Drug Safety Information for CAPITAL WITH CODEINE (Codeine)

FDA Safety-related Labeling Changes for PHENERGAN VC W/ CODEINE (CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE) Brand name discontinued; available as generic: Safety Information Link

FDA Safety-related Labeling Changes for CODEINE SULFATE (CODEINE SULFATE) Rx Drug: Safety Information Link

Adverse Drug Reactions for CAPITAL WITH CODEINE* (Codeine)

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 CAPITAL WITH CODEINE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug hypersensitivity1342
2Drug abuse721
3Toxicity to various agents576
4Nausea450
5Vomiting404
6Dyspnoea363
7Diarrhoea348
8Death292
9Dizziness279
10Malaise276
11Headache265
12Fatigue264
13Pain255
14Drug interaction245
15Pyrexia222
16Pneumonia217
17Overdose217
18Asthenia206
19Completed suicide194
20Cough192

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

Top 10 Reasons for Taking CAPITAL WITH CODEINE
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication6825
2Pain2617
3Analgesic therapy1319
4Cough876
5Back pain301
6Diarrhoea251
7Migraine228
8Muscle spasms202
9Headache199
10Intentional overdose95

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


Types of Adverse Events for CAPITAL WITH CODEINE

Total Reports Filed with FDA: 35512


Number of FDA Adverse Event Reports by Patient Age for CAPITAL WITH CODEINE

Total Reports Filed with FDA: 35512*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Codeine (Codeine phosphate, Bromphen dc, Vopac, Codeinum, Colrex, Calcidrine, Nucofed, Empirin with codeine, Capital with codeine, Tussirex, Ardinex, Novahistine dh)

Charts are based on 35512 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 CAPITAL WITH CODEINE 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.