December 9, 2023

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

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

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

Mild side effects

Mild side effects* of Fiasp can include:

  • injection or infusion site reaction†
  • lipodystrophy (a change in how your body stores fat)
  • weight gain‡
  • cold or flu‡
  • headache‡

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

* This is a partial list of mild side effects from Fiasp. To learn about other mild side effects, talk with your doctor or pharmacist, or view Fiasp’s prescribing information.
† Fiasp is administered by subcutaneous injection using different delivery options. In rare cases, it can also be given by IV infusion by a healthcare professional. For additional information, see the “How to take Fiasp” section below.
‡ For more information about this side effect, see “Side effect details” below.

Serious side effects

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

Serious side effects and their symptoms can include:

* For more information about this side effect, see “Side effect details” below.

Side effects in children

In clinical trials, children taking Fiasp had many of the same side effects as adults.

Common side effects in trials of children taking this medication included:

  • cold or flu*
  • headache*
  • runny nose
  • fever
  • vomiting
  • low blood sugar level
  • injection or infusion reaction†

If you have additional questions or concerns about side effects in children, talk with your child’s doctor.

* For more information about this side effect, see “Side effect details” below.
† Fiasp is administered by subcutaneous injection using different delivery options. In rare cases, it can also be given by IV infusion by a healthcare professional. For additional information, see the “How to take Fiasp” section below.

Side effect details

Here’s some detail on certain side effects this drug may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Fiasp.

Weight gain

Some people may gain weight while taking Fiasp. Weight gain is a common side effect of any insulin medication, including Fiasp.

In clinical trials, adults taking Fiasp for type 1 diabetes gained about 0.7 kilograms (kg). This is about 1.54 5 pounds (lb). Adults taking Fiasp for type 2 diabetes gained about 2.7 kg (about 5.94 lb).

What you can do

If you’re concerned about gaining weight during your Fiasp treatment, talk with your doctor. They’ll likely recommend a diet and exercise plan to help manage weight gain that may occur.

Cold or flu

There may be an increased risk of developing an infection, such as cold or flu, during Fiasp treatment. These infections were not commonly reported side effects in clinical trials of Fiasp.

Colds were reported in trials of adults and children taking Fiasp for type 1 diabetes. However, neither cold nor flu was reported in adults with type 2 diabetes. And it’s not known if cold or flu occurred in children with type 2 diabetes.

Signs and symptoms of an infection may include:

  • runny nose
  • sore throat
  • fever
  • cough

What you can do

During your Fiasp treatment, be sure to watch for the above signs and symptoms of an infection.

If you develop symptoms of an infection, talk with your doctor. They will likely recommend resting and hydrating your body. In some cases, they may recommend an antibiotic or an antiviral medication to treat your cold or flu.

Tell your doctor if you notice you’re having frequent cold or flu symptoms. In this case, they may recommend a different treatment option for you.

Headache

Some people may experience headaches from taking Fiasp. Headaches were not a common side effect of this medication. In fact, headaches were only reported in children taking Fiasp for type 1 diabetes.

If you have headaches during your Fiasp treatment, talk with your doctor. In some cases, headaches may be a symptom of hypoglycemia (low blood sugar), which can be dangerous. Your doctor may recommend you check your blood sugar level right away to be sure it’s not too low.

If your headache is due to hypoglycemia, you may also experience other symptoms such as:

  • dizziness
  • blurry vision
  • anxiety or irritability
  • sweating

What you can do

If you have headaches, especially if they are frequent or bothersome, talk with your doctor. They can help you determine what may be causing your headaches.

If you’re experiencing hypoglycemia that’s causing your headaches, your doctor will likely decrease your dosage of Fiasp. This will help decrease your risk of hypoglycemia, which can help reduce the risk of headaches.

Hypoglycemia can be very serious or even life threatening, so if your blood sugar level is low while you’re experiencing a headache, be sure to treat it right away. Your doctor will recommend the best ways to treat low blood sugar when you start taking Fiasp.

If your headaches aren’t due to low blood sugar, your doctor may recommend treating them with over-the-counter pain medications. For example, they may recommend acetaminophen (Tylenol) or ibuprofen (Advil). Talk with your doctor about the best ways to decrease your headaches while you’re taking Fiasp.

ALLERGIC REACTION

As with most drugs, some people can have an allergic reaction after taking Fiasp. Allergic reactions occurred in clinical trials of Fiasp but they were not common.

Symptoms of a mild allergic reaction can include:

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

Call your doctor right away if you have an allergic reaction to Fiasp, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

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