Drug Safety Information for ALOCRIL (Nedocromil sodium)

Adverse Drug Reactions for ALOCRIL* (Nedocromil sodium)

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 ALOCRIL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Headache14
2Nausea*13
3Chest pain13
4Fatigue12
5Dizziness11
6Chest discomfort11
7Dyspnoea11
8Drug interaction10
9Palpitations8
10Drug ineffective8
11Cough8
12Asthma8
13Flatulence8
14Gastrooesophageal reflux disease8
15Vision blurred8
16Heart rate increased7
17Dyspepsia7
18Pain7
19Pruritus7
20Laboratory test abnormal6

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

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

Reason # of FDA Reports
1Asthma*174
2Product used for unknown indication77
3Seasonal allergy36
4Cough32
5Conjunctivitis allergic14
6Multiple allergies8
7Hypersensitivity4
8Acute sinusitis3
9Tinnitus2

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


Types of Adverse Events for ALOCRIL

Total Reports Filed with FDA: 919


Number of FDA Adverse Event Reports by Patient Age for ALOCRIL

Total Reports Filed with FDA: 919*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Nedocromil sodium (Nedocromil, Nedocromil sodium, Tilade, Alocril)

Charts are based on 919 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.

Click to go back to search results and ALOCRIL Reviews and Review Summary .

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.