Drug Safety Information for ROCEPHIN (Ceftriaxone sodium)

Safety-related Labeling Changes for ROCEPHIN (CEFTRIAXONE SODIUM) Brand name discontinued; available as generic: FDA Link

Safety-related Labeling Changes for CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER (CEFTRIAXONE SODIUM) Rx Drug: FDA Link

Adverse Drug Reactions for ROCEPHIN* (Ceftriaxone 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 ROCEPHIN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pyrexia1023
2Renal failure acute759
3Dyspnoea661
4Pneumonia618
5Rash*515
6Vomiting503
7Diarrhoea*502
8Hypotension467
9Thrombocytopenia466
10Nausea463
11Anaemia438
12Renal failure434
13Pain*409
14Death381
15Sepsis378
16Drug interaction375
17Asthenia359
18Pruritus358
19Abdominal pain325
20Respiratory failure323

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

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

Reason # of FDA Reports
1Product used for unknown indication6802
2Pneumonia*2689
3Infection*1272
4Urinary tract infection*1209
5Pyrexia796
6Bronchitis*695
7Sepsis635
8Pyelonephritis616
9Prophylaxis497
10Meningitis431

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


Types of Adverse Events for ROCEPHIN

Total Reports Filed with FDA: 69338


Number of FDA Adverse Event Reports by Patient Age for ROCEPHIN

Total Reports Filed with FDA: 69338*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Ceftriaxone sodium (Ceftriaxona, Ceftriaxon, Ceftriaxone sodium, Rocephin, Ceftriaxone)

Charts are based on 69338 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 ROCEPHIN 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.