Lumbago, osteoarthritis, humeroscapular periarthritis, tendinitis/tendovaginitis, peritendinitis, humeral epicondylitis, myalgia and post-traumatic swelling/pain:
Of a total number of 1,156 cases, 57 cases (4.93%) reported adverse reactions.
The major adverse reactions included the following: 54 events of contact dermatitis (4.67%), i.e., 11 events of rash, 9 events of reddening, 18 events of itching, and 5 events of irritation; 1 event (0.09%) of blister at the application site; 1 event (0.09%) of heart throbbing; and 1 event (0.09%) of edema of the face and hands.
Of a total number of 525 cases, 45 cases (8.57%) reported adverse reactions. The major adverse reactions included the following: 17 events of contact dermatitis, 12 events of application site itching, 6 events of application site erythema, 6 events of application site rash, and 3 events of application site dermatitis.
In addition to the previously-mentioned adverse reactions, spontaneous reports made by physicians and other health care professionals have described shock, anaphylaxis, induction of an asthmatic attack (aspirin-induced asthma), and the onset of photosensitive reactions.
Severe adverse reactions: Shock (incidence unknown), Anaphylaxis (less than 0.1%):
As shock and anaphylaxis (e.g., urticaria, dyspnea and facial edema) may develop, carefully observe the patient's condition and stop using when any abnormal finding is observed and treat it appropriately.
Induction of attacks of asthma (aspirin-induced asthma) (less than 0.1%):
This product may induce attacks of asthma. Stop using when initial symptoms, including dry rales, wheezing and dyspnea, develop. Caution should be exercised as about 10% of patients with bronchial asthma may latently have aspirin-induced asthma. Furthermore, an asthmatic attack induced by this product has developed several hours after application. (See Contraindications.)
Contact dermatitis (less than 5%, the incidence is unknown for serious cases):
Itching, irritation, erythema, rash/reddening which have developed on the application sites may worsen and result in severe skin symptoms such as swelling, edema, and blister/erosion, and pigmentation and depigmentation, and dermatitis may become serious extending to the whole body, and therefore immediately stop use when any abnormal finding is observed, cover the affected site from sunlight and treat it appropriately. Such symptoms may occur a few days after the discontinuation of use.
Photosensitive reactions (incidence unknown):
Exposure of the application site to ultraviolet light may induce severe dermatitis such as erythema with accompanying extreme itching, rash, irritation, swelling, edema and blister/erosion, as well as pigmentation and depigmentation. Some dermatitis may extend to the whole body and become serious and therefore immediately stop use when any abnormal finding is observed, cover the affected site from sunlight and treat it appropriately. Such symptoms may develop from a few days to a few months after the discontinuation of use.
Other adverse reactions:
Other adverse reactions were reported with this product including local rash, reddening, swelling, itching, irritation, blister/erosion, pigmentation etc. (0.1% to less than 5%), subcutaneous bleeding (less than 0.1%), skin exfoliation (incidence unknown) and hypersensitivity such as urticaria, eyelid edema and facial edema (incidence unknown). Discontinue the use immediately when such a symptom occurred.