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Lyrica CR

  • Generic Name: pregabalin extended-release tablets
  • Brand Name: Lyrica CR

Lyrica CR(Pregabalin Extended-Release Tablets) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Lyrica CR Side Effects Center

What Is Lyrica CR?

Lyrica CR (pregabalin) extended-release is an anti-epileptic drug (AED) indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) and postherpetic neuralgia (PHN).

What Are Side Effects of Lyrica CR?

Common side effects of Lyrica CR include:

Dosage for Lyrica CR

The dosing recommendations for Lyrica CR for diabetic peripheral neuropathy and postherpetic neuralgia are 165 mg once/day.

What Drugs, Substances, or Supplements Interact with Lyrica CR?

Lyrica CR may interact with other drugs. Tell your doctor all medications and supplements you use. Lyrica CR is not recommended for use during pregnancy; it may harm a fetus.

Lyrica CR During Pregnancy and Breastfeeding

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Lyrica CR during pregnancy. Pregnant patients taking Lyrica CR are advised to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. Small amounts of Lyrica CR pass into breast milk. Breastfeeding is not recommended while using Lyrica CR. Withdrawal symptoms including insomnia, nausea, headache diarrhea, or anxiety may occur if you suddenly stop taking Lyrica CR.

Additional Information

Our Lyrica CR (pregabalin) Extended-Release Tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Lyrica CR Consumer Information

Pregabalin can cause a severe allergic reaction. Stop taking this medicine and get emergency medical help if you have: hives or blisters on your skin; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

  • weak or shallow breathing;
  • blue-colored skin, lips, fingers, and toes;
  • confusion, extreme drowsiness or weakness;
  • vision problems;
  • skin sores (if you have diabetes);
  • easy bruising, unusual bleeding;
  • swelling in your hands or feet, rapid weight gain (especially if you have diabetes or heart problems); or
  • unexplained muscle pain, tenderness, or weakness (especially if you also have fever or don't feel well).

Pregabalin can cause life-threatening breathing problems. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up. Breathing problems may be more likely in older adults or in people with COPD.

If you have diabetes, tell your doctor right away if you have any new sores or other skin problems.

Common side effects may include:

  • dizziness, drowsiness;
  • swelling in your hands and feet;
  • trouble concentrating;
  • increased appetite;
  • weight gain;
  • dry mouth; or
  • blurred vision.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Lyrica CR (Pregabalin Extended-Release Tablets)

 

Lyrica CR Professional Information

SIDE EFFECTS

The following adverse reactions are described elsewhere in the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Two randomized placebo-controlled clinical trials were conducted in patients with postherpetic neuralgia and fibromyalgia in which a total of 1242 patients received LYRICA CR. Both studies were randomized withdrawal design where a 6-week single-blind, dose optimization phase was followed by a 13-week double-blind phase. The most common adverse events leading to discontinuation from the single-blind phase of the study occurring in greater than or equal to 0.3% of patients were dizziness, somnolence, peripheral edema, fatigue, blurred vision, and increased weight. Sixty-four percent of patients experienced adverse events during the single-blind phase, with the most common adverse events occurring in greater than or equal to 4% of patients being dizziness, somnolence, headache, fatigue, peripheral edema, nausea, blurred vision, dry mouth, and weight gain.

Controlled Study In Postherpetic Neuralgia

Adverse Reactions Leading To Discontinuation

In a clinical trial in patients with postherpetic neuralgia, 8.9% of patients treated with LYRICA CR discontinued prematurely during the single-blind phase due to adverse reactions. The most common reasons for discontinuation due to adverse reactions were dizziness (2.1%), somnolence (0.87%), and peripheral edema (0.50%).

Most Common Adverse Reactions

Table 4 lists all adverse reactions, regardless of causality, occurring in greater than or equal to 1% of patients with postherpetic neuralgia who received LYRICA CR, regardless of the phase of the study.

Table 4: Incidence of Adverse Reactions Reported in Greater Than or Equal to 1% of Subjects in Any Phase of the LYRICA CR Study in Patients With Postherpetic Neuralgia*

System Organ Class Preferred Term Single-Blind Phase Double-Blind Phase
LYRICA CR
[N=801] n (%)		 LYRICA CR
[N=208] n (%)		 Placebo
[N=205] n (%)
Ear and labyrinth disorders
Vertigo 31 (3.9) 2 (1.0) 1 (0.5)
Eye disorders
Vision blurred 30 (3.7) 1 (0.5) 0
Diplopia 8 (1.0) 1 (0.5) 0
Gastrointestinal disorders
Dry mouth 30 (3.7) 1 (0.5) 0
Nausea 24 (3.0) 7 (3.4) 0
Constipation 22 (2.7) 0 0
Diarrhea 11 (1.4) 2 (1.0) 1 (0.5)
Vomiting 9 (1.1) 3 (1.4) 1 (0.5)
General disorders and administration site conditions
Edema peripheral 39 (4.9) 8 (3.8) 1 (0.5)
Fatigue 31 (3.9) 3 (1.4) 2 (1.0)
Edema 3 (0.4) 3 (1.4) 0
Infections and infestations
Nasopharyngitis 12 (1.5) 3 (1.4) 0
Urinary tract infection 11 (1.4) 3 (1.4) 1 (0.5)
Bronchitis 4 (0.5) 3 (1.4) 2 (1.0)
Respiratory tract infection viral 3 (0.4) 3 (1.4) 1 (0.5)
Sinusitis 3 (0.4) 2 (1.0) 0
Gastroenteritis viral 2 (0.2) 2 (1.0) 0
Investigations
Weight increased 20 (2.5) 8 (3.8) 2 (1.0)
Alanine aminotransferase increased 2 (0.2) 3 (1.4) 0
Aspartate aminotransferase increased 2 (0.2) 2 (1.0) 0
Musculoskeletal and connective tissue disorders
Arthralgia 6 (0.7) 2 (1.0) 1 (0.5)
Joint swelling 0 4 (1.9) 0
Nervous system disorders
Dizziness 137 (17.1) 7 (3.4) 1 (0.5)
Somnolence 91 (11.4) 1 (0.5) 0
Headache 31 (3.9) 4 (1.9) 1 (0.5)
Balance disorder 21 (2.6) 1 (0.5) 0
Reproductive system and breast disorders
Erectile dysfunction 2 (0.6) 1 (14) 0
Respiratory, thoracic, and mediastinal disorders
Cough 2 (0.2) 2 (1.0) 1 (0.5)
Skin and subcutaneous tissue disorders
Dermatitis contact 0 2 (1.0) 0
* Table is limited to adverse reactions that occurred with higher incidence in LYRICA CR-treated patients than in placebo-treated patients for the DB Phase of the study.

Other Adverse Reactions Observed During Clinical Studies With LYRICA And LYRICA CR

In addition to the adverse reactions reported during the controlled studies with LYRICA CR in postherpetic neuralgia, the following adverse reactions have been reported in patients treated with LYRICA and LYRICA CR during all clinical studies. This listing does not include those adverse reactions already listed above. The adverse reactions are categorized by system organ class and listed in order of decreasing frequency according to the following definitions: frequent adverse reactions are those occurring on 1 or more occasions in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1000 patients; rare reactions are those occurring in fewer than 1/1000 patients. Adverse reactions of major clinical importance are described in the Warnings and Precautions section (5).

Cardiac Disorders - Infrequent: Palpitations, Deep thrombophlebitis, Heart failure, Hypotension, Postural hypotension, Retinal vascular disorder, Syncope; Rare: Cardiac failure, Tachycardia

Eye Disorders - Infrequent: Periorbital edema

Gastrointestinal Disorders - Frequent: Increased appetite; Infrequent: Abdominal distension, Abdominal pain, Dysphagia, Pancreatitis, Tongue edema

General Disorders - Frequent: Fever; Infrequent: Chest pain, Face edema; Rare: Facial pain, Mucosal dryness

Hemic and Lymphatic System Disorders - Frequent: Ecchymosis; Infrequent: Anemia, Eosinophilia, Hypochromic anemia, Leukocytosis, Leukopenia, Lymphadenopathy, Thrombocytopenia; Rare: Myelofibrosis, Polycythemia, Prothrombin decreased, Purpura, Thrombocythemia

Infections and Infestations - Infrequent: Otitis media, Pneumonia

Investigations - Rare: Glucose urine present, Lipase increased, Neutrophil count increased, Proteinuria

Metabolic and Nutritional Disorders - Rare: Glucose Tolerance Decreased, Urate Crystalluria

Musculoskeletal and Connective Tissue Disorders - Frequent: Leg cramps, Myalgia, Myasthenia; Infrequent: Joint stiffness; Rare: Coccydynia, Myokymia

Nervous System Disorders - Frequent: Anxiety, Depersonalization, Hypertonia, Hypoesthesia, Libido decreased, Nystagmus, Paresthesia, Sedation, Stupor, Twitching; Infrequent: Coordination abnormal, Abnormal dreams, Agitation, Amnesia, Apathy, Aphasia, Circumoral paresthesia, Cognitive disorder, Dysarthria, Dysgeusia, Hallucinations, Hostility, Hyperalgesia, Hyperesthesia, Hyperkinesia, Hypokinesia, Hypotonia, Libido increased, Myoclonus, Neuralgia, Sciatica, Sleep phase rhythm disturbance; Rare: Addiction, Altered state of consciousness, Bradykinesia, Cerebellar syndrome, Cogwheel rigidity, Coma, Delirium, Delusions, Depressed level of consciousness, Dysautonomia, Dyskinesia, Dystonia, Encephalopathy, Extrapyramidal syndrome, Psychomotor hyperactivity, Psychomotor skills impaired

Psychiatric Disorders - Infrequent: Irritability

Respiratory System Disorders - Rare: Lung edema

Skin Disorders - Frequent: Pruritus; Rare: Stevens-Johnson syndrome

Special Senses - Frequent: Conjunctivitis, Tinnitus

Urogenital System Disorders - Frequent: Anorgasmia, Impotence, Urinary frequency, Urinary incontinence; Infrequent: Abnormal ejaculation, Albuminuria, Dysuria, Hematuria, Kidney calculus, Leukorrhea, Nephritis, Oliguria, Urinary retention

Postmarketing Experience With LYRICA

The following adverse reactions have been identified during post-approval use of LYRICA. These adverse reactions have not been listed above and data are insufficient to support an estimate of their incidence or to establish causation. The listing is alphabetized: breast enlargement, gynecomastia.

There are also postmarketing reports of respiratory failure and coma in patients taking pregabalin and other CNS depressant medications. In addition, there are postmarketing reports of events related to reduced lower gastrointestinal tract function (e.g., intestinal obstruction, paralytic ileus, constipation) when LYRICA was co-administered with medications that have the potential to produce constipation, such as opioid analgesics.

Read the entire FDA prescribing information for Lyrica CR (Pregabalin Extended-Release Tablets)

&Copy; Lyrica CR Patient Information is supplied by Cerner Multum, Inc. and Lyrica CR Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.