Index of reports
> Cases with Product Quality Issue (20)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Benadryl (Diphenhydramine) where reactions include product quality issue. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Benadryl side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-19
Patient: female
Reactions: Product Quality Issue, Drug Ineffective, Oedema Peripheral, Extrasystoles, Dizziness
Drug(s) suspected as cause:
Benadryl
Administration route: Oral
Indication: Multiple Allergies
Epipen
Dosage: 11-12 years
Indication: Multiple Allergies
Zyrtec Allergy
Administration route: Oral
Zyrtec Allergy
Dosage: 11-12 years
Administration route: Oral
Indication: Multiple Allergies
Other drugs received by patient: ALL Other Therapeutic Products; Unspecified Blood Pressure Meds
Possible Benadryl side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-22
Patient: female
Reactions: Product Quality Issue, Drug Ineffective, Extrasystoles, Oedema Peripheral, Dizziness
Drug(s) suspected as cause:
Benadryl
Administration route: Oral
Indication: Multiple Allergies
Epipen
Dosage: 11-12 years
Indication: Multiple Allergies
Zyrtec Allergy
Administration route: Oral
Zyrtec Allergy
Dosage: 11-12 years
Administration route: Oral
Indication: Multiple Allergies
Other drugs received by patient: Unspecified Blood Pressure Meds; ALL Other Therapeutic Products
Possible Benadryl side effects in 34 year old female
Reported by a consumer/non-health professional from United States on 2012-06-19
Patient: 34 year old female
Reactions: Product Quality Issue, Off Label Use, Fatigue, Convulsion
Drug(s) suspected as cause:
Benadryl
Other drugs received by patient: Levetiracetam; Vimpat
Possible Benadryl side effects in 83 year old male
Reported by a consumer/non-health professional from United States on 2012-05-29
Patient: 83 year old male
Reactions: Product Quality Issue, Homicide, Completed Suicide, Abnormal Behaviour, Hallucination
Adverse event resulted in: death
Drug(s) suspected as cause:
Tramadol HCL
Indication: Pain Management
Benadryl
Indication: Antiallergic Therapy
Citalopram Hydrobromide
Indication: Antidepressant Therapy
Acetaminophen
Indication: Pain Management
Benzodiazepine NOS
Indication: Antidepressant Therapy
Acetaminophen
Indication: Pyrexia
Possible Benadryl side effects in 83 year old male
Reported by a consumer/non-health professional from United States on 2012-05-18
Patient: 83 year old male
Reactions: Homicide, Product Quality Issue, Completed Suicide, Abnormal Behaviour, Hallucination
Adverse event resulted in: death
Drug(s) suspected as cause:
Benzodiazepine NOS
Indication: Antidepressant Therapy
Tramadol Hydrochloride
Indication: Pain Management
Benadryl
Indication: Antiallergic Therapy
Acetaminophen
Indication: Pyrexia
Citalopram Hydrobromide
Indication: Antidepressant Therapy
Acetaminophen
Indication: Pain Management
Possible Benadryl side effects in 83 year old male
Reported by a consumer/non-health professional from United States on 2012-05-16
Patient: 83 year old male
Reactions: Homicide, Product Quality Issue, Completed Suicide, Abnormal Behaviour, Hallucination
Adverse event resulted in: death
Drug(s) suspected as cause:
Benzodiazepine NOS
Indication: Antidepressant Therapy
Citalopram Hydrobromide
Indication: Antidepressant Therapy
Benadryl
Indication: Antiallergic Therapy
Acetaminophen
Indication: Pyrexia
Acetaminophen
Indication: Pain Management
Tramadol Hydrochloride
Indication: Pain Management
Possible Benadryl side effects in 83 year old male
Reported by a consumer/non-health professional from United States on 2012-05-15
Patient: 83 year old male
Reactions: Homicide, Product Quality Issue, Completed Suicide, Abnormal Behaviour, Hallucination
Adverse event resulted in: death
Drug(s) suspected as cause:
Acetaminophen
Indication: Pain Management
Tramadol Hydrochloride
Indication: Pain Management
Benzodiazepine NOS
Indication: Antidepressant Therapy
Benadryl
Indication: Antiallergic Therapy
Acetaminophen
Indication: Pyrexia
Citalopram Hydrobromide
Indication: Antidepressant Therapy
Possible Benadryl side effects in 83 year old male
Reported by a consumer/non-health professional from United States on 2012-05-04
Patient: 83 year old male
Reactions: Product Quality Issue, Homicide, Completed Suicide, Abnormal Behaviour, Hallucination
Adverse event resulted in: death
Drug(s) suspected as cause:
Benzodiazepine NOS
Indication: Antidepressant Therapy
Tramadol HCL
Indication: Pain Management
Acetaminophen
Indication: Pyrexia
Benadryl
Indication: Antiallergic Therapy
Acetaminophen
Indication: Pain Management
Citalopram Hydrobromide
Indication: Antidepressant Therapy
Possible Benadryl side effects in 5 year old female
Reported by a consumer/non-health professional from United States on 2012-04-25
Patient: 5 year old female
Reactions: Off Label Use, Product Quality Issue, Expired Drug Administered, Adverse Reaction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Benadryl
Administration route: Oral
Indication: Pruritus
Benadryl
Administration route: Oral
Indication: Food Allergy
Benadryl
Administration route: Oral
Indication: Hypersensitivity
Possible Benadryl side effects in 5 year old female
Reported by a consumer/non-health professional from United States on 2012-04-25
Patient: 5 year old female
Reactions: Product Quality Issue, Wrong Drug Administered, Adverse Reaction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Benadryl
Dosage: 1 tablet as needed, upc # 5058034818
Administration route: Oral
Indication: Pruritus
Benadryl
Dosage: 1 tablet as needed, upc # 5058034818
Administration route: Oral
Indication: Hypersensitivity
Possible Benadryl side effects in 83 year old male
Reported by a consumer/non-health professional from United States on 2012-04-20
Patient: 83 year old male
Reactions: Product Quality Issue, Homicide, Completed Suicide, Abnormal Behaviour, Hallucination
Adverse event resulted in: death
Drug(s) suspected as cause:
Tramadol Hydrochloride
Indication: Pain Management
Benzodiazepine NOS
Indication: Antidepressant Therapy
Citalopram Hydrobromide
Indication: Antidepressant Therapy
Benadryl
Indication: Antiallergic Therapy
Acetaminophen
Indication: Pain Management
Acetaminophen
Indication: Pyrexia
Possible Benadryl side effects in female
Reported by a consumer/non-health professional from United States on 2012-04-03
Patient: female
Reactions: Product Quality Issue, Drug Ineffective, Extrasystoles, Oedema Peripheral, Dizziness
Drug(s) suspected as cause:
Benadryl
Administration route: Oral
Indication: Multiple Allergies
Zyrtec Allergy
Dosage: 11-12 years
Administration route: Oral
Indication: Multiple Allergies
Epipen
Dosage: 11-12 years
Indication: Multiple Allergies
Zyrtec Allergy
Administration route: Oral
Other drugs received by patient: Unspecified Blood Pressure Meds; ALL Other Therapeutic Products
Possible Benadryl side effects in 23 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-14
Patient: 23 year old female
Reactions: Product Quality Issue, Death, Toxicity To Various Agents, Drug Abuse
Adverse event resulted in: death
Drug(s) suspected as cause:
Xanax
Indication: Product Used FOR Unknown Indication
Benadryl
Tramadol HCL
Indication: Product Used FOR Unknown Indication
Diazepam
Indication: Product Used FOR Unknown Indication
Benadryl
Indication: Product Used FOR Unknown Indication
Possible Benadryl side effects in 7 year old male
Reported by a consumer/non-health professional from United States on 2012-02-22
Patient: 7 year old male
Reactions: Product Quality Issue, Chest Discomfort, Hypersensitivity, Angioedema, Nausea, Wheezing, Urticaria, Impaired Work Ability, Pyrexia, Rash, Headache, Pallor, Malaise, Cough
Drug(s) suspected as cause:
Acetaminophen
Junior Strength Motrin
Benadryl
Indication: Product Used FOR Unknown Indication
Junior Strength Motrin
Indication: Ill-Defined Disorder
Acetaminophen
Indication: Product Used FOR Unknown Indication
Benadryl
Possible Benadryl side effects in 25 year old female
Reported by a consumer/non-health professional from United States on 2012-02-21
Patient: 25 year old female
Reactions: Product Quality Issue, Nausea, Diarrhoea, Urticaria, Swelling, Chills, Headache
Drug(s) suspected as cause:
Tylenol-500
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Benadryl
Administration route: Oral
Tylenol-500
Administration route: Oral
Extra Strength Tylenol
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Extra Strength Tylenol
Administration route: Oral
Benadryl
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Unspecified Birth Control
Possible Benadryl side effects in 79 year old male
Reported by a physician from United States on 2012-02-17
Patient: 79 year old male, weighing 64.4 kg (141.7 pounds)
Reactions: Off Label Use, Product Quality Issue, Vomiting, Nausea, Skin Discolouration, Chromaturia, Gait Disturbance
Drug(s) suspected as cause:
Benadryl
Dosage: daily dose text: 2 pills every 4-6 hours twice daily
Administration route: Oral
Indication: Prophylaxis
Start date: 2009-03-01
Benadryl
Dosage: daily dose text: 2 pills every 4-6 hours twice daily
Administration route: Oral
Indication: Sinus Disorder
Start date: 2009-03-01
Acetaminophen
Dosage: daily dose text: one tablet twice daily
Indication: Prophylaxis
Acetaminophen
Dosage: daily dose text: one tablet twice daily
Indication: Back Pain
Other drugs received by patient: Immune Globulin NOS
Possible Benadryl side effects in male
Reported by a consumer/non-health professional from United States on 2012-02-16
Patient: male
Reactions: Product Quality Issue, Vomiting, Nausea, Chromaturia, Gait Disturbance
Drug(s) suspected as cause:
Acetaminophen
Dosage: 650 mg every month at the time of his immunoglobulin infusions and as needed for his back disorder
Indication: Prophylaxis
Benadryl
Administration route: Oral
Indication: Sinus Disorder
Benadryl
Administration route: Oral
Indication: Prophylaxis
Acetaminophen
Dosage: 650 mg every month at the time of his immunoglobulin infusions and as needed for his back disorder
Indication: Back Disorder
Other drugs received by patient: Immune Globulin NOS
Possible Benadryl side effects in 75 year old female
Reported by a consumer/non-health professional from United States on 2011-11-10
Patient: 75 year old female, weighing 44.5 kg (97.8 pounds)
Reactions: Product Quality Issue, Off Label Use, Vertigo
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Benadryl
Dosage: one, every 4-5 hours
Administration route: Oral
Indication: Arthropod Sting
Start date: 2001-08-02
End date: 2011-08-03
Benadryl
Administration route: Oral
Possible Benadryl side effects in male
Reported by a consumer/non-health professional from United States on 2011-10-27
Patient: male
Reactions: Product Quality Issue, Gastric Dilatation, Gastritis
Drug(s) suspected as cause:
Benadryl
Benadryl
Dosage: as of 15-oct-2011, it is unspecified if the patient is still taking the product.
Indication: Product Used FOR Unknown Indication
Possible Benadryl side effects in 40 year old female
Reported by a consumer/non-health professional from United States on 2011-10-11
Patient: 40 year old female
Reactions: Product Quality Issue, Pruritus Generalised, Rash, Secretion Discharge, Suicidal Ideation
Drug(s) suspected as cause:
Benadryl
Administration route: Topical
Indication: Product Used FOR Unknown Indication
Benadryl
Administration route: Topical
Benadryl
Administration route: Oral
Benadryl
Dosage: recommeded amount at the recommened frequency
Administration route: Oral
Indication: Multiple Allergies
Benadryl
Administration route: Oral
Benadryl
Administration route: Oral
Indication: Multiple Allergies
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