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Indocin (Indomethacin) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The adverse reactions for Capsules INDOCIN listed in the following table have been arranged into two groups: (1) incidence greater than 1%; and (2) incidence less than 1%. The incidence for group (1) was obtained from 33 double-blind controlled clinical trials reported in the literature (1,092 patients). The incidence for group (2) was based on reports in clinical trials, in the literature, and on voluntary reports since marketing. The probability of a causal relationship exists between INDOCIN and these adverse reactions, some of which have been reported only rarely.

The adverse reactions reported with Capsules INDOCIN may occur with use of the suppositories. In addition, rectal irritation and tenesmus have been reported in patients who have received the suppositories.

The adverse reactions reported with Capsules INDOCIN may also occur with use of the suspension.

Incidence greater than 1% Incidence less than 1%
GASTROINTESTINAL
nausea * with or
without vomiting
dyspepsia *
(including
indigestion,
heartburn and
epigastric pain)
diarrhea
abdominal distress
or pain
constipation
anorexia
bloating (includes
distention)
flatulence
peptic ulcer
gastroenteritis
rectal bleeding
proctitis
single or
multiple ulcerations,
including
perforation and
hemorrhage of
the esophagus,
stomach,
duodenum or
small and large
intestines
intestinal ulceration
associated with
stenosis and
obstruction
gastrointestinal
bleeding without
obvious ulcer
formation and
perforation of pre-
existing sigmoid
lesions
(diverticulum,
carcinoma, etc.)
development of
ulcerative colitis
and regional ileitis
ulcerative stomatitis
toxic hepatitis and
jaundice (some
fatal cases have
been reported)
intestinal strictures
(diaphragms)
CENTRAL NERVOUS SYSTEM
headache (11.7%)
dizziness *
vertigo
somnolence
depression and
fatigue (including
malaise and
listlessness)
anxiety (includes
nervousness)
muscle weakness
involuntary muscle
movements
insomnia
muzziness
psychic distur-
bances including
psychotic
episodes
mental confusion
drowsiness
light-headedness
syncope
paresthesia
aggravation of epilepsy
and parkinsonism
depersonalization
coma
peripheral neuropathy
convulsions
dysarthria
SPECIAL SENSES
tinnitus ocular--corneal
deposits and
retinal distur-
bances, including
those of the
macula, have been
reported in some
patients on pro-
longed therapy
with INDOCIN
blurred vision
diplopia
hearing disturbances,
deafness

Incidence greater than 1% Incidence less than 1%
CARDIOVASCULAR
none hypertension
hypotension
tachycardia
chest pain
congestive heart failure
arrhythmia;
palpitations
METABOLIC
none edema
weight gain
fluid retention
flushing or sweating
hyperglycemia
glycosuria
hyperkalemia
INTEGUMENTARY
none pruritus
rash; urticaria
petechiae or
ecchymosis
exfoliative dermatitis
erythema nodosum
loss of hair
Stevens-Johnson
syndrome
erythema multiforme
toxic epidermal
necrolysis
HEMATOLOGIC
none leukopenia
bone marrow
depression
anemia secondary
to obvious or
occult
gastrointestinal
bleeding
aplastic anemia
hemolytic anemia
agranulocytosis
thrombocytopenic
purpura
disseminated intravascular
coagulation
HYPERSENSITIVITY
none acute anaphylaxis
acute respiratory
distress
rapid fall in blood
pressure
resembling a
shock-like state
angioedema
dyspnea
asthma
purpura
angiitis
pulmonary edema
fever
GENITOURINARY
none hematuria
vaginal bleeding
proteinuria
nephrotic syndrome
interstitial nephritis
BUN elevation
renal insufficiency,
including renal
failure
MISCELLANEOUS
none epistaxis
breast changes,
including
enlargement and
tenderness, or
gynecomastia
* Reactions occurring in 3% to 9% of patients treated with INDOCIN. (Those reactions occurring in less than 3% of the patients are unmarked.)

Causal relationship unknown: Other reactions have been reported but occurred under circumstances where a causal relationship could not be established. However, in these rarely reported events, the possibility cannot be excluded. Therefore, these observations are being listed to serve as alerting information to physicians:

Cardiovascular: Thrombophlebitis

Hematologic: Although there have been several reports of leukemia, the supporting information is weak.

Genitourinary: Urinary frequency.

A rare occurrence of fulminant necrotizing fasciitis, particularly in association with Group A (beta)-hemolytic streptococcus, has been described in persons treated with non-steroidal anti-inflammatory agents, including indomethacin, sometimes with fatal outcome (see also PRECAUTIONS, General).



REPORTS OF SUSPECTED INDOCIN SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Indocin. The information is not vetted and should not be considered as verified clinical evidence.

Possible Indocin side effects / adverse reactions in 79 year old female

Reported by a consumer/non-health professional from United States on 2011-10-17

Patient: 79 year old female

Reactions: Abdominal Discomfort, Drug Effect Decreased, Overdose

Suspect drug(s):
Ibuprofen
    Dosage: 800 mg, unk
    Indication: Myalgia

Indocin
    Dosage: unk

Ibuprofen (Advil)
    Indication: Arthropathy

Ibuprofen (Advil)
    Dosage: 400 mg, 2x/day
    Indication: Osteoporosis

Ibuprofen (Advil)
    Indication: Arthritis

Mobic
    Dosage: unk
    Indication: Osteoporosis
    Start date: 2011-01-01
    End date: 2011-01-01

Ibuprofen (Advil)
    Indication: Myalgia

Mobic
    Indication: Arthritis

Naprosyn
    Dosage: unk

Ibuprofen
    Indication: Inflammation



Possible Indocin side effects / adverse reactions in 59 year old male

Reported by a consumer/non-health professional from United States on 2011-12-19

Patient: 59 year old male

Reactions: Blood Pressure Increased, Drug Ineffective, Stress

Suspect drug(s):
Voltaren
    Dosage: 25 mg
    Indication: Pain

Diflucan

Diclofenac Sodium

Indocin

Voltaren-XR
    Dosage: 75 mg
    Indication: Bursitis

Voltaren
    Dosage: 50 mg,



Possible Indocin side effects / adverse reactions in 59 year old male

Reported by a consumer/non-health professional from United States on 2011-12-19

Patient: 59 year old male

Reactions: Blood Pressure Increased, Drug Ineffective, Stress

Suspect drug(s):
Diflucan

Voltaren-XR
    Dosage: 75 mg
    Indication: Bursitis

Voltaren
    Dosage: 25 mg
    Indication: Pain

Voltaren
    Dosage: 50 mg,

Indocin

Diclofenac Sodium D.r. Tablets USP



See index of all Indocin side effect reports >>

Drug label data at the top of this Page last updated: 2006-04-08

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