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Overview: Utebzi is an antibiotic medicine used for certain infections of the bladder or kidneys. It works by killing some types of bacteria. Common side effects are diarrhea, headache, nausea, and stomach pain. Stop taking Utebzi and get help right away if you have a seizure, confusion, rash, or trouble breathing, as these could be signs of a serious side effect. Do not stop treatment early or take Utebzi longer than recommended by your health care provider.

Uses

What is Utebzi used for?

Utebzi (tebipenem pivoxil) is commonly used to treat complicated kidney or bladder infections, including pyelonephritis, caused by certain bacteria. It is generally used when there are few or no other oral (by mouth) antibiotics that are likely to work for the infection.

Utebzi may not be the right medicine for some infections, depending on which germs are causing the infection. Bacteria in some locations may have become resistant to Utebzi, which will make it or other similar antibiotics not work as well.

Utebzi may also be used for other conditions as determined by your health care provider.

How does Utebzi work (mechanism of action)?

Utebzi is an antibiotic that kills certain types of bacteria by blocking their ability to build a protective outer wall. Without this outer wall, the bacteria cannot survive. This helps your body clear the infection.

How is Utebzi supplied (dosage forms)?

Utebzi is available in a 300 mg oral tablet that is taken by mouth.

How should I store Utebzi?

Store Utebzi at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of Utebzi?

The most common side effects of Utebzi are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Diarrhea (see below)
  • Headache
  • Nausea
  • Stomach pain
  • Raised liver enzymes

There may be other side effects of Utebzi that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Utebzi?

While less common, the most serious side effects of Utebzi are described below, along with what to do if they happen.

Severe Allergic Reactions. Utebzi may cause allergic reactions, which can be serious. Stop taking Utebzi and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Seizures or Other Central Nervous System (CNS) Problems. Utebzi may cause seizures or affect your brain or central nervous system (CNS). The risk may be higher in people who already have a seizure disorder, CNS problems, or kidney problems. Tell your health care provider right away if you have the following signs or symptoms of a possible seizure or other CNS problem.

  • Muscle twitching, jerking, spasms, tremors, or other uncontrolled movements
  • Stiffening of your arms and legs
  • Feeling anxious, nervous, confused, or a sense of dread
  • Feeling dizzy or lightheaded
  • Falling or losing consciousness
  • Confusion
  • Seeing or hearing things that others do not see or hear (hallucinations)

Low Carnitine Levels. Utebzi may cause low carnitine levels. Carnitine helps your body make energy. Low levels of carnitine can cause problems with your muscles, liver, and heart. This side effect may be more likely to affect people who take Utebzi for longer than recommended or are at risk for low carnitine levels, such as people with kidney problems, low muscle mass, or those taking certain medicines. Tell your health care provider if you have any of the following symptoms of low carnitine levels. 

  • Muscle aches or weakness
  • Tiredness
  • Fainting
  • Seizures
  • Confusion
  • Low blood sugar (hypoglycemia), which may cause symptoms such as crankiness, anxiety, hunger, dizziness, blurry vision, slurred speech, sweating, or feeling jittery

Antibiotic-Associated Diarrhea. An overgrowth of germs called Clostridioides difficile, or C. diff, can happen in your gut with many types of antibiotics, including Utebzi. This can cause a condition known as antibiotic-associated diarrhea and can happen over 2 months after stopping the antibiotic. Call your health care provider right away if you have any of the following symptoms of this condition.

  • Watery diarrhea
  • Diarrhea that does not go away
  • Blood in your stool (poop)
  • Severe stomach cramps
  • Fever that starts after you start or finish the medicine

Warnings & Precautions

Who should not use Utebzi?

Allergies to Ingredients. People who are allergic to any of the following should not take Utebzi.

  • Tebipenem pivoxil
  • Utebzi
  • Any other medicine known as a beta-lactam antibiotic, such as penicillin
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Utebzi.

Low Carnitine. People with low carnitine levels (carnitine deficiency) should not take Utebzi. Utebzi can lower carnitine levels in the body, which can make the condition worse.

What should I know about Utebzi before using it?

Do not take Utebzi unless it has been prescribed to you by a health care provider. Take it as prescribed. Swallow the tablets whole.

Do not share Utebzi with other people, even if they have the same condition as you. It may harm them.

Keep Utebzi out of the reach of children.

Do not stop it early or take it longer than recommended by your health care provider. Stopping treatment early may allow the infection to return and become harder to treat, while taking it longer than recommended may increase the risk of side effects.

Utebzi only treats certain infections caused by some types of bacteria. It will not treat infections caused by viruses, such as the common cold, the flu, or coronavirus. It also will not work for any other infections that are not caused by bacteria. Taking Utebzi or any other antibiotic when it is not needed may cause the antibiotic to not work for bacterial infections in the future.

What should I tell my health care provider before using Utebzi?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Utebzi is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Kidney problems
  • Low muscle mass
  • Seizures or other problems affecting the brain or central nervous system (CNS)

Other Medicines and Supplements. Utebzi may interact with other medicines and supplements. Before taking Utebzi, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details. 

Pregnancy. It is not known if or how Utebzi could affect pregnancy or harm a fetus. Tell your health care provider if you are pregnant or plan to become pregnant. If you take Utebzi while pregnant, you or your health care provider can call the drugmaker at 888-825-5249 to take part in a pregnancy safety study.

Taking Utebzi during pregnancy may cause a false positive result on a newborn screening test. This means the test may incorrectly suggest that a baby has isovaleric acidemia (a rare disorder that affects how the body breaks down leucine). Before giving birth, tell all of your health care providers if you took Utebzi.

Breastfeeding. It is not known if Utebzi passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should take Utebzi while breastfeeding.

How can I get more information about Utebzi?

For more information about Utebzi, you can visit the drugmaker’s website at www.gsk.com or call them at 888-825-5249.

Interactions

Does Utebzi interact with foods or drinks?

There are no known interactions between Utebzi and foods or drinks.

It is unknown if drinking alcohol will affect Utebzi, but heavy drinking can slow your immune response and make it harder for your body to fight infections.

Does Utebzi interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Utebzi.

  • Divalproex sodium, valproate sodium (Depakote and others), or valproic acid, which are medicines used for seizures and other conditions
  • Probenecid, which is a medicine commonly used for gout
  • Adefovir dipivoxil (Hepsera), which is a medicine used for hepatitis B
  • Pivmecillinam (Pivya), which is a medicine used for urinary tract infection

This may not be a complete list of medicines that can interact with Utebzi. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Utebzi?

If you or someone else has taken too much Utebzi, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Utebzi?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take a double dose to make up for a missed one. 

It is important to complete your prescribed course of Utebzi, even if your symptoms get better or go away. This will reduce the risk that future infections are resistant to Utebzi or other similar medicines.