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Lunesta (Eszopiclone) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Lunesta (Eszopiclone) 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 (78)
Death (7)
Life Threatening Events (6)
Disability (3)

Reports by Reaction Type

Drug Ineffective (16)Insomnia (15)Somnolence (7)Agitation (6)Fatigue (6)Depression (6)Anxiety (6)Middle Insomnia (6)Somnambulism (6)Confusional State (5)Headache (5)Abnormal Dreams (5)

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

Possible Lunesta side effects in 79 year old female

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

Patient: 79 year old female

Reactions: Hallucination, Visual, Hallucination, Auditory, Drug Interaction, Toxicity To Various Agents, Somnolence, Crying

Drug(s) suspected as cause:
Lunesta
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Oxycontin
    Indication: Pain

Oxycontin

Lexapro
    Indication: Depression
    Start date: 2007-01-01

Morphine
    Indication: Pain
    Start date: 2011-11-01
    End date: 2012-02-01

Other drugs received by patient: Vicodin



Possible Lunesta side effects in 61 year old male

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 61 year old male

Reactions: Abnormal Dreams, Peripheral Coldness, Inappropriate Schedule of Drug Administration, Muscle Atrophy, Middle Insomnia, Arthralgia, Arterial Thrombosis Limb

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lunesta
    Administration route: Oral
    Start date: 2010-12-01
    End date: 2012-03-01

Lunesta
    Administration route: Oral
    Indication: Sleep Disorder
    Start date: 2012-04-01

Other drugs received by patient: Citalopram; Celebrex; Trazodone Hydrochloride; Oxycodone HCL; Zantac; Plavix; Losartan Potassium



Possible Lunesta side effects in 79 year old female

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: 79 year old female

Reactions: Hallucination, Auditory, Hallucination, Visual, Drug Interaction, Toxicity To Various Agents, Somnolence, Crying

Drug(s) suspected as cause:
Oxycontin
    Indication: Pain

Morphine
    Indication: Pain
    Start date: 2011-11-01
    End date: 2012-02-01

Lunesta
    Dosage: 3 mg

Oxycontin
    Dosage: 40 mg every 8 hours as needed

Lexapro
    Dosage: 20 mg
    Administration route: Oral
    Indication: Depression
    Start date: 2007-01-01

Other drugs received by patient: Vicodin



Possible Lunesta side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: female

Reactions: Confusional State, Agitation, Nightmare, Drug Ineffective, Hyperglycaemia, Rash, Toxicity To Various Agents, Convulsion, Tremor, Weight Increased, Bipolar Disorder, Chest Pain

Drug(s) suspected as cause:
Trileptal

Tizanidine Hydrochloride
    Indication: Migraine

Depakote

Darvocet-N 50

Skelaxin

Prozac

Paxil

Lunesta

Beta Blocking Agents

Topamax

Zonegran

Valium
    Indication: Agitation

Reglan

Abilify

Elavil

Zyprexa

Tegretol

Requip

MAO Inhibitors

Remeron

Buspar

Adderall

Erythromycin

Ritalin

Effexor

Sumatriptan

Wellbutrin

Tofranil

Zoloft

Daytrana

Antidepressants

Steroids NOS

Desyrel

Neurontin

Sinequan

Seroquel

Pamelor

Other drugs received by patient: Aspirin; Vitamin B-Complex, Other Combinations; Ensure; Caltrate +D; ONE A DAY



Possible Lunesta side effects in 45 year old male

Reported by a physician from United States on 2012-08-06

Patient: 45 year old male

Reactions: Blood Pressure Increased, Blood Creatine Phosphokinase Increased, Muscular Weakness, Headache, Hypoaesthesia, Paraesthesia, Myopathy, Uhthoff's Phenomenon, Palpitations, Chest Pain, Intervertebral Disc Degeneration, Sinus Tachycardia, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Crestor
    Administration route: Oral
    Indication: Dyslipidaemia
    Start date: 2009-01-01
    End date: 2012-06-23

Lunesta
    Administration route: Oral
    Indication: Insomnia
    Start date: 2011-10-01

Alcohol
    Dosage: 6-8 beers per day 5 out of 7 days per week.

Alcohol

Lunesta
    Administration route: Oral
    End date: 2012-07-01

Other drugs received by patient: Ibuprofen



Possible Lunesta side effects in 28 year old male

Reported by a individual with unspecified qualification from United States on 2012-08-02

Patient: 28 year old male, weighing 81.6 kg (179.5 pounds)

Reactions: Insomnia, Sensation of Heaviness, Muscular Weakness, Asthenia

Drug(s) suspected as cause:
Seroquel
    Administration route: Oral
    Indication: Schizoaffective Disorder

Klonopin
    Indication: Sleep Disorder

Lunesta
    Indication: Sleep Disorder

Seroquel
    Administration route: Oral
    Start date: 2012-01-01

Klonopin
    Indication: Anxiety

Seroquel
    Administration route: Oral
    Indication: Insomnia

Seroquel
    Administration route: Oral
    Start date: 2012-01-01



Possible Lunesta side effects in 39 year old female

Reported by a consumer/non-health professional from United States on 2012-07-27

Patient: 39 year old female, weighing 79.4 kg (174.7 pounds)

Reactions: Malaise, Drug Ineffective, Insomnia, Intentional Drug Misuse

Drug(s) suspected as cause:
Ambien

Lunesta

Seroquel
    Administration route: Oral
    Indication: Bipolar Disorder

Seroquel
    Administration route: Oral
    Indication: Depression

Other drugs received by patient: Other Prescription; Other Prescription



Possible Lunesta side effects in 38 year old female

Reported by a consumer/non-health professional from United States on 2012-07-27

Patient: 38 year old female, weighing 77.1 kg (169.6 pounds)

Reactions: Myalgia, Bone Pain, Oedema

Drug(s) suspected as cause:
Lunesta
    Administration route: Oral
    Indication: Insomnia
    Start date: 2011-10-01

Levothyroxine Sodium
    Administration route: Oral
    Indication: Hypothyroidism
    Start date: 2011-10-01

Cymbalta
    Administration route: Oral
    Indication: Depression
    Start date: 2011-10-01

Other drugs received by patient: Clonazepam



Possible Lunesta side effects in 71 year old female

Reported by a consumer/non-health professional from United States on 2012-07-26

Patient: 71 year old female, weighing 70.3 kg (154.7 pounds)

Reactions: Wrong Technique in Drug Usage Process, Platelet Count Increased, Intentional Drug Misuse, Somnolence, Fall, Off Label Use, Abnormal Dreams, Weight Increased, Fatigue, Throat Irritation, Insomnia, Depressed Mood, Feeling Abnormal

Drug(s) suspected as cause:
Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral

Lunesta

Lunesta
    Start date: 2007-01-01

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral
    Indication: Insomnia
    Start date: 2006-01-01

Seroquel
    Administration route: Oral
    Indication: Depression
    Start date: 2006-01-01

Seroquel
    Administration route: Oral
    Indication: Sleep Disorder
    Start date: 2006-01-01

Seroquel
    Administration route: Oral

Other drugs received by patient: Enalapril Maleate; Enalapril Maleate; Atenolol



Possible Lunesta side effects in 74 year old female

Reported by a consumer/non-health professional from United States on 2012-07-20

Patient: 74 year old female

Reactions: Coronary Artery Occlusion, Myocardial Infarction

Drug(s) suspected as cause:
Lunesta



Possible Lunesta side effects in 24 year old female

Reported by a pharmacist from Japan on 2012-07-19

Patient: 24 year old female

Reactions: Epilepsy

Drug(s) suspected as cause:
Lunesta
    Administration route: Oral
    Start date: 2012-05-01

Lunesta
    Administration route: Oral
    Indication: Insomnia
    Start date: 2012-05-01
    End date: 2012-05-01

Other drugs received by patient: ALL Other Therapeutic Products; Clotiazepam



Possible Lunesta side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-19

Patient: female

Reactions: Anxiety, Abdominal Discomfort, Suicide Attempt, Depression

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Lunesta



Possible Lunesta side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-12

Patient: female

Reactions: Drug Ineffective

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

Lunesta
    Dosage: unk

Ambien
    Dosage: unk



Possible Lunesta side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-11

Patient: female, weighing 74.4 kg (163.6 pounds)

Reactions: Drug Ineffective, Insomnia, Blood Thyroid Stimulating Hormone Increased

Drug(s) suspected as cause:
Cytomel
    Dosage: unk
    Administration route: Oral
    Indication: Hypothyroidism

Ambien
    Dosage: unk
    Indication: Insomnia

Sonata
    Dosage: unk
    Indication: Insomnia

Acetaminophen
    Dosage: unk
    Indication: Insomnia

Lunesta
    Dosage: unk
    Indication: Insomnia

Synthroid
    Dosage: 75 ug, unk
    Administration route: Oral
    Indication: Hypothyroidism

Synthroid
    Dosage: unk
    Administration route: Oral



Possible Lunesta side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-11

Patient: female

Reactions: Confusional State, Agitation, Nightmare, Drug Ineffective, Hyperglycaemia, Toxicity To Various Agents, Rash, Convulsion, Tremor, Weight Increased, Bipolar Disorder, Chest Pain

Drug(s) suspected as cause:
Tegretol

Requip

Neurontin

Darvocet-N 50

Remeron

Reglan

Depakote

Imitrex

Zonegran

Erythromycin

Ritalin

Sinequan

Elavil

Adderall 5

Wellbutrin

Pamelor

Prozac

Buspar

Lunesta

Trileptal

Topamax

Beta Blocking Agents

Abilify

Valium
    Indication: Agitation

Steroids NOS

Seroquel

MAO Inhibitors

Tofranil

Zoloft

Paxil

Daytrana

Effexor

Skelaxin

Antidepressants

Tizanidine Hydrochloride

Desyrel

Zyprexa

Other drugs received by patient: Vitamin B-Complex, Other Combinations; Caltrate +D; Ensure; ONE A DAY; Aspirin



Possible Lunesta side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-13

Patient: male

Reactions: Dyspnoea, Contusion, Gout, Stent Placement, Ulcer, Irritability, Feeling Hot, Blood Pressure Abnormal, Injury

Drug(s) suspected as cause:
Lisinopril
    Dosage: unk, unknown

Lunesta
    Dosage: unk, unknown

Effient
    Dosage: 10 mg, qd
    Indication: Stent Placement
    Start date: 2011-03-01



Possible Lunesta side effects in 71 year old female

Reported by a consumer/non-health professional from United States on 2012-06-11

Patient: 71 year old female, weighing 57.6 kg (126.7 pounds)

Reactions: Confusional State, Weight Decreased, Dyspnoea, Drug Hypersensitivity, Disorientation, Amnesia, Grand MAL Convulsion, Emotional Distress, Activities of Daily Living Impaired, Visual Impairment, Heart Rate Increased, Vision Blurred, Sleep Apnoea Syndrome, Hallucination

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Lunesta
    Dosage: 2 tablets by mouth at night
    Administration route: Oral
    Indication: Anxiety
    Start date: 2012-01-01
    End date: 2012-01-01

Lunesta
    Dosage: 2 tablets by mouth at night
    Administration route: Oral
    Indication: Insomnia
    Start date: 2012-01-01
    End date: 2012-01-01

Cymbalta
    Dosage: 1 capsule at night
    Indication: Insomnia
    Start date: 2012-01-01
    End date: 2012-01-01

Cymbalta
    Dosage: 1 capsule at night
    Indication: Anxiety
    Start date: 2012-01-01
    End date: 2012-01-01



Possible Lunesta side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-08

Patient: female

Reactions: Agitation, Confusional State, Nightmare, Drug Ineffective, Hyperglycaemia, Rash, Toxicity To Various Agents, Tremor, Convulsion, Weight Increased, Bipolar Disorder, Chest Pain

Drug(s) suspected as cause:
Skelaxin

Elavil

Prozac

Reglan

Tegretol

Depakote

Steroids NOS

Zonegran

MAO Inhibitors

Pamelor

Paxil

Requip

Sinequan

Abilify

Remeron

Tofranil

Buspar

Topamax

Imitrex

Darvocet-N 50

Seroquel

Tizanidine Hydrochloride

Adderall 5

Neurontin

Beta Blocking Agents

Desyrel

Zoloft

Ritalin

Trileptal

Valium
    Indication: Agitation

Lunesta

Daytrana

Erythromycin

Effexor

Antidepressants

Wellbutrin

Zyprexa

Other drugs received by patient: Aspirin; Caltrate +D; ONE A DAY; Vitamin B-Complex, Other Combinations; Ensure



Possible Lunesta side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-06

Patient: male

Reactions: Abnormal Dreams, Insomnia

Drug(s) suspected as cause:
Lunesta
    Dosage: unk
    Indication: Insomnia

Chantix
    Dosage: unk

Chantix
    Dosage: unk



Possible Lunesta side effects in 24 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-05-30

Patient: 24 year old female

Reactions: Epilepsy

Drug(s) suspected as cause:
Lunesta
    Administration route: Oral
    Start date: 2012-05-01

Lunesta
    Administration route: Oral
    Indication: Insomnia
    Start date: 2012-05-01
    End date: 2012-05-01

Other drugs received by patient: Clotiazepam



Possible Lunesta side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-29

Patient: female

Reactions: Somnolence

Drug(s) suspected as cause:
Lunesta
    Dosage: 3 mg, (hs) once nightly at bedtime
    Administration route: Oral
    Indication: Insomnia
    Start date: 2009-01-01

Lyrica
    Dosage: unk
    Indication: Back Pain
    Start date: 2011-07-01



Possible Lunesta side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-25

Patient: male

Reactions: Suicide Attempt

Drug(s) suspected as cause:
Lunesta
    Indication: Product Used FOR Unknown Indication

Celexa
    Indication: Product Used FOR Unknown Indication

Percocet
    Indication: Product Used FOR Unknown Indication

Xanax
    Indication: Product Used FOR Unknown Indication

Oxycodone HCL
    Indication: Product Used FOR Unknown Indication

Ambien
    Indication: Product Used FOR Unknown Indication

Klonopin
    Indication: Product Used FOR Unknown Indication



Possible Lunesta side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-25

Patient: female

Reactions: Muscle Contractions Involuntary, Muscle Twitching, Joint Stiffness

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

Flexeril
    Dosage: unk

Lunesta
    Dosage: unk

Lamictal
    Dosage: unk



Possible Lunesta side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-23

Patient: male

Reactions: Abnormal Dreams, Insomnia

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

Lunesta
    Dosage: unk
    Indication: Insomnia



Possible Lunesta side effects in 59 year old female

Reported by a consumer/non-health professional from United States on 2012-05-18

Patient: 59 year old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Lunesta



Possible Lunesta side effects in 20 year old female

Reported by a physician from United States on 2012-05-17

Patient: 20 year old female, weighing 55.3 kg (121.7 pounds)

Reactions: Confusional State, Incorrect Dose Administered, Memory Impairment

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lunesta



Possible Lunesta side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-10

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Lunesta



Possible Lunesta side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-04

Patient:

Reactions: Dysgeusia

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

Pristiq
    Dosage: unk



Possible Lunesta side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-04

Patient: male

Reactions: Abdominal Pain, Urticaria, Local Swelling, Rash, Depression

Drug(s) suspected as cause:
Lyrica
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-01-01

Lunesta
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-01-01

Nucynta
    Administration route: Oral
    Indication: Analgesic Therapy
    Start date: 2012-01-01
    End date: 2012-01-01



Possible Lunesta side effects in female

Reported by a lawyer from United States on 2012-05-01

Patient: female, weighing 74.4 kg (163.6 pounds)

Reactions: Agitation, Drug Ineffective, Folliculitis, Bipolar II Disorder, Obesity, Depression, Sinusitis, Arteriosclerosis, Migraine, Libido Decreased, Stress, Seborrhoea, Anxiety, Cholelithiasis, Hysterectomy, Affective Disorder, Insomnia, Withdrawal Syndrome, Memory Impairment, Feeling Abnormal, Respiratory Tract Infection, Salpingo-Oophorectomy Bilateral

Drug(s) suspected as cause:
Zoloft
    Dosage: 50 mg, 1x/day
    Start date: 1999-06-15

Effexor
    Dosage: 75 mg, 1x/day
    Indication: Anxiety
    Start date: 2006-10-17

Zoloft
    Dosage: 25mg, a day for seven days
    Indication: Depression
    Start date: 1999-03-01
    End date: 1999-03-07

Xanax
    Dosage: 0.5 mg, every 8 hours
    Start date: 2002-11-19

Wellbutrin
    Dosage: 200mg, one daily
    Indication: Depression
    Start date: 2004-05-18
    End date: 2004-05-20

Lortab
    Dosage: 7.5/500 one every 6-8 hours as needed
    Indication: Headache
    Start date: 2004-01-01
    End date: 2005-02-02

Zoloft
    Dosage: 50 mg, 2x/day
    Start date: 1999-12-06

Xanax
    Dosage: 0.25 mg, 2x/day
    Indication: Anxiety

Calan
    Dosage: unk
    Indication: Migraine

Wellbutrin
    Dosage: 150 mg, 1x/day
    Indication: Affective Disorder
    Start date: 2004-11-11

Topamax
    Dosage: 25 mg, at night for 17 days
    Start date: 2004-05-04

Midrin
    Dosage: two capsules at start of migraine
    Indication: Migraine
    Start date: 2011-11-11

Excedrin (Migraine)
    Indication: Migraine

Zoloft
    Dosage: 75 mg, 1x/day
    Indication: Adjustment Disorder
    Start date: 1999-06-01

Effexor
    Dosage: 37.5 mg, 1x/day
    Indication: Depression
    Start date: 2006-10-10
    End date: 2006-10-16

Lunesta
    Dosage: unk
    Indication: Sleep Disorder
    Start date: 2009-06-01

Topamax
    Dosage: 25 mg, x7days in the morning
    Start date: 2005-02-16

Mirapex
    Indication: Sleep Disorder

Paxil
    Dosage: 20 mg, 1x/day
    Start date: 1999-01-01

Zoloft
    Dosage: 20 mg, 1x/day for 4 weeks

Zoloft
    Dosage: 100 mg, for 6 months
    Start date: 2004-06-23

Ultram
    Dosage: 50 mg, as needed, every 8 hours
    Indication: Headache
    Start date: 2004-11-17

Wellbutrin
    Dosage: 300 mg, unk
    Start date: 2004-11-17

Zoloft
    Dosage: 50mg, for four weeks
    Indication: Affective Disorder
    Start date: 1999-03-08

Zoloft
    Dosage: 100 mg, 1x/day
    Start date: 1999-07-27

Zoloft
    Dosage: 75 mg, unk
    Start date: 2002-11-19

Zoloft
    Dosage: 50 mg, unk
    Administration route: Oral
    Start date: 2002-05-20

Inderal LA
    Dosage: 60mg 1 at night

Topamax
    Dosage: 25, twice a day for seven days
    Indication: Migraine
    Start date: 2005-02-02

Lortab
    Dosage: 5/500 one every 8 hours as needed
    Start date: 2005-01-18
    End date: 2005-02-02

Cymbalta
    Dosage: 30 mg, 1x/day
    Indication: Insomnia

Paxil
    Dosage: 10 mg, 1x/day
    Administration route: Oral
    Start date: 1999-06-01

Elavil
    Dosage: unk
    Indication: Migraine

Lexapro
    Dosage: 10 mg, unk
    Start date: 2004-06-23

Topamax
    Dosage: 50 mg and 25 mg in the morning for 7 days
    Start date: 2005-02-09

Motrin
    Indication: Migraine

Other drugs received by patient: Ortho-Novum

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