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Lyrica (Pregabalin) - Side Effects and Adverse Reactions

 
 



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 (3%). 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
[N=77]
%
150
mg/day
[N=212]
%
300
mg/day
[N=321]
%
600
mg/day
[N=369]
%
All PGBPGB: pregabalin
[N=979]
%
Placebo
[N=459]
%
Body as a whole
Asthenia424752
Accidental injury522643
Back pain021220
Chest pain411221
Face edema011210
Digestive system
Dry mouth325751
Constipation024642
Flatulence302321
Metabolic and nutritional disorders
Peripheral edema4691292
Weight gain044640
Edema024220
Hypoglycemia132121
Nervous system
Dizziness892329215
Somnolence461316123
Neuropathy922543
Ataxia612431
Vertigo122431
Confusion012321
Euphoria003220
Incoordination102220
Thinking abnormalThinking abnormal primarily consists of events related to difficulty with concentration/attention but also includes events related to cognition and language problems and slowed thinking.101320
Tremor111210
Abnormal gait101310
Amnesia310210
Nervousness011110
Respiratory system
Dyspnea302221
Special senses
Blurry visionInvestigator term; summary level term is amblyopia313642
Abnormal vision101110

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".

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
[N=84]
%
150 mg/d
[N=302]
%
300 mg/d
[N=312]
%
600 mg/d
[N=154]
%
All PGBPGB: pregabalin
[N=852]
%
Placebo
[N=398]
%
Body as a whole
Infection1486374
Headache595875
Pain545554
Accidental injury433532
Flu syndrome122121
Face edema021321
Digestive system
Dry mouth7761583
Constipation455552
Flatulence212321
Vomiting113321
Metabolic and nutritional disorders
Peripheral edema081616124
Weight gain125740
Edema012621
Musculoskeletal system
Myasthenia111110
Nervous system
Dizziness11183137269
Somnolence8121825165
Ataxia125951
Abnormal gait024841
Confusion123730
Thinking abnormalThinking abnormal primarily consists of events related to difficulty with concentration/attention but also includes events related to cognition and language problems and slowed thinking.021622
Incoordination221320
Amnesia011420
Speech disorder001310
Respiratory system
Bronchitis011311
Special senses
Blurry visionInvestigator term; summary level term is amblyopia155953
Diplopia022420
Abnormal vision012520
Eye Disorder011210
Urogenital System
Urinary Incontinence011210

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 System150 mg/d300 mg/d600 mg/dAll PGBPGB: pregabalinPlacebo
- Preferred Term[N = 185][N = 90][N = 395][N = 670]Excludes patients who received the 50 mg dose in Study E1.[N = 294]
%%%%%
Body as a Whole
Accidental Injury7111095
Pain32543
Digestive System
Increased Appetite23651
Dry Mouth12641
Constipation11742
Metabolic and Nutritional Disorders
Weight Gain5716121
Peripheral Edema33652
Nervous System
Dizziness1831383211
Somnolence1118282211
Ataxia61020154
Tremor371184
Thinking AbnormalThinking abnormal primarily consists of events related to difficulty with concentration/attention but also includes events related to cognition and language problems and slowed thinking.48982
Amnesia32652
Speech Disorder12751
Incoordination13641
Abnormal Gait13540
Twitching04541
Confusion12542
Myoclonus10420
Special Senses
Blurred VisionInvestigator term; summary level term is amblyopia.5812104
Diplopia571294
Abnormal Vision31541

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
[N=132]
%
300 mg/d
[N=502]
%
450 mg/d
[N=505]
%
600 mg/d
[N=378]
%
All PGBPGB: pregabalin
[N=1517]
%
Placebo
[N=505]
%
Ear and Labyrinth Disorders
Vertigo222120
Eye Disorders
Vision blurred8771281
Gastrointestinal Disorders
Dry mouth769982
Constipation4471072
Vomiting233232
Flatulence112221
Abdominal distension222221
General Disorders and Administrative Site Conditions
Fatigue576874
Edema peripheral556962
Chest pain211221
Feeling abnormal132220
Edema121221
Feeling drunk121220
Infections and Infestations
Sinusitis457554
Investigations
Weight increased 8101014112
Metabolism and Nutrition Disorders
Increased appetite435751
Fluid retention233221
Musculoskeletal and Connective Tissue Disorders
Arthralgia433642
Muscle spasms244442
Back pain234333
Nervous System Disorders
Dizziness23314345389
Somnolence13182222204
Headache111214101212
Disturbance in attention446651
Balance disorder236950
Memory impairment134430
Coordination abnormal212221
Hypoaesthesia223221
Lethargy221220
Tremor013220
Psychiatric Disorders
Euphoric Mood256761
Confusional state023430
Anxiety222221
Disorientation102120
Depression222222
Respiratory, Thoracic and Mediastinal Disorders
Pharyngolaryngeal pain213322

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, Hypesthesia, Libido decreased, Nystagmus, Paresthesia, 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



REPORTS OF SUSPECTED LYRICA SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Lyrica. The information is not vetted and should not be considered as verified clinical evidence.

Possible Lyrica side effects / adverse reactions in 58 year old female

Reported by a consumer/non-health professional from United States on 2011-09-29

Patient: 58 year old female weighing 77.1 kg (169.6 pounds)

Reactions: Dyspnoea, Pruritus, Diabetes Mellitus, Tendon Rupture, Urticaria, Rash, Erythema, Oedema Peripheral, Dizziness, Mental Disorder, Disturbance in Attention, Neuralgia

Suspect drug(s):
Premarin
    Dosage: 0.625 mg ; 0.3 mg ; 0.625 mg
    Indication: Inadequate Lubrication

Etodolac
    Dosage: 200 mg
    Indication: Inflammation
    End date: 2011-07-01

Lyrica
    Dosage: 300 mg;bid;po ; 50 mg;po ; 100 mg;po ; 150 mg;po ; 200 mg;po
    Administration route: Oral
    Indication: Neuralgia
    Start date: 2009-12-01

Lyrica
    Dosage: 300 mg;bid;po ; 50 mg;po ; 100 mg;po ; 150 mg;po ; 200 mg;po
    Administration route: Oral
    Indication: Neuralgia
    End date: 2010-07-01

Lyrica
    Dosage: 300 mg;bid;po ; 50 mg;po ; 100 mg;po ; 150 mg;po ; 200 mg;po
    Administration route: Oral
    Indication: Neuralgia
    Start date: 2011-07-31
    End date: 2011-07-31

Lyrica
    Dosage: 300 mg;bid;po ; 50 mg;po ; 100 mg;po ; 150 mg;po ; 200 mg;po
    Administration route: Oral
    Indication: Neuralgia
    Start date: 2011-08-02

Lyrica
    Dosage: 300 mg;bid;po ; 50 mg;po ; 100 mg;po ; 150 mg;po ; 200 mg;po
    Administration route: Oral
    Indication: Neuralgia
    Start date: 2011-08-01
    End date: 2011-08-01

Ultram
    Indication: Pain
    End date: 2011-07-01

Advil Liqui-Gels
    Indication: Pain
    End date: 2011-07-30



Possible Lyrica side effects / adverse reactions in 40 year old female

Reported by a physician from Japan on 2011-10-03

Patient: 40 year old female weighing 47.0 kg (103.4 pounds)

Reactions: Diplopia, Fall, Loss of Consciousness

Suspect drug(s):
Lyrica
    Dosage: 150 mg, 1x/day
    Administration route: Oral
    Start date: 2010-12-28
    End date: 2011-01-04

Lyrica
    Dosage: 300 mg/day
    Administration route: Oral
    Indication: Procedural Pain
    Start date: 2010-01-01
    End date: 2010-12-20

Lyrica
    Dosage: 75 mg, 1x/day
    Administration route: Oral
    Start date: 2010-12-21
    End date: 2010-12-27

Other drugs received by patient: Tegretol; Clonazepam; Doral; Cymbalta



Possible Lyrica side effects / adverse reactions in 41 year old female

Reported by a consumer/non-health professional from United States on 2011-10-03

Patient: 41 year old female weighing 56.7 kg (124.7 pounds)

Reactions: Migraine, Urinary Retention, Depression, Bladder Disorder, Stress Urinary Incontinence, Micturition Urgency

Adverse event resulted in: hospitalization, disablity

Suspect drug(s):
Lyrica

Other drugs received by patient: Darvocet



See index of all Lyrica side effect reports >>

Drug label data at the top of this Page last updated: 2009-05-06

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