Drug Safety Information for BENADRYL PRESERVATIVE FREE (Diphenhydramine hydrochloride)

FDA Safety Communication for BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) Rx to OTC Drug: FDA Link

FDA warns about serious problems with high doses of the allergy medicine diphenhydramine. Teen misuse sparked by dangerous “Benadryl Challenge” promoted on social media

Safety-related Labeling Changes for ALEVE PM (DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM) Over-the-counter Drug: FDA Link

Adverse Drug Reactions for BENADRYL PRESERVATIVE FREE* (Diphenhydramine hydrochloride)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with BENADRYL PRESERVATIVE FREE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea3176
2Dyspnoea3088
3Fatigue*2604
4Death2522
5Vomiting2256
6Toxicity to various agents2249
7Headache2231
8Infusion related reaction2127
9Pain2106
10Rash1979
11Pruritus1966
12Completed suicide1898
13Diarrhoea1831
14Pyrexia1821
15Dizziness*1723
16Drug abuse1699
17Drug ineffective1648
18Urticaria1460
19Asthenia1443
20Anxiety*1314

* This side effect also appears in "Top 10 Side Effects of BENADRYL PRESERVATIVE FREE " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking BENADRYL PRESERVATIVE FREE
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Premedication26471
2Product used for unknown indication23402
3Hypersensitivity*6075
4Pruritus*3675
5Insomnia*2882
6Prophylaxis2023
7Sleep disorder1962
8Suicide attempt1358
9Multiple allergies1319
10Urticaria*1275

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for BENADRYL PRESERVATIVE FREE

Total Reports Filed with FDA: 220044


Number of FDA Adverse Event Reports by Patient Age for BENADRYL PRESERVATIVE FREE

Total Reports Filed with FDA: 220044*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Diphenhydramine hydrochloride (Sleepinal, Diphenhydramine, Simply sleep, Silphen, Beldin, Hydramine, Sleep, Zzzquil, Dibenil, Sleep aid, Childrens wal-dryl, Correct dose, Dg health allergy, Help i cant sleep, Wal-dryl allergy, Leader allergy, Medique diphen, North antihistamine, Quenalin cough, Rest simply, Rexall sleep aid, Smart sense allergy, Topcare sleep aid, Unisom sleepmelts, Wal dryl allergy, Aller-g-time, Allergy get relief, Aphenap, Benaldryl, Careone allergy, Conrx allergy, Health mart allergy, Histaprin, Nite aid sleep aid, Pharbedryl, Sleep-aid, Sominex max, Somnitab, Wal-sleep z, Wal-som, Complete allergy, Nighttime sleep, Dye-free allergy, Dye-free wal-dryl, Ez nite sleep, Health mart z sleep, Health mart z-sleep, Leader sleeptime, Shoprite sleep aid, Sleep ii, Sleep tabs, Sleeptime, Sleep time, Snoozease, Sohmed allergy, Somnitabs, Sunmark z sleep, Sunmark z-sleep, Topcare zzz sleep, Zzzsleep, Zzz sleep, Zzztime, Zzz time, Benadryl allergy, Vicks formula 44, Wal-dryl, Banophen, Diphenhydramine hcl, Qdryl allergy, Nighttime sleep easy, Allergy medicine, Sominex, Nighttime sleep-aid, 7 select allergy, Naramin, Nytol, Diphenylhydramine, Night time sleep aid, Allergy medication, Dg health sleep aid, Tranquil, Nighttime sleep aid, Sleep easy, Diphenhist, Itch relief, Benylin, Belix, Benadryl, Diphen, Antitussive)

Charts are based on 220044 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

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Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.