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Lyrica

"Oct. 28, 2013 -- A new blood test may predict fibromyalgia, a condition that can be hard to diagnose.

Research about the new test was presented Sunday at the annual meeting of the American College of Rheumatology in San Diego.

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Lyrica

Lyrica

Lyrica Side Effects Center

Pharmacy Editor: Omudhome Ogbru, PharmD

Lyrica (pregabalin) is an oral medication that is chemically related to gabapentin (Neurontin, Gabarone). It is used for neuropathic pain associated with diabetic peripheral neuropathy or postherpetic neuralgia, and for treating partial onset seizures in adults, and fibromyalgia. Common side effects of Lyrica include dizziness, drowsiness, dry mouth, edema, blurred vision, weight gain, and difficulty concentrating.

The recommended dose of Lyrica is 75-600 mg daily. Alcohol and drugs that cause sedation may increase the sedative effects of Lyrica. There are no adequate studies of Lyrica in pregnant women. It is not known whether Lyrica is excreted in human breast milk.

Our Lyrica Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Lyrica in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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

Call your doctor at once if you have any of these serious side effects:

  • muscle pain, weakness, or tenderness (especially if you also have a fever and feel tired);
  • vision problems;
  • easy bruising or bleeding; or
  • swelling in your hands or feet, rapid weight gain.

Less serious side effects may include:

  • dizziness, drowsiness;
  • loss of balance or coordination;
  • problems with memory or concentration;
  • breast swelling;
  • tremors; or
  • dry mouth, constipation.

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 (Pregabalin) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Lyrica Overview - Patient Information: Side Effects

SIDE EFFECTS: Drowsiness, dizziness, dry mouth, constipation, difficulty concentrating, swollen arms/legs, and weight gain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any unlikely but serious side effects, including: blurred vision, unusual bleeding/bruising, unsteadiness, confusion, muscle pain/tenderness/weakness (especially if you are tired or have a fever), swelling of hands/legs/feet, change in amount of urine.

A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Lyrica (Pregabalin)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Lyrica FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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
[N=77]
%
150 mg/day
[N=212]
%
300 mg/day
[N=321]
%
600 mg/day
[N=369]
%
All PGB*
[N=979]
%
Placebo
[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
* PGB: pregabalin
† Thinking abnormal primarily consists of events related to difficulty with concentration/attention but also includes events related to cognition and language problems and slowed thinking.
‡ Investigator term; summary level term is amblyopia

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
[N=84]
%
150 mg/d
[N=302]
%
300 mg/d
[N=312]
%
600 mg/d
[N=154]
%
All PGB*
[N=852]
%
Placebo
[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
* PGB: pregabalin
† Thinking abnormal primarily consists of events related to difficulty with concentration/attention but also includes events related to cognition and language problems and slowed thinking.
‡ Investigator term; summary level term is amblyopia

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
* PGB: pregabalin
† Excludes patients who received the 50 mg dose in Study E1.
‡ Thinking abnormal primarily consists of events related to difficulty with concentration/attention but also includes events related to cognition and language problems and slowed thinking.
§ Investigator term; summary level term is amblyopia.

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 PGB*
[N=1517]
%
Placebo
[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
* PGB: pregabalin

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 2.9
Constipation 8.2 5.7
Nausea 4.9 4
Vomiting 2.7 1.1
General disorders and administration site conditions
Fatigue 11 4
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
* PGB: Pregabalin

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 .

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 coadministered 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.

Read the entire FDA prescribing information for Lyrica (Pregabalin) »

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