Drug Safety Information for NUBAIN (Nalbuphine hydrochloride)

Safety-related Labeling Changes for NUBAIN (NALBUPHINE HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for NUBAIN* (Nalbuphine 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 NUBAIN
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Vomiting	56
2	Nausea*	51
3	Pain	51
4	Headache	51
5	Convulsion	47
6	Drug hypersensitivity	40
7	Pyrexia	36
8	Drug withdrawal syndrome	33
9	Injury	31
10	Dyspnoea	28
11	Anxiety*	28
12	Somnolence*	28
13	Drug interaction	28
14	Renal failure acute	26
15	Chest pain	25
16	Hyperhidrosis*	23
17	Drug ineffective	22
18	Asthenia	22
19	Confusional state	20
20	Hypotension	20

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

Top 10 Reasons for Taking NUBAIN
(associated with FDA Medwatch/FAERS Reports)

	Reason	# of FDA Reports
1	Pain*	563
2	Product used for unknown indication	222
3	Headache*	78
4	Analgesic therapy	65
5	Migraine*	64
6	Labour pain	62
7	Pruritus*	51
8	Anaesthesia	48
9	Back pain	35
10	Sedation	22

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

Types of Adverse Events for NUBAIN

Total Reports Filed with FDA: 4520

Number of FDA Adverse Event Reports by Patient Age for NUBAIN

Total Reports Filed with FDA: 4520*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Nalbuphine hydrochloride (Nalbuphine, Nubain)

Charts are based on 4520 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.

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.