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LYRICA® CR, CV Adverse Reactions (pregabalin extended-release)


The following adverse reactions are described elsewhere in the labeling:

6.1 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 PhaseDouble-Blind Phase
n (%)
n (%)
n (%)
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.
Ear and labyrinth disorders
  Vertigo31 (3.9)2 (1.0)1 (0.5)
Eye disorders
  Vision blurred30 (3.7)1 (0.5)0
  Diplopia8 (1.0)1 (0.5)0
Gastrointestinal disorders
  Dry mouth30 (3.7)1 (0.5)0
  Nausea24 (3.0)7 (3.4)0
  Constipation22 (2.7)00
  Diarrhea11 (1.4)2 (1.0)1 (0.5)
  Vomiting9 (1.1)3 (1.4)1 (0.5)
General disorders and administration site conditions
  Edema peripheral39 (4.9)8 (3.8)1 (0.5)
  Fatigue31 (3.9)3 (1.4)2 (1.0)
  Edema3 (0.4)3 (1.4)0
Infections and infestations
  Nasopharyngitis12 (1.5)3 (1.4)0
  Urinary tract infection11 (1.4)3 (1.4)1 (0.5)
  Bronchitis4 (0.5)3 (1.4)2 (1.0)
  Respiratory tract infection viral3 (0.4)3 (1.4)1 (0.5)
  Sinusitis3 (0.4)2 (1.0)0
  Gastroenteritis viral2 (0.2)2 (1.0)0
  Weight increased20 (2.5)8 (3.8)2 (1.0)
  Alanine aminotransferase increased2 (0.2)3 (1.4)0
  Aspartate aminotransferase increased2 (0.2)2 (1.0)0
Musculoskeletal and connective tissue disorders
  Arthralgia6 (0.7)2 (1.0)1 (0.5)
  Joint swelling04 (1.9)0
Nervous system disorders
  Dizziness137 (17.1)7 (3.4)1 (0.5)
  Somnolence91 (11.4)1 (0.5)0
  Headache31 (3.9)4 (1.9)1 (0.5)
  Balance disorder21 (2.6)1 (0.5)0
Reproductive system and breast disorders
  Erectile dysfunction 2 (0.6)1 (1.4)0
Respiratory, thoracic, and mediastinal disorders
  Cough2 (0.2)2 (1.0)1 (0.5)
Skin and subcutaneous tissue disorders
  Dermatitis contact02 (1.0)0

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

6.2 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, bullous pemphigoid, gynecomastia.

There are postmarketing reports of life-threatening or fatal respiratory depression in patients taking pregabalin with opioids or other CNS depressants, or in the setting of underlying respiratory impairment.

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.

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