Drug Safety Information for BENADRYL (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* (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
(reported in FDA Medwatch/FAERS Reports)
Side Effect | # of FDA Reports | |
---|---|---|
1 | Nausea | 3176 |
2 | Dyspnoea | 3088 |
3 | Fatigue* | 2604 |
4 | Death | 2522 |
5 | Vomiting | 2256 |
6 | Toxicity to various agents | 2249 |
7 | Headache | 2231 |
8 | Infusion related reaction | 2127 |
9 | Pain | 2106 |
10 | Rash | 1979 |
11 | Pruritus | 1966 |
12 | Completed suicide | 1898 |
13 | Diarrhoea | 1831 |
14 | Pyrexia | 1821 |
15 | Dizziness* | 1723 |
16 | Drug abuse | 1699 |
17 | Drug ineffective | 1648 |
18 | Urticaria | 1460 |
19 | Asthenia | 1443 |
20 | Anxiety* | 1314 |
* This side effect also appears in "Top 10 Side Effects of BENADRYL " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking BENADRYL
(associated with FDA Medwatch/FAERS Reports)
Reason | # of FDA Reports | |
---|---|---|
1 | Premedication | 26471 |
2 | Product used for unknown indication | 23402 |
3 | Hypersensitivity* | 6075 |
4 | Pruritus* | 3675 |
5 | Insomnia* | 2882 |
6 | Prophylaxis | 2023 |
7 | Sleep disorder | 1962 |
8 | Suicide attempt | 1358 |
9 | Multiple allergies | 1319 |
10 | Urticaria* | 1275 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for BENADRYL
Total Reports Filed with FDA: 220044
Number of FDA Adverse Event Reports by Patient Age for BENADRYL
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.
Click to go back to search results and BENADRYL Reviews and Review Summary .
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.