Drug Safety Information for AXID (Nizatidine)

Recall for NIZATIDINE (NIZATIDINE) Rx Drug: FDA Link

NDMA contamination voluntary recalls of some products

Safety-related Labeling Changes for AXID AR (NIZATIDINE) Over-the-counter Drug: FDA Link

Adverse Drug Reactions for AXID* (Nizatidine)

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 AXID
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Nausea	82
2	Dyspnoea	78
3	Pain	73
4	Dizziness	68
5	Pyrexia	67
6	Vomiting	63
7	Drug ineffective	62
8	Chest pain	60
9	Pneumonia	57
10	Fatigue	56
11	Gastrooesophageal reflux disease	56
12	Headache	55
13	Asthenia	54
14	Anxiety	53
15	Depression*	53
16	Anaemia	50
17	Diarrhoea	50
18	Fall	49
19	Arthralgia	49
20	Oedema peripheral	47

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

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

	Reason	# of FDA Reports
1	Gastrooesophageal reflux disease	342
2	Product used for unknown indication	278
3	Dyspepsia*	132
4	Gastritis	98
5	Prophylaxis	83
6	Gastric ulcer	63
7	Gastrointestinal disorder	36
8	Abdominal discomfort	29
9	Ill-defined disorder	28
10	Gastric disorder	27

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

Types of Adverse Events for AXID

Total Reports Filed with FDA: 9242

Number of FDA Adverse Event Reports by Patient Age for AXID

Total Reports Filed with FDA: 9242*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Nizatidine (Axid, Axid ar, Nizatidine)

Charts are based on 9242 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.