Diphenhydramine

Common brands: Histaprin, Nightime Sleep Aid, Pain Relief, Tylenol Extra Strength, Tylenol Regular Strength

Top reporter: Aaa Pharmaceutical, Inc.

Nonsteroidal Anti-inflammatory Drug [EPC]Corticosteroid [EPC]Catecholamine [EPC]alpha-Adrenergic Agonist [EPC]beta-Adrenergic Agonist [EPC]
61,653
Total Reports
32,327
Serious Reports
11,642
Death Reports
30
Reported Reactions
Death Report Ratio: High (18.88%)

Patient Demographics

Male
19,073
Female
34,261

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Diphenhydramine.

# Reaction Reports % of Total
1 OFF LABEL USE 8,050
8.0%
2 HEADACHE 5,230
5.2%
3 FATIGUE 5,180
5.2%
4 NAUSEA 4,587
4.6%
5 PAIN 4,092
4.1%
6 DRUG INEFFECTIVE 3,932
3.9%
7 SINUSITIS 3,708
3.7%
8 TOXICITY TO VARIOUS AGENTS 3,544
3.5%
9 PYREXIA 3,467
3.5%
10 DYSPNOEA 3,452
3.4%
11 INFUSION RELATED REACTION 3,410
3.4%
12 PNEUMONIA 3,175
3.2%
13 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION 3,038
3.0%
14 ARTHRALGIA 3,035
3.0%
15 COMPLETED SUICIDE 2,891
2.9%
16 PRURITUS 2,883
2.9%
17 MALAISE 2,881
2.9%
18 COUGH 2,818
2.8%
19 BLOOD PRESSURE INCREASED 2,757
2.8%
20 INTENTIONAL PRODUCT USE ISSUE 2,714
2.7%
21 NASOPHARYNGITIS 2,638
2.6%
22 CONDITION AGGRAVATED 2,626
2.6%
23 DIARRHOEA 2,611
2.6%
24 COVID-19 2,592
2.6%
25 RASH 2,558
2.6%
26 VOMITING 2,544
2.5%
27 WEIGHT DECREASED 2,507
2.5%
28 HYPERTENSION 2,467
2.5%
29 DEATH 2,356
2.4%
30 DIZZINESS 2,318
2.3%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.