PREGABALIN - pregabalin capsule 
Ascend Laboratories, LLC
Reference Label Set Id: 2a229a7c-0231-41e9-88af-3a99f2e66c69



PREGABALIN (pre gab' a lin) capsules, CV

Read this Medication Guide before you start taking pregabalin capsules and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. If you have any questions about pregabalin capsules, ask your healthcare provider or pharmacist.

What is the most important information I should know about pregabalin?

Pregabalin may cause serious side effects including:

These serious side effects are described below:

Stop taking pregabalin and call your healthcare provider right away if you have any of these signs of a serious allergic reaction:

        o   swelling of your face, mouth, lips, gums, tongue, throat or neck

        o   trouble breathing

        o   rash, hives (raised bumps) or blisters

If you have suicidal thoughts or actions, do not stop pregabalin without first talking to a healthcare provider.

    o   Stopping pregabalin suddenly can cause serious problems.

    o   Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare       provider may check for other causes.

How can I watch for early symptoms of suicidal thoughts and actions?

What is pregabalin capsule?

Pregabalin capsule is a prescription medicine used in adults, 18 years of age and older, to treat:

It is not known if pregabalin is safe and effective in people under 18 years of age for the treatment of fibromyalgia and neuropathic pain with diabetes, shingles, or spinal cord injury.

Pregabalin capsule is a prescription medicine used in people 17 years of age and older to treat:

For the treatment of partial-onset seizures when taken together with other seizure medicines, it is not known if pregabalin is safe and effective in children under 1 month of age.

Who should not take pregabalin capsules?

Do not take pregabalin capsules if you are allergic to pregabalin or any of the ingredients in pregabalin capsules.

See “What is the most important information I should know about pregabalin capsules?” for the signs of an allergic reaction.

See the end of this medication guide for a complete list of ingredients in pregabalin capsules.

What should I tell my healthcare provider before taking pregabalin capsules?

Before taking pregabalin capsules, tell your healthcare provider about all your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins or herbal supplements. Pregabalin and other medicines may affect each other causing side effects. Especially tell your healthcare provider if you take: 

Know the medicines you take. Keep a list of them with you to show your healthcare provider and pharmacist each time you get a new medicine. Do not start a new medicine without talking with your healthcare provider.

How should I take pregabalin capsules?

What should I avoid while taking pregabalin capsules?

What are the possible side effects of pregabalin capsules?

Pregabalin capsules may cause serious side effects, including:

The most common side effects of pregabalin capsules in adults are:

Pregabalin caused skin sores in animal studies. Skin sores did not happen in studies in people. If you have diabetes, you should pay attention to your skin while taking pregabalin and tell your healthcare provider about any sores or skin problems.

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the possible side effects of pregabalin. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store pregabalin capsules?

Keep pregabalin capsules and all medicines out of the reach of children.

General information about the safe and effective use of pregabalin capsules.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use pregabalin capsules for a condition for which it was not prescribed. Do not give pregabalin capsules to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about pregabalin capsules that is written for health professionals.

You can also call on Ascend Laboratories, LLC at 1-877-ASC-RX01 (877-272-7901).

What are the ingredients in pregabalin capsules?

Active ingredient: pregabalin

Inactive ingredients:

Pregabalin capsules: Pregelatinized starch, talc

Capsule shell: gelatin, sodium lauryl sulfate and titanium dioxide; orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg): red iron oxide; yellow iron oxide

Imprinting ink: black iron oxide, potassium hydroxide, propylene glycol and shellac.

Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.   

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured by:

Alkem Laboratories Ltd.,


Distributed by:

Ascend Laboratories, LLC

Parsippany, NJ 07054

Revised: November, 2021

PT 3212-05

Revised: 5/2022
Ascend Laboratories, LLC