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Diphenhydramine (Diphenhydramine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Diphenhydramine 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 (9)
Death (7)

Reports by Reaction Type

Completed Suicide (3)Respiratory Arrest (3)Cardiac Arrest (3)Drug Abuse (2)Injury (2)Electrocardiogram QT Prolonged (1)Coma (1)Hepatic Failure (1)Overdose (1)Medication Error (1)Multiple Drug Overdose (1)Product Label Confusion (1)

Possible Diphenhydramine side effects in 22 year old male

Reported by a physician from United States on 2012-07-09

Patient: 22 year old male, weighing 61.3 kg (134.9 pounds)

Reactions: Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased, Suicide Attempt, Coma, Multiple Drug Overdose

Adverse event resulted in: hospitalization

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

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

Acetaminophen
    Administration route: Oral



Possible Diphenhydramine side effects in

Reported by a consumer/non-health professional from United States on 2012-06-26

Patient:

Reactions: Medication Error, Product Label Confusion

Drug(s) suspected as cause:
Diphenhydramine



Possible Diphenhydramine side effects in 30 year old female

Reported by a physician from United States on 2012-04-23

Patient: 30 year old female

Reactions: Electrocardiogram QT Prolonged, Overdose, Metabolic Acidosis, Respiratory Failure, Completed Suicide, Hypotension, Hepatic Failure

Adverse event resulted in: death

Drug(s) suspected as cause:
Diphenhydramine
    Dosage: 48 diphenhydramine 25 mg
    Indication: Suicide Attempt

Ibuprofen
    Dosage: 15 ibuprofen, 200 mg
    Indication: Suicide Attempt

Paroxetine
    Dosage: unknown number 10 mg
    Indication: Suicide Attempt

Paracetamol
    Dosage: unk
    Indication: Suicide Attempt



Possible Diphenhydramine side effects in 17 year old female

Reported by a physician from United States on 2012-01-03

Patient: 17 year old female

Reactions: Completed Suicide

Adverse event resulted in: death

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

Theophylline
    Dosage: unk

Diphenhydramine
    Dosage: unk
    Administration route: Oral



Possible Diphenhydramine side effects in 45 year old female

Reported by a physician from United States on 2011-12-29

Patient: 45 year old female

Reactions: Respiratory Arrest, Cardiac Arrest, Drug Abuse

Adverse event resulted in: death

Drug(s) suspected as cause:
Diphenhydramine

Alprazolam

Fluoxetine

Propoxyphene Hydrochloride



Possible Diphenhydramine side effects in 51 year old male

Reported by a physician from United States on 2011-12-22

Patient: 51 year old male

Reactions: Drug Abuse

Adverse event resulted in: death

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

Alprazolam
    Dosage: unk
    Administration route: Oral

Methadone
    Dosage: unk
    Administration route: Oral



Possible Diphenhydramine side effects in 4 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-22

Patient: 4 year old male

Reactions: Respiratory Arrest, Injury, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Diphenhydramine

Ethanol

Isopropanol

Chlorpheniramine Maleate

Acetone

Alprazolam

Dextromethorphan Hydrobromide



Possible Diphenhydramine side effects in 4 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-22

Patient: 4 year old male

Reactions: Respiratory Arrest, Injury, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Alprazolam

Dextromethorphan Hydrobromide

Ethanol

Acetone

Isopropanol

Diphenhydramine

Chlorpheniramine Maleate



Possible Diphenhydramine side effects in 57 year old female

Reported by a physician from United States on 2011-12-22

Patient: 57 year old female

Reactions: Completed Suicide, Toxicity To Various Agents

Adverse event resulted in: death

Drug(s) suspected as cause:
Gabapentin

Venlafaxine HCL

Diltiazem HCL

Methotrexate Sodium

Clonazepam

Baclofen

Fluoxetine

Diphenhydramine

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