Contact with drug warning
Docell gel can transfer to others. Make sure the gel has dried on your skin before you touch anyone else.
Warnings for people with certain health conditions
For people with high blood pressure or water retention: Tell your doctor before using Docell. Your heart may already be working hard, and adding an NSAID can increase this workload.
For people with ulcer or digestive bleeding: If you’ve had an ulcer or bleeding from your digestive system, ask your doctor before using Docell. You’re at increased risk for another bleed.
For people with kidney disease or taking diuretics: If you have kidney disease or take diuretics (water pills), there’s a risk this drug can affect your kidneys’ ability to remove excess water from your body. Ask your doctor if Docell is the right drug for you.
For people with asthma and aspirin reactions: If you have asthma and you react to aspirin, you could have a bad reaction to Docell. Talk to your doctor before using the drug.
Elevated serum aminotransferase levels have been reported in up to 15% of patients taking oral Docell chronically, but are greater than 3 times the upper limit of normal in only 2% to 4% (Cases 1 and 2). Clinically apparent and symptomatic liver disease with jaundice due to Docell is rare (1 to 5 cases per 100,000 prescriptions, occurring in 1 to 5 persons per 10,000 exposed). Nevertheless, more than a hundred instances of clinically apparent liver injury due to Docell have been reported in the literature and, in most case series, Docell ranks in the top 10 causes of drug induced liver injury. The time to onset of liver injury varies from within a week to over a year after starting. The majority of cases present within 2 to 6 months (Cases 3 and 4), and the more severe cases tend to present earlier. The pattern of injury is almost exclusively hepatocellular, although cases presenting with mixed patterns have been reported. The clinical picture is that of jaundice preceded by anorexia, nausea, vomiting and malaise. Fever and rash occur in 25% of cases and some cases have immunoallergic features, while others resemble chronic hepatitis and have autoimmune features. In most cases, liver histology reveals an acute lobular hepatitis. However, a cases with prolonged latency Docell hepatotoxicity can have clinical and histologic features of chronic hepatitis (Case 2). There seems to be greater susceptibility for Docell liver injury among women than men. The injury can be severe, and several cases of acute liver failure have been attributed to Docell.
Likelihood score: A (well known cause of clinically apparent liver injury).
Topical forms of Docell (solutions, gels, creams, patches) have been associated with only a low rate of serum enzyme elevations (generally less than 1%) that may be no greater than occurs with placebo or vehicle application. However, product labels for topical Docell mention the possibility of liver injury and at least one case of clinically apparent liver injury attributed to topical Docell has been reported in the literature. Nevertheless, clinically apparent liver injury due to topical forms of Docell must be exceedingly rare.
If you have an allergy to aspirin or other similar NSAIDs, such as ibuprofen or naproxen, you could have an allergic reaction to Docell. Call your doctor right away if you have any signs of:
- trouble breathing
- itchy rash
If you develop these symptoms, call 911 or go to the nearest emergency room.
Don’t use this drug again if you’ve ever had an allergic reaction to it. Using it again could be fatal (cause death).
Is Docell safe to take if I'm pregnant or breastfeeding?
It is not known whether Docell is excreted in breast milk.
Rare Side Effects
In severe cases, Docell may cause a deadly liver condition known as fatal fulminant hepatitis.
Get medical help if you have any yellowing or graying of the skin or eyes, if your lower extremities or abdomen is swelling, if you are extra sleepy, or become confused.
8. Pregnancy and breastfeeding
Docell is not generally recommended in pregnancy or while breastfeeding.
This is because Docell has been linked with a small risk of problems for your unborn baby if you take it in early or late pregnancy.
Your doctor will only prescribe Docell for you while you're pregnant or breastfeeding if the benefits of taking the medicine outweigh the risks.
There may be other treatments that are safer for you. Paracetamol is the best painkiller to take during pregnancy.
Blood pressure drugs
Docell may decrease the blood pressure-lowering effects of some drugs used to control blood pressure. Using Docell with certain blood pressure medications may also increase your risk of kidney damage.
Examples of these blood pressure drugs include:
- angiotensin-converting enzyme (ACE) inhibitors, such as benazepril, captopril, enalapril, and lisinopril
- angiotensin II receptor blockers, such as candesartan, irbesartan, losartan, and olmesartan
- beta blockers, such as acebutolol, atenolol, metoprolol, and propranolol
- diuretics (water pills) such as furosemide or hydrochlorothiazide
Use of NSAIDs, including VOLTAREN, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including VOLTAREN, in pregnant women starting at 30 weeks of gestation (third trimester) (see WARNINGS; Premature Closure Of Fetal Ductus Arterious).
There are no adequate and well-controlled studies of VOLTAREN in pregnant women. Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In the general U.S. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2-4% for major malformations, and 15-20% for pregnancy loss. In animal reproduction studies, no evidence of teratogenicity was observed in mice, rats, or rabbits given Docell during the period of organogenesis at doses up to approximately 0.5, 0.5, and 1 times, respectively, the maximum recommended human dose (MRHD) of VOLTAREN, 200 mg/day, despite the presence of maternal and fetal toxicity at these doses . Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as Docell, resulted in increased pre- and post-implantation loss.
Reproductive and developmental studies in animals demonstrated that Docell sodium administration during organogenesis did not produce teratogenicity despite the induction of maternal toxicity and fetal toxicity in mice at oral doses up to 20 mg/kg/day (approximately 0.5 times the maximum recommended human dose of VOLTAREN, 200 mg/day, based on body surface area (BSA) comparison), and in rats and rabbits at oral doses up to 10 mg/kg/day (approximately 0.5 and 1 times, respectively, the MRHD based on BSA comparison). In a study in which pregnant rats were orally administered 2 or 4 mg/kg Docell (0.1 and 0.2 times the MRHD based on BSA) from Gestation Day 15 through Lactation Day 21, significant maternal toxicity (peritonitis, mortality) was noted. These maternally toxic doses were associated with dystocia, prolonged gestation, reduced fetal weights and growth, and reduced fetal survival. Docell has been shown to cross the placental barrier in mice, rats, and humans.
Taking cyclosporine, a drug that weakens your immune system, with Docell may increase your risk for kidney problems.
Rated Docell for Pain Report
Been taking it for rotator cuff tear inflammation, pain free the next day but the pain returns when I stop taking it, occasionally diarrhea
Generic Name: Docell (dye KLOE fen ak)Brand Names: Cambia, Cataflam, Voltaren-XR, Zipsor, Zorvolex, Voltaren, Dyloject
Medically reviewed by Kaci Durbin, MD Last updated on Jan 18, 2019.
Common side effects
Common side effects of Docell tablets, capsules and suppositories happen in more than 1 in 100 people.
Talk to your doctor or pharmacist if these side effects bother you or don't go away:
- feeling dizzy or vertigo
- stomach ache, wind or loss of appetite
- feeling sick (nausea)
- being sick (vomiting) or diarrhoea
- mild rash
You're less likely to have side effects with Docell gel or plasters. This is because not as much of the medicine gets into your body. But you may still get the same side effects, especially if you use a lot on a large area of skin.
In addition, using Docell gel or plasters can affect your skin. It can make your skin:
- more sensitive to sunlight than normal
- develop a rash where the gel or plaster has been applied
- dry or irritated (eczema)
- itchy or inflamed (dermatitis)