Norplant (Levonorgestrel Implants (Unavailable in US)) Drug Information: Side Effects and Drug Interactions

Pill Identifier Search

May 27, 2012

Norplant

Birth Control (Types and Options) »

Introduction to birth control types and options

If a woman is sexually active and she is fertile — physically able to become pregnant — she needs to ask herself, "Do I want to become pregnant now?" If her answer is "No," she must use some method of birth control (contraception).

If a woman does not want to get pregnant at this point in her life, does she plan to become pregnant in the future? Soon? Much later? Never? Her answers to these questions can determine the method of birth control that she and her male sexual partner use — now and in the future.

There are a number of different ways to describe birth control. Terms include contraception, pregnancy prevention, fertility control, and family planning. But no matter what the process is called, sexually active people can choose from a plethora of methods to reduce the possibility of their becoming pregnant. Nevertheless, no method of birth control av...

Read the Birth Control (Types and Options) article »

Norplant

Birth Control Slideshow Pictures

font size

SIDE EFFECTS

The following adverse reactions have been associated with the NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM during the first year of use in clinical trials:

Many bleeding days or prolonged bleeding	27.6%
Spotting	17.1%
Amenorrhea	9.4%
Irregular (onsets of) bleeding	7.6%
Frequent bleeding onsets	7.0%
Scanty bleeding	5.2%
Pain or itching near implant site (usually transient)	3.7%
Infection at implant site	0.7%

In addition, removal difficulties affecting subjects (including multiple incisions, capsule fragments remaining, pain, multiple visits, deep placement, lengthy removal procedure, or other) have been reported with a frequency of 6.2%, which is based on 849 removals occurring through 5 years of use. See “WARNINGS” and “PRECAUTIONS.”

Clinical studies comparing NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM users with other contraceptive method users suggest that the following adverse reactions occurring during the first year are probably associated with NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM use. These adverse reactions have also been reported post-marketing:

Headache	Acne
Nervousness/Anxiety	Change of appetite
Nausea/Vomiting	Mastalgia
Dizziness	Weight gain
Adnexal enlargement	Hirsutism, hypertrichosis,
Dermatitis/Rash	and scalp-hair loss

In addition, the following adverse reactions have been reported in clinical trials with a frequency of 5% or greater during the first year and are possibly related to NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM use:

Breast discharge	Abdominal discomfort
Cervicitis	Leukorrhea
Musculoskeletal pain	Vaginitis

The following adverse reactions have been reported post-marketing with an incidence of less than 1% and are possibly related to NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM use:

Arm pain
Gallbladder disease
Hypertension
Idiopathic intracranial hypertension (IIH) (pseudotumor cerebri, benign intracranial hypertension)
Insertion/removal site reactions including abscess, cellulitis; blistering; bruising; edema; excessive scarring; hyperpigmentation; induration; nerve injury; numbness; sloughing; tingling;
ulcerations
Migraine headaches
Ovarian cysts
Phlebitis

The following adverse reactions have been reported post-marketing and a causal relationship to the NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM has not been established:

Asthenia (fatigue/weakness)
Breast cancer
Congenital anomalies
Deep vein thrombosis
Dysmenorrhea
Emotional lability and depression, sometimes severe
Myocardial infarction
Pulmonary embolism
Stroke
Superficial venous thrombosis
Thrombotic thrombocytopenic purpura (TTP)
Urticaria, pruritus
Vaginal bleeding, heavy
Visual disturbances
Weight gain of more than 10 pounds

DRUG INTERACTIONS

Reduced efficacy (pregnancy) has been reported for NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM users taking phenytoin and carbamazepine. These drugs may increase the metabolism of levonorgestrel through induction of microsomal liver enzymes. NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM users should be warned of the possibility of decreased efficacy with the use of drugs exhibiting enzyme-inducing activity such as those noted above and rifampin. For women receiving long-term therapy with hepatic enzyme inducers, another method of contraception should be considered.