ADVERSE REACTIONS
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.
In all controlled and uncontrolled trials across various patient populations during the premarketing development of LYRICA, more than 10,000 patients have received LYRICA. Approximately 5000 patients were treated for 6 months or more, over 3100 patients were treated for 1 year or longer, and over 1400 patients were treated for at least 2 years.
Adverse Reactions Most Commonly Leading to Discontinuation in All Premarketing Controlled Clinical Studies
In premarketing controlled trials of all populations combined, 14% of patients treated with LYRICA and 7% of patients treated with placebo discontinued prematurely due to adverse reactions. In the LYRICA treatment group, the adverse reactions most frequently leading to discontinuation were dizziness (4%) and somnolence (4%). In the placebo group, 1% of patients withdrew due to dizziness and <1% withdrew due to somnolence. Other adverse reactions that led to discontinuation from controlled trials more frequently in the LYRICA group compared to the placebo group were ataxia, confusion, asthenia, thinking abnormal, blurred vision, incoordination, and peripheral edema (1% each).
Most Common Adverse Reactions in All Premarketing Controlled Clinical Studies
In premarketing controlled trials of all patient populations combined, dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and "thinking abnormal" (primarily difficulty with concentration/attention) were more commonly reported by subjects treated with LYRICA than by subjects treated with placebo (≥5% and twice the rate of that seen in placebo).
Controlled Studies with Neuropathic Pain Associated with Diabetic Peripheral Neuropathy
Adverse Reactions Leading to Discontinuation
In clinical trials in patients with neuropathic pain associated with diabetic peripheral neuropathy, 9% of patients treated with LYRICA and 4% of patients treated with placebo discontinued prematurely due to adverse reactions. In the LYRICA treatment group, the most common reasons for discontinuation due to adverse reactions were dizziness (3%) and somnolence (2%). In comparison, <1% of placebo patients withdrew due to dizziness and somnolence. Other reasons for discontinuation from the trials, occurring with greater frequency in the LYRICA group than in the placebo group, were asthenia, confusion, and peripheral edema. Each of these events led to withdrawal in approximately 1% of patients.
Most Common Adverse Reactions
Table 3 lists all adverse reactions, regardless of causality, occurring in ≥1% of patients with neuropathic pain associated with diabetic neuropathy in the combined LYRICA group for which the incidence was greater in this combined LYRICA group than in the placebo group. A majority of pregabalin-treated patients in clinical studies had adverse reactions with a maximum intensity of "mild" or "moderate".
Table 3. Treatment-emergent adverse reaction incidence in controlled trials in neuropathic pain associated with diabetic peripheral neuropathy (events in at least 1% of all LYRICA-treated patients and at least numerically more in all LYRICA than in the placebo group)
Body system Preferred term |
75 mg/day |
150 mg/day |
300 mg/day |
600 mg/day |
All PGB
|
Placebo |
|
[N=77] % |
[N=212] % |
[N=321] % |
[N=369] % |
[N=979] % |
[N=459] % |
Body as a whole
|
|
|
|
|
|
|
Asthenia |
4 |
2 |
4 |
7 |
5 |
2 |
Accidental injury |
5 |
2 |
2 |
6 |
4 |
3 |
Back pain |
0 |
2 |
1 |
2 |
2 |
0 |
Chest pain |
4 |
1 |
1 |
2 |
2 |
1 |
Face edema |
0 |
1 |
1 |
2 |
1 |
0 |
Digestive system
|
|
|
|
|
|
|
Dry mouth |
3 |
2 |
5 |
7 |
5 |
1 |
Constipation |
0 |
2 |
4 |
6 |
4 |
2 |
Flatulence |
3 |
0 |
2 |
3 |
2 |
1 |
Metabolic and nutritional disorders
|
Peripheral edema |
4 |
6 |
9 |
12 |
9 |
2 |
Weight gain |
0 |
4 |
4 |
6 |
4 |
0 |
Edema |
0 |
2 |
4 |
2 |
2 |
0 |
Hypoglycemia |
1 |
3 |
2 |
1 |
2 |
1 |
Nervous system
|
|
|
|
|
|
|
Dizziness |
8 |
9 |
23 |
29 |
21 |
5 |
Somnolence |
4 |
6 |
13 |
16 |
12 |
3 |
Neuropathy |
9 |
2 |
2 |
5 |
4 |
3 |
Ataxia |
6 |
1 |
2 |
4 |
3 |
1 |
Vertigo |
1 |
2 |
2 |
4 |
3 |
1 |
Confusion |
0 |
1 |
2 |
3 |
2 |
1 |
Euphoria |
0 |
0 |
3 |
2 |
2 |
0 |
Incoordination |
1 |
0 |
2 |
2 |
2 |
0 |
Thinking abnormal
|
1 |
0 |
1 |
3 |
2 |
0 |
Tremor |
1 |
1 |
1 |
2 |
1 |
0 |
Abnormal gait |
1 |
0 |
1 |
3 |
1 |
0 |
Amnesia |
3 |
1 |
0 |
2 |
1 |
0 |
Nervousness |
0 |
1 |
1 |
1 |
1 |
0 |
Respiratory system
|
|
|
|
|
|
|
Dyspnea |
3 |
0 |
2 |
2 |
2 |
1 |
Special senses
|
|
|
|
|
|
|
Blurry vision
|
3 |
1 |
3 |
6 |
4 |
2 |
Abnormal vision |
1 |
0 |
1 |
1 |
1 |
0 |
Controlled Studies in Postherpetic Neuralgia
Adverse Reactions Leading to Discontinuation
In clinical trials in patients with postherpetic neuralgia, 14% of patients treated with LYRICA and 7% of patients treated with placebo discontinued prematurely due to adverse reactions. In the LYRICA treatment group, the most common reasons for discontinuation due to adverse reactions were dizziness (4%) and somnolence (3%). In comparison, less than 1% of placebo patients withdrew due to dizziness and somnolence. Other reasons for discontinuation from the trials, occurring in greater frequency in the LYRICA group than in the placebo group, were confusion (2%), as well as peripheral edema, asthenia, ataxia, and abnormal gait (1% each).
Most Common Adverse Reactions
Table 4 lists all adverse reactions, regardless of causality, occurring in ≥ 1% of patients with neuropathic pain associated with postherpetic neuralgia in the combined LYRICA group for which the incidence was greater in this combined LYRICA group than in the placebo group. In addition, an event is included, even if the incidence in the all LYRICA group is not greater than in the placebo group, if the incidence of the event in the 600 mg/day group is more than twice that in the placebo group. A majority of pregabalin-treated patients in clinical studies had adverse reactions with a maximum intensity of "mild" or "moderate". Overall, 12.4% of all pregabalin-treated patients and 9.0% of all placebo-treated patients had at least one severe event while 8% of pregabalin-treated patients and 4.3% of placebo-treated patients had at least one severe treatment-related adverse event.
Table 4. Treatment-emergent adverse reaction incidence in controlled trials in neuropathic pain associated with postherpetic neuralgia (events in at least 1% of all LYRICA-treated patients and at least numerically more in all LYRICA than in the placebo group)
Body system Preferred term |
75 mg/d |
150 mg/d |
300 mg/d |
600 mg/d |
All PGB
|
Placebo |
|
[N=84] % |
[N=302] % |
[N=312] % |
[N=154] % |
[N=852] % |
[N=398] % |
Body as a whole
|
|
|
|
|
|
|
Infection |
14 |
8 |
6 |
3 |
7 |
4 |
Headache |
5 |
9 |
5 |
8 |
7 |
5 |
Pain |
5 |
4 |
5 |
5 |
5 |
4 |
Accidental injury |
4 |
3 |
3 |
5 |
3 |
2 |
Flu syndrome |
1 |
2 |
2 |
1 |
2 |
1 |
Face edema |
0 |
2 |
1 |
3 |
2 |
1 |
Digestive system
|
|
|
|
|
|
|
Dry mouth |
7 |
7 |
6 |
15 |
8 |
3 |
Constipation |
4 |
5 |
5 |
5 |
5 |
2 |
Flatulence |
2 |
1 |
2 |
3 |
2 |
1 |
Vomiting |
1 |
1 |
3 |
3 |
2 |
1 |
Metabolic and nutritional disorders
|
Peripheral edema |
0 |
8 |
16 |
16 |
12 |
4 |
Weight gain |
1 |
2 |
5 |
7 |
4 |
0 |
Edema |
0 |
1 |
2 |
6 |
2 |
1 |
Musculoskeletal system
|
Myasthenia |
1 |
1 |
1 |
1 |
1 |
0 |
Nervous system
|
|
|
|
|
|
|
Dizziness |
11 |
18 |
31 |
37 |
26 |
9 |
Somnolence |
8 |
12 |
18 |
25 |
16 |
5 |
Ataxia |
1 |
2 |
5 |
9 |
5 |
1 |
Abnormal gait |
0 |
2 |
4 |
8 |
4 |
1 |
Confusion |
1 |
2 |
3 |
7 |
3 |
0 |
Thinking abnormal
|
0 |
2 |
1 |
6 |
2 |
2 |
Incoordination |
2 |
2 |
1 |
3 |
2 |
0 |
Amnesia |
0 |
1 |
1 |
4 |
2 |
0 |
Speech disorder |
0 |
0 |
1 |
3 |
1 |
0 |
Respiratory system
|
|
|
|
|
|
|
Bronchitis |
0 |
1 |
1 |
3 |
1 |
1 |
Special senses
|
|
|
|
|
|
|
Blurry vision
|
1 |
5 |
5 |
9 |
5 |
3 |
Diplopia |
0 |
2 |
2 |
4 |
2 |
0 |
Abnormal vision |
0 |
1 |
2 |
5 |
2 |
0 |
Eye Disorder |
0 |
1 |
1 |
2 |
1 |
0 |
Urogenital System
|
Urinary Incontinence |
0 |
1 |
1 |
2 |
1 |
0 |
Controlled Add-On Studies in Adjunctive Therapy for Adult Patients with Partial Onset Seizures
Adverse Reactions Leading to Discontinuation
Approximately 15% of patients receiving LYRICA and 6% of patients receiving placebo in add-on epilepsy trials discontinued prematurely due to adverse reactions. In the LYRICA treatment group, the adverse reactions most frequently leading to discontinuation were dizziness (6%), ataxia (4%), and somnolence (3%). In comparison, <1% of patients in the placebo group withdrew due to each of these events. Other adverse reactions that led to discontinuation of at least 1% of patients in the LYRICA group and at least twice as frequently compared to the placebo group were asthenia, diplopia, blurred vision, thinking abnormal, nausea, tremor, vertigo, headache, and confusion (which each led to withdrawal in 2% or less of patients).
Most Common Adverse Reactions
Table 5 lists all dose-related adverse reactions occurring in at least 2% of all LYRICA-treated patients. Dose-relatedness was defined as the incidence of the adverse event in the 600 mg/day group was at least 2% greater than the rate in both the placebo and 150 mg/day groups. In these studies, 758 patients received LYRICA and 294 patients received placebo for up to 12 weeks. Because patients were also treated with 1 to 3 other AEDs, it is not possible to determine whether the following adverse reactions can be ascribed to LYRICA alone, or the combination of LYRICA and other AEDs. A majority of pregabalin-treated patients in clinical studies had adverse reactions with a maximum intensity of "mild" or "moderate".
Table 5. Dose-related treatment-emergent adverse reaction incidence in controlled trials in adjunctive therapy for adult patients with partial onset seizures (events in at least 2% of all LYRICA-treated patients and the adverse reaction in the 600 mg/day group was ≥2% the rate in both the placebo and 150 mg/day groups)
Body System Preferred Term |
150 mg/d
[N = 185] % |
300 mg/d
[N = 90] % |
600 mg/d
[N = 395] % |
All PGB
[N = 670]
% |
Placebo
[N = 294] % |
Body as a Whole
|
|
|
|
|
|
Accidental Injury |
7 |
11 |
10 |
9 |
5 |
Pain |
3 |
2 |
5 |
4 |
3 |
Digestive System
|
|
|
|
|
|
Increased Appetite |
2 |
3 |
6 |
5 |
1 |
Dry Mouth |
1 |
2 |
6 |
4 |
1 |
Constipation |
1 |
1 |
7 |
4 |
2 |
Metabolic and Nutritional Disorders
|
|
Weight Gain |
5 |
7 |
16 |
12 |
1 |
Peripheral Edema |
3 |
3 |
6 |
5 |
2 |
Nervous System
|
|
|
|
|
|
Dizziness |
18 |
31 |
38 |
32 |
11 |
Somnolence |
11 |
18 |
28 |
22 |
11 |
Ataxia |
6 |
10 |
20 |
15 |
4 |
Tremor |
3 |
7 |
11 |
8 |
4 |
Thinking Abnormal
|
4 |
8 |
9 |
8 |
2 |
Amnesia |
3 |
2 |
6 |
5 |
2 |
Speech Disorder |
1 |
2 |
7 |
5 |
1 |
Incoordination |
1 |
3 |
6 |
4 |
1 |
Abnormal Gait |
1 |
3 |
5 |
4 |
0 |
Twitching |
0 |
4 |
5 |
4 |
1 |
Confusion |
1 |
2 |
5 |
4 |
2 |
Myoclonus |
1 |
0 |
4 |
2 |
0 |
Special Senses
|
|
|
|
|
|
Blurred Vision
|
5 |
8 |
12 |
10 |
4 |
Diplopia |
5 |
7 |
12 |
9 |
4 |
Abnormal Vision |
3 |
1 |
5 |
4 |
1 |
Controlled Studies with Fibromyalgia
Adverse Reactions Leading to Discontinuation
In clinical trials of patients with fibromyalgia, 19% of patients treated with pregabalin (150–600 mg/day) and 10% of patients treated with placebo discontinued prematurely due to adverse reactions. In the pregabalin treatment group, the most common reasons for discontinuation due to adverse reactions were dizziness (6%) and somnolence (3%). In comparison, <1% of placebo-treated patients withdrew due to dizziness and somnolence. Other reasons for discontinuation from the trials, occurring with greater frequency in the pregabalin treatment group than in the placebo treatment group, were fatigue, headache, balance disorder, and weight increased. Each of these adverse reactions led to withdrawal in approximately 1% of patients.
Most Common Adverse Reactions
Table 6 lists all adverse reactions, regardless of causality, occurring in ≥2% of patients with fibromyalgia in the 'all pregabalin' treatment group for which the incidence was greater than in the placebo treatment group. A majority of pregabalin-treated patients in clinical studies experienced adverse reactions with a maximum intensity of "mild" or "moderate".
Table 6. Treatment-emergent adverse reaction incidence in controlled trials in fibromyalgia (events) in at least 2% of all LYRICA-treated patients and occurring more frequently in the all pregabalin-group than in the placebo treatment group)
System Organ Class Preferred term |
150 mg/d |
300 mg/d |
450 mg/d |
600 mg/d |
All PGB
|
Placebo |
|
[N=132] % |
[N=502] % |
[N=505] % |
[N=378] % |
[N=1517] % |
[N=505] % |
Ear and Labyrinth Disorders
|
Vertigo |
2 |
2 |
2 |
1 |
2 |
0 |
Eye Disorders
|
|
|
|
|
|
|
Vision blurred |
8 |
7 |
7 |
12 |
8 |
1 |
Gastrointestinal Disorders
|
Dry mouth |
7 |
6 |
9 |
9 |
8 |
2 |
Constipation |
4 |
4 |
7 |
10 |
7 |
2 |
Vomiting |
2 |
3 |
3 |
2 |
3 |
2 |
Flatulence |
1 |
1 |
2 |
2 |
2 |
1 |
Abdominal distension |
2 |
2 |
2 |
2 |
2 |
1 |
General Disorders and Administrative Site Conditions
|
Fatigue |
5 |
7 |
6 |
8 |
7 |
4 |
Edema peripheral |
5 |
5 |
6 |
9 |
6 |
2 |
Chest pain |
2 |
1 |
1 |
2 |
2 |
1 |
Feeling abnormal |
1 |
3 |
2 |
2 |
2 |
0 |
Edema |
1 |
2 |
1 |
2 |
2 |
1 |
Feeling drunk |
1 |
2 |
1 |
2 |
2 |
0 |
Infections and Infestations
|
Sinusitis |
4 |
5 |
7 |
5 |
5 |
4 |
Investigations
|
Weight increased |
8 |
10 |
10 |
14 |
11 |
2 |
Metabolism and Nutrition Disorders
|
Increased appetite |
4 |
3 |
5 |
7 |
5 |
1 |
Fluid retention |
2 |
3 |
3 |
2 |
2 |
1 |
Musculoskeletal and Connective Tissue Disorders
|
Arthralgia |
4 |
3 |
3 |
6 |
4 |
2 |
Muscle spasms |
2 |
4 |
4 |
4 |
4 |
2 |
Back pain |
2 |
3 |
4 |
3 |
3 |
3 |
Nervous System Disorders
|
Dizziness |
23 |
31 |
43 |
45 |
38 |
9 |
Somnolence |
13 |
18 |
22 |
22 |
20 |
4 |
Headache |
11 |
12 |
14 |
10 |
12 |
12 |
Disturbance in attention |
4 |
4 |
6 |
6 |
5 |
1 |
Balance disorder |
2 |
3 |
6 |
9 |
5 |
0 |
Memory impairment |
1 |
3 |
4 |
4 |
3 |
0 |
Coordination abnormal |
2 |
1 |
2 |
2 |
2 |
1 |
Hypoesthesia |
2 |
2 |
3 |
2 |
2 |
1 |
Lethargy |
2 |
2 |
1 |
2 |
2 |
0 |
Tremor |
0 |
1 |
3 |
2 |
2 |
0 |
Psychiatric Disorders
|
Euphoric Mood |
2 |
5 |
6 |
7 |
6 |
1 |
Confusional state |
0 |
2 |
3 |
4 |
3 |
0 |
Anxiety |
2 |
2 |
2 |
2 |
2 |
1 |
Disorientation |
1 |
0 |
2 |
1 |
2 |
0 |
Depression |
2 |
2 |
2 |
2 |
2 |
2 |
Respiratory, Thoracic and Mediastinal Disorders
|
Pharyngolaryngeal pain |
2 |
1 |
3 |
3 |
2 |
2 |
Controlled Studies in Neuropathic Pain Associated with Spinal Cord Injury
Adverse Reactions Leading to Discontinuation
In clinical trials of patients with neuropathic pain associated with spinal cord injury, 13% of patients treated with pregabalin and 10% of patients treated with placebo discontinued prematurely due to adverse reactions. In the pregabalin treatment group, the most common reasons for discontinuation due to adverse reactions were somnolence (3%) and edema (2%). In comparison, none of the placebo-treated patients withdrew due to somnolence and edema. Other reasons for discontinuation from the trials, occurring with greater frequency in the pregabalin treatment group than in the placebo treatment group, were fatigue and balance disorder. Each of these adverse reactions led to withdrawal in less than 2% of patients.
Most Common Adverse Reactions
Table 7 lists all adverse reactions, regardless of causality, occurring in ≥2% of patients with neuropathic pain associated with spinal cord injury in the controlled trials. A majority of pregabalin-treated patients in clinical studies experienced adverse reactions with a maximum intensity of "mild" or "moderate".
Table 7. Treatment-emergent adverse reaction incidence in controlled trials in neuropathic pain associated with spinal cord injury (events in at least 2% of all LYRICA-treated patients and occurring more frequently in the all pregabalin-group than in the placebo treatment group)
System Organ Class Preferred term |
PGB
(N=182) |
Placebo (N=174) |
% |
% |
Ear and labryrinth disorders
|
Vertigo |
2.7 |
1.1 |
Eye disorders
|
Vision blurred |
6.6 |
1.1 |
Gastrointestinal disorders
|
|
|
Dry mouth |
11.0 |
2.9 |
Constipation |
8.2 |
5.7 |
Nausea |
4.9 |
4.0 |
Vomiting |
2.7 |
1.1 |
General disorders and administration site conditions
|
Fatigue |
11.0 |
4.0 |
Edema peripheral |
10.4 |
5.2 |
Edema |
8.2 |
1.1 |
Pain |
3.3 |
1.1 |
Infections and infestations
|
Nasopharyngitis |
8.2 |
4.6 |
Investigations
|
Weight increased |
3.3 |
1.1 |
Blood creatine phosphokinase increased |
2.7 |
0 |
Musculoskeletal and connective tissue disorders
|
Muscular weakness |
4.9 |
1.7 |
Pain in extremity |
3.3 |
2.3 |
Neck pain |
2.7 |
1.1 |
Back pain |
2.2 |
1.7 |
Joint swelling |
2.2 |
0 |
Nervous system disorders
|
Somnolence |
35.7 |
11.5 |
Dizziness |
20.9 |
6.9 |
Disturbance in attention |
3.8 |
0 |
Memory impairment |
3.3 |
1.1 |
Paresthesia |
2.2 |
0.6 |
Psychiatric disorders
|
|
|
Insomnia |
3.8 |
2.9 |
Euphoric mood |
2.2 |
0.6 |
Renal and urinary disorders
|
Urinary incontinence |
2.7 |
1.1 |
Skin and subcutaneous tissue disorders
|
Decubitus ulcer |
2.7 |
1.1 |
Vascular disorders
|
Hypertension |
2.2 |
1.1 |
Hypotension |
2.2 |
0 |
Other Adverse Reactions Observed During the Clinical Studies of LYRICA
Following is a list of treatment-emergent adverse reactions reported by patients treated with LYRICA during all clinical trials. The listing does not include those events already listed in the previous tables or elsewhere in labeling, those events for which a drug cause was remote, those events which were so general as to be uninformative, and those events reported only once which did not have a substantial probability of being acutely life-threatening.
Events are categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse reactions are those occurring on one 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. Events of major clinical importance are described in the Warnings and Precautions section (5).
Body as a Whole – Frequent: Abdominal pain, Allergic reaction, Fever, Infrequent: Abscess, Cellulitis, Chills, Malaise, Neck rigidity, Overdose, Pelvic pain, Photosensitivity reaction, Rare: Anaphylactoid reaction, Ascites, Granuloma, Hangover effect, Intentional Injury, Retroperitoneal Fibrosis, Shock
Cardiovascular System – Infrequent: Deep thrombophlebitis, Heart failure, Hypotension, Postural hypotension, Retinal vascular disorder, Syncope; Rare: ST Depressed, Ventricular Fibrillation
Digestive System – Frequent: Gastroenteritis, Increased appetite; Infrequent: Cholecystitis, Cholelithiasis, Colitis, Dysphagia, Esophagitis, Gastritis, Gastrointestinal hemorrhage, Melena, Mouth ulceration, Pancreatitis, Rectal hemorrhage, Tongue edema; Rare: Aphthous stomatitis, Esophageal Ulcer, Periodontal abscess
Hemic and Lymphatic System – Frequent: Ecchymosis; Infrequent: Anemia, Eosinophilia, Hypochromic anemia, Leukocytosis, Leukopenia, Lymphadenopathy, Thrombocytopenia; Rare: Myelofibrosis, Polycythemia, Prothrombin decreased, Purpura, Thrombocythemia
Metabolic and Nutritional Disorders – Rare: Glucose Tolerance Decreased, Urate Crystalluria
Musculoskeletal System – Frequent: Arthralgia, Leg cramps, Myalgia, Myasthenia; Infrequent: Arthrosis; Rare: Chondrodystrophy, Generalized Spasm
Nervous System – Frequent: Anxiety, Depersonalization, Hypertonia, Hypoesthesia, Libido decreased, Nystagmus, Paresthesia, Sedation, Stupor, Twitching; Infrequent: Abnormal dreams, Agitation, Apathy, Aphasia, Circumoral paresthesia, Dysarthria, Hallucinations, Hostility, Hyperalgesia, Hyperesthesia, Hyperkinesia, Hypokinesia, Hypotonia, Libido increased, Myoclonus, Neuralgia, Rare: Addiction, Cerebellar syndrome, Cogwheel rigidity, Coma, Delirium, Delusions, Dysautonomia, Dyskinesia, Dystonia, Encephalopathy, Extrapyramidal syndrome, Guillain-Barré syndrome, Hypalgesia, Intracranial hypertension, Manic reaction, Paranoid reaction, Peripheral neuritis, Personality disorder, Psychotic depression, Schizophrenic reaction, Sleep disorder, Torticollis, Trismus
Respiratory System – Rare: Apnea, Atelectasis, Bronchiolitis, Hiccup, Laryngismus, Lung edema, Lung fibrosis, Yawn
Skin and Appendages – Frequent: Pruritus, Infrequent: Alopecia, Dry skin, Eczema, Hirsutism, Skin ulcer, Urticaria, Vesiculobullous rash; Rare: Angioedema, Exfoliative dermatitis, Lichenoid dermatitis, Melanosis, Nail Disorder, Petechial rash, Purpuric rash, Pustular rash, Skin atrophy, Skin necrosis, Skin nodule, Stevens-Johnson syndrome, Subcutaneous nodule
Special senses – Frequent: Conjunctivitis, Diplopia, Otitis media, Tinnitus; Infrequent: Abnormality of accommodation, Blepharitis, Dry eyes, Eye hemorrhage, Hyperacusis, Photophobia, Retinal edema, Taste loss, Taste perversion; Rare: Anisocoria, Blindness, Corneal ulcer, Exophthalmos, Extraocular palsy, Iritis, Keratitis, Keratoconjunctivitis, Miosis, Mydriasis, Night blindness, Ophthalmoplegia, Optic atrophy, Papilledema, Parosmia, Ptosis, Uveitis
Urogenital System – Frequent: Anorgasmia, Impotence, Urinary frequency, Urinary incontinence; Infrequent: Abnormal ejaculation, Albuminuria, Amenorrhea, Dysmenorrhea, Dysuria, Hematuria, Kidney calculus, Leukorrhea, Menorrhagia, Metrorrhagia, Nephritis, Oliguria, Urinary retention, Urine abnormality; Rare: Acute kidney failure, Balanitis, Bladder Neoplasm, Cervicitis, Dyspareunia, Epididymitis, Female lactation, Glomerulitis, Ovarian disorder, Pyelonephritis
Comparison of Gender and Race
The overall adverse event profile of pregabalin was similar between women and men. There are insufficient data to support a statement regarding the distribution of adverse experience reports by race.
Post-marketing Experience
The following adverse reactions have been identified during postapproval use of LYRICA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Nervous System Disorders – Headache
Gastrointestinal Disorders – Nausea, Diarrhea
Reproductive System and Breast Disorders – Gynecomastia, Breast Enlargement
In addition, there are post-marketing 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. There are also post-marketing reports of respiratory failure and coma in patients taking pregabalin and other CNS depressant medications.
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