What´s the name of the product for which you want to report a side effect?
ABOUT THIS MEDICINE
How is this medicine related to the side effect?
Suspected Concomitant Medication Used for treatment of the side effect WHEN AND WHY THIS MEDICINE WAS TAKEN:
When did the person experiencing the side effect start taking the medicine?
End Date: WHY DID THEY TAKE THIS MEDICINE?
HOW THE MEDICINE WAS TAKEN?
Which formulation of the medicine were they taking?
Select formulation Cream Capsule Drop Solution Patch Tablet unknown Other
How did they take it?
Please select Cutaneous- on the skin Inhalation Intramuscular Intrathecal Intravenous Nasal Ophthalmic Oral Parentheral Rectal Subcutaneous Sublingual Transdermal Transplacental Unknown Vaginal Other
What dose were they taking?
Select dose unit mg (milligram) ug (microgram) mg/kg (milligram/kilogram) Gtt (Drop) DF (Dosage Form) kg (kilogram) g (gram) ml (mililitre) % (percent) ug/kg (microgram/kilogram) ul (microlitre) mbq (mecabequeral) mol (mole) mmol (milimole) umol (micromole) IU (international Unit)
How often did they take it?
Please select Once daily Twice a day Three Times a day Four times a day Every evening Every 12 hours Every 48 hours Every 72 hours Every other day Once a week Once every two weeks Once a month One single dose As needed Other
What action was taken with the medicine as result of the side effect?
Lot or batch No.
2. SIDE EFFECT
What is the side effect you want to report?
ABOUT THE SIDE EFFECT
What was the outcome of the side effect?
Select the outcome Complete recovery Clinical deterioration Clinical improvement No modification observed Fatal Recovered with sequelae Unknown
How long did the patient experience the adverse event?
End Date: DESCRIBE THE SIDE EFFECT IN MORE DETAIL AND IF ANY TREATMENT WAS NEEDED:
What was the side effect serious?
Unknown No, it was not serious Yes, it was serious 3. PATIENT
ABOUT THE PERSON EXPERIENCING THE SIDE EFFECT
What is the gender of the person experiencing the side effect?
Male Female Unknown DETAILS ABOUT THE PERSON
What are the initials of the person who experienced the side effect?
How old was the patient at the time of the side effect?
Ages Months Days
What was their height?
Cm Feet Inches
What was their weight?
What is their date of birth?
What is the patient’s medical history?
Please provide results of tests/labs, medical history, allergies, etc. Do not provide any patient identifiable information (e.g. name, DOB) in this box
4. CONTACT DETAILS
REPORTER AND CONTACT INFORMATION
What is your country?
CONFIRMATION OF THIS REPORT
What is your email address?
Type of reporter
Select reporter type Health Care Professional Patient/Consumer Other Non-Health Care Professional Health Authority
Can we contact a health care professional if we need more information about your report?
Yes, contact my health care professional for more information about this report No, you cannot contact my health care professional
Can we contact a you if we need more information about your report?
Yes, you can contact me No, you cannot contact me