you suspect might be causing this side effect?
Is the person a poor metabolizer of drugs, does the person need lower doses, or does the person have a history of sensitivity to drugs?*
- Yes
- No
- Don't know
Could the person have taken too high a dose?*
- Yes
- No
- Don't know
Have any of the person's blood relatives ever experienced this side effect when on the same or a similar drug?*
- Yes
- No
- Don't know
If a doctor or pharmacist has reviewed this side effect, does he/she see a link between the side effect and the drug?*
- Yes
- No
- No one has reviewed the side effect
Is this side effect a rare condition in people not on a drug?*
- Very rare
- Rare
- Don't know
Are there previous reports of side effects on STARTING the drug in the RxISK database or in a drug regulator database (e.g., FDA, Health Canada, Yellow Card) or elsewhere?*
- Yes
- No
- Don't know

Section 7 — Impact
What is the overall impact of the primary side effect on the person? This information can be most important in understanding what is happening.
Physical activities:
Did the side effect limit the person's physical activities or ability to do things?
- Yes
- No
- Don't know
How much of an impact did the side effect have on the person's physical activities or ability to do things?
- Very little
- Some
- Quite a lot
- Extreme (life altering)
If you'd like, tell us the story behind the rating you've chosen.
Mental abilities:
Did the person experience a change in any of his or her mental abilities, psychological state, or behaviour as a result of the side effect?
- Yes
- No
- Don't know
How much of an impact did the side effect have on the person's mental abilities, psychological state, or behavior?
- Very little
- Some
- Quite a lot
- Extreme (life altering)
If you'd like, tell us the story.
Work impact:
Was the person's work affected (paid or unpaid) as a result of the side effect?
- Yes
- No
- Don't know
Is the person paid or unpaid in their primary work role?
- Paid
- Unpaid
How many days off work?
How many days was the person's work performance impaired?
Social activities:
Did the person experience any change in his or her usual social activities, friendships, or relationships as a result of the side effect?
- Yes
- No
- Don't know
Describe the change in the person's usual social activities, friendships, or relationships.
Other impacts:
Please list any other changes that haven't been covered.
Examples: greater or lesser desire to drink alcohol or take drugs, change in the effects of the person's usual drugs or alcohol, change of odour affecting the person's relationship, change in interests, change in political affiliation, good or bad effects on personality or sense of physical or mental well-being, good or bad effects on other conditions, another unrelated condition getting better.

Section 8 — Drug review
How you feel about a drug depends on how its benefits balance against unwanted side effects. This section lets others know whether, on balance, the person taking the drug feels the drug was "worth it." Please note that we may publish some of the information from this section. Sharing stories and not just numbers of reports is hugely valuable in allowing others to learn from your experience and understand their own. Please remove any information you don’t wish to share with other people (especially if it might allow people to identify you in some way).
Considering both the treatment of the person's condition and the side effect(s) they experienced, how would they rate their experience on the drug?
- Very satisfied
- Satisfied
- Neutral
- Unsatisfied
- Very unsatisfied
Did the person continue taking the drug?
- Yes
- No
Please explain why. [share#]
#No contact details will be published.
What advice would the person give to someone who was considering taking the drug? [share#]
#No contact details will be published.
Did the person or their doctor or pharmacist find ways to reduce the side effect(s) of the drug other than stopping the drug or reducing the dose?
- Yes
- No
Please describe them. [share#]
#No contact details will be published.
Report Share Code

9. Preview your submission
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Complete a RxISK Report

Section 1 — Contact details

Section 2 — About the person who experienced the side effect

Section 3 — About the drug suspected to have caused the side effect

Section 4 — About other drugs or medications used at the same time

Section 5 — About the primary side effect

Section 6 — RxISK causality score

Section 7 — Impact

Section 8 — Drug review

9. Preview your submission

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