What is the most
important information
I should know about
RYBELSUS®?
RYBELSUS® may cause
serious side effects,
including:
•Possible thyroid
tumors, including
cancer. Tell your
healthcare provider if
you get a lump or
swelling in your neck,
hoarseness, trouble
swallowing, or
shortness of breath.
These may be
symptoms of thyroid
cancer. In studies with
rodents, RYBELSUS®
and medicines that
work like RYBELSUS®
caused thyroid tumors,
including thyroid
cancer. It is not known
if RYBELSUS® will cause
thyroid tumors or a
type of thyroid cancer
called medullary
thyroid carcinoma
(MTC) in people
Do not use RYBELSUS®
if:
•you or any of your
family have ever had
MTC, or if you have an
endocrine system
condition called
Multiple Endocrine
Neoplasia syndrome
type 2 (MEN 2)
•you have had a serious
allergic reaction to
semaglutide or any of
the ingredients in
RYBELSUS®. See
symptoms of serious
allergic reaction in
“What are the
possible side effects
of RYBELSUS®?”
What is
RYBELSUS®?
RYBELSUS®
(semaglutide) tablets
7 mg or 14 mg is a
prescription medicine
used along with diet and
exercise to improve
blood sugar (glucose) in
adults with type 2
diabetes.
•It is not known if
RYBELSUS® can be
used in people who
have had pancreatitis
•RYBELSUS® is not for
use in people with type
1 diabetes
•It is not known if
RYBELSUS® is safe and
effective for use in
children under 18
years of age
Important Safety
Information
Before using
RYBELSUS®, tell your
healthcare provider if
you have any other
medical conditions,
including if you:
•have or have had
problems with your
pancreas or kidneys
•have a history of vision
problems related to
your diabetes
•are pregnant or plan to
become pregnant. It is
not known if
RYBELSUS® will harm
your unborn baby. You
should stop using
RYBELSUS® 2 months
before you plan to
become pregnant. Talk
to your healthcare
provider about the
best way to control
your blood sugar if
you plan to become
pregnant or while you
are pregnant
•are breastfeeding or
plan to breastfeed.
Breastfeeding is not
recommended during
treatment with
RYBELSUS®
Tell your healthcare
provider about all the
medicines you take,
including prescription
and over-the-counter
medicines, vitamins, and
herbal supplements.
RYBELSUS® may affect
the way some medicines
work and some
medicines may affect
the way RYBELSUS®
works.
What are the possible
side effects of
RYBELSUS®?
RYBELSUS® may cause
serious side effects,
including:
•inflammation of your
pancreas
(pancreatitis). Stop
using RYBELSUS® and
call your healthcare
provider right away if
you have severe pain
in your stomach area
(abdomen) that will
not go away, with or
without vomiting. You
may feel the pain from
your abdomen to your
back
•changes in vision. Tell
your healthcare
provider if you have
changes in vision
during treatment with
RYBELSUS®
•low blood sugar (hypoglycemia). Your
risk for getting low
blood sugar may be
higher if you use
RYBELSUS® with
another medicine that
can cause low blood
sugar, such as a
sulfonylurea or insulin.
Signs and symptoms
of low blood sugar
may include: dizziness
or lightheadedness,
blurred vision, anxiety,
irritability or mood
changes, sweating,
slurred speech,
hunger, confusion or
drowsiness, shakiness,
weakness, headache,
fast heartbeat, and
feeling jittery
•kidney problems
(kidney failure). In
people who have
kidney problems,
diarrhea, nausea, and
vomiting may cause a
loss of fluids
(dehydration), which
may cause kidney
problems to get worse.
It is important for you
to drink fluids to help
reduce your chance of
dehydration
•serious allergic
reactions. Stop using
RYBELSUS® and get
medical help right
away, if you have any
symptoms of a serious
allergic reaction,
including swelling of
your face, lips, tongue,
or throat; problems
breathing or
swallowing; severe
rash or itching;
fainting or feeling
dizzy; or very rapid
heartbeat
•
gallbladder problems.
Gallbladder problems
have happened in
some people who take
RYBELSUS®. Tell your
healthcare provider
right away if you get
symptoms of
gallbladder problems,
which may include:
pain in your upper
stomach (abdomen),
yellowing of skin or
eyes (jaundice), fever,
and clay-colored stools
The most common side
effects of RYBELSUS®
may include nausea,
stomach (abdominal)
pain, diarrhea,
decreased appetite,
vomiting, and
constipation. Nausea,
vomiting, and diarrhea
are most common when
you first start
RYBELSUS®.
Please see Prescribing
Information and
Medication Guide.
RYBELSUS® is a
prescription medication.
You are encouraged to
report negative side
effects of prescription
drugs to the FDA. Visit
www.fda.gov/medwatch
or call 1-800-FDA-1088.
RYBELSUS® is a
registered trademark of
Novo Nordisk A/S.
Novo Nordisk is a
registered trademark of
Novo Nordisk A/S.
© 2023 Novo Nordisk
All rights reserved.
US22RYB01080
April 2023