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Lyrica (Pregabalin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Lyrica (Pregabalin) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (10079)
Death (317)
Life Threatening Events (197)
Disability (272)

Reports by Reaction Type

Pain (1561)Drug Ineffective (952)Dizziness (696)Weight Increased (605)Feeling Abnormal (562)Somnolence (501)Malaise (471)Pain in Extremity (471)Oedema Peripheral (440)Insomnia (373)Vision Blurred (359)Headache (358)

Below are a few examples of reports where side effects / adverse reactions may be related to Lyrica (Pregabalin). For a complete list or a specific selection of reports, please use the links above.

Possible Lyrica side effects in 44 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 44 year old female, weighing 52.0 kg (114.4 pounds)

Reactions: Drug Effect Decreased, Pleurisy, Pain, Cerebrovascular Accident

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Lyrica

Other drugs received by patient: Xanax; Coumadin



Possible Lyrica side effects in female

Reported by a physician from United States on 2012-08-27

Patient: female

Reactions: Panic Attack, Neuropathy Peripheral, Fibromyalgia, Neoplasm Malignant, Bladder Cancer

Drug(s) suspected as cause:
Lyrica



Possible Lyrica side effects in 42 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 42 year old female, weighing 59.9 kg (131.7 pounds)

Reactions: Weight Increased, Drug Ineffective, Heart Rate Increased, Myocardial Infarction, Neuralgia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lyrica
    Dosage: 50 mg, 2x/day
    Administration route: Oral
    Indication: Sciatica
    Start date: 2012-02-01
    End date: 2012-03-01

Lyrica
    Dosage: 75 mg, 2x/day
    Administration route: Oral
    Start date: 2012-03-01
    End date: 2012-08-01

Other drugs received by patient: Flexeril; Percocet



Possible Lyrica side effects in 50 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 50 year old female, weighing 65.8 kg (144.8 pounds)

Reactions: Diplopia, Hallucination

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lyrica
    Indication: Migraine

Lyrica
    Dosage: 50 mg, 2x/day
    Indication: Intervertebral Disc Disorder
    Start date: 2012-01-01

Vistaril
    Indication: Panic Attack

Vistaril
    Dosage: unk, as needed
    Indication: Anxiety

Other drugs received by patient: Celexa; Wellbutrin; Buspar



Possible Lyrica side effects in 65 year old female

Reported by a health professional (non-physician/pharmacist) from Israel on 2012-08-27

Patient: 65 year old female, weighing 69.8 kg (153.7 pounds)

Reactions: Burning Sensation, Glossodynia

Drug(s) suspected as cause:
Atenolol
    Dosage: 1 df, qd
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-11-15

Atorvastatin
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: Hypercholesterolaemia
    Start date: 2011-09-14

Citalopram Hydrobromide
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: Anxiety
    Start date: 2011-08-23

Domperidone
    Dosage: 1 df, tid
    Administration route: Oral
    Indication: Acid Base Balance Abnormal
    Start date: 2012-03-01

Lyrica
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: Stress
    Start date: 2011-09-19

Ranitidine
    Dosage: 1 df, bid
    Administration route: Oral
    Indication: Hernia
    Start date: 2012-05-02



Possible Lyrica side effects in male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-27

Patient: male, weighing 73.0 kg (160.6 pounds)

Reactions: Intentional Overdose, Suicide Attempt

Drug(s) suspected as cause:
Citalopram Hydrobromide
    Dosage: 100mg single dose
    Administration route: Oral
    Start date: 2012-08-23

Keppra
    Dosage: 14000mg single dose
    Administration route: Oral
    Start date: 2012-08-23

Lamictal
    Dosage: 2100mg single dose
    Administration route: Oral
    Start date: 2012-08-23

Lyrica
    Dosage: 1500mg single dose
    Administration route: Oral
    Start date: 2012-08-23

Methionine CAP
    Dosage: 150mg single dose
    Administration route: Oral
    Start date: 2012-08-23



Possible Lyrica side effects in 85 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 85 year old male, weighing 73.5 kg (161.6 pounds)

Reactions: Myalgia, Joint Swelling, Gait Disturbance, Blood Pressure Fluctuation

Drug(s) suspected as cause:
Lyrica

Other drugs received by patient: Warfarin; Digoxin; Nystatin



Possible Lyrica side effects in 46 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 46 year old female

Reactions: Abasia

Drug(s) suspected as cause:
Lyrica

Other drugs received by patient: Dilantin; Fentanyl



Possible Lyrica side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: male

Reactions: Confusional State

Drug(s) suspected as cause:
Lyrica



Possible Lyrica side effects in

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient:

Reactions: Narcolepsy

Drug(s) suspected as cause:
Lyrica



Possible Lyrica side effects in 74 year old female

Reported by a consumer/non-health professional from Colombia on 2012-08-27

Patient: 74 year old female

Reactions: Malaise, Vomiting, Pulmonary Mass, Facial Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lyrica

Other drugs received by patient: Gemfibrozil; Aspirin; Isosorbide; Diltiazem; Omeprazole



Possible Lyrica side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: female

Reactions: Clavicle Fracture, Visual Impairment, Fall

Drug(s) suspected as cause:
Lyrica



Possible Lyrica side effects in 66 year old male

Reported by a physician from Japan on 2012-08-27

Patient: 66 year old male, weighing 50.0 kg (110.0 pounds)

Reactions: Pneumonia Aspiration, Dysphonia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Lyrica
    Dosage: 50 mg, 2x/day (100 mg/day)
    Administration route: Oral
    Indication: Neuralgia
    Start date: 2012-06-22
    End date: 2012-06-22

Lyrica
    Dosage: 25 mg, 2x/day (50 mg/day)
    Start date: 2012-06-23
    End date: 2012-06-28

Other drugs received by patient: Oxycodone Hydrochloride; Fentanyl-100



Possible Lyrica side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Mental Impairment

Drug(s) suspected as cause:
Lyrica



Possible Lyrica side effects in male

Reported by a pharmacist from Japan on 2012-08-27

Patient: male

Reactions: Lymphangiosis Carcinomatosa

Drug(s) suspected as cause:
Lyrica



Possible Lyrica side effects in 66 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: 66 year old female

Reactions: Surgery

Drug(s) suspected as cause:
Lyrica
    Dosage: 75 mg, 2x/day

Premarin
    Dosage: unk



Possible Lyrica side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Surgery, Pain, Coma, Toxicity To Various Agents

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lyrica
    Dosage: unk

Morphine Sulfate
    Dosage: unk
    Indication: Pain



Possible Lyrica side effects in 78 year old male

Reported by a consumer/non-health professional from Japan on 2012-08-27

Patient: 78 year old male

Reactions: Haemoglobin Decreased, Haematocrit Decreased, Loss of Consciousness, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Diclofenac Sodium
    Dosage: 25 mg, tid
    Administration route: Oral
    Indication: Herpes Zoster
    Start date: 2012-08-09
    End date: 2012-08-10

Famvir
    Dosage: 500 mg, tid
    Administration route: Oral
    Indication: Herpes Zoster
    Start date: 2012-08-09
    End date: 2012-08-10

Lyrica
    Dosage: 150 mg per day
    Administration route: Oral
    Indication: Herpes Zoster
    Start date: 2012-08-09
    End date: 2012-08-10

Other drugs received by patient: Vitamin B-12



Possible Lyrica side effects in 68 year old female

Reported by a consumer/non-health professional from Colombia on 2012-08-27

Patient: 68 year old female

Reactions: Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lyrica



Possible Lyrica side effects in 72 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 72 year old female, weighing 75.3 kg (165.6 pounds)

Reactions: Middle Insomnia, Swelling Face, Sleep Disorder, Activities of Daily Living Impaired, Dizziness, Headache, Somnolence

Drug(s) suspected as cause:
Lyrica

Other drugs received by patient: Benazepril



Possible Lyrica side effects in 77 year old female

Reported by a physician from Japan on 2012-08-27

Patient: 77 year old female

Reactions: Convulsion

Drug(s) suspected as cause:
Lyrica



Possible Lyrica side effects in 34 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 34 year old female, weighing 61.2 kg (134.7 pounds)

Reactions: Incorrect Drug Dosage Form Administered, Snake Bite, Drug Ineffective, Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lyrica
    Dosage: 50 mg, daily
    Administration route: Oral
    Start date: 2012-08-19
    End date: 2012-08-20

Lyrica
    Dosage: 50 mg, 2x/day
    Administration route: Oral
    Indication: Fibromyalgia
    Start date: 2012-07-27

Lyrica
    Dosage: 50 mg, 4x/day
    Administration route: Oral
    Start date: 2012-08-01

Norco
    Dosage: 20/650 mg, every 4 hrs
    Administration route: Oral
    Indication: Pain
    Start date: 2012-08-01



Possible Lyrica side effects in 64 year old female

Reported by a pharmacist from Japan on 2012-08-27

Patient: 64 year old female

Reactions: Drug Eruption

Drug(s) suspected as cause:
Lyrica
    Dosage: unk
    Administration route: Oral
    Indication: Pain
    Start date: 2012-08-07

Lyrica
    Dosage: unk
    Administration route: Oral
    Start date: 2012-08-19
    End date: 2012-08-20

Lyrica
    Dosage: unk
    Administration route: Oral
    Start date: 2012-08-18
    End date: 2012-08-18

Other drugs received by patient: Rocephin; Lansoprazole



Possible Lyrica side effects in 76 year old female

Reported by a pharmacist from Japan on 2012-08-27

Patient: 76 year old female

Reactions: Fracture, Fall, Loss of Consciousness

Drug(s) suspected as cause:
Lyrica



Possible Lyrica side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Gait Disturbance, Muscle Twitching, Fall

Drug(s) suspected as cause:
Lyrica



Possible Lyrica side effects in 46 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 46 year old male

Reactions: Drug Ineffective, Pain, Gastric Disorder

Drug(s) suspected as cause:
Lyrica
    Dosage: 75 mg, 3x/day
    Administration route: Oral

Neurontin
    Dosage: unk
    Indication: Neuropathy Peripheral

Zoloft
    Dosage: 50 mg, 1x/day
    Administration route: Oral



Possible Lyrica side effects in 55 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 55 year old female, weighing 72.6 kg (159.6 pounds)

Reactions: Weight Increased, Pain in Extremity, Sleep Disorder, Spinal Disorder

Drug(s) suspected as cause:
Lyrica
    Dosage: 300 mg, 1x/day
    Administration route: Oral
    Indication: Neuralgia
    Start date: 2010-02-01

Lyrica
    Indication: Spinal Disorder

Lyrica
    Indication: Multiple Sclerosis

Other drugs received by patient: Lipitor



Possible Lyrica side effects in female

Reported by a physician from France on 2012-08-27

Patient: female

Reactions: Confusional State, Acute Pulmonary Oedema, Agitation, Renal Failure Acute

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Acetaminophen
    Administration route: Oral
    End date: 2012-07-26

Aspirin
    Administration route: Oral

Atorvastatin
    Administration route: Oral

Bisoprolol Fumarate
    Dosage: 2.5 mg in the morning and 1.25 mg in the evening
    Administration route: Oral
    End date: 2012-07-27

Cymbalta
    Administration route: Oral
    End date: 2012-07-26

Duragesic-100
    End date: 2012-07-26

Lercanidipine
    Administration route: Oral
    End date: 2012-07-26

Lyrica
    Administration route: Oral
    End date: 2012-07-26

Nexium
    Administration route: Oral

Nitroglycerin
    End date: 2012-07-26

Plavix
    Administration route: Oral

Ramipril
    Administration route: Oral
    End date: 2012-07-26

Zometa
    Start date: 2012-07-19
    End date: 2012-07-19



Possible Lyrica side effects in 38 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 38 year old male, weighing 98.4 kg (216.5 pounds)

Reactions: Weight Decreased, Pain, Hepatic Failure, Headache, Somnolence, Myalgia, Weight Increased, Overdose, Malaise, Fatigue, Musculoskeletal Stiffness, Depression, Swelling, Nervous System Disorder, Feeling Abnormal, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dilantin
    Dosage: unk
    Indication: Convulsion

Ibuprofen
    Dosage: 4000 mg in a day
    Indication: Headache

Lyrica
    Dosage: 300 mg, 3x/day
    Administration route: Oral
    Indication: Convulsion

Lyrica
    Dosage: 100 mg, 3x/day
    Administration route: Oral
    Start date: 2012-06-01

Lyrica
    Dosage: 300 mg, 2x/day
    Administration route: Oral
    End date: 2012-06-01

Other drugs received by patient: Morphine; Hydrocodone; Lamictal; Butalbital



Possible Lyrica side effects in 61 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 61 year old female, weighing 74.8 kg (164.6 pounds)

Reactions: Confusional State, Fear, Visual Acuity Reduced, Somnolence, Impaired Driving Ability, Mood Altered, Blindness Unilateral, Weight Fluctuation, Toothache, Blister, Gingival Bleeding, Cataract, Pain in Extremity, Rash, Oral Pain, Visual Impairment, JAW Disorder, Muscle Disorder, Tooth Disorder

Drug(s) suspected as cause:
Lyrica
    Dosage: 75 mg, 1x/day
    Administration route: Oral
    Indication: Fibromyalgia
    Start date: 2009-01-01

Lyrica
    Dosage: 75 mg, 3x/day
    Administration route: Oral
    End date: 2012-01-01

Lyrica
    Dosage: 75 mg, 2x/day
    Administration route: Oral
    Start date: 2010-06-01

Lyrica
    Dosage: unk

Lyrica
    Dosage: 75 mg, 1x/day
    Administration route: Oral
    Start date: 2012-01-01

Other drugs received by patient: Norvasc; Prilosec; Fish OIL; Ibuprofen; Perdiem Fiber; Aspirin

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