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Misoprostol Safety Reports submitted to FDA
Misoprostol FDA safety alerts: 2002 2005 .
Reported deaths: 1 Reported hospitalizations: 5.
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Reported Misoprostol Side Effects: loss of consciousness, premature separation of placenta, vaginal haemorrhage, cardiac arrest, induced abortion failed, pallor, pain, impaired work ability, feeling abnormal, muscle spasms, neutropenia.
Misoprostol Usage.
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Misoprostol Side Effects Report #5219879-9
Consumer or non-health professional from UNITED STATES reported MISOPROSTOL problem on Jan 18, 2007. Female patient, 27 years of age, was diagnosed with abortion induced and was treated with MISOPROSTOL. After drug was administered, patient experienced the following problems/side effects: induced abortion failed, pre-eclampsia. MISOPROSTOL dosage: unknown. During the same period patient was treated with METHOTREXATE. Patient recovered.
Misoprostol Side Effects Report #5225532-8
MISOPROSTOL problem was reported by a Health Professional from UNITED KINGDOM on Jan 22, 2007. Female patient, 39 years of age, was treated with MISOPROSTOL. After drug was administered, patient experienced the following problems/side effects: uterine rupture. MISOPROSTOL dosage: unknown. During the same period patient was treated with OXYTOCIN, GEMEPROST, MIFEPRISTONE, NIMODIPINE, RISPERDAL. Patient was hospitalized. Patient recovered.
Misoprostol Side Effects Report #5234794-2
Pharmacist from BRAZIL reported MISOPROSTOL problem on Feb 01, 2007. Female patient, 23 years of age, was diagnosed with abortion and was treated with MISOPROSTOL. After drug was administered, patient experienced the following problems/side effects: premature separation of placenta. MISOPROSTOL dosage: unknown. Patient recovered.
Misoprostol Side Effects Report #5283548-X
MISOPROSTOL problem was reported by a Pharmacist from UNITED STATES on Mar 29, 2007. Female patient, weighting 130.0 lb, was diagnosed with abortion and was treated with MISOPROSTOL. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, loss of consciousness, syncope, ventricular tachycardia. MISOPROSTOL dosage: unknown. Patient recovered.
Misoprostol Side Effects Report #5293925-9
Consumer or non-health professional from DENMARK reported MISOPROSTOL problem on Mar 30, 2007. Female patient, 41 years of age, weighting 143.3 lb, was diagnosed with abortion induced and was treated with MISOPROSTOL. After drug was administered, patient experienced the following problems/side effects: haemorrhage, retained products of conception. MISOPROSTOL dosage: unknown. Patient was hospitalized. Patient recovered.
Misoprostol Side Effects Report #5357681-8
MISOPROSTOL problem was reported by a Health Professional from UNITED KINGDOM on June 06, 2007. Female patient, 30 years of age, weighting 154.3 lb, was diagnosed with postpartum haemorrhage and was treated with MISOPROSTOL. After drug was administered, patient experienced the following problems/side effects: hysterectomy. MISOPROSTOL dosage: unknown. Patient recovered.
Misoprostol Side Effects Report #5096971-3
Physician from UNITED KINGDOM reported MISOPROSTOL problem on Aug 25, 2006. Female patient was diagnosed with labour induction and was treated with MISOPROSTOL. After drug was administered, patient experienced the following problems/side effects: foetal distress syndrome, foetal heart rate abnormal, foetal heart rate deceleration. MISOPROSTOL dosage: unknown. During the same period patient was treated with SYNTOCINON. Patient recovered.
Misoprostol Side Effects Report #5097566-8
MISOPROSTOL problem was reported by a Consumer or non-health professional from ROMANIA on Aug 23, 2006. Female patient was treated with MISOPROSTOL. After drug was administered, patient experienced the following problems/side effects: congenital anomaly, respiratory disorder, shock. MISOPROSTOL dosage: unknown. Patient died on 08/22/2006.
Misoprostol Side Effects Report #5119597-1
Consumer or non-health professional from UNITED STATES reported MISOPROSTOL problem on Sept 21, 2006. Female patient, 45 years of age, was diagnosed with abortion, obstetrical procedure and was treated with MISOPROSTOL. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction, cardiac arrest, loss of consciousness, nausea, vomiting. MISOPROSTOL dosage: unknown. Patient was hospitalized and became disabled. Patient died.
Misoprostol Side Effects Report #5136901-9
MISOPROSTOL problem was reported by a Physician from GREECE on Oct 10, 2006. Female patient, 26 years of age, was diagnosed with abortion induced and was treated with MISOPROSTOL. After drug was administered, patient experienced the following problems/side effects: antepartum haemorrhage, iatrogenic injury, uterine perforation. MISOPROSTOL dosage: unknown. Patient was hospitalized. Patient recovered.
Misoprostol Side Effects Report #5164318-X
Consumer or non-health professional from INDIA reported MISOPROSTOL problem on Nov 27, 2006. Female patient, 42 years of age, weighting 110.2 lb, was diagnosed with pregnancy and was treated with MISOPROSTOL. After drug was administered, patient experienced the following problems/side effects: blood folate decreased, glossitis, mouth ulceration. MISOPROSTOL dosage: unknown. Patient recovered.
Misoprostol Side Effects Report #5170161-8
MISOPROSTOL problem was reported by a Physician from GERMANY on Nov 14, 2006. Female patient was diagnosed with abortion missed and was treated with MISOPROSTOL. After drug was administered, patient experienced the following problems/side effects: developmental delay, skull malformation, visual acuity reduced. MISOPROSTOL dosage: 0.4 MG (0.2 MG, SINGLE DOSE). Patient recovered.
Misoprostol Side Effects Report #5192410-2
Pharmacist from BRAZIL reported MISOPROSTOL problem on Dec 08, 2006. Female patient, 23 years of age, was diagnosed with abortion and was treated with MISOPROSTOL. After drug was administered, patient experienced the following problems/side effects: premature separation of placenta. MISOPROSTOL dosage: unknown. Patient recovered.
Misoprostol Side Effects Report #5196925-2
MISOPROSTOL problem was reported by a Pharmacist from BRAZIL on Dec 08, 2006. Female patient was diagnosed with abortion and was treated with MISOPROSTOL. After drug was administered, patient experienced the following problems/side effects: premature separation of placenta. MISOPROSTOL dosage: unknown. Patient recovered.
Misoprostol Side Effects Report #5379333-0
Health Professional from UNITED KINGDOM reported MISOPROSTOL problem on June 26, 2007. Female patient, 18 years of age, was diagnosed with abortion induced and was treated with MISOPROSTOL. After drug was administered, patient experienced the following problems/side effects: loss of consciousness, tonic clonic movements, urinary incontinence. MISOPROSTOL dosage: unknown. During the same period patient was treated with MIFEPRISTONE, SYNTOCINON. Patient recovered.
Misoprostol Side Effects Report #5464810-4
MISOPROSTOL problem was reported by a Health Professional from FRANCE on Sept 11, 2007. Female patient, 55 years of age, weighting 114.6 lb, was diagnosed with peptic ulcer, depression, polyarthritis and was treated with MISOPROSTOL. After drug was administered, patient experienced the following problems/side effects: neutropenia. MISOPROSTOL dosage: unknown. During the same period patient was treated with INIPOMP, VENLAFAXINE, ETANERCEPT, MORPHINE SULPHATE, ARTHROTEC. Patient was hospitalized. Patient recovered.
Misoprostol Side Effects Report #5467487-7
Health Professional from FRANCE reported MISOPROSTOL problem on Sept 13, 2007. Female patient, 37 years of age, was diagnosed with hypertension and was treated with MISOPROSTOL. After drug was administered, patient experienced the following problems/side effects: induced abortion failed. MISOPROSTOL dosage: unknown. During the same period patient was treated with MIFEPRISTONE, DICLOFENAC, SOTALOL HYDROCHLORIDE. Patient recovered.
Misoprostol Side Effects Report #5474385-1
MISOPROSTOL problem was reported by a Health Professional from UNITED STATES on May 17, 2007. Female patient, 18 years of age, was treated with MISOPROSTOL. After drug was administered, patient experienced the following problems/side effects: muscle spasms, vaginal haemorrhage. MISOPROSTOL dosage: unknown. Patient recovered.
Misoprostol Side Effects Report #5475621-8
Consumer or non-health professional from UNITED STATES reported MISOPROSTOL problem on May 29, 2007. Female patient, 28 years of age, weighting 149.9 lb, was diagnosed with abortion induced and was treated with MISOPROSTOL. After drug was administered, patient experienced the following problems/side effects: feeling abnormal, impaired work ability, pain, pallor, vaginal haemorrhage. MISOPROSTOL dosage: unknown. Patient recovered.
Drug Information: Misoprostol
URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a689009.html
(mye soe prost' ole)IMPORTANT WARNING:
| Do not take misoprostol to prevent ulcers if you are pregnant or plan to become pregnant. Misoprostol may cause miscarriages, premature labor, or birth defects.If you are a woman of childbearing age, you may take misoprostol to prevent ulcers only if you have had a negative pregnancy test in the past 2 weeks and if you use a reliable method of birth control while taking misoprostol. You must begin taking misoprostol on the second or third day of your menstrual period. If you become pregnant while taking misoprostol, stop taking it and call your doctor immediately.Before taking misoprostol, ask your pharmacist or doctor for a copy of the manufacturer's information for the patient and read it carefully. Talk to your doctor about the risks of taking misoprostol.Do not let anyone else take your medication, especially a woman who is or may become pregnant. |
Why is this medication prescribed?
Misoprostol is used to prevent ulcers in people who take certain arthritis or pain medicines, including aspirin, that can cause ulcers. It protects the stomach lining and decreases stomach acid secretion.
How should this medicine be used?
Misoprostol comes as a tablet to take by mouth. It is usually taken 4 times a day, after meals and at bedtime with food. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take misoprostol exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Misoprostol must be taken regularly to be effective. Women should not take their first dose until the second or third day of their menstrual period (to be sure that they are not pregnant). Do not stop taking misoprostol without talking to your doctor.
Other uses for this medicine
Misoprostol is also used sometimes to treat ulcers and to induce labor. Misoprostol is used in combination with mifepristone to end an early pregnancy. Talk to your doctor about the possible risks of using this drug for your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking misoprostol,
- tell your doctor and pharmacist if you are allergic to misoprostol or any other drugs.
- tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially antacids, aspirin, arthritis medications, and vitamins.
- tell your doctor if you are breast-feeding.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Misoprostol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- diarrhea
- headache
- stomach pain
- upset stomach
- gas
- vomiting
- constipation
- indigestion
If you experience any of the following symptoms, call your doctor immediately:
- vomiting blood
- bloody or black, tarry stools
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].
What storage conditions are needed for this medicine?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
What other information should I know?
Keep all appointments with your doctor.
Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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