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Benadryl Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 1440 

Neurotoxicity, Product Substitution Issue, Vomiting, Dehydration, Angioedema, Nausea (8444795-9)
on Jun 12, 2012 Female from UNITED STATES , 60 years of age, weighting 114.0 lb, was treated with Benadryl. Directly after, patient experienced the unwanted or unexpected Benadryl side effects: neurotoxicity, product substitution issue, vomiting, dehydration, angioedema, nausea. Benadryl dosage: N/A.
Associated medications used:
  • Hydrocortisone Cream
  • Prednisone
  • Rite Aid Compare To Eucerin Mois 160z -11b- 454 G Rite Aid Corporation (Used Hand Fuls 2-3 Times Top)
  • Levoceterizine


Hyperhidrosis, Herpes Zoster, Oral Pruritus, Skin Disorder, Tongue Pruritus, Dyspnoea (8439113-6)
Patient was taking Benadryl. Patient felt the following Benadryl side effects: hyperhidrosis, herpes zoster, oral pruritus, skin disorder, tongue pruritus, dyspnoea on Jun 01, 2012 from UNITED STATES Additional patient health information: Female , 39 years of age, . Benadryl dosage: N/A.
Multiple prescriptions taken:
  • Cimzia


Off Label Use, Loss Of Consciousness (8435703-5)
Adverse event was reported on Jun 11, 2012 by a Female taking Benadryl (Dosage: One Pill One Time) was diagnosed with
  • sinus disorder
and. Location: UNITED STATES , 79 years of age, After Benadryl was administered, patient encountered several Benadryl side effects: off label use, loss of consciousness.

Fall, Pain, Rib Fracture (8434763-5)
on Jun 04, 2012 Female from CANADA , weighting 127.9 lb, was treated with Benadryl. Directly after, patient experienced the unwanted or unexpected Benadryl side effects: fall, pain, rib fracture. Benadryl dosage: N/A.
Associated medications used:
  • Remicade (52 Weeks)
  • Lipitor (For Approximately 10 Years)



Memory Impairment, Hypoaesthesia, Lymphoproliferative Disorder, Oedema Peripheral, Dyspnoea Exertional, Progressive Multifocal Leukoencephalopathy, Reading Disorder, Aphasia, Balance Disorder (8432680-8)
on May 23, 2012 Female from UNITED STATES , 38 years of age, weighting 127.0 lb, was treated with Benadryl. Patient felt the following Benadryl side effects: memory impairment, hypoaesthesia, lymphoproliferative disorder, oedema peripheral, dyspnoea exertional, progressive multifocal leukoencephalopathy, reading disorder, aphasia, balance disorder. Benadryl dosage: N/A.
Multiple prescriptions taken:
  • Levothroid
  • Fluconazole
  • Abilify
  • Imodium Advanced (loperamide, Simeticone)
  • Prochlorperazine (prochlorperazine Maleate)
  • Adcetris (1.8 Mg/kg, Q21d)


Convulsion, Neoplasm Malignant, Vomiting (8432203-3)
Patient was taking Benadryl. After Benadryl was administered, patient encountered several Benadryl side effects: convulsion, neoplasm malignant, vomiting on Jun 05, 2012 from UNITED STATES Additional patient health information: Female , 34 years of age, . Benadryl dosage: N/A.
Multiple concurrent drugs taken:
  • Keppra
  • Marinol
  • Ipilimumab
  • Inapsine
  • Decadron
  • Compazine
  • Dilantin (1 Df-300 Units Nos)
  • Metoprolol Tartrate
Patient was hospitalized.

Fatigue, Off Label Use, Convulsion (8429935-X)
Adverse event was reported on Jun 06, 2012 by a Female taking Benadryl (Dosage: N/A) . Location: UNITED STATES , 34 years of age, Directly after, patient experienced the unwanted or unexpected Benadryl side effects: fatigue, off label use, convulsion.
Associated medications used:
  • Levetiracetam
  • Vimpat


Urticaria, Insomnia, Neck Pain, Hot Flush, Recurrent Cancer, Pruritus, Asthenia, Oedema Peripheral, Arthralgia (8428154-0)
on Jun 05, 2012 Female from UNITED STATES , 67 years of age, weighting 128.1 lb, was treated with Benadryl. Patient felt the following Benadryl side effects: urticaria, insomnia, neck pain, hot flush, recurrent cancer, pruritus, asthenia, oedema peripheral, arthralgia. Benadryl dosage: N/A.
Multiple prescriptions taken:
  • Aspirin
  • Arimidex


Diabetes Mellitus, Pruritus, Nephrolithiasis, Infection (8425310-2)
on May 30, 2012 Male from CANADA , weighting 187.4 lb, was treated with Benadryl. After Benadryl was administered, patient encountered several Benadryl side effects: diabetes mellitus, pruritus, nephrolithiasis, infection. Benadryl dosage: N/A.
Multiple concurrent drugs taken:
  • Remicade
  • Solu-cortef
  • Remicade
  • Ciprofloxacin (7 Days)


Adverse Event, Hospitalisation (8425203-0)
Patient was taking Benadryl. Directly after, patient experienced the unwanted or unexpected Benadryl side effects: adverse event, hospitalisation on May 16, 2012 from UNITED STATES Additional patient health information: Female , 54 years of age, weighting 160.0 lb, . Benadryl dosage: N/A.
Associated medications used:
  • Zemaira ((60 Mg/kg 1x/week, 1045 Mg/vial; 0.08 Ml; Per Kg Per Kin (5.8 Ml Per Min) Intravenous)
  • Trazodone Hcl
  • Multivitamin (multivitamin /00831701/)
  • Lamictal
  • Sodium Chloride 0.9%
  • Fluoxetine
Patient was hospitalized.

Feeling Abnormal, Crying, Glossodynia, Pain, Pruritus (8424286-1)
Adverse event was reported on Nov 28, 2011 by a Male taking Benadryl (Dosage: N/A) was diagnosed with
  • multiple allergies
  • asthma
and. Location: UNITED STATES , child 3 years of age, weighting 33.95 lb, Patient felt the following Benadryl side effects: feeling abnormal, crying, glossodynia, pain, pruritus.
Multiple prescriptions taken:
  • Singulair
  • Albuterol
  • Pulmicort (0.5 Mg/ 2 Ml Daily)


Irritability, Anaphylactic Reaction, Eye Irritation, Candidiasis, Respiration Abnormal, Aphonia, Respiratory Tract Irritation, Burning Sensation, Swelling (8422845-3)
on Jun 04, 2012 Female from UNITED STATES , 58 years of age, was treated with Benadryl. After Benadryl was administered, patient encountered several Benadryl side effects: irritability, anaphylactic reaction, eye irritation, candidiasis, respiration abnormal, aphonia, respiratory tract irritation, burning sensation, swelling. Benadryl dosage: N/A.
Multiple concurrent drugs taken:
  • Elocon
  • Darvocet
  • Nostrilla
  • Advair Diskus 100/50 (1puff Twice Per Day)
  • Trazodone Hcl
  • Butalbital
  • Hydroxyzine
  • Rhinocort


Renal Disorder (8421407-1)
on May 29, 2012 Male from CANADA , weighting 194.0 lb, was treated with Benadryl. Directly after, patient experienced the unwanted or unexpected Benadryl side effects: renal disorder. Benadryl dosage: N/A.
Associated medications used:
  • Remicade


Pain In Extremity, Dry Mouth, Arthralgia, Hypoaesthesia, Weight Increased, Joint Swelling, Oedema Peripheral (8420256-8)
Patient was taking Benadryl. Patient felt the following Benadryl side effects: pain in extremity, dry mouth, arthralgia, hypoaesthesia, weight increased, joint swelling, oedema peripheral on Jun 04, 2012 from UNITED STATES Additional patient health information: Male , weighting 179.9 lb, was diagnosed with
  • sleep disorder
  • hypertension
  • diabetic neuropathy
and. Benadryl dosage: 20 Mg, Daily.
Multiple prescriptions taken:
  • Atenolol (50 Mg, Daily)
  • Lyrica (Unk, 3x/day)
  • Lyrica (150 Mg, 3x/day)


Transitional Cell Carcinoma (8420075-2)
Adverse event was reported on Jun 06, 2012 by a Male taking Benadryl (Dosage: 25 Mg, Qwk) . Location: CANADA , 56 years of age, weighting 140.0 lb, After Benadryl was administered, patient encountered several Benadryl side effects: transitional cell carcinoma.
Multiple concurrent drugs taken:
  • Methotrexate (20 Mg, Qwk)
  • Wellbutrin Xl (150 Mg, Qd)
  • Norvasc (10 Mg, Qd)
  • Lipitor (10 Mg, Qd)
  • Hyzaar (Unk Unk, Qd)
  • Etanercept (50 Mg, Qwk)
  • Aspirin (81 Mg, Qd)
  • Pantoprazole Sodium (40 Mg, Qd)


Thrombocytopenia, Neutropenia (8418458-X)
on Jul 22, 2011 Female from UNITED STATES , 73 years of age, was treated with Benadryl. Directly after, patient experienced the unwanted or unexpected Benadryl side effects: thrombocytopenia, neutropenia. Benadryl dosage: N/A.
Associated medications used:
  • Revlimid (10 Mg, 1 In 1 D, Po ; 5 Mg, Qod, Po)
  • Revlimid (10 Mg, 1 In 1 D, Po ; 5 Mg, Qod, Po)
  • Revlimid (10 Mg, 1 In 1 D, Po ; 5 Mg, Qod, Po)
  • Procrit
  • Zinc (zinc)
  • Ziac
  • Lexapro
  • Centrum (centrum)


Deep Vein Thrombosis, Post Thrombotic Syndrome, Pain, Anhedonia, Pain In Extremity, Anxiety, Injury, Oedema Peripheral (8418163-X)
on May 30, 2012 Female from UNITED STATES , 49 years of age, weighting 135.0 lb, was treated with Benadryl. Patient felt the following Benadryl side effects: deep vein thrombosis, post thrombotic syndrome, pain, anhedonia, pain in extremity, anxiety, injury, oedema peripheral. Benadryl dosage: 12.5 Mg, Prn.
Multiple prescriptions taken:
  • Yasmin (Unk)
  • Drospirenone And Ethinyl Estradiol (Unk)
  • Aciphex (20 Mg 2 [times] Day Every Day)
  • Yasmin
  • Aciphex (Unk)
  • Phenazopyridine Hcl Tab (200 Mg, Tid)
  • Multi-vitamin (Unk)
  • Phenazopyridine Hcl Tab (200 Mg, [one] Tid Prn)


Slow Response To Stimuli, Dysarthria, Off Label Use, Hallucination, Gait Disturbance (8418063-5)
Patient was taking Benadryl. After Benadryl was administered, patient encountered several Benadryl side effects: slow response to stimuli, dysarthria, off label use, hallucination, gait disturbance on Jun 01, 2012 from UNITED STATES Additional patient health information: Female , 72 years of age, was diagnosed with
  • pruritus
  • cardiac disorder
and. Benadryl dosage: N/A.
Multiple concurrent drugs taken:
  • Coumadin (All Other Evenings Except Monday And Friday)
  • Coumadin (On Monday And Friday Evenings)


Mitral Valve Hypoplasia, Atrioventricular Septal Defect, Renal Tubular Necrosis, Foetal Exposure During Pregnancy, Right Ventricular Hypertrophy, Lung Disorder, Patent Ductus Arteriosus, Persistent Foetal Circulation, Hepatic Congestion (8417421-2)
Adverse event was reported on Jun 01, 2012 by a Female taking Benadryl (Dosage: Unk) . Location: UNITED STATES , weighting 5.82 lb, Directly after, patient experienced the unwanted or unexpected Benadryl side effects: mitral valve hypoplasia, atrioventricular septal defect, renal tubular necrosis, foetal exposure during pregnancy, right ventricular hypertrophy, lung disorder, patent ductus arteriosus, persistent foetal circulation, hepatic congestion.
Associated medications used:
  • Acetaminophen (Unk)
  • Robitussin ^robins^ (Unk)
  • Zithromax (Unk)
  • Kaopectate (Unk)
  • Lexapro (10 Mg, 1x/day)
  • Multi-vitamins (Unk)
  • Zyrtec (10 Mg, Unk)
  • Zoloft (50 Mg, 1x/day)


Chest Discomfort, Back Pain, Hypoaesthesia, Erythema (8409688-1)
on May 15, 2012 Female from UNITED STATES , 69 years of age, weighting 158.3 lb, was treated with Benadryl. Patient felt the following Benadryl side effects: chest discomfort, back pain, hypoaesthesia, erythema. Benadryl dosage: N/A.
Multiple prescriptions taken:
  • Decadron
  • Paclitaxel (300 Mg, Q 3 Wk, Intravenous)
  • Pepcid
  • Aloxi


Oral Discomfort, Product Quality Issue, Throat Irritation (8395487-6)
on Apr 18, 2011 Female from UNITED STATES , 69 years of age, was treated with Benadryl. After Benadryl was administered, patient encountered several Benadryl side effects: oral discomfort, product quality issue, throat irritation. Benadryl dosage: N/A.
Multiple concurrent drugs taken:
  • Ventolin (2puff Twice Per Day)
  • Hydrochlorothiazide


Weight Decreased, Decreased Appetite, Cellulitis, Off Label Use (8390494-1)
Patient was taking Benadryl. Directly after, patient experienced the unwanted or unexpected Benadryl side effects: weight decreased, decreased appetite, cellulitis, off label use on May 23, 2012 from UNITED STATES Additional patient health information: Female , 54 years of age, weighting 237.0 lb, was diagnosed with
  • pruritus
  • hypertension
and. Benadryl dosage: N/A.
Associated medications used:
  • Clonidine Hydrochloride
Patient was hospitalized.

Infusion Related Reaction, Erythema, Paraesthesia Oral, Chest Discomfort (8386913-7)
Adverse event was reported on May 15, 2012 by a Female taking Benadryl (Dosage: N/A) . Location: CANADA , weighting 138.9 lb, Patient felt the following Benadryl side effects: infusion related reaction, erythema, paraesthesia oral, chest discomfort.
Multiple prescriptions taken:
  • Remicade


Tooth Repair, Restless Legs Syndrome, Fatigue, Pneumonia, Feeling Jittery, Somnolence (8381959-7)
on Apr 20, 2012 Male from UNITED STATES , weighting 267.4 lb, was diagnosed with
  • alpha-1 anti-trypsin deficiency
and was treated with Benadryl. After Benadryl was administered, patient encountered several Benadryl side effects: tooth repair, restless legs syndrome, fatigue, pneumonia, feeling jittery, somnolence. Benadryl dosage: 50mg, Weekly, Po.
Multiple concurrent drugs taken:
  • Carvedilol
  • Home Oxygen
  • Glassia (7000mg, Weekly, Iv)
  • Immune Globulin Intravenous (human)
  • Coumadin
  • Emla
Patient was hospitalized.

Abdominal Discomfort, Palpitations (8381083-3)
on Apr 19, 2012 Female from CANADA , 42 years of age, weighting 209.4 lb, was treated with Benadryl. Directly after, patient experienced the unwanted or unexpected Benadryl side effects: abdominal discomfort, palpitations. Benadryl dosage: N/A.
Associated medications used:
  • Prednisone Tab
  • Solu-medrol
  • Gamunex (95 Gm;total;iv)
  • Gamunex
  • Gamunex
  • Imuran


Showing 1-25 of 1440 

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It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Benadryl Information

CAMPHOR ( DIPHENHYD

Active Ingredient: CAMPHOR ( DIPHENHYD

Benadryl Dosage, Warnings, Usage.

Side Effects reported to FDA: 1440. View Benadryl Adverse Reports

Benadryl safety alerts: 2010

Reported deaths: 63

Reported hospitalizations: 297

Benadryl Extra Strength Itch Stopping Gel: Packaging Changes to Reduce Use Errors

Audience: Consumers, Pharmacists

[Posted 05/12/2010] Johnson & Johnson and FDA notified consumers and healthcare professionals of changes to the graphics and information displayed on the front of the product container to reduce the risk of serious side effects from swallowing the topical Benadryl Extra Strength Itch Stopping Gel intended ??For Skin Use Only". FDA received reports of consumers ingesting the gel rather than using it topically. Swallowing the gel can result in people receiving dangerously large amounts of the active ingredient diphenhydramine.

Between 2001 and 2009, 121 cases of ingestion of Benadryl Extra Strength Itch Relief Gel were reported to the manufacturer. Of these cases, 7 were considered serious because patients required treatment in the emergency room, hospitalization, or admission to the intensive care unit. Others reported adverse events included hallucinations, unconsciousness, sleepiness, difficulty walking, dizziness and inability to speak.

[05/12/2010 - Drug Safety Communication - FDA]

[05/12/2010 - Consumer Update - FDA]

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