Medical Editor: John P. Cunha, DO, FACOEP
What Is Dyloject?
Dyloject (diclofenac sodium) for Injection is a nonsteroidal anti-inflammatory drug (NSAID) used for management of mild to moderate pain and management of moderate to severe pain alone or in combination with opioid analgesics.
What Are Side Effects of Dyloject?
Common side effects of Dyloject include:
- infusion site pain
- low blood pressure (hypotension
- fever, and
- low blood iron (anemia)
Dosage for Dyloject?
The recommended dose of Dyloject is 37.5 mg administered by intravenous bolus injection over 15 seconds every 6 hours as needed, not to exceed 150 mg/day.
What Drugs, Substances, or Supplements Interact with Dyloject?
Dyloject may interact with aspirin, anticoagulants, or ACE inhibitors. Tell your doctor all medications and supplements you use.
Dyloject During Pregnancy and Breastfeeding
During pregnancy, use only if approved by your obstetrician and avoid use of Dyloject after 30 weeks. It may harm a fetus. This drug may pass into breast milk. Consult your doctor before breastfeeding.
Our Dyloject (diclofenac sodium) for Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Cardiovascular Thrombotic Events [see WARNINGS AND PRECAUTIONS]
- GI Bleeding, Ulceration and Perforation [see WARNINGS AND PRECAUTIONS]
- Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
- Hypertension [see WARNINGS AND PRECAUTIONS]
- Heart Failure and Edema [see WARNINGS AND PRECAUTIONS]
- Renal Toxicity and Hyperkalemia [see WARNINGS AND PRECAUTIONS]
- Anaphylactic Reactions [see WARNINGS AND PRECAUTIONS]
- Serious Skin Reactions [see WARNINGS AND PRECAUTIONS]
- Hematologic Toxicity [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
During clinical development, 1,156 patients were exposed to DYLOJECT in multiple-dose, controlled and open-label studies. DYLOJECT was administered post-surgically every 6 hours for up to 5 days. The incidence rates of adverse reactions listed in the following table are derived from multicenter, controlled clinical studies in post-operative patients comparing DYLOJECT to placebo in patients who may have also received morphine rescue medication.
Table 1: Proportion of Patients Experiencing Common
Adverse Reactions in Placebo-Controlled Clinical Studies in Patients with Acute
Moderate-to-Severe Postoperative Pain occurring in greater than or equal to 3%
in patients treated with DYLOJECT
|MedDRA Preferred Term||Placebo*
|Any Reaction||104 (83%)||146 (78%)|
|Nausea||50 (40%)||45 (24%)|
|Constipation||14 (11%)||25 (13%)|
|Headache||20 (16%)||19 (10%)|
|Infusion Site Pain||10 (8%)||19 (10%)|
|Dizziness||2 (2%)||15 (8%)|
|Flatulence||20 (16%)||15 (8%)|
|Vomiting||23 (18%)||12 (6%)|
|Insomnia||12 (10%)||11 (6%)|
|Pruritus||10 (8%)||9 (5%)|
|Hypotension||6 (5%)||9 (5%)|
|Pyrexia||13 (10%)||8 (4%)|
|Anemia||9 (7%)||8 (4%)|
|Infusion Site Extravasation||1 (1%)||6 (3%)|
|* Intravenous morphine was permitted as rescue medication for pain management.|
Adverse Reactions Of Special Interest
Based on the analysis of the pooled data from the multi-dose, controlled clinical trials, post-operative patients treated with DYLOJECT had more adverse reactions related to wound healing (7.5%) compared to patients treated with placebo (4%).
Adverse Reactions From Clinical Studies Or Spontaneous Reports For Other Formulations Of Diclofenac And Other NSAIDs
In patients taking diclofenac or other NSAIDs, the most frequently reported adverse reactions occurring in approximately 1%-10% of patients are:
Gastrointestinal experiences including abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, GI ulcers (gastric/duodenal) and vomiting. Abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritus, rashes and tinnitus.
Additional adverse reactions reported occasionally include:
Body as a Whole: fever, infection, sepsis
Metabolic and Nutritional: weight changes
Special Senses: blurred vision
Other adverse reactions, which occur rarely are:
Body as a Whole: anaphylactic reactions, appetite changes, death
Metabolic and Nutritional: hyperglycemia
Nervous System: convulsions, coma, hallucinations, meningitis
Respiratory System: respiratory depression, pneumonia
Special Senses: conjunctivitis, hearing impairment
Read the entire FDA prescribing information for Dyloject (Diclofenac Sodium for Injection)
© Dyloject Patient Information is supplied by Cerner Multum, Inc. and Dyloject Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.