DOLEX CHILDREN PAIN AND FEVER

Generic: ACETAMINOPHEN

Manufacturer: Pharmadel Llc

Nonsteroidal Anti-inflammatory Drug [EPC]Corticosteroid [EPC]Benzodiazepine [EPC]Proton Pump Inhibitor [EPC]Vitamin C [EPC]
239,386
Total Reports
147,148
Serious Reports
46,899
Death Reports
30
Reported Reactions
Death Report Ratio: High (19.59%)

Patient Demographics

Male
78,905
Female
130,772

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for DOLEX CHILDREN PAIN AND FEVER.

# Reaction Reports % of Total
1 OFF LABEL USE 21,664
6.0%
2 FATIGUE 19,927
5.5%
3 DRUG INEFFECTIVE 17,784
4.9%
4 PAIN 17,749
4.9%
5 NAUSEA 17,125
4.8%
6 HEADACHE 16,297
4.5%
7 TOXICITY TO VARIOUS AGENTS 14,613
4.1%
8 DYSPNOEA 14,174
3.9%
9 ARTHRALGIA 14,092
3.9%
10 PYREXIA 13,961
3.9%
11 VOMITING 13,608
3.8%
12 DIARRHOEA 13,043
3.6%
13 RASH 12,162
3.4%
14 INFUSION RELATED REACTION 10,763
3.0%
15 PNEUMONIA 10,707
3.0%
16 MALAISE 9,991
2.8%
17 CONDITION AGGRAVATED 9,503
2.6%
18 DIZZINESS 9,386
2.6%
19 ASTHENIA 9,367
2.6%
20 PRURITUS 9,287
2.6%
21 NASOPHARYNGITIS 8,948
2.5%
22 DEATH 8,931
2.5%
23 JOINT SWELLING 8,783
2.4%
24 RHEUMATOID ARTHRITIS 8,705
2.4%
25 WEIGHT INCREASED 8,448
2.3%
26 SINUSITIS 8,283
2.3%
27 HYPERTENSION 8,207
2.3%
28 FALL 8,193
2.3%
29 HYPERSENSITIVITY 8,057
2.2%
30 COMPLETED SUICIDE 7,992
2.2%

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.