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Benadryl (Diphenhydramine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Benadryl (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 (341)
Death (28)
Life Threatening Events (10)
Disability (10)

Reports by Reaction Type

Off Label Use (56)Drug Hypersensitivity (35)Urticaria (31)Hypersensitivity (27)Nausea (27)Drug Ineffective (26)Hallucination (25)Pain (23)Pruritus (22)Product Quality Issue (20)Somnolence (19)Fatigue (19)

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

Possible Benadryl side effects in 55 year old female

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

Patient: 55 year old female, weighing 56.7 kg (124.7 pounds)

Reactions: Off Label Use, Burning Sensation, Tinnitus, Swelling Face, Heart Rate Increased, Therapeutic Response Unexpected, Erythema

Drug(s) suspected as cause:
Benadryl

Other drugs received by patient: Diovan HCT; Hydrocodone Bitartrate; Oxygen; Diltiazem; Dexilant; Blood Pressure Medication NOS; Anxiety Medication; Inhaler (Unspecified); Xanax; Heart Medication (Unknown); Acid Reflux Medication



Possible Benadryl side effects in 46 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: 46 year old female

Reactions: Drug Hypersensitivity

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

Codeine Sulfate
    Dosage: unk

Demerol
    Dosage: unk

Keflex
    Dosage: unk

Prevacid
    Dosage: unk

Prilosec
    Dosage: unk

Tobramycin
    Dosage: unk



Possible Benadryl side effects in 4 year old female

Reported by a physician from United States on 2012-08-24

Patient: 4 year old female

Reactions: Off Label Use, Wrong Drug Administered, Drug Interaction, Toxicity To Various Agents

Adverse event resulted in: death

Drug(s) suspected as cause:
Benadryl

Other drugs received by patient possibly interacting with the suspect drug:
Tussionex
    Dosage: half teaspoon, once a day
    Indication: Croup Infectious



Possible Benadryl side effects in 21 year old female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 21 year old female, weighing 78.0 kg (171.6 pounds)

Reactions: Hypersensitivity

Drug(s) suspected as cause:
Benadryl
    Dosage: unk
    Start date: 1988-01-01

Cortisone Acetate
    Dosage: unk
    Indication: Pain
    Start date: 1988-01-01

Darvocet-N 50
    Dosage: unk
    Indication: Pain
    Start date: 2008-01-01

Demerol
    Dosage: unk
    Indication: Pain

Hydrocodone Bitartrate
    Dosage: unk
    Indication: Pain
    Start date: 2011-11-01

Morphine Sulfate
    Dosage: unk
    Indication: Pain
    Start date: 1984-01-01



Possible Benadryl side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: female, weighing 71.7 kg (157.7 pounds)

Reactions: Breast Cancer, Off Label Use, Pruritus, Fatigue, Anaemia, Swelling

Drug(s) suspected as cause:
Benadryl
    Indication: Sleep Disorder Therapy

Benadryl
    Administration route: Topical
    Indication: Arthropod Bite

Benadryl
    Indication: Arthropod Bite

Benadryl
    Indication: Pruritus

Other drugs received by patient: Vitamin D; Multi-Vitamins; Lipitor; Aspirin; Atenolol; Lisinopril; Melatonin; Ascorbic Acid; AN Unknown Medication



Possible Benadryl side effects in 64 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient: 64 year old female, weighing 90.7 kg (199.5 pounds)

Reactions: Pruritus, Blood Cholesterol Increased, Somnolence

Drug(s) suspected as cause:
Atorvastatin Calcium
    Dosage: 20 mg, daily
    Indication: Blood Cholesterol Increased
    Start date: 2012-01-01
    End date: 2012-01-01

Benadryl
    Dosage: unk

Other drugs received by patient: Cozaar; Norvasc; Atenolol



Possible Benadryl side effects in 60 year old male

Reported by a physician from United States on 2012-08-22

Patient: 60 year old male, weighing 88.5 kg (194.6 pounds)

Reactions: Raynaud's Phenomenon

Drug(s) suspected as cause:
Benadryl

Risperidone
    Dosage: po 1 1/2 tabs at hs
    Administration route: Oral
    Indication: Psychotic Disorder
    Start date: 2011-07-10
    End date: 2011-11-02



Possible Benadryl side effects in

Reported by a pharmacist from United States on 2012-08-22

Patient:

Reactions: Accidental Overdose

Adverse event resulted in: death

Drug(s) suspected as cause:
Benadryl



Possible Benadryl side effects in 16 year old male

Reported by a physician from United States on 2012-08-22

Patient: 16 year old male

Reactions: Rash Generalised, Urticaria, Rash Pruritic

Drug(s) suspected as cause:
Benadryl
    Dosage: 50 mg, po tid
    Administration route: Oral
    Indication: Urticaria
    Start date: 2011-09-19
    End date: 2011-09-23

Buprion SR 100 MG
    Dosage: 1 tab daily for 3 days then 1 tab twice daily
    Administration route: Oral
    Start date: 2011-08-25
    End date: 2011-09-21

Methylprednisolone
    Dosage: 4 mg, po tid
    Administration route: Oral
    Indication: Urticaria
    Start date: 2011-09-22
    End date: 2011-09-28



Possible Benadryl side effects in 70 year old female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: 70 year old female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Benadryl

Epinephrine



Possible Benadryl side effects in 64 year old male

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: 64 year old male, weighing 71.7 kg (157.7 pounds)

Reactions: Off Label Use, Neuropathy Peripheral, Therapeutic Response Unexpected

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

Benadryl
    Dosage: 1 -2 pills 1-2 times each night
    Administration route: Oral
    Indication: Pruritus

Benadryl
    Dosage: 1 -2 pills 1-2 times each night
    Administration route: Oral
    Indication: Drug Effect Increased

Benadryl
    Dosage: 1 -2 pills 1-2 times each night
    Administration route: Oral
    Indication: Sleep Disorder Therapy

Other drugs received by patient: Digoxin; Lyrica; Aspirin; Cymbalta; Rythmol; Nucynta; Soma; Lyrica; Savella; Lipitor; Skelaxin; Savella; Flexeril; Cymbalta; Toprol-XL; Nucynta



Possible Benadryl side effects in 19 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: 19 year old male

Reactions: Drug Diversion, Toxicity To Various Agents, Drug Abuse

Adverse event resulted in: death

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

Benadryl
    Dosage: daily dose text: unspecified
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Cough and Cold Preparations
    Dosage: daily dose text: unspecified
    Indication: Product Used FOR Unknown Indication

Dextromethorphan Hydrobromide
    Dosage: daily dose text: unspecified
    Administration route: Oral
    Indication: Substance Use



Possible Benadryl side effects in 19 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: 19 year old male

Reactions: Drug Diversion, Toxicity To Various Agents, Drug Abuse

Adverse event resulted in: death

Drug(s) suspected as cause:
Benadryl
    Dosage: daily dose text: unspecified
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Cough and Cold Preparations
    Dosage: daily dose text: unspecified
    Indication: Product Used FOR Unknown Indication

Dextromethorphan Hydrobromide
    Dosage: daily dose text: unspecified
    Administration route: Oral
    Indication: Substance Use



Possible Benadryl side effects in female

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

Patient: female

Reactions: Off Label Use, Diarrhoea

Drug(s) suspected as cause:
Benadryl
    Administration route: Oral
    Indication: Throat Irritation
    Start date: 2012-08-01

Benadryl
    Administration route: Oral
    Indication: Unevaluable Event
    Start date: 2012-08-01

Benadryl
    Administration route: Oral
    Indication: Rhinorrhoea
    Start date: 2012-08-01

Benadryl
    Administration route: Oral
    Indication: Lacrimation Increased
    Start date: 2012-08-01



Possible Benadryl side effects in female

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

Patient: female

Reactions: Atrial Fibrillation, Somnolence

Drug(s) suspected as cause:
Benadryl



Possible Benadryl side effects in 3 year old male

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: 3 year old male, weighing 12.7 kg (27.9 pounds)

Reactions: Hospitalisation, Failure of Child Resistant Mechanism FOR Pharmaceutical Product, Accidental Drug Intake by Child

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Benadryl



Possible Benadryl side effects in 55 year old female

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

Patient: 55 year old female, weighing 49.9 kg (109.8 pounds)

Reactions: Off Label Use, Anaphylactic Reaction

Drug(s) suspected as cause:
Benadryl
    Administration route: Oral
    Indication: Dermatitis Contact
    Start date: 1978-01-01

Benadryl
    Administration route: Oral
    Indication: Pruritus
    Start date: 1978-01-01

Other drugs received by patient: Lovaza; Clonidine; Epipen



Possible Benadryl side effects in 33 year old female

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

Patient: 33 year old female, weighing 68.0 kg (149.7 pounds)

Reactions: Weight Increased, Night Sweats, Hot Flush, Drug Ineffective, Insomnia, Somnolence

Drug(s) suspected as cause:
Benadryl
    Dosage: unk
    Indication: Sleep Disorder
    Start date: 2012-01-01
    End date: 2012-01-01

Black Cohosh
    Indication: Weight Increased

Black Cohosh
    Indication: Sleep Disorder

Black Cohosh
    Dosage: unk
    Indication: Hot Flush
    Start date: 2012-01-01

Black Cohosh
    Indication: Night Sweats

Estroven
    Indication: Sleep Disorder

Estroven
    Dosage: unk
    Indication: Hot Flush
    Start date: 2012-01-01

Estroven
    Indication: Night Sweats

Estroven
    Indication: Weight Increased

Premarin
    Dosage: 0.9 mg, daily
    Administration route: Oral

Premarin
    Dosage: 1.25 mg, daily
    Administration route: Oral
    End date: 2012-01-01

Premarin
    Dosage: 0.45 mg, daily
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 2006-01-01

Other drugs received by patient: Naproxen (Aleve)



Possible Benadryl side effects in female

Reported by a physician from United States on 2012-08-03

Patient: female, weighing 52.2 kg (114.7 pounds)

Reactions: Auricular Swelling, Fatigue, Urticaria

Drug(s) suspected as cause:
Advil Liqui-Gels
    Dosage: 2 x 200 mg capsules, daily
    Administration route: Oral
    Indication: Medical Device Complication
    Start date: 2012-07-02
    End date: 2012-07-02

Benadryl
    Indication: Auricular Swelling

Benadryl
    Dosage: 50 mg, unk
    Indication: Rash Generalised
    Start date: 2012-07-02



Possible Benadryl side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-02

Patient: female

Reactions: Angioedema, Pruritus, Dyspepsia, Paraesthesia Oral, Drug Ineffective FOR Unapproved Indication

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Benadryl

Other drugs received by patient: Remicade; AN Unknown Medication



Possible Benadryl side effects in 64 year old female

Reported by a consumer/non-health professional from United States on 2012-08-01

Patient: 64 year old female

Reactions: Off Label Use, Tinnitus, Therapeutic Response Unexpected

Drug(s) suspected as cause:
Benadryl



Possible Benadryl side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient: female, weighing 83.9 kg (184.6 pounds)

Reactions: Procedural Pain, Hypersensitivity, Contusion, Fall

Drug(s) suspected as cause:
Benadryl
    Administration route: Oral
    Indication: Urticaria
    Start date: 2012-06-20
    End date: 2012-06-01

Corticosteroids
    Dosage: given once
    Indication: Urticaria
    Start date: 2012-06-01
    End date: 2012-06-01

Hydrocodone
    Administration route: Oral
    Indication: Procedural Pain
    Start date: 2012-06-11
    End date: 2012-06-01

Hydroxyzine HCL
    Administration route: Oral
    Indication: Urticaria
    Start date: 2012-06-01

Skelaxin
    Administration route: Oral
    Indication: Muscle Relaxant Therapy
    Start date: 2012-06-11
    End date: 2012-06-01

Stelara
    Indication: Psoriasis
    Start date: 2012-03-01

Tramadol Hydrochloride
    Administration route: Oral
    Indication: Procedural Pain
    Start date: 2012-06-11



Possible Benadryl side effects in

Reported by a lawyer from United States on 2012-07-31

Patient:

Reactions: Asthma, Contusion, Urticaria, Pain, Headache, Abdominal Pain Upper, Fatigue, Papilloma Viral Infection, Pain in Extremity, Drug Hypersensitivity, Ovarian Cyst, Varicose Vein, Venous Insufficiency, Hypercoagulation, Dysmenorrhoea, Arthralgia, Deep Vein Thrombosis

Adverse event resulted in: hospitalization, disablity

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

Nuvaring
    Dosage: unk unk, qm
    Indication: Contraception
    Start date: 2007-01-01
    End date: 2009-11-01



Possible Benadryl side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: male, weighing 93.0 kg (204.6 pounds)

Reactions: Overdose, Suicide Attempt

Drug(s) suspected as cause:
Benadryl
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-20

Extra Strength Tylenol PM
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-20



Possible Benadryl side effects in 72 year old female

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: 72 year old female, weighing 93.2 kg (205.0 pounds)

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Benadryl
    Indication: Pruritus

Zantac
    Indication: Pruritus

Other drugs received by patient: Multiple Medication; Lovaza; Imdur



Possible Benadryl side effects in female

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

Patient: female, weighing 97.5 kg (214.5 pounds)

Reactions: Drug Screen Positive

Drug(s) suspected as cause:
Benadryl
    Indication: Sleep Disorder

Celexa
    Indication: Depression

Depakote
    Indication: Convulsion
    Start date: 2011-03-01

Geodon
    Indication: Bipolar Disorder

Seroquel
    Administration route: Oral
    Indication: Sleep Disorder



Possible Benadryl side effects in 31 year old female

Reported by a physician from United States on 2012-07-27

Patient: 31 year old female

Reactions: Aphagia, Vitamin D Deficiency, Initial Insomnia, Chronic Fatigue Syndrome, Personality Disorder, Anxiety, Anorexia Nervosa, Suicide Attempt, Hypothyroidism, Dermal Cyst, Major Depression, Depression, Bulimia Nervosa

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Benadryl

Seroquel XR
    Administration route: Oral

Seroquel XR
    Administration route: Oral

Other drugs received by patient: Synthroid; Klonopin; Vitamin D; Prozac



Possible Benadryl side effects in

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

Patient:

Reactions: Epistaxis

Drug(s) suspected as cause:
Benadryl
    Start date: 2009-05-07

Seroquel XR
    Administration route: Oral
    Start date: 2010-11-12

Seroquel XR
    Administration route: Oral
    Indication: Depression
    End date: 2010-11-12

Other drugs received by patient: Ventolin HFA; Ventolin HFA; Vitamin D; Nyquil Gel Caps; Furosemide; Buspirone HCL; Xanax; Nexium; Ventolin HFA; Imodium; Senna Laxative; Lamictal; Vitamin and Mineral Prenatal Supplement W / Folic Acid CAP; Calcium , Vitamin D; Klor-CON; Celexa; Promethazine; Hyomax-SL; Tylenol



Possible Benadryl side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-25

Patient: female

Reactions: Drug Hypersensitivity

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

Aspirin
    Dosage: unk

Benadryl
    Dosage: unk

Demerol
    Dosage: unk

Keflex
    Dosage: unk

Lisinopril
    Dosage: unk

Morphine Sulfate
    Dosage: unk

Ranitidine
    Dosage: unk

Ropinirole
    Dosage: unk

Seroquel
    Dosage: unk

Tetracycline HCL
    Dosage: unk



Possible Benadryl side effects in male

Reported by a physician from United States on 2012-07-24

Patient: male

Reactions: Hypersensitivity, Pain, Eye Oedema

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

Bicillin L-A
    Dosage: 1.2 mg, unk
    Indication: Lyme Disease

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