US - FDA Adverse Effects reporting website + phone #


#1

Report your Finasteride side effects and adverse effects to the FDA:

By Phone: 1-800-332-1088
Fax: 1-800-FDA-0178

Online: accessdata.fda.gov/scripts/ … online.htm

By Mail: fda.gov/medwatch/getforms.htm
– Form FDA 3500 - Voluntary Reporting - fda.gov/downloads/Safety/Med … 082725.pdf

– instructions: fda.gov/Safety/MedWatch/HowT … 149236.htm

Editable PDFs (can’t save typed data unless you have Full version of Adobe Acrobat):
fda.gov/medwatch/safety/FDA3 … 1-2006.pdf


#2

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#3

I just did this via the net, took me time to figure out how it was done. Everyone who has had side effects such as ours and, especially if you have seen a doctor/had labs done, should definitely submit a report. There is no excuse for not doing this if you meet those requirements.


#4

i contacted medwatch and made online report. i mentioned this site in the report. if you are gonna contact them our word will be more clear, more spread and more effective.
thanks


#5

Dear Reporter:

Thank you for submitting your report to MedWatch, The FDA Safety Information and Adverse Event Reporting Program.

This acknowledgement confirms that your report was received. Reports are added to a postmarketing safety database with similar reports and reviewed by the FDA’s postmarketing safety staff. Voluntary reports are essential for ensuring the continued safety of FDA-regulated products. One or two well-documented case reports may provide an early signal of unexpected problems and lead to additional evaluation. This may result in FDA regulatory actions that improve the safety of the products used in patient care each day.
You might be contacted by an FDA staff member if additional information on your report
is needed.

Again, thank you for taking the time to submit your report.

Sincerely yours,

MedWatch


#6

Yes, I got the same confirmation response - it’s automated. Interesting what they say though. Now we know for sure they have at least two adverse effect reports from us.


#7

Has anyone tried reporting adverse reactions to the FDA before? If enough people complain, the FDA should investigate right?

I just found this and am planning on submitting a report.

fda.gov/Safety/MedWatch/default.htm


#8

Thank you for submitting your report to MedWatch, The FDA Safety Information and
Adverse Event Reporting Program.

This acknowledgement confirms that your report was received. Reports are added
to a postmarketing safety database with similar reports and reviewed by the
FDA’s postmarketing safety staff. Voluntary reports are essential for ensuring
the continued safety of FDA-regulated products. One or two well-documented case
reports may provide an early signal of unexpected problems and lead to
additional evaluation. This may result in FDA regulatory actions that improve
the safety of the products used in patient care each day.

You might be contacted by an FDA staff member if additional information on your
report
is needed.

Again, thank you for taking the time to submit your report.

Sincerely yours,

MedWatch


#9

I just took like 3 hours filling out this form, but at the end it asked me for an address and it only accepted U.S. addresses. How do i submit one if ièm in canada then?

Anyone know?


#10

Neverind. Found it a few links down.

haha :unamused: