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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