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Doxepin (Doxepin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Doxepin 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 (87)
Death (56)
Life Threatening Events (2)
Disability (1)

Reports by Reaction Type

Completed Suicide (34)Toxicity To Various Agents (21)Death (17)Cardio-Respiratory Arrest (13)Somnolence (10)Multiple Drug Overdose Intentional (9)Cardiac Arrest (9)Depression (8)Respiratory Arrest (8)Suicide Attempt (8)Conversion Disorder (7)Therapeutic Response Unexpected (7)

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

Possible Doxepin side effects in 52 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-24

Patient: 52 year old male

Reactions: Suicide Attempt, Gastrointestinal Sounds Abnormal, Alcohol Poisoning

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Doxepin
    Administration route: Oral
    Start date: 2012-08-11

Tramadol HCL
    Administration route: Oral

Voltaren
    Administration route: Oral



Possible Doxepin side effects in 48 year old male

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: 48 year old male, weighing 70.3 kg (154.7 pounds)

Reactions: Drug Dose Omission, Head Injury, Conversion Disorder, Therapeutic Response Unexpected, Pain, Musculoskeletal Discomfort, Cognitive Disorder, Stress, Somnolence, Depression, Injury, Metabolic Disorder, Memory Impairment

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Seroquel XR
    Administration route: Oral
    Indication: Major Depression

Seroquel XR
    Administration route: Oral
    Start date: 2008-01-01

Doxepin

Other drugs received by patient: Ventolin; Zyrtec; Pramosone; Celexa; Donnatal; Omeprazole; Valium; Zantac; Azalastine; Valium; Tylenol; Benadryl; Naco3; Albuterol; Sumatriptan; Simvastatin; Immunotherapy Treatment; Veramyst; Dulera; Zofran; Carafate; Gaviscon; Melatonin



Possible Doxepin side effects in 54 year old male

Reported by a physician from Germany on 2012-08-15

Patient: 54 year old male

Reactions: Weight Increased, Angina Pectoris, Insomnia, Hypertension, Multiple Sclerosis Relapse

Drug(s) suspected as cause:
Prednisolone
    Start date: 2009-07-01
    End date: 2009-07-01

Doxepin
    Administration route: Oral
    Indication: Insomnia
    End date: 2008-11-01

Doxepin
    Administration route: Oral
    End date: 2011-02-01

Rebif
    Indication: Multiple Sclerosis
    Start date: 2008-04-01

Prednisolone
    Start date: 2008-05-01
    End date: 2008-05-01

Prednisolone
    Indication: Multiple Sclerosis
    Start date: 2008-02-01
    End date: 2008-02-01

Prednisolone
    Start date: 2008-12-01
    End date: 2008-12-01

Doxepin
    Administration route: Oral
    Start date: 2008-11-01

Doxepin
    Administration route: Oral
    Indication: Depression
    Start date: 2008-08-01

Rebif
    Start date: 2008-02-01
    End date: 2008-04-01

Prednisolone
    Start date: 2008-04-01
    End date: 2008-04-01

Other drugs received by patient: Escitalopram; Edronax; Gabapentin; Symbicort; Berodual



Possible Doxepin side effects in 48 year old male

Reported by a individual with unspecified qualification from United States on 2012-08-14

Patient: 48 year old male, weighing 70.3 kg (154.7 pounds)

Reactions: Drug Dose Omission, Conversion Disorder, Therapeutic Response Unexpected, Musculoskeletal Discomfort, Cognitive Disorder, Somnolence, Stress, Depression, Injury, Memory Impairment

Drug(s) suspected as cause:
Seroquel XR
    Administration route: Oral
    Start date: 2008-01-01

Seroquel XR
    Administration route: Oral
    Indication: Major Depression

Doxepin

Other drugs received by patient: Dulera; Ventolin; Zyrtec; Azalastine; Veramyst; Simvastatin; Benadryl; Valium; Donnatal; Zofran; Gaviscon; Omeprazole; Zantac; Imitrex; Pramosone; Naco3; Carafate; Albuterol; Valium; Melatonin; Celexa; Immunotherapy Treatment; Tylenol



Possible Doxepin side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-13

Patient: female, weighing 89.4 kg (196.6 pounds)

Reactions: Toxicity To Various Agents

Adverse event resulted in: death

Drug(s) suspected as cause:
Duragesic-100
    Indication: Arthralgia

Duragesic-100
    Indication: Pain

Diphenhydramine Hydrochloride

Dextromethorphan Hydrobromide
    Indication: Product Used FOR Unknown Indication

Fentanyl-100
    Indication: Product Used FOR Unknown Indication

Dextromethorphan Hydrobromide

Doxepin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Diphenhydramine Hydrochloride
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Doxylamine Succinate; Hydrochlorothiazide; Acetaminophen; Oxycodone; Labetalol HCL



Possible Doxepin side effects in

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-10

Patient:

Reactions: Blood Potassium Increased, Inappropriate Antidiuretic Hormone Secretion, Rhythm Idioventricular, Bradycardia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Doxepin



Possible Doxepin side effects in 48 year old male

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: 48 year old male, weighing 70.3 kg (154.7 pounds)

Reactions: Drug Dose Omission, Therapeutic Response Unexpected, Conversion Disorder, Musculoskeletal Discomfort, Cognitive Disorder, Somnolence, Memory Impairment, Depression, Injury

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

Doxepin

Seroquel XR
    Administration route: Oral
    Indication: Major Depression
    Start date: 2008-01-01

Other drugs received by patient: Veramyst; Celexa; Simvastatin; Azalastine; Gaviscon; Omeprazole; Zyrtec; Carafate; Albuterol; Valium; Pramosone; Tylenol; Ventolin; Donnatal; Dulera; Valium; Zantac; Benadryl; Immunotherapy Treatment; Imitrex; Melatonin; Zofran; Naco3



Possible Doxepin side effects in 48 year old male

Reported by a individual with unspecified qualification from United States on 2012-08-10

Patient: 48 year old male, weighing 70.3 kg (154.7 pounds)

Reactions: Drug Dose Omission, Conversion Disorder, Therapeutic Response Unexpected, Musculoskeletal Discomfort, Cognitive Disorder, Somnolence, Injury, Memory Impairment, Depression

Drug(s) suspected as cause:
Seroquel XR
    Administration route: Oral
    Indication: Major Depression
    Start date: 2008-01-01

Seroquel XR
    Administration route: Oral

Doxepin

Other drugs received by patient: Veramyst; Ventolin; Gaviscon; Melatonin; Azalastine; Donnatal; Simvastatin; Zyrtec; Celexa; Valium; Zofran; Zantac; Carafate; Albuterol; Valium; Immunotherapy Treatment; Pramosone; Tylenol; Naco3; Dulera; Benadryl; Omeprazole; Imitrex



Possible Doxepin side effects in 48 year old male

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: 48 year old male, weighing 70.3 kg (154.7 pounds)

Reactions: Drug Dose Omission, Therapeutic Response Unexpected, Conversion Disorder, Musculoskeletal Discomfort, Cognitive Disorder, Somnolence, Injury, Memory Impairment, Depression

Drug(s) suspected as cause:
Seroquel XR
    Administration route: Oral
    Indication: Major Depression
    Start date: 2008-01-01

Seroquel XR
    Administration route: Oral

Doxepin

Other drugs received by patient: Immunotherapy Treatment; Omeprazole; Albuterol; Simvastatin; Veramyst; Zantac; Azalastine; Imitrex; Gaviscon; Celexa; Zofran; Benadryl; Donnatal; Valium; Valium; Ventolin; Pramosone; Tylenol; Naco3; Dulera; Zyrtec; Carafate; Melatonin



Possible Doxepin side effects in 58 year old female

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

Patient: 58 year old female, weighing 94.3 kg (207.6 pounds)

Reactions: Movement Disorder, Pruritus, Rash, Fall, Ankle Fracture, Muscle Twitching, Eye Pain, Tremor, Syncope, Balance Disorder, Mood Swings

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Doxepin
    Start date: 2012-04-12

Doxepin
    Dosage: 1-2 capsules at bedtime
    Indication: Depression
    Start date: 2012-03-19

Doxepin
    Dosage: 1-2 capsules at bedtime
    Indication: Insomnia
    Start date: 2012-03-19



Possible Doxepin side effects in 54 year old male

Reported by a physician from Germany on 2012-08-07

Patient: 54 year old male

Reactions: Weight Increased, Angina Pectoris, Insomnia, Hypertension, Multiple Sclerosis Relapse

Drug(s) suspected as cause:
Rebif
    Indication: Multiple Sclerosis
    Start date: 2008-04-01

Doxepin
    Administration route: Oral
    Start date: 2008-11-01

Doxepin
    Administration route: Oral
    Indication: Insomnia
    End date: 2008-11-01

Rebif
    Start date: 2008-02-01
    End date: 2008-04-01

Doxepin
    Administration route: Oral
    Indication: Depression
    Start date: 2008-08-01

Doxepin
    Administration route: Oral
    End date: 2011-02-01

Other drugs received by patient: Gabapentin; Escitalopram; Edronax; Berodual; Symbicort



Possible Doxepin side effects in male

Reported by a consumer/non-health professional from Germany on 2012-07-24

Patient: male

Reactions: Lumbar Vertebral Fracture

Drug(s) suspected as cause:
Doxepin



Possible Doxepin side effects in 48 year old male

Reported by a consumer/non-health professional from United States on 2012-07-16

Patient: 48 year old male, weighing 70.3 kg (154.7 pounds)

Reactions: Therapeutic Response Unexpected, Conversion Disorder, Musculoskeletal Discomfort, Cognitive Disorder, Intentional Drug Misuse, Somnolence, Memory Impairment, Depression, Injury

Drug(s) suspected as cause:
Seroquel XR
    Administration route: Oral
    Indication: Major Depression
    Start date: 2008-01-01

Seroquel XR
    Administration route: Oral

Doxepin

Other drugs received by patient: Zyrtec; Zofran; Simvastatin; Carafate; Donnatal; Melatonin; Veramyst; Benadryl; Acetaminophen; Albuterol; Ventolin; Valium; Azalastine; Immunotherapy Treatment; Dulera; Valium; Omeprazole; Celexa; Zantac; Imitrex; Pramosone; Gaviscon



Possible Doxepin side effects in 27 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-07-13

Patient: 27 year old male, weighing 80.0 kg (176.0 pounds)

Reactions: Intentional Overdose, Tachycardia, Coma, Drug Abuse, Somnolence, Aggression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Doxepin
    Administration route: Oral
    Start date: 2011-12-31
    End date: 2011-12-31

Cocaine



Possible Doxepin side effects in 63 year old female

Reported by a physician from United States on 2012-07-11

Patient: 63 year old female, weighing 55.0 kg (121.0 pounds)

Reactions: Coma, Multiple Drug Overdose Intentional, Suicide Attempt

Adverse event resulted in: hospitalization

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

Ibuprofen
    Indication: Product Used FOR Unknown Indication

Tylenol TAB

Alprazolam
    Indication: Product Used FOR Unknown Indication

Doxepin
    Indication: Product Used FOR Unknown Indication



Possible Doxepin side effects in female

Reported by a physician from Germany on 2012-07-06

Patient: female, weighing 60.0 kg (132.0 pounds)

Reactions: Tachycardia, Coma, Suicide Attempt, Multiple Drug Overdose Intentional, Sopor, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Topamax
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-27
    End date: 2012-04-27

Doxepin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-27
    End date: 2012-04-27

Buprenorphine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-27
    End date: 2012-04-27

Ethanol
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-27
    End date: 2012-04-27

Metoprolol
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-27
    End date: 2012-04-27

Benzodiazepine NOS
    Indication: Product Used FOR Unknown Indication



Possible Doxepin side effects in 48 year old male

Reported by a consumer/non-health professional from United States on 2012-07-05

Patient: 48 year old male, weighing 70.3 kg (154.7 pounds)

Reactions: Therapeutic Response Unexpected, Conversion Disorder, Musculoskeletal Discomfort, Depression, Injury, Memory Impairment, Cognitive Disorder

Drug(s) suspected as cause:
Seroquel XR
    Administration route: Oral
    Indication: Major Depression
    Start date: 2008-01-01

Doxepin



Possible Doxepin side effects in 65 year old male

Reported by a pharmacist from United States on 2012-06-29

Patient: 65 year old male, weighing 112.0 kg (246.4 pounds)

Reactions: Balance Disorder, Muscular Weakness, Asthenia, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Doxepin
    Dosage: 150 mg at bedtime po
    Administration route: Oral
    Indication: Depression
    Start date: 2012-02-23
    End date: 2012-03-21

Venlafaxine
    Dosage: 300mg mg am po
    Administration route: Oral
    Indication: Depression
    Start date: 2012-02-23
    End date: 2012-03-21



Possible Doxepin side effects in

Reported by a individual with unspecified qualification from China on 2012-06-27

Patient:

Reactions: Death, Bronchopneumonia, Completed Suicide, Drug Interaction, Toxicity To Various Agents

Adverse event resulted in: death

Drug(s) suspected as cause:
Doxepin

Other drugs received by patient possibly interacting with the suspect drug:
Sulpiride
    Dosage: unk, unknown
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Doxepin side effects in 47 year old female

Reported by a health professional (non-physician/pharmacist) from China on 2012-06-15

Patient: 47 year old female

Reactions: Bronchopneumonia, Intentional Overdose, Completed Suicide, Drug Interaction, Toxicity To Various Agents, Thyroiditis Chronic

Adverse event resulted in: death

Drug(s) suspected as cause:
Doxepin

Other drugs received by patient possibly interacting with the suspect drug:
Sulpiride



Possible Doxepin side effects in 61 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-12

Patient: 61 year old male

Reactions: Completed Suicide

Adverse event resulted in: death

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

Cyclobenzaprine HCL
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Doxepin
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Escitalopram
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Verapamil HCL
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Doxepin side effects in 47 year old female

Reported by a health professional (non-physician/pharmacist) from China on 2012-06-12

Patient: 47 year old female

Reactions: Intentional Overdose, Bronchopneumonia, Completed Suicide, Toxicity To Various Agents, Thyroiditis Chronic

Adverse event resulted in: death

Drug(s) suspected as cause:
Doxepin

Sulpiride



Possible Doxepin side effects in female

Reported by a physician from Germany on 2012-06-05

Patient: female, weighing 60.0 kg (132.0 pounds)

Reactions: Tachycardia, Suicide Attempt, Multiple Drug Overdose Intentional, Coma, Sopor, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ethanol
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-27
    End date: 2012-04-27

Topamax
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-27
    End date: 2012-04-27

Doxepin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-27
    End date: 2012-04-27

Buprenorphine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-27
    End date: 2012-04-27

Metoprolol Tartrate
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-27
    End date: 2012-04-27

Benzodiazepine NOS
    Indication: Product Used FOR Unknown Indication



Possible Doxepin side effects in female

Reported by a physician from Germany on 2012-05-30

Patient: female, weighing 60.0 kg (132.0 pounds)

Reactions: Tachycardia, Multiple Drug Overdose Intentional, Coma, Suicide Attempt, Sopor, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ethanol
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-27
    End date: 2012-04-27

Doxepin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-27
    End date: 2012-04-27

Buprenorphine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-27
    End date: 2012-04-27

Topamax
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-27
    End date: 2012-04-27

Metoprolol Tartrate
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-27
    End date: 2012-04-27



Possible Doxepin side effects in female

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

Patient: female, weighing 89.4 kg (196.6 pounds)

Reactions: Toxicity To Various Agents

Adverse event resulted in: death

Drug(s) suspected as cause:
Duragesic-100
    Indication: Pain

Fentanyl-100
    Indication: Product Used FOR Unknown Indication

Duragesic-100
    Indication: Arthralgia

Dextromethorphan Hydrobromide
    Indication: Product Used FOR Unknown Indication

Dextromethorphan Hydrobromide

Doxepin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Diphenhydramine Hydrochloride

Diphenhydramine Hydrochloride
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Labetalol HCL; Doxylamine Succinate; Hydrochlorothiazide; Acetaminophen; Oxycodone HCL



Possible Doxepin side effects in 65 year old male

Reported by a physician from United States on 2012-05-30

Patient: 65 year old male

Reactions: Cardio-Respiratory Arrest, Completed Suicide, Toxicity To Various Agents

Adverse event resulted in: death

Drug(s) suspected as cause:
Venlafaxine
    Dosage: unk
    Administration route: Oral

Lamotrigine
    Dosage: unk
    Administration route: Oral

Acetaminophen
    Dosage: unk
    Administration route: Oral

Alprazolam
    Dosage: unk
    Administration route: Oral

Propranolol HCL
    Dosage: unk
    Administration route: Oral

Modafinil
    Dosage: unk
    Administration route: Oral

Doxepin
    Dosage: unk
    Administration route: Oral

Warfarin
    Dosage: unk
    Administration route: Oral



Possible Doxepin side effects in 45 year old female

Reported by a physician from Germany on 2012-05-04

Patient: 45 year old female, weighing 60.0 kg (132.0 pounds)

Reactions: Tachycardia, Suicide Attempt, Coma, Multiple Drug Overdose Intentional, Sopor, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ethanol
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-27
    End date: 2012-04-27

Buprenorphine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-27
    End date: 2012-04-27

Doxepin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-27
    End date: 2012-04-27

Topamax
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-27
    End date: 2012-04-27

Metoprolol Tartrate
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-27
    End date: 2012-04-27



Possible Doxepin side effects in 51 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-27

Patient: 51 year old female

Reactions: Completed Suicide

Adverse event resulted in: death

Drug(s) suspected as cause:
Zolpidem

Clonazepam

Carbamazepine

Doxepin



Possible Doxepin side effects in 51 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-27

Patient: 51 year old female

Reactions: Completed Suicide

Adverse event resulted in: death

Drug(s) suspected as cause:
Clonazepam

Carbamazepine

Doxepin

Zolpidem



Possible Doxepin side effects in

Reported by a individual with unspecified qualification from China on 2012-04-24

Patient:

Reactions: Death, Bronchopneumonia, Completed Suicide, Toxicity To Various Agents

Adverse event resulted in: death

Drug(s) suspected as cause:
Doxepin
    Dosage: unk, unknown
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Sulpiride
    Dosage: unk, unknown
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

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