Indocin Side Effects
Generic Name: Indomethacin
Please note - some side effects for Indocin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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Side Effects of Indocin - for the consumer
Indocin
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Indocin:
Seek medical attention right away if any of these SEVERE side effects occur when using Indocin:Constipation; diarrhea; dizziness; drowsiness; gas; headache; heartburn; nausea; stomach upset.
Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; rectal bleeding; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; unusual vaginal bleeding; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.
Indocin IV
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Indocin IV:
Seek medical attention right away if any of these SEVERE side effects occur when using Indocin IV:Redness, pain, or oozing at the injection site.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in vomit, stool, or urine; dark, tarry stools; decreased urination; slow heartbeat; unusual bruising or bleeding; unusual weight gain.
Indocin Suppositories
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Indocin Suppositories:
Seek medical attention right away if any of these SEVERE side effects occur when using Indocin Suppositories:Constipation; diarrhea; dizziness; drowsiness; gas; headache; heartburn; nausea; rectal irritation; stomach upset.
Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; inability to urinate or pass a stool even though you have the urge; mental or mood changes; numbness of an arm or leg; one-sided weakness; rectal bleeding; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; unusual vaginal bleeding; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.
Indocin Suspension
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Indocin Suspension:
Seek medical attention right away if any of these SEVERE side effects occur when using Indocin Suspension:Constipation; diarrhea; dizziness; drowsiness; gas; headache; heartburn; nausea; stomach upset.
Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; rectal bleeding; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; unusual vaginal bleeding; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.
Indocin SR Sustained-Release Capsules
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Indocin SR Sustained-Release Capsules:
Seek medical attention right away if any of these SEVERE side effects occur when using Indocin SR Sustained-Release Capsules:Constipation; diarrhea; dizziness; drowsiness; gas; headache; heartburn; nausea; stomach upset.
TopSevere allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; rectal bleeding; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; unusual vaginal bleeding; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.
For the professional
Indocin
In a gastroscopic study in 45 healthy subjects, the number of gastric mucosal abnormalities was significantly higher in the group receiving Capsules Indocin than in the group taking Suppositories Indocin or placebo.
In a double-blind comparative clinical study involving 175 patients with rheumatoid arthritis, however, the incidence of upper gastrointestinal adverse effects with Suppositories or Capsules Indocin was comparable. The incidence of lower gastrointestinal adverse effects was greater in the suppository group.
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% | |
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| GASTROINTESTINAL | ||
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nausea* with or without vomiting dyspepsia* (including indigestion, diarrhea abdominal distress or pain constipation |
anorexia bloating (includes distension) flatulence peptic ulcer gastroenteritis rectal bleeding proctitis single or multiple ulcerations, intestinal
ulceration associated with |
gastrointestinal bleeding
without ulcerative stomatitis toxic hepatitis and jaundice (some intestinal strictures (diaphragms) |
| CENTRAL NERVOUS SYSTEM | ||
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headache (11.7%) dizziness* vertigo somnolence depression
and fatigue (including |
anxiety (includes nervousness) muscle weakness involuntary muscle movements insomnia muzziness psychic disturbances including mental confusion drowsiness |
light-headedness syncope paresthesia aggravation of epilepsy and depersonalization coma peripheral neuropathy convulsion dysarthria |
| SPECIAL SENSES | ||
tinnitus |
ocular — corneal deposits
and retinal |
blurred vision diplopia hearing disturbances, deafness |
| 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 |
aplastic anemia hemolytic anemia agranulocytosis thrombocytopenic purpura disseminated
intravascular |
| HYPERSENSITIVITY | ||
none |
acute anaphylaxis acute respiratory distress rapid
fall in blood pressure resembling angioedema |
dyspnea asthma purpura angiitis pulmonary edema fever |
| GENITOURINARY | ||
none |
hematuria vaginal bleeding proteinuria nephrotic syndrome interstitial nephritis |
BUN elevation renal insufficiency, including renal |
| MISCELLANEOUS | ||
none |
epistaxis breast changes, including enlargement |
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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 Aβ hemolytic streptococcus, has been described in persons treated with non-steroidal anti-inflammatory agents, including indomethacin, sometimes with fatal outcome.
TopMore resources:
Indocin SR Sustained-Release Capsules
Indocin - Includes detailed dosage instructions.
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