Oxybate

Common brands: Xyrem, Adderall Xr, Adderall, Provigil, Nuvigil

Top reporter: Jazz Pharmaceuticals, Inc.

Nonsteroidal Anti-inflammatory Drug [EPC]Benzodiazepine [EPC]Sympathomimetic-like Agent [EPC]Provitamin D2 Compound [EPC]Proton Pump Inhibitor [EPC]
65,315
Total Reports
14,064
Serious Reports
939
Death Reports
30
Reported Reactions
Death Report Ratio: Moderate (1.44%)

Patient Demographics

Male
17,929
Female
45,877

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Oxybate.

# Reaction Reports % of Total
1 NAUSEA 4,904
6.7%
2 ANXIETY 3,955
5.4%
3 SOMNOLENCE 3,935
5.3%
4 INSOMNIA 3,346
4.5%
5 FEELING ABNORMAL 3,209
4.4%
6 HEADACHE 3,191
4.3%
7 FATIGUE 3,187
4.3%
8 DEPRESSION 3,161
4.3%
9 DIZZINESS 2,952
4.0%
10 WEIGHT DECREASED 2,883
3.9%
11 CONDITION AGGRAVATED 2,802
3.8%
12 DRUG INEFFECTIVE 2,622
3.6%
13 SLEEP APNOEA SYNDROME 2,578
3.5%
14 FALL 2,574
3.5%
15 UNEVALUABLE EVENT 2,378
3.2%
16 VOMITING 2,338
3.2%
17 PRE-EXISTING CONDITION IMPROVED 2,219
3.0%
18 HYPERTENSION 2,104
2.9%
19 MALAISE 1,737
2.4%
20 BLOOD PRESSURE INCREASED 1,731
2.3%
21 THERAPEUTIC RESPONSE UNEXPECTED 1,730
2.3%
22 INTENTIONAL PRODUCT USE ISSUE 1,724
2.3%
23 SURGERY 1,697
2.3%
24 PAIN 1,666
2.3%
25 OFF LABEL USE 1,649
2.2%
26 NASOPHARYNGITIS 1,553
2.1%
27 TREMOR 1,515
2.1%
28 SUICIDAL IDEATION 1,483
2.0%
29 WRONG TECHNIQUE IN PRODUCT USAGE PROCESS 1,463
2.0%
30 DYSPNOEA 1,441
2.0%

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.