Liraglutide Injection [ Victoza ] 2Pens

Victoza can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Victoza. These lists do not include all possible side effects.

For more information on the possible side effects of Victoza, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs they’ve approved. If you would like to report to the FDA a side effect you’ve had with Victoza, you can do so through MedWatch.

More common side effects

The more common side effects of Victoza can include:

• headache
• nausea
• vomiting
• diarrhea
• constipation
• indigestion
• loss of appetite
• hypoglycemia (low blood sugar), which is more common in children than in adults

Most of these side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Victoza aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include the following:

• Gallbladder disease. Symptoms can include:
  • pain in your belly
  • nausea
  • vomiting
  • fever
  • diarrhea
  • jaundice (yellowing of your skin and the whites of your eyes)
• Kidney problems, which may be caused by dehydration. Symptoms can include:
  • urinating less often than usual
  • swelling in your feet and lower legs
  • drowsiness
  • confusion
  • shortness of breath
  • nausea

Other serious side effects, which are discussed in detail below, include:

• pancreatitis (inflammation in your pancreas)
• severe allergic reaction
• possible risk of thyroid cancer*

* Victoza has a boxed warningTrusted Source from the FDA regarding the possible risk of thyroid cancer in humans. A boxed warning is the strongest warning the FDA requires. It alerts doctors and patients about drug effects that may be dangerous.

Side effect details

You may wonder how often certain side effects occur with this drugor whether certain side effects pertain to it. Here’s some detail on several of the side effects this drug may or may not cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Victoza. It’s not known how many people taking Victoza have had an allergic reaction to the drug. Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing or speaking

Call your doctor right away if you have a severe allergic reaction to Victoza. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Pancreatitis

Pancreatitis (inflammation in your pancreas) is a possible side effect of Victoza. This condition occurred in people taking the drug during clinical studies.

In clinical studies, 2.7 cases of pancreatitis occurred out of every 1,000 people taking Victoza for 1 year. Out of every 1,000 people taking glimepiride (a different diabetes drug that’s taken by mouth) for 1 year, 0.5 cases of pancreatitis occurred.

There have also been cases of pancreatitis in post-marketing reports of Victoza. These cases of the condition were reported after Victoza was made available to the public.

However, it’s not usually possible to determine if a drug caused the condition seen in post-marketing reports. It’s also not possible to know how common the condition is in people taking the drug.

When you take Victoza, your doctor will monitor you for symptoms of pancreatitis. These symptoms may include:

• severe pain that wraps around your upper belly (stomach pain) and your back
• upset stomach
• nausea
• vomiting
• bloating
• fever

It’s not known if you’ll have a higher risk of pancreatitis while you’re taking Victoza if you’ve had pancreatitis in the past.

If you have any symptoms of pancreatitis while taking Victoza, tell your doctor right away. They will likely stop Victoza treatment to help treat your pancreatitis. It’s recommended that you don’t restart Victoza treatment after you’ve had pancreatitis.

Nausea

You may have nausea while you’re taking Victoza. It’s one of the most common side effects of the drug. In clinical studies, 18% to 20% of people who took Victoza had nausea. Of those who took a placebo (treatment with no active drug), 5% had nausea.

Nausea can also be a symptom of more serious side effects of Victoza, such as pancreatitis or gallbladder disease.

If you have nausea while you’re taking Victoza, tell your doctor. They will recommend ways to reduce this side effect. They’ll also determine whether your nausea is related to more serious side effects.

Diarrhea

Some people have diarrhea while taking Victoza. This is a common side effect of the drug. In clinical studies, 10% to 12% of people who took Victoza had diarrhea. Of people who took a placebo (treatment with no active drug), 4% had diarrhea.

If you have diarrhea while you’re taking Victoza, tell your doctor. They will recommend ways to reduce this side effect. They will also recommend ways to prevent dehydration (low fluid level), which can lead to more serious problems, such as kidney damage.

Constipation

It’s possible to feel constipated while you’re using Victoza. In clinical studies, 5% of people who took Victoza had constipation. Of people who took a placebo (treatment with no active drug), 1% had constipation.

If you have constipation while you’re taking Victoza, tell your doctor. They will recommend ways to help you keep your bowel movements regular in timing.

Cancer

Cancer was not reported as a side effect of Victoza in clinical studies. However, animal studies of the drug found an increased risk of thyroid cancer. (See the section below called “Thyroid cancer” for more details.)A clinical studythat included more than 9,000 people looked at the risk of neoplasms (abnormal growths, including cancer) in people taking Victoza. People with type 2 diabetes who had risk of cardiovascular problems were studied.

In this study, people took either Victoza or a placebo (treatment with no active drug) for 3.5 to 5 years. The researchers didn’t find an increased risk of cancer in people taking Victoza compared to people taking the placebo. However, more studies are needed to confirm these results.

If you’ve ever had cancer or you have a family history of cancer, talk with your doctor. They can discuss whether Victoza is safe for you.

Thyroid cancer

In animal studies, Victoza was found to cause thyroid tumors (abnormal growths) and thyroid cancer. It’s not known if Victoza causes thyroid tumors or thyroid cancer in humans.

Because of this potential risk, Victoza has a boxed warningTrusted Source for increased risk of thyroid tumors. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.

However, in clinical studies, the rate of papillary thyroid cancer (the most common type of thyroid cancer) was 1.5 cases for every 1,000 people taking Victoza for a year. Of those taking either a placebo (treatment with no active drug) or a different diabetes drug, the rate was 0.5 cases for every 1,000 people taking the drug or placebo for a year.

There have also been cases of medullary thyroid cancer (MTC) in post-marketing reports. (This means these cases were reported after Victoza was made available to the public.)

However, it’s typically not possible to determine whether a drug caused the condition seen in post-marketing reports. It’s also not possible to know how common this type of cancer is in people using the drug.

Because of these reports, you shouldn’t take Victoza if you or any of your family members have had MTC. You also shouldn’t take Victoza if you have a condition called multiple endocrine neoplasia syndrome type 2 (MEN 2). This syndrome is a hormone-related condition that may increase your risk of thyroid cancer if you take Victoza.

Tell your doctor if you have any unusual symptoms that may be related to thyroid tumors or thyroid cancer. Symptoms of these conditions may include:

• a lump or swollen area in your throat
• hoarseness in your voice
• trouble swallowing
• shortness of breath

If you’d like to know more about the possible risk of thyroid cancer while using Victoza, talk with your doctor.

Headache

You may have headaches while you’re taking Victoza. This is one of the most common side effects of the drug. In clinical studies, 10% to 11% of people who took Victoza had headaches. Of people who took a placebo (treatment with no active drug), 7% had headaches.

If you have headaches while you’re taking Victoza, talk with your doctor. They can recommend ways to help reduce this side effect.

Hypoglycemia

Hypoglycemia (low blood sugar) is a possible side effect of Victoza. In clinical studies, there were 7.5 cases of severe hypoglycemia for every 1,000 people taking Victoza for 1 year. The hypoglycemia that occurred required help from another person to treat.

Of the people affected, 87.5% of them were taking Victoza in combination with a sulfonylurea (a class of diabetes drugs that are taken by mouth). Examples of sulfonylurea drugs include glimepiride (Amaryl) and glipizide (Glucotrol).

People who took Victoza also had hypoglycemia events that they were able to treat themselves. In clinical studies, the number of hypoglycemia events for each person who took the following drugs for 1 year were:

• 3.6 events in people taking Victoza and metformin (compared to 2.5 events in those taking a placebo and metformin)
• 7.5 events in people taking Victoza and glimepiride (compared to 2.6 events in those taking a placebo and glimepiride)
• 7.9 events in people taking Victoza, metformin, and rosiglitazone (compared to 4.6 events in those taking a placebo, metformin, and rosiglitazone)
• 27.4 events in people taking Victoza, metformin, and glimepiride (compared to 16.7 events in those taking a placebo, metformin, and glimepiride)

Note: A placebo is a treatment that doesn’t contain any active drug.

Symptoms of hypoglycemia can include:

• shakiness
• dizziness
• confusion
• sweating
• anxiety
• fast heart rate
• headache

If you have symptoms of hypoglycemia, check your blood sugar level right away. If you don’t have a blood glucose (sugar) meter and aren’t able to check your level, you should treat yourself for hypoglycemia anyway.

Treating hypoglycemia

You can treat mild or moderate hypoglycemia by eating or drinking things that have at least 15 grams of glucose in them. Examples of these items include:

• half a cup of fruit juice, such as orange juice
• half a cup of non-diet soda
• 3 or 4 glucose tablets (you can purchase these from your pharmacy)
• 1 tablespoon of sugar or honey

After you’ve had something to eat or drink, check your blood sugar level again in 15 minutes. If the level is still low, you may need to consume more glucose.

If your hypoglycemia is more severe and you need assistance, tell people who are around that you need help or call 911. Don’t try to drive yourself to the emergency room.

Liver side effects

It’s possible to have liver side effects while you’re taking Victoza. Post-marketing reports showed that some people who took Victoza have had hepatitis (inflammation in their liver). Post-marketing reports show cases of side effects that happened after the drug was made available to the public.

There have also been post-marketing reports of people taking Victoza who had high levels of liver enzymes (certain proteins made in your liver). High levels of liver enzymes are often a sign of liver damage.

However, it’s typically not possible to determine whether a drug caused a side effect seen in post-marketing reports. It’s also not possible to know how common a side effect may be in people taking the drug.

Symptoms of liver problems include:

• nausea
• diarrhea
• loss of appetite
• fatigue (lack of energy)
• jaundice (yellowing of your skin and the whites of your eyes)
• fluid buildup in your belly and legs

If you have symptoms of liver problems while taking Victoza, tell your doctor. They can order tests and recommend medical treatment if needed.

Skin rash

You may have skin rashes while you’re using Victoza.

In clinical studies, about 2% of people who took Victoza had a rash near the area of their Victoza injection site (called an injection site reaction). However, less than 0.2% of people who took Victoza stopped treatment because of injection site reactions.

Skin rash may also be a symptom of an allergic reaction to Victoza. See the “Allergic reaction” section above for more information.

If you have a rash while you’re taking Victoza, tell your doctor right away. If you have a rash along with other symptoms, such as trouble breathing or swelling of your tongue, lips, or throat, call 911 and get medical help right away. These could be signs of a severe allergic reaction.

Gastroparesis (not a side effect)

Gastroparesis was not reported as a side effect of Victoza during clinical studies. With this condition, your stomach empties very slowly as it moves food through your digestive tract.

Although it hasn’t been shown to cause gastroparesis, Victoza can worsen the condition in people who already have it. Victoza works to improve your blood sugar levels by slowing the action of your stomach muscles. This causes food to move more slowly through your gastrointestinal system than it usually does. So if you already have gastroparesis, Victoza could worsen your condition.

If you have gastroparesis or problems digesting food, talk with your doctor. They’ll advise whether it’s safe for you to take Victoza.

Side effects in children

During clinical studies, side effects of Victoza were similar in both children and adults. However, children had higher rates of hypoglycemia (low blood sugar) than adults did.

In a 26-week clinical study, children with type 2 diabetes took Victoza and metformin. Some of the children also took a long-acting insulin.

In this study, 21.2% of the children had hypoglycemia episodes. This rate can be described as 335 hypoglycemia events for every 1,000 children who took Victoza for 1 year. None of the hypoglycemia episodes were considered severe enough to need another person to help treat the children.

However, if you care for a child who takes Victoza, be prepared to recognize the symptoms of hypoglycemia and treat the condition. (See the “Hypoglycemia” section above.) Treating hypoglycemia right away can help prevent a medical emergency.