Voltaren (Diclofenac Sodium) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

During clinical development, 913 patients were exposed to Voltaren® Gel in randomized, double-blind, multicenter, vehicle-controlled, parallel-group studies in osteoarthritis of the superficial joints of the extremities. Of these, 513 patients received Voltaren® Gel for osteoarthritis of the knee and 400 were treated for osteoarthritis of the hand. Additionally, 583 patients were exposed to Voltaren® Gel in an uncontrolled, open-label, long-term safety trial in osteoarthritis of the knee. Of these, 355 patients were treated for osteoarthritis of 1 knee and 228 were treated for osteoarthritis of both knees. Duration of exposure ranged from 8 to 12 weeks for the placebo-controlled studies, and up to 12 months for the open-label safety trial.

Short-Term Placebo-Controlled Trials:

Adverse reactions observed in at least 1% of patients treated with Voltaren® Gel:

Non-serious adverse reactions that were reported during the short-term placebo-controlled studies comparing Voltaren® Gel and placebo (vehicle gel) over study periods of 8 to 12 weeks (16 g per day), were application site reactions. These were the only adverse reactions that occurred in > 1% of treated patients with a greater frequency in the Voltaren® Gel group (7%) than the placebo group (2%). 

Table 1 lists the types of application site reactions reported. Application site dermatitis was the most frequent type of application site reaction and was reported by 4% of patients treated with Voltaren® Gel, compared to 1% of placebo patients.

Table 1: Non-serious Application Site Adverse Reactions (≥ 1% Voltaren^® Gel Patients) – Short-term Controlled Trials

Adverse Reaction †	Voltaren ®   Gel N = 913	Placebo (vehicle) N = 876
	N (%)	N (%)
Any application site reaction	62 (7)	19 (2)
Application site dermatitis	32 (4)	6 (<1)
Application site pruritus	7 (<1)	1 (<1)
Application site erythema	6 (<1)	3 (<1)
Application site paresthesia	5 (<1)	3 (<1)
Application site dryness	4 (<1)	3 (<1)
Application site vesicles	3 (<1)	0
Application site irritation	2 (<1)	0
Application site papules	1 (<1)	0

^† Preferred Term according to MedDRA 9.1.

In the placebo-controlled trials, the discontinuation rate due to adverse reactions was 5% for patients treated with Voltaren® Gel, and 3% for patients in the placebo group. Application site reactions, including application site dermatitis, were the most frequent reason for treatment discontinuation. 

Long-term Open-label Safety Trial:

In the open-label, long-term safety study, distribution of adverse reactions was similar to that in the placebo-controlled studies. In this study, where patients were treated for up to 1 year with Voltaren® Gel up to 32 g per day, application site dermatitis was observed in 11% of patients. Adverse reactions that led to the discontinuation of the study drug were experienced in 12% of patients. The most common adverse reaction that led to discontinuation of the study was application site dermatitis, which was experienced by 6% of patients.

REPORTS OF SUSPECTED VOLTAREN SIDE EFFECTS / ADVERSE REACTIONS

Possible Voltaren side effects / adverse reactions in 48 year old female

Reported by a physician from France on 2011-08-26

Patient: 48 year old female

Reactions: Dermatitis Bullous, Toxic Skin Eruption

Adverse event resulted in: hospitalization

Suspect drug(s):
Omeprazole
    Dosage: 1 df;qd;po
    Administration route: Oral

Augmentin '125'
    Dosage: ;po
    Administration route: Oral
    Start date: 2011-08-03

Myolastan (Tetrazepam)
    Dosage: 25 mg;qd;po
    Administration route: Oral

Acetaminophen W/ Codeine
    Dosage: prn;po
    Administration route: Oral

Desloratadine
    Dosage: 5 mg;qd;po
    Administration route: Oral
    Start date: 2011-08-01

Pyostacine (Pristinamycin)
    Dosage: 1000 mg;bid;po
    Administration route: Oral
    Start date: 2011-08-01

Voltaren
    Dosage: 75 mg;bid;po
    Administration route: Oral
    Indication: Sciatica
    Start date: 2011-07-06
    End date: 2011-07-30

Other drugs received by patient: Ialuset (Hyaluronic Acid); Biafine (Trolamine)

Possible Voltaren side effects / adverse reactions in 66 year old female

Reported by a consumer/non-health professional from United States on 2011-10-03

Patient: 66 year old female

Reactions: Malaise, Nasopharyngitis, Pharyngitis Streptococcal, Myocardial Infarction

Adverse event resulted in: death

Suspect drug(s):
Voltaren

Possible Voltaren side effects / adverse reactions in 48 year old female

Reported by a physician from Russian Federation on 2011-10-03

Patient: 48 year old female

Reactions: Hypersensitivity, Injection Site Abscess

Adverse event resulted in: hospitalization

Suspect drug(s):
Voltaren

Other drugs received by patient: Nicotinic Acid