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 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 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 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: Atrial Fibrillation, Somnolence
Drug(s) suspected as cause:
Benadryl
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 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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