May 11, 2022

Side effects, cost, operation, etc.

Ofev can cause mild or severe side effects. The following lists contain some of the main side effects that can occur when taking Ofev. These lists do not include all possible side effects.

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

To note: The Food and Drug Administration (FDA) tracks the side effects of drugs it has approved. If you would like to notify the FDA about a side effect you have had with Ofev, you can do so via MedWatch.

Mild side effects

Mild side effects* of Ofev may include:

Most of these side effects may disappear within a few days or weeks. But if they get worse or don’t go away, talk to your doctor or pharmacist.

*This is a partial list of mild Ofev side effects. For more information about other mild side effects, talk to your doctor or pharmacist, or read the Package Leaflet for Ofev. prescribing information.
† For more information on this side effect, see “Details of side effects” below.

Serious side effects

Serious side effects from Ofev are not common, but they can occur. Call your doctor right away if you experience any serious side effects. Call 911 or your local emergency number if your symptoms are life-threatening or you think you have a medical emergency.

Serious side effects and their symptoms may include:

  • Liver damage. Symptoms can include:
    • pain in the upper right abdomen
    • dark or brown urine
    • bruising or bleeding easily
  • Blood clot in an artery, which can cause a heart attack or stroke. Symptoms may include:
    • pain or pressure in the jaw, neck, back, shoulder, or arm
    • weakness or numbness on one side of your body
  • Increased risk of bleeding. Symptoms may include:
    • take longer than usual to stop bleeding if you injure yourself
  • Gastrointestinal perforation. (Hole or tear in the wall of your stomach or intestine.) Symptoms may include:
    • severe pain in the abdomen
    • swelling or hardness in your abdomen
  • Proteinuria (protein in your urine), which could be a sign of kidney problems. Symptoms may include:
    • swelling of the face, arms, hands, legs, or feet
  • Severe diarrhea.*
  • Allergic reaction.*

* For more information on this side effect, see ‘Details of side effects’ below.

Details of side effects

Here are some details about some side effects that this drug can cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Ofev.

Diarrhea

You may have diarrhea while taking Ofev. In clinical testsdiarrhea was the most common side effect reported with Ofev.

You are most likely to have diarrhea during the first 3 months of taking Ofev. Diarrhea is usually mild or moderate, but in some cases it can be severe.

Diarrhea causes your body to lose more fluid and electrolytes (salts such as sodium and potassium) than usual. If left unmanaged, it can lead to dehydration (low fluid level in your body).

what you can do

If you have diarrhea while taking Ofev, see your doctor straight away. It is important to have prompt management of diarrhea if you have this side effect.

Your doctor will likely recommend that you take an antidiarrheal medication such as loperamide (Imodium) to help stop your diarrhea. They may also temporarily reduce your dose of Ofev or tell you to stop taking Ofev until your diarrhea goes away.

Also, it’s important to drink plenty of fluids while you have diarrhea to help prevent dehydration. Your doctor may recommend oral rehydration solutions such as Pedialyte. These solutions help replace lost fluids and electrolytes.

If your diarrhea does not improve within a few days or gets worse, see your doctor right away.

Hair loss

Some people may lose their hair while taking Ofev. However, in clinical testshair loss was rare with Ofev.

what you can do

If you are concerned about hair loss with Ofev, talk to your doctor. They can recommend ways to manage this side effect.

Fatigue

You may feel tired while taking Ofev. In clinical testsfatigue was common at Ofev.

Note that the lung diseases for which Ofev is prescribed can also cause fatigue. This is because these lung conditions prevent your body from getting enough oxygen. Your body needs oxygen to function normally and produce energy. These lung conditions can also cause coughing and difficulty breathing, which can prevent you from getting enough sleep. It can also lead to fatigue.

what you can do

If you suffer from fatigue, talk to your doctor about ways to manage it.

Here are some tips that can help you:

  • Try to break activities down into smaller tasks and take regular breaks in between.
  • Ask for help and accept help when offered.
  • Rest when you can.
  • Try light exercise to help increase your strength (this can make activities less demanding, so you have more energy to spare).
  • Try to improve your sleep, for example, using extra pillows to elevate you can help relieve shortness of breath.

Allergic reaction

As with most medicines, some people may have an allergic reaction after taking Ofev.

Symptoms of a mild allergic reaction may include:

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

  • swelling under the skin, usually in the eyelids, lips, hands, or feet
  • swelling of the tongue, mouth or throat
  • difficulty breathing

Call your doctor right away if you have an allergic reaction to Ofev, as the reaction could become serious. Call 911 or your local emergency number if your symptoms are life-threatening or you think you have a medical emergency.


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