Hemabate Side Effects

Generic Name: carboprost

Note: This page contains information about the side effects of carboprost. Some of the dosage forms included on this document may not apply to the brand name Hemabate.

Not all side effects for Hemabate may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to carboprost: intramuscular solution

In addition to its needed effects, some unwanted effects may be caused by carboprost (the active ingredient contained in Hemabate). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking carboprost:

Less common or rare
  • Fast or slow heartbeat
  • headache (severe and continuing)
  • hives or skin rash
  • increased pain of the uterus
  • pale, cool, blotchy skin on arms or legs
  • pressing or painful feeling in chest
  • shortness of breath
  • swelling of face, inside the nose, and eyelids
  • tightness in chest
  • trouble in breathing
  • weak or absent pulse in arms or legs
  • wheezing

If any of the following side effects occur while taking carboprost, check with your doctor or nurse as soon as possible:

  • Constipation
  • pain or inflammation at place of injection
  • tender or mildly bloated abdomen or stomach

Some of the side effects that can occur with carboprost may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Diarrhea
  • nausea
  • vomiting
Less common or rare
  • Chills or shivering
  • dizziness
  • fever (temporary)
  • flushing or redness of face
  • headache
  • stomach cramps or pain

This procedure may result in some effects, which occur after the procedure is completed, that need medical attention. Check with your doctor if you notice any of the following:

  • Chills or shivering (continuing)
  • fever (continuing)
  • foul-smelling vaginal discharge
  • increase in uterus bleeding
  • pain in lower abdomen

For Healthcare Professionals

Applies to carboprost: injectable solution

General

-Contractile effect on smooth muscle, nausea, vomiting, diarrhea, increased temperature and flushing are the most frequent adverse reactions observed.
-Adverse effects of this drug are generally transient and reversible when therapy ends.
-Endometritis, retained placental fragments, and excessive uterine bleeding were the most common complications after discharge from the hospital.

Transient pyrexia may be due to the effect of carboprost on hypothalamic thermoregulation. Temperature elevation exceeding 2 degrees Fahrenheit have been reported in approximately 12.5% of the patients who received the recommended dosage regimen. In all cases, temperature returned to normal when therapy ended.

Gastrointestinal

Pretreatment or concurrent administration of antiemetic and antidiarrheal drugs considerably decreases the very high incidence of gastrointestinal side effects that are common with all prostaglandins used for abortion.

Very common (10% or more): Vomiting and diarrhea (66%), nausea (33%)
Uncommon (0.1% to 1%): Hematemesis, upper abdominal pain, dry mouth
Frequency not reported: Epigastric pain, excessive thirst, taste alterations, gagging
Postmarketing reports: Retching

Other

Very common (10% or more): Body temperature increased (12%)
Uncommon (0.1% to 1%): Vertigo, tinnitus
Frequency not reported: Retained placental fragment
Postmarketing reports: Chest pain, asthenia

Cardiovascular

The degree of hypertension was moderate and it is not certain as to whether it was due to a direct effect of carboprost (the active ingredient contained in Hemabate) or a return to a status of pregnancy associated hypertension manifested by the correction of hypovolemic shock.

Common (1% to 10%): Flushing, hot flushing, chills
Uncommon (0.1% to 1%): Septic shock, tachycardia
Frequency not reported: Hypertension, shivering
Postmarketing reports: Palpitations

Genitourinary

When carboprost (the active ingredient contained in Hemabate) was used for abortion, the most common complications which required additional treatment after discharge from the hospital were endometritis, retained placental fragments, and excessive uterine bleeding which was reported to have occurred in approximately 2% of patients.

Common (1% to 10%): Endometritis, uterine hemorrhage, retained placenta or membranes
Uncommon (0.1% to 1%): Urinary tract infection, uterine rupture, uterine cervical laceration, pelvic pain
Frequency not reported: Dysmenorrhea-like pain, uterine disorder, perforated uterus, uterine sacculation, uterine rupture

Nervous system

Common (1% to 10%): Headaches
Uncommon (0.1% to 1%): Syncope vasovagal, dizziness, dystonia, paresthesia, somnolence, dysgeusia, lethargy
Frequency not reported: Drowsiness, faintness, lightheadedness
Postmarketing reports: Nervousness, syncope

Respiratory

Common (1% to 10%): Cough
Uncommon (0.1% to 1%): Asthma, respiratory distress, dyspnea, hyperventilation, wheezing, hiccups
Frequency not reported: Nosebleed, bronchospasm, pharyngeal edema, upper respiratory tract infection, pulmonary edema, shortness of breath, fullness of throat
Postmarketing reports: Chocking sensation, epistaxis, dry throat

Dermatologic

Uncommon (0.1% to 1%): Hyperhidrosis
Frequency not reported: Diaphoresis
Postmarketing reports: Rash

Local

Uncommon (0.1% to 1%): Injection side pain

Musculoskeletal

Uncommon (0.1% to 1%): Torticollis, back pain, myalgia
Frequency not reported: Breast tenderness, muscular pain, muscle spasms, leg cramps
Postmarketing reports: Blepharospasm

Ocular

Uncommon (0.1% to 1%): Blurred vision, eye pain
Frequency not reported: Twitching eyelids

Psychiatric

Uncommon (0.1% to 1%): Sleep disorders
Postmarketing reports: Anxiety

Endocrine

Frequency not reported: Thyroid storm
Postmarketing reports: Thyrotoxic crisis

Hypersensitivity

Postmarketing reports: Anaphylactic reactions, anaphylactic shock, anaphylactoid reaction, angioedema

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